Summary of the 29th ISBT Regional Congress (2023)

Table of Contents
Local/Neighbors Day: Innovation in Austria 1A-01-01 SOUND OF MUSIC: QUANTUM MECHANICS OF INNOVATION IN AUSTRIA 1A-01-02 INNOVATION IN CELL THERAPY: EXCITEMENT AND HOPE 1A-01-03 INFLUENCE OF ANEMIA ON OUTCOME IN PATIENTS WITH ORTHOTOPIC LIVER TRANSPLANTATION Local/Neighbours' Day: Innovation in France 1B-02-01 TRANSFUSION DRUGS FOR SICKLE CELL PATIENTS: FROM BLOOD DONOR BANK TO GENE THERAPY 1B‐02‐02 IMMUNOTHERAPY CART CELLS: FROM TARGET IDENTIFICATION TO THE CLINIC 1B-02-03 TRANSFUSION IN THE SETTING OF ACUTE BLEEDING: MASSIVE TRANSFUSION PROTOCOLS, INTRODUCTION OF NEW “OLD” BLOOD PRODUCTS SUCH AS WHOLE BLOOD Local/Neighbors Day: Innovation in Germany 1C-03-01 MESENCYMAL STROMAL CELLS FOR REGENERATIVE THERAPY 1C‐03‐02 IN VITRO PRODUCTION OF MEGAKARYOCYTES Local/Neighbors Day: Innovation in Switzerland 1D-04-01 WE ARE STARDUST – WHAT'S NEXT TELL US ABOUT OUR ORIGINS 1D-04-02 THE SKY IS THE LIMIT: NEXT GENERATION ENGINEERED CELL THERAPIES 1D-04-03 CELL-FREE NUCLEIC ACIDS IN TRANSFUSION MEDICINE Academy Day: Various Facets of Donor Management 2A-01-01 IMPACT OF BLOOD DONATION ON EXERCISE TOLERANCE 2A-01-02 HOW DOES THE POSTPONEMENT AFFECT THE BLOOD DONOR? 2A‐01‐03 THE GIFT OF LIFE - DOES IT APPLY TO THE RESEARCH DONATION? Academy Day: Transfusion challenges in patients with sickle cell disease 2A-02-01 IMMUNOHEMATOLOGICAL CHARACTERISTICS OF PATIENTS WITH SICKLE CELL DISEASE 2A-02-02 MATCHING PHENOTYPES AND ALLELES: HOW FAR SHOULD WE GO? 2A-02-03 MANAGEMENT OF DELAYED HEMOLYTIC TRANSFUSION REACTIONS AND HYPERHEMOLYSIS SYNDROME Academy Day: Artificial Intelligence and Ethics 2B-03-01 THE USE OF ARTIFICIAL INTELLIGENCE TO IMPROVE HEALTH CARE: WHAT DOES IT CONTRIBUTE TO TRANSFUSION MEDICINE? 2B‐03‐02 BLOOD DONATION: INCENTIVES AND INCENTIVES: WHERE TO DRAW THE LINE? Academy Day: Transfusion-Related Issues in Babies and Children 2B-04-01 TRIGGERS OF PLATELET TRANSFUSION IN NEONATES 2B-04-02 TACO DIAGNOSIS IN CHILDREN 2B-04-03 APPLICATION OF PRINCIPLES OF PATIENT BLOOD MANAGEMENT (PBM) IN PEDIATRIC PATIENTS Academy Day: Managing Transfusion-Transmitted Infections 2C-05-01 A RISK-BASED DECISION-MAKING FRAMEWORK FOR BLOOD SAFETY: WHAT IS THE CASE FOR ZIKA? 2C‐05‐02 SCREENING STRATEGIES TO MINIMIZE THE RISK OF TT-HEV INFECTIONS 2C-05-03 UPDATE ON PATHOGEN INACTIVATION TECHNOLOGY Academy Day: Immunohematology 2C-06-01 P1PK: A BLOOD GROUP SYSTEM WITH IDENTITY CRISIS 2C‐06‐02 WHY ARE THE GATA AND KLF REGULATORY GENES INCLUDED IN THE BLOOD GROUP TABLES? 2C‐06‐03 CELL-FREE FETAL DNA FOR FETAL BLOOD GROUP GENOTYPING: NON-INVASIVE PRENATAL TESTING Academy Day: New technologies for transfusion medicine 2D-07-01 IT IN BLOOD BANKS, PRESENT AND FUTURE. A NORDIC PERSPECTIVE 2D-07-02 APPLYING DRONES TO SUPPLY BLOOD TO REMOTE AREAS: THE RWANDAN EXPERIENCE 2D-07-03 NEW CHALLENGES IN BLOOD INVENTORY MANAGEMENT AND CABIN-SIDE TRANSFUSION Academy Day: Platelet and Granulocyte Immunology 2D-08-01 WORK IN THE CASE OF GRANULOCYTE ANTIBODIES 2D-08-02 OPTIMAL ALGORITHMS FOR MOLECULAR AND SEROLOGICAL TYPING IN RESEARCH ON PLATELET ALLOANTIBODIES 2D-08-03 MOLECULAR BASIS OF HNA-2 EXPRESSION Clinical - Clinical Transfusion I 3A‐S01‐01 BECOMING WISE WITH KIDNEY TRANSPLANTATION RELATED TO AN ABO INCOMPATIBLE LIVING: AN EXPERIENCE IN A TERTIARY CENTER 3A‐S01‐02 DEVELOPMENT OF DETAILED TRANSFUSION EXPOSURE INFORMATION FROM PATIENT ELECTRONIC MEDICAL RECORDS USING NATURAL LANGUAGE PROCESSING 3A‐S01‐03 RHD IMMUNOGLOBULIN: ARE WE DOING IT RIGHT IN OBSTETRICS? 3A‐S01‐04 THE EFFECT OF INTRAUTERINE TRANSFUSION ON FETAL RETICULOCYTE COUNT AND OUTCOME IN ALLIOMMUNE HEMOLYTIC DISEASE OF THE FETUS AND NEWBORN 3A-S01-05 IDARUCIZUMAB FOR DABIGATRAN REVERSAL: A SINGLE CENTER ANALYSIS OF TWO YEARS EXPERIENCE 3A-S01-06 REDUCTION OF PATHOGENS FROM FROZEN PLATELETS Immunobiology - Blood group genomics: a debate 3A‐S02‐01 PHENO- AND GENOTYPE IN THE TYPING OF BLOOD GROUPS – TWO SIDES OF THE COIN – PART I 3A‐S02‐02 PHENOTYPE AND GENOTYPE IN THE TYPING OF BLOOD GROUPS – TWO SIDES OF THE COIN – PART II 3A-S02-03 REFERENCE DATABASE: THE COMPLETE DATABASE FOR RHD VARIANTS 3A-S02-04 AUTOMATED TYPING OF HR COMPLEX GENOTYPES FROM GENOME WIDE SEQUENCES Adverse events: safety of blood from a virome perspective 3A‐S03‐01 METAGENOMICS AND BLOOD DERIVED PRODUCTS 3A-S03-02 MOLECULAR AND IMMUNOMAGNETIC AGGLUTINATION ASSAYS IN A SINGLE ANALYTICAL PLATFORM: APPLICATION TO THE DIAGNOSIS OF ARBOVIRAL INFECTIONS 3A‐S03‐03 INCIDENCE OF ZIKA, CHIKUNGUNYA AND DENGUE VIRUSES IN BLOOD DONORS IN BRAZIL 2016–2018 3A-S03-04 VECTOR-BORNE DISEASES AND SAFETY IN BLOOD TRANSFUSION: A EUROPEAN PERSPECTIVE 3A-S03-05 APPLICATION OF A ZIKA VIRUS SEROLOGICAL ASSAY TO ASSESS INFECTION RATES IN DONORS AFTER THE 2016 EPIDEMIC IN PUERTO RICO Blood products: problems with blood components 3A‐S04‐01 BENEFITS OF THAWED PLASMA IN BLOOD SUPPLY MANAGEMENT 3A-S04-02 CHALLENGING THE 30 MINUTE RULE FOR THAWED PLASMA 3A-S04-03 SEX HORMONE INTAKE IN FEMALE BLOOD DONORS MODULATES THE SUSCEPTIBILITY OF RED CELL CELLS TO SPONTANEOUS AND STRESS-INDUCED HEMOLYSIS DURING COLD STORAGE 3A‐S04‐04 THE DEHT PLASTICISER PRESERVES THE QUALITY OF RED CELLS WELL DURING STORAGE IN PVC BLOOD BAGS 3A-S04-05 PROTEAsome MODULATION IN STORED RBC: STORAGE AGE AND DONOR EFFECTS Donors and Giving: Reach and retain donors in low-, middle-, and high-income settings 3A‐S05‐01 REACH AND RETAIN DONORS IN UNDER-RESOURCED CONTEXTS 3A‐S05‐02 RECRUITMENT OF FUTURE BLOOD DONORS TO SUPPLY THE SAFER BLOOD AND NATIONAL SELF-SUFFICIENCY OF BLOOD SUPPLY 3A‐S05‐03 EFFECTIVE METHODS TO REACTIVATE INACTIVE BLOOD DONORS: A RANDOMIZED STRATIFIED CONTROLLED STUDY 3A‐S05‐04 PROMOTING VOLUNTARY BLOOD DONATIONS IN PAKISTAN THROUGH FACEBOOK'S BLOOD DONATION FEATURE 3A‐S05‐05 RECRUITMENT OF NON-CAUCASIAN BLOOD DONORS: THE EXPERIENCE OF A SWITZERLAND BLOOD DONATION CENTER Plenary Session - Closing the Gap PL‐01‐01 TRANSFUSION AND TREATMENT OF SEVERE ANEMIA IN AFRICAN CHILDREN TRIAL (TRACT) PL‐01‐02 GLOBAL PERSPECTIVE OF ETHICS IN THE HEALTH SUPPLY – CRITICAL APPRAISAL PL‐01‐03 Transfusion in locations with limited infrastructure Immunobiology - Genotyping 3C‐S06‐01 HLA TYPING AND BLOOD GROUPS WITH NGS – ONE-STOP SHOP 3C‐S06‐02 A complete and customizable sequencing panel for genotyping of red blood cells, platelets and neutrophils 3C‐S06‐03 DONOR CHARACTERIZATION: A NEW PLATFORM FOR INTEGRAL GENOTYPING, RESULTS OF A LARGE-SCALE STUDY 3C‐S06‐04 PROFILE OF THE GENOTYPE OF THE WHOLE BLOOD GROUP BY SEQUENCING ANALYSIS OF THE WHOLE GENOME OF THE NATIONAL BIOBANK 3C-S06-05 GENOTYPING OF THE EXTENDED BLOOD GROUP OF THE BEL-A2 IMMORTALIZED ERYTHROID CELL LINE USING NEXT GENERATION WHOLE EXOME SEQUENCING Clinical: focus on pediatrics 3C-S07-01 TREATMENT OF ITP IN PEDIATRIC PATIENTS 3C‐S07‐02 INTERNATIONAL VARIATION IN PLATELET TRANSFUSION PRACTICES IN CRITICALLY ILL CHILDREN 3C-S07-03 PROPHYLACTIC PLATELET TRANSFUSION IN PEDIATRIC PATIENTS WITH CANCER: THE EXPERIENCE OF THE BAMBINO GESU CHILDREN'S HOSPITAL 3C‐S07‐04 RESULTS OF PATHOGEN-REDUCED RED CELL SUSPENSION TRANSFUSION IN CHILDREN WITH ONCOLOGICAL AND HEMATOLOGICAL DISEASES 3C-S07-05 5-YEAR TEMPORARY TRENDS IN PERIOPERATIVE RED CELL TRANSFUSION IN CHILDREN: NATIONALLY REPRESENTATIVE DATA FROM A LARGE NORTH AMERICAN PROSPECTIVE REGISTRY Adverse Events: TTIs, Immune Interactions, and Risk 3C‐S08‐01 TTI AND PATIENTS WITH IMMUNODEFICIENCY: SELECTED DERIVATIVES OR CLOSE FOLLOW-UP 3C‐S08‐02 CHARACTERIZATION OF HEPATITIS B VIRUS STRAINS INFECTING BLOOD DONORS WITH HIGH HBSAG LEVELS AND INCONSISTENT DETECTABLE HBV DNA: IMPLICATIONS FOR BLOOD SAFETY POLICY AND SCREENING 3C‐S08‐03 INFECTION BY THE HEPATITIS B VIRUS AFTER VACCINATION IN A BLOOD DONOR: A CASE REPORT 3C‐S08‐04 SERUM HEPATITIS B CORE-RELATED ANTIGEN (HBCRAG) ASSAY IN BLOOD DONORS WITH OCCULT HEPATITIS B VIRUS INFECTION 3C‐S08‐05 ANALYSIS OF THE IMMUNOLOGICAL CHARACTERISTICS OF T CELLS OF OCCULT HEPATITIS B INFECTION Young Investigators - Excellence in Transfusion 3C-S09-01 DEVELOPING SCENARIOS FOR FUTURE DEMAND FOR BLOOD PRODUCTS IN THE NETHERLANDS: SCENARIO SESSIONS 3C‐S09‐02 POLYGENIC RISK SCORES BASED ON PLASMA FERRITIN DO NOT PREDICT FATIGUE/LACK OF ENERGY IN WOMEN BLOOD DONORS: RESULTS FROM THE DANISH BLOOD DONOR STUDY 3C‐S09‐03 MOLECULAR EPIDEMIOLOGY OF HIV-1 AND PREVALENCE OF RESISTANCE ASSOCIATED MUTATIONS IN UNTREATED BLOOD DONORS 3C‐S09‐04 BIOTINYLATION OF PLATELETS FOR TRANSFUSION PURPOSES: A NEW METHOD FOR LABELING PLATELETS IN A CLOSED SYSTEM 3C‐S09‐05 ISOLATOR A1 REDUCES THE GENOTOXICITY OF A BETA-GLOBIN LENTIVIRAL VECTOR 3C‐S09‐06 WEAK D ANTIGEN EXPRESSION IS A COMMON RESULT OF SPLICING DISRUPTION: CHARACTERIZATION OF NOVEL SPLICING SITE VARIANTS AND CORRELATION BETWEEN IN SILICO PREDICTION AND EXTENSIVE FUNCTIONAL STUDIES Donors and donation: retention of blood donors and the role of side effects 3C‐S10‐01 INCENTIVES FOR BLOOD DONORS: DONOR RETURN RATE BETWEEN COMPENSATED AND NON-COMPENSATED BLOOD DONORS 3C‐S10‐02 DEFERRAL AS THE POINT OF NO RETURN: A MIXED METHODS APPROACH TO UNDERSTANDING WLE BLOOD DONOR EXPIRATION AFTER TEMPORARY DEFERRAL 3C‐S10‐03 PREDICTION OF HEMOGLOBIN IN BLOOD DONORS USING A LATENT CLASS MIXED EFFECTS TRANSITION MODEL 3C‐S10‐04 INTERVENTION STUDY FOR THE PREVENTION OF VASOVAGAL REACTIONS: ANALYSIS OF DONOR RETURN FOR SUBSEQUENT DONATION 3C‐S10‐05 HEALTH STATUS, DONATION PATTERNS, AND IRON DEFICIENCY IN ELDERLY BLOOD DONORS: EVIDENCE FROM A LARGE POPULATION-BASED COHORT AND HEALTH SERVICES USE DATA Transfusion Practitioner session - Management of anemia - The importance of the Transfusion Practitioner in the multidisciplinary team 3C‐TP01‐01 THE IMPORTANCE OF ANEMIA MANAGEMENT AND IMPACT ON THE HEALTH ENVIRONMENT 3C‐TP01‐02 THE ROLE OF THE TRANSFUSION DOCTOR IN THE EVALUATION AND MANAGEMENT OF ANEMIA: PROCESSES, ADVICE AND RESOURCES TO CREATE CHANGE Immunobiology: red blood cell destruction and immune regulation 3D‐S11‐01 INNATE IMMUNITY AND IMMUNE HEMOLYTIC ANEMIA 3D‐S11‐02 UNDERSTANDING RBC CLEARANCE 3D‐S11‐03 RED CELLS AS MODULATORS OF IMMUNITY Clinical - Hemoglobinopathies; The last 3D‐S12‐01 TRANSFUSION TREATMENT IN SICKLE CELL DISEASE: WHAT INDICATIONS AND FOR HOW LONG? 3D‐S12‐02 TREATMENT OF THALASSEMIA 3D‐S12‐03 BLOOD SAFETY PROTECTION FOR THALASSEMIA PATIENTS 3D-S12-04 HEPCIDIN GENE POLYMORPHISMS AND IRON OVERLOAD IN PATIENTS WITH β-THALASSEMIA MAJOR REFRACTORY TO IRON CHELATION THERAPY Adverse events: update on retroviruses in transfusion medicine 3D‐S13‐01 ENDING AIDS IN AFRICA - VISION OR ILLUSION? 3D‐S13‐02 EVOLUTION OF THE BLOOD DONOR DEFERRAL POLICY FOR MEN WHO HAVE SEX WITH MEN IN FRANCE: IMPACT ON THE RISK OF HIV TRANSMISSION THROUGH TRANSFUSION 3D‐S13‐03 RISK FACTORS FOR RECENTLY ACQUIRED HIV INFECTION IN BLOOD DONORS IN SOUTH AFRICA 3D‐S13‐04 SETS OF HIV-1 AND RISK FACTORS IN BLOOD DONORS FOUND POSITIVE FOR HIV IN FRANCE 3D‐S13‐05 FROM UNIVERSAL TO SELECTIVE HTLV SCREENING IN THE UNITED KINGDOM Management and organization: improvement of the organization and practice of transfusions 3D‐S14‐01 MANAGING THE BLOOD SUPPLY IN A COUNTRY WITH LONG DISTANCES 3D‐S14‐02 EDUCATING THE MASSES: THE USE OF E-learning IN TRANSFUSION MEDICINE 3D‐S14‐03 PLATELET PROSPECTIVE AUDIT: ANALYSIS OF STUDENT COMPLIANCE WITH THE GUIDELINES 3D‐S14‐04 WHAT CAN WE LEARN FROM HOW ADVERSE EVENTS ARE DETECTED? 3D‐S14‐05 HEMOGLOBIN MEASUREMENT: HOW TO ASSESS THE COMPETENCE OF NURSES AND THE ACCURACY OF THE METHOD AT THE POINT OF CARE (POC) Donors and Donation - Blood Donation; Iron loss, anemia and beyond 3D‐S15‐01 BLOOD DONATION AND IRON LOSS, WHAT ARE THE IMPLICATIONS? 3D‐S15‐02 SUPERDONORS: GENETIC RISK PROFILE AND RISK OF POSTPONEMENT OF LOW HEMOGLOBIN 3D‐S15‐03 MODELING OF OPTIMAL INTERVALS BETWEEN DONATIONS WITH PERSONALIZED RISK ASSESSMENT FOR ADVERSE IRON OUTCOMES 3D‐S15‐04 A COMPOSITE MEASURE OF HEME IRON CONSUMPTION PREDICTS INCIDENT IRON DEPLETION IN REPEATED BLOOD DONORS 3D‐S15‐05 DIETARY INTAKE OF HEME IRON IS ASSOCIATED WITH FERRITIN AND HB LEVELS IN DUTCH BLOOD DONORS: RESULTS FROM DONOR INSIGHT Immunobiology: news in blood cell autoimmunity 4A‐S16‐01 DETECTION OF PLATELET AUTOANTIBODIES TO IDENTIFY PTI STATE OF THE ART 4A‐S16‐02 TREATMENT WITH THROMBOPOIETIN RECEPTOR AGONISTS (TPO‐RA) RAISES PLATELET COUNT AND INDUCE IMMUNOMODULATION IN IMMUNE THROMBOCYTOPENIA (ITP) 4A‐S16‐03 AUTOANTIBODY-mediated changes in the pattern of platelet glycans: potential impact on platelet function and lifespan in immune thrombocytopenia 4A‐S16‐04 AUTOIMMUNE HEMOLYTIC ANEMIA: SEROLOGICAL CHARACTERISTICS AND TRANSFUSION CHALLENGES 4A‐S16‐05 AUTOIMMUNE HEMOLYTIC ANEMIA: A SURVEY OF DIAGNOSTIC AND MANAGEMENT PRACTICE IN ENGLAND Clinician - Patient blood management 4A-S17-01 AN UPDATE ON PATIENT BLOOD MANAGEMENT 4A-S17-02 LOW VS. HIGH HEMOGLOBIN TRIGGER FOR TRANSFUSION IN VASCULAR SURGERY (TV): A RANDOMIZED CLINICAL FEASIBILITY TRIAL (THE TV TRIAL) 4A-S17-03 REDUCTION OF RED CELL USE THROUGH AN HB-ACTIVATED SINGLE UNIT TRANSFUSION POLICY IN A POPULATION OF HOSPITALIZED HEMATO-ONCOLOGY PATIENTS: A SINGLE-CENTER RETROSPECTIVE ANALYSIS 4A-S17-04 ASSESSING THE HB CONTENT OF PACKAGED RED GERBLES (PRBC): IS IT TIME TO LABEL EACH UNIT WITH THE HB CONTENT? 4A-S17-05 EVALUATION OF CLINICAL PRACTICES OF RED CELL TRANSFUSION IN A TERTIARY CARE ONCOLOGY CENTER Adverse events: current relevance of viral, parasitic and bacterial infections in transfusion medicine 4A-S18-01 APPROACHES TO CONTROL INFECTIONS IN VARIOUS CONTEXTS 4A‐S18‐02 BABESIA SCREENING IN US BLOOD DONORS 4A-S18-03 PREVALENCE OF BABESIA MICROTI IN CANADIAN BLOOD DONORS 4A‐S18‐04 SEROEPIDEMIOLOGY OF TOXOPLASMA GONDII IN BLOOD DONORS IN PORTUGAL 4A-S18-05 WHO IS EXCLUDED FROM SYPHILIS TESTS? Donors and donation: tools for personalized donor care 4A-S19-01 CURRENT OPINION ON DONOR HEALTH – PERSONALIZED CARE FOR THE DONOR 4A-S19-02 PILOT OF THE TOOL FOR CLASSIFICATION OF THE SEVERITY OF ADVERSE EVENTS OF THE DONOR IN A LARGE BLOOD COLLECTION CENTER 4A-S19-03 COMPLICATIONS OF BLOOD DONATION: ELEVEN YEARS OF INTERNATIONAL DATA 4A‐S19‐04 IMPLEMENTATION OF FERRITIN TESTING IN STOCKHOLM: FIRST REPORT 4A-S19-05 FERRITIN SCREENING IN THE NETHERLANDS: FIRST RESULTS OF A NATIONWIDE DONOR DEFERRAL POLICY Plenary Session - Big Data PL‐02‐01 CURRENT OPINION ON DONOR HEALTH – PERSONALIZED CARE FOR THE DONOR PL‐02‐02 FROM MOLECULAR GENETICS TO GENOMICS PL‐02‐03 METHODOLOGICAL CONSIDERATIONS FOR BIG DATA APPROACHES TO RESEARCH IN TRANSFUSION MEDICINE Immunobiology: new blood group alleles 4C‐S20‐01 A GREAT REMOVAL SPREADXGYGYG2CONSTITUTES A GENETIC BASE OF THE XGNULL PHENOTYPE, UNDERLYING ANTI-XgaPRODUCTION 4C‐S20‐02 GYPB*S WITH TWO MUFFLER CHANGES THAT ARE COMMONLY INHERITED INDEPENDENTLY 4C‐S20‐03 A LUTHERAN-RELATED ANTIBODY DETECTED IN A PATIENT WITH A HOMOZYGOUS MISSENSE BCAM MUTATION INDICATING A NEW SYSTEM ANTIGEN 4C‐S20‐04 A NEW HIGH-FREQUENCY ANTIGEN IN THE LUTHERAN BLOOD GROUP SYSTEM (LUNU) 4C‐S20‐05 CHARACTERIZATION OF A NEW ANTIGEN OF HIGH PREVALENCE IN THE JMH BLOOD GROUP SYSTEM 4C‐S20‐06 β1,3GalNAc-T1 DEPENDENT EXTENSION OF GROUP B ANTIGEN FROM HUMAN BLOOD RESULTS IN A NEW ABO-RELATED GLYCOLIPID STRUCTURE IN RBCs Clinical - What about platelet function? 4C-S21-01 An update on antiplatelet agents 4C‐S21‐02 MEASUREMENTS OF PLATELET FUNCTION IN TRANSFUSION MEDICINE 4C‐S21‐03 PLATELET COMPATIBILITY AND DETECTION OF PLATELET ANTIBODIES: A STEP TO RESOLVE THE DILEMMA IN THE MANAGEMENT OF PLATELET REFRACTORITY IN ONCOLOGICAL PATIENTS 4C-S21-04 EVALUATION OF THE CORRELATION OF THE RESULTS OF CROSS-MATCHING OF PLATELETS USING THE SOLID PHASE RED CELL ADHESION ASSAY (SPRCA) WITH INCREASED POST-TRANSFUSION PLATELET COUNT IN ADULT HEMATO-ONCOLOGY PATIENTS Adverse events: serious adverse events other than TTID 4C‐S22‐01 UPDATE ON TRALI/TACO AND TAD (PRE-AABB MEETING) 4C‐S22‐02 IRON OVERLOAD DUE TO TRANSFUSION AND IMPACT ON TRANSPLANT OUTCOMES 4C‐S22‐03 IMPACT OF BLOOD DONOR GENDER ON RECIPIENT OUTCOMES Management and organization: challenges in resource-constrained environments 4C‐S23‐01 CHALLENGES OF THERAPY WITH BLOOD COMPONENTS IN SUB-SAHARA AFRICA 4C‐S23‐02 CHALLENGES OF CLINICAL TRIALS IN RESOURCE LIMITED SETTINGS: PERSPECTIVES FROM UGANDA 4C‐S23‐03 Towards an Appropriate Pathogen Reduction Technology for Whole Blood in Resource Limited Settings Donors and donation - Collection of blood components - Effects on donors and recipients 4C‐S24‐01 FIRST-TIME PLASMA DONOR RECOVERY: FINDINGS FROM AN INTERVENTION STUDY 4C‐S24‐02 DOUBLE ERYTHROCYTE APHERESIS VERSUS CONVENTIONAL WHOLE BLOOD PHLEBOTOMY AS THE TREATMENT OF IRON DEPRESSION IN HEALTHY CARRIERS OF HFE MUTATIONS WITH HYPERFERRITHINEMIA 4C‐S24‐03 LONG-TERM EVOLUTION OF HEMOGLOBIN AND FERRITIN VALUES IN HIGH-FREQUENCY BLOOD DONORS WHOLE BLOOD OR DOUBLE ERYTHROCYTE APHERESIS 4C‐S24‐04 IMPACT OF HYDROXYETILL STARCH AND MODIFIED FLUID GELATIN ON GRANULOCYTE PHENOTYPE AND FUNCTION 4C‐S24‐05 PLATE PHERESIS DONATIONS AND DONOR RISK OF SUSTAINED THROMBOPENIA Immunobiology ‐ Platelet alloimmunity 4D-S25-01 HLA IN BLOOD TRANSFUSION 4D‐S25‐02 DETECTION OF GLYCOSYLATION OF ANTI-HPA 1A ANTIBODIES BASED ON SURFACE PLASMON RESONANCE, AN ASSAY FOR PREDICTING DISEASE SEVERITY IN ALOIMMUNE CYTOPENIAS 4D‐S25‐03 RESULTS OF THE HPA-1A SCREENING PROGRAM FOR THE IDENTIFICATION OF PREGNANT WOMEN AT RISK OF FETAL/NEONATAL ALOIMMUNE THROMBOCYTOPENIA (FNAIT) 4D‐S25‐04 PLATELET ALLOIMMUNIZATION AND CLINICAL MANIFESTATIONS IN THE MATERNAL-FETAL CONTEXT 4D‐S25‐05 RAPID, LOW-COST MATERNAL HPA-1A ELISA FOR HIGH-THROUGH DETECTION OF WOMEN AT RISK OF FNAIT Adverse events: evaluation of new screening platforms/trials 4D-S26-01 EVALUATION OF AN AUTOMATED CMV DETECTION ASSAY AT IBTS: A CHALLENGING PROCESS FOR BLOOD DETECTION LABORATORIES 4D‐S26‐02 DRY PLASMA SPOT TESTING: THE ANSWER TO MAKE BLOOD TRANSFUSION TESTING SAFER IN AFRICA? 4D‐S26‐03 EXPERIENCE WITH ALINITY S ASSAYS AFTER 5 MONTHS OF ROUTINE USE IN LARGE VOLUME SCREENING OF BLOOD DONATIONS 4D‐S26‐04 EVALUATION OF THE USABILITY OF THE NEWLY LAUNCHED ALINITY S AND THE SPECIFICITY OF HIV COMBO, ANTI‐HCV, HBSAG AND SYPHILIS IN A BLOOD DONOR SCREENING SETTING 4D‐S26‐05 ELECSYS CLINICAL PERFORMANCE EVALUATION®INFECTIOUS DISEASE PARAMETERS ON THE COBAS E 801 ANALYZER FOR ROUTINE SCREENING OF FIRST-TIME BLOOD DONORS 4D‐S26‐06 SIDE-BY-SIDE COMPARISON OF THE SPECIFICITY OF THE ALINITY S AND COBAS E801 SEROLOGICAL ASSAYS IN SERUM AND PLASMA SAMPLES Cellular therapies: looking for more 4D-S27-01 SPECIFIC CELL THERAPIES FOR TUMOR 4D-S27-02 CELL THERAPIES IN THE ERA OF CRISPR‐CAS 4D-S27-03 T-CELL CELL THERAPIES Donors and Donation: Approaches for Safe Donors 4D-S28-01 TOWARDS UNREMUNERATED VOLUNTARY BLOOD DONATION IN THE BALTIC STATES: A COMMON STARTING POINT DOES NOT GUARANTEE THE SAME RESULTS 4D‐S28‐02 DEMOGRAPHIC AND HEMATOLOGICAL PARAMETERS IN FIRST BLOOD DONORS 4D‐S28‐04 POST-DONATION INFORMATION MANAGEMENT ‐ CONTRIBUTION TO THE SAFETY OF TRANSFUSION TREATMENT 4D‐S28‐05 THE DEXTOR PROJECT: TRANSFUSION DATA EXCHANGE, OPEN RESOURCE Immunobiology: red blood cell alloimmunity 5A-S29-01 RECEPTOR FACTORS INFLUENCING RED CELL ALLOIMMUNIZATION 5A-S29-02 FREQUENCY OF RED CELL ALLOIMMUNIZATION IN PATIENTS WITH SICKLE CELL DISEASE IN OMAN 5A-S29-03 ANTIBODIES TO BALLOONS IN PATIENTS WITH SICKLE CELL DISEASE WHO RECEIVED MULTIPLE TRANSFUSION IN GHANA; PREVALENCE, SPECIFICITIES AND RISK FACTORS 5A-S29-04 STRONG ANTI-D IMMUNIZATION INDUCED BY PREGNANCY IN THE PHENOTYPE OF WITH ALLELE RHD*01EL.04 5A-S29-05 ANTI-RBA IS A VERY COMMON RED CELL ANTIBODY IN GERMANY Clinical - Hemovigilance 5A-S30-01 THE IMPORTANCE AND APPROACH TO IMPLEMENTING A HEMOSURVEILLANCE SYSTEM 5A-S30-02 LEARNING FROM TRANSFUSION "NEVER EVENTS": REVIEW OF UNINTENDED OR INCOMPATIBLE TRANSFUSION AS REPORTED ABOUT SERIOUS TRANSFUSION RISKS 2010-2017 5A-S30-03 REDUCED WHOLE BLOOD HEMOSURVEILLANCE IN PATHOGENS FROM MIRASOL IN GHANA 5A-S30-04 USE OF IRRADIATED BLOOD PRODUCTS IN PATIENTS AT RISK OF TRANSFUSION ASSOCIATED GRAFT VERSUS HOST DISEASE 5A-S30-05 REPORTING OF TRANSFUSION-RELATED ADVERSE EVENTS AND DOCUMENTATION COMPLIANCE AMONG HEALTHCARE PROFESSIONALS IN DEVELOPING COUNTRIES WITH THE OBJECTIVE OF IMPROVING PRACTICES Adverse events: new indications for pathogen reduction methods 5A-S31-01 IMPACT OF PATHOGEN INACTIVATION ON PLATELET SURVIVAL AND ALLOIMMUNIZATION 5A-S31-02 EFFICIENT INACTIVATION OF BRUCELLA CLINICAL ISOLATES IN HUMAN PLATELET CONCENTRATES IN 100% PLASMA WITH AMOTOSALEN AND TREATMENT WITH UV LIGHT A 5A-S31-03 THERAPEUTIC RESPONSE TO MOTOSALEN/GRAPE-TREATED PLATELETS WITH UP TO 7 DAYS OF STORAGE DURING 5 YEARS OF ROUTINE PRACTICE 5A-S31-04 NIPAH VIRUS IS EFFICIENTLY INACTIVATED IN PLATELETE CONCENTRATES BY UVC LIGHT USING THERAFLEX UV PLATELET TECHNOLOGY 5A-S31-05 USE OF PLATELET PATHOGEN REDUCTION TO IMPROVE STOCK MANAGEMENT IN A NATIONAL BLOOD SERVICE Donors and donation - Donor adherence - are we doing the right thing? 5A-S32-01 KEEP THE BLOOD FLOWING 5A‐S32‐02 THE BEHAVIOR CHARACTERISTICS OF THE FIRST BLOOD DONORS IN TURKEY: AN EXTENSIVE ANALYSIS OF THE MODEL OF THE THEORY OF PLANNED BEHAVIOR 5A‐S32‐03 TOWARDS MORE UNIFORM DONOR ELIGIBILITY CRITERIA: OVERVIEW OF THE FIRST RESULTS OF TRANSPOSE 5A‐S32‐04 CURRENT PRACTICES IN THE SELECTION AND PROTECTION OF DONORS IN EUROPEAN COUNTRIES AND SUGGESTIONS FOR IMPROVEMENT: THE CASE OF BLOOD AND PLASMA 5A‐S32‐05 LARGE DIFFERENCES IN THE REPORTING OF ADVERSE REACTIONS IN BLOOD AND PLASMA DONATIONS WITHIN THE EUROPEAN UNION – RESULTS OF THE TRANSPOSE PROJECT Plenary session: a glimpse into the future PL‐03‐01 INVISIBLE ORGANS PL‐03‐02 GENE EDITING IN SICKLE CELL DISEASE PL‐03‐03 WATT WORMS – TAKE A DEEP BREATH Management and Organization - Organizational issues P-001 WHO IS A DONOR RECRUITER; AN UPDATED PERSPECTIVE P-002 IS AFRICA ON THE PATH TOWARDS A SAFE AND SUFFICIENT BLOOD SUPPLY? P-003 REVISION OF THE PERSONNEL LIST FOR THE BLOOD DONATION TESTING LABORATORY (BDT) P-004 A MODEL FOR CRISIS MANAGEMENT IN EMERGENCY TRANSFUSION: EMERGENCY TRANSFUSION KIT FOR DISASTER AND CRISIS SITUATIONS P-005 P-006 COMPUTERIZATION IN BLOOD BANKS: CHALLENGES AND SOLUTIONS P-007 BLOOD SYSTEMS OF THE COUNTRIES OF THE WHO EASTERN MEDITERRANEAN REGION: EXISTING LEGISLATIVE INSTRUMENTS P‐008 BLOOD TRANSFUSION SERVICE IN POLAND IN THE PERIOD 2008–2017 P-009 DEVELOPMENT OF GUIDELINES FOR CHANGE MANAGEMENT IN THE BLOOD TRANSFUSION SERVICE FOR A MORE EFFICIENT BLOOD SUPPLY USING BIG DATA AND DATA MINING METHODS - STAGE 1 P-010 POSITIVE IMPACT OF THE NATIONAL TRANSFUSION SOCIETY; 20 YEARS OF EXPERIENCE OF BLOOD BANKS AND TRANSFUSION SOCIETY OF Türkiye P-011 Information technology P-012 IMPLEMENTATION OF THE INFORMATION TECHNOLOGY GOVERNANCE FRAMEWORK FOR BLOOD SERVICES IN RESOURCE LIMITED CONTEXTS P-013 IMPACT OF THE INTRODUCTION OF AN INTEGRATED ELECTRONIC MEDICAL RECORD OF HOSPITALIZED PATIENTS ON THE QUALITY OF PATHOLOGY SAMPLES P-014 IMPLEMENTATION OF A PAPERLESS ELECTRONIC BLOOD BANK TEST REQUEST SYSTEM IN A GENERAL AND ACUTE CARE HOSPITAL P-015 ELECTRONIC RECORD OF TRANSFUSION: A PILOT STUDY FOR SCWEB®APPLICATION OF THE TRANSFUSION SYSTEM AT THE CABIN SIDE P-016 ANALYSIS AND DESIGN OF AN ELECTRONIC MEDICAL RECORD SYSTEM IN BLOOD TRANSFUSION SERVICES IN A GOVERNMENT. HOSPITAL Cost effectiveness P-017 COSTS ASSOCIATED WITH TRANSFUSION IN A PEDIATRIC INTENSIVE CARE UNIT P-018 THE INFLUENCE OF STRATEGIES TO LIMIT THE NUMBER OF PRE-TRANSFUSION TESTS TOWARDS EFFECTIVENESS IN RELATION TO THE COSTS OF REQUESTING PACKED RED BALLOONS AT DR. HASAN SADIKIN HOSPITAL BLOOD BANK, BANDUNG-INDONESIA training and education P-019 IMPACT OF AN EDUCATIONAL INTERVENTION ON THE KNOWLEDGE AND AWARENESS OF NURSES AT A TERRITORY CARE TEACHING HOSPITAL ABOUT BLOOD TRANSFUSION SERVICES AND PRACTICES P-020 P-021 TRAINING AND COMPETENCE ASSESSMENT TOOL (TACT): A GAP ANALYSIS OF THE TACT PROGRAM VERSUS PRE-TRANSFUSION TESTING GUIDELINES AND PRACTICES ABROAD: ADAPTATION OF TACT FOR INTERNATIONAL APPLICATION P-022 IMPROVING NEONATAL AND PEDIATRIC CLINICAL OUTCOMES THROUGH EDUCATION IN PATIENT BLOOD MANAGEMENT P‐023 EVALUATION OF TRANSFUSION KNOWLEDGE AND PRACTICES IN NURSES ACCORDING TO THEIR TIME OF EXERCISE Risk models, standards and regulation P-024 INCONSISTENCY IN THE SELECTION CRITERIA FOR WHOLE BLOOD DONORS EVALUATED BY EXPERTS IN THE TRANSPOSE PROJECT COMPARED TO DIRECTIVE 2004/33/EC P‐025 RISK MANAGEMENT OF BLOOD SERVICES: THE RESULTS OF A 10-YEAR BRAZILIAN EXPERIENCE P-026 ANALYSIS OF THE EFFECT OF FAILURE MODE ON PATIENT SAFETY IN THE BLOOD TRANSFUSION CHAIN ​​IN THE DEMOCRATIC REPUBLIC OF THE CONGO Management and utilization of the blood supply P‐027 BLUSTAR.NRW: A PROJECT TO TYPE REFUGEES AND MIGRANTS AS POTENTIAL BLOOD AND STEM CELL DONORS IN NORTH RHINE-WESTPHALIA P‐028 TRANSFUSION PRACTICES IN MAJOR TRAUMA PATIENTS IN AN EMERGENCY DEPARTMENT: EXPERIENCE AT LEVEL 1 TRAUMA CENTER IN INDIA P‐029 THE MANAGEMENT OF THE SUPPLY OF PLATELET CONCENTRATE FOR RECIPIENTS OF ALLOGENIC STEM CELLS IS A REAL CHALLENGE FOR A BLOOD BLOOD CENTER: THE EXPERIENCE OF THE UNIVERSITY HOSPITAL OF GENEVA P‐030 P‐031 WASTE REDUCTION THROUGH THE CARDIAC SURGERY BLOOD COOLER INITIATIVE P-032 SAFETY AND EFFICACY OF THE PRE-OPERATIVE AUTOLOGOUS BLOOD DONATION PROGRAM IN HONG KONG P‐033 INTERACTIVE METRICS TO MONITOR THE BLOOD SUPPLY MANAGEMENT SYSTEM IN A LOW-RESOURCE ENVIRONMENT P-034 IMPLEMENTATION OF A MASSIVE TRANSFUSION (MT) SYSTEMATIC REVIEW PROCESS IN AN AUSTRALIAN TERTIARY HOSPITAL P-035 QUALIFICATION OF BIOLOG-ID RFID TAGS FOR COMMON CONDITIONS IN BLOOD PROCESSING, INCLUDING CENTRIFUGATION, PRINTING, QUICK FREEZING AND IRRADIATION P-036 IDENTIFICATION OF COMPATIBLE BLOOD FOR HR ALLOIMMUNIZED PATIENTS: AN INTERNATIONAL CASE P-037 IMPROVE THE SUPPLY OF BLOOD COMPONENTS IN THE CLINIC AND ENSURE THE SAFETY OF BLOOD TRANSFUSION BY IMPROVING A BLOOD TRANSFUSION DATABASE PLATFORM P‐038 DONOR ACTIVITY DURING THE PERIOD OF TERRORIST ATTACKS P‐039 IMPORTANCE OF THE RH AND KELL PHENOTYPE IN MULTI-TRANSFUSION PATIENTS IN A DEVELOPING COUNTRY P‐040 DISTRIBUTION OF BALLOOG ANTIGEN AMONG DONORS IN THE MOSCOW REGION P-041 P‐042 P‐043 P‐044 P-045 BLOOD UTILIZATION MANAGEMENT IN THE SOUTHWEST PART OF SLOVENIA P-046 DISTRIBUTION OF BLOOD DONORS IN DIFFERENT AGE GROUPS IN KATHMANDU NEPAL Quality management P-047 DISCREPANCIES OF ABO AND RHD TYPES IN BLOOD DONORS IDENTIFIED BY THE NATIONAL HEMOVIGILANCE SYSTEM SIHEVI-INS© IN COLOMBIA AFTER ITS IMPLEMENTATION IN 2018 P-048 INTERNAL EVALUATION OF THE NEO IRIS AUTOMATED SYSTEM FOR ANALYSIS OF BLOOD DONORS AT THE NIS BLOOD TRANSFUSION INSTITUTE P‐049 LABORATORY QUALITY ASSESSMENT THROUGH EXTERNAL QUALITY ASSURANCE SCHEME IN HISTOCOMPATIBILITY TESTS P‐050 THE SURVEY OF LABORATORY TESTS RELATED TO TRANSFUSION FOR THE IMPROVEMENT OF THE QUALITY OF THE MANAGEMENT OF THE HOSPITAL BLOOD BANK P-051 P-052 SOLID QUALITY MANAGEMENT SYSTEM AS A PREREQUISITE FOR HIGH-QUALITY SERVICE: MACEDONIAN EXPERIENCE P‐053 DETERMINING QUALITY CONTROL LIMITS FOR SEROLOGICAL BLOOD TESTS USING HISTORICAL DATA IN THE PHILIPPINES RED CROSS P-054 IMPACT OF MONITORING QUALITY INDICATORS OF THE ADMINISTRATION OF BLOOD COMPONENTS: AN EXPERIENCE FROM A TERTIARY HEALTH CARE CENTER IN WEST INDIA P‐055 EVALUATION OF THE EFFICACY OF AUTOMATED ANTIBODY TITRATION VERSUS THE MANUAL METHOD USING GEL MICRO-COLUMN TECHNOLOGY P‐056 EVALUATION OF THE NEW DG READER NET IN A REAL LABORATORY ENVIRONMENT P-057 THE ROLE OF QUALITY CONTROL SAMPLES IN IDENTIFYING PROBLEMS IN BLOOD GROUP INTERPRETATION P‐058 SURVEILLANCE METHOD TO STANDARDIZE THE DELIVERY TIME OF RED BALLOONS IN A TERTIARY CARE FACILITY IN SOUTH INDIA Blood Donation ‐ Blood Donor Recruitment P-059 HEMATOLOGICAL AND PHYSIOLOGICAL CHARACTERISTICS OF REGULAR BLOOD DONORS WITH BETA-THALASSEMIA TRAITS P‐060 IS THE INCREASING POPULARITY OF TATTOOS A THREAT TO THE SAFETY OF BLOOD AND ITS COMPONENTS? P‐061 DEFERRED DONOR REFUNDS INCREASE: A REMINDER MESSAGE FOR DONORS WHO REACH THE END OF THEIR DEFERRED DONOR PERIOD P-062 PUBLIC PERCEPTION ABOUT THE TRANSFUSION SERVICE AND BLOOD DONATION PRACTICES P‐063 EVIDENCE ON THE OVERWEIGHT OF REGULAR BLOOD DONORS IN A CENTER IN SOUTH ITALY P-064 INFLUENCE OF RECRUITMENT OF PEER-DERIVED DONORS ON THE PERCEPTION OF BLOOD DONATION AMONG STUDENTS OF SULTAN QABOOS UNIVERSITY P-065 UNIQUE LINGUAL NEEDS OF THE BLOOD DONOR CLIENT IN DUBAI P-066 PREVALENCE OF METABOLIC DISORDERS AMONG BLOOD DONORS IN A HIGH-TECH INDUSTRIAL PARK IN NORTHERN TAIWAN P-067 REASONS FOR DIFFERENTIATION OF BLOOD DONORS IN A BLOOD BANK IN MEDELLÍN, 2012-2018. P‐068 INTERNET AS AN INTERACTIVE TOOL TO CLARIFY RESERVATIONS AND DOUBTS REGARDING BLOOD DONATION P‐069 BLOOD DONATION IN THE REGION OF BANJA LUKA, REPUBLIC OF SRPSKA, FOR THE PERIOD 2009–2019 P‐070 P‐071 CHARACTERISTICS OF WHOLE BLOOD AND APHERESIS DONORS IN THE RUSSIAN FEDERATION P‐072 DIFFERENTIATION PATTERN OF YOUNG BLOOD DONORS: A CHALLENGE FOR BLOOD DONATION AMONG UNIVERSITY STUDENTS P‐073 EVALUATION OF HEMOGLOBIN LEVELS IN VOLUNTARY DONORS REFERRED TO THE BLOOD SERVICE OF THE PROVINCE OF FARS DURING THE LAST TWO YEARS P‐074 FINNISH BIOBANK OF BLOOD DONORS P‐075 REASONS FOR DEFERRAL OF BLOOD DONORS AMONG VOLUNTARY BLOOD DONORS IN A TERTIARY CARE HOSPITAL IN KATHMANDU, NEPAL P-076 AN ANALYSIS OF THE SITUATION OF CURRENT PLASMA DONORS IN IRAN P‐077 P‐078 P‐079 SELECTION OF DONORS THROUGH THE PRISM OF REASONS FOR POSTPONEMENT P‐080 SCREENING FOR FAMILY HYPERCHOLESTEROLEMIA IN A BLOOD DONATION PROGRAM P-081 STOP BEING TERRIFIED START DONATING: AN EXPERIENCE FROM A COUNTRY WITH RESOURCE RESTRICTIONS P‐082 FERRIDON: A NATIONAL CROSS-SECTION STUDY EVALUATING THE PREVALENCE OF IRON DEFICIENCY USING THE FERRITIN ASSAY AMONG WHOLE BLOOD DONORS IN FRANCE P‐083 PROMOTING BLOOD DONATION IN A CENTRAL HOSPITAL: AN ENDLESS WORK P‐084 INCREASE IN THE NUMBER OF VOLUNTARY UNREMUNERATED BLOOD DONORS (VNRBD) IN INDONESIAN RED CROSS BLOOD CENTERS FROM 2008 TO 2018 P‐085 VOLUNTARY BLOOD DONORS: PROFILE, RETENTION RATE AND ASSOCIATED FACTORS. A RETROSPECTIVE CROSS-SECTION STUDY IN THE PROVINCIAL BLOOD TRANSFUSION CENTER OF SOUTH KIVU (DR CONGO) P‐086 DISTRIBUTION OF THE ABO AND RH BLOOD GROUP IN THE NEPALESE POPULATION P‐087 POSTPONEMENT OF BLOOD DONORS IN MIRPUR, AZAD JAMMU AND KASHMIR, PAKISTAN P‐088 P‐089 P‐090 WORK OF THE BLOOD SERVICES OF RUSSIA AND KAZAKHSTAN Blood collection including apheresis P‐091 VALIDATION OF THE SKIN DISINFECTION METHOD USED IN BLOOD DONATION P‐092 THE SANGUINSTATS GROUP: AN INTERNATIONAL NETWORK OF STATISTICAL METHODOLOGY FOR THE ANALYSIS OF BLOOD DONATION DATA P‐093 VENOUS SAMPLE FOR BLOOD DONOR SECONDLINE DETECTION OF HEMOGLOBIN AT THE DONATION SITE REDUCES LOW HEMOGLOBIN DEFERRALS P‐094 DOES THE HEMOGLOBIN LEVEL OF ELDERLY BLOOD DONORS CHANGE WITH AGE? A MULTI-CENTER RETROSPECTIVE OBSERVATIONAL STUDY P‐095 EVALUATION OF DRUG USE FOR DONOR ELIGIBILITY P‐096 EXPERIENCE IN A BLOOD CENTER WITH TRIMA ACCEL 7 AND TOMES SOFTWARE P‐097 PERSPECTIVES ON SECURITY AND DONOR RETENTION RATES VS COLLECTION VOLUME; RESULTS OF AN INTERNATIONAL SURVEY OF PLASMA PHERESIS PRACTICES P‐098 THE REPETITIVE DONATION OF PLATELETS BY APHERESIS WITH INTERVALS OF LESS THAN THREE MONTHS REDUCES THE SERUM FERRITIN CONCENTRATIONS OF DONORS LOCATED IN A BLOOD BANK AT INTERMEDIATE ALTITUDE P‐099 PERFORMANCE COMPARISON OF TRIMA ACCEL SOFTWARE VERSION 6.06 WITH VERSION 7 P‐100 COMPARATIVE EVALUATION OF TRIMA ACCEL 7 IN A COHORT OF BLOOD DONORS IN NAVARRA, SPAIN P‐101 COMPARED EXPERIENCE OF DONORS IN TRIMA ACCEL 7 WITH TRIMA ACCEL VERSION 6 P‐102 THE EXPERIENCE OF THE USE OF TRIMA ACCEL AT THE NATIONAL CENTER FOR RESEARCH IN HEMATOLOGY P‐103 P‐104 COLLECTION OF PLATELET APHERESIS FROM A SINGLE DONOR AT THE INSTITUTE OF TRANSFUSION MEDICINE - SURVEY OF 9 YEARS OLD P‐105 PRECISION AND EFFICIENCY CUPRIC SULFATE SOLUTION WITH SPECIFIC GRAVITY 1.062 Donor Adverse Events P‐106 PREDICTING HB LEVELS USING ZPP IN A BLOOD BANK SETTING: APPLICATION OF ADVANCED STATISTICAL METHODOLOGY TO A PRACTICAL PROBLEM P‐107 DONORS OLDER THAN 66 YEARS OLD HAVE MORE ADVERSE EVENTS COMPARED TO OTHER AGE GROUPS P‐108 RARE BUT REAL RISK: DEEP VEIN THROMBOSIS OF THE UPPER LIMB AFTER BLOOD DONATION - REPORT OF THREE UK CASES OVER THE PAST THREE YEARS P‐109 HEMOSURVEILLANCE REPORTS OF ADVERSE BLOOD DONOR REACTION AMONG VOLUNTARY BLOOD DONORS AT TERTIARY CARE HOSPITAL IN KATHMANDU, NEPAL P‐110 PROTECTION AGAINST POLLEN ALLERGY AND ASTHMA IN BLOOD DONORS BY PRESEASONAL ORAL SUPPLEMENTATION WITH AN IMMUNOMODULATORY MUSHROOM EXTRACT BASED ON AGARICUS BLAZEI: A RANDOMIZED PLACEBO-CONTROLLED STUDY P‐111 DONOR HEMOSURVEILLANCE PROGRAM (DHV) AT THE CENTRAL BLOOD BANK, DEPARTMENT OF BLOOD BANK SERVICES, MUSCAT - 5 YEARS OF EXPERIENCE P‐112 SEASONAL VARIATION OF DONOR DIFFERENTIATION RATES IN WHOLE BLOOD DONORS P‐113 ON-SITE AND EXTERNAL DEFERRALS OF NEW AND WHOLE BLOOD DONORS DUE TO RISK RELATED TO WEST NILE VIRUS TRAVEL IN THE NETHERLANDS P‐114 P‐115 COMPLIANCE WITH IRON SUPPLEMENTATION AFTER BLOOD DONATION. HOW FAR ARE WE? P‐116 ANXIOUS, SHAME AND DISAPPOINTED: HOW VASOVAGAL REACTIONS CHANGE BLOOD DONOR BEHAVIOR P‐117 CHANGES IN SELF-ASSESSMENT OF HEALTH DURING THE FINDONOR STUDY AND ITS RELATIONSHIP WITH IRON BIOMARKERS P‐118 THE ANALYSIS OF ADVERSE REACTION OF BLOOD DONATION IN XISHUANGBANNA DAI AUTONOMOUS PREFECTURE IN 2018 P‐119 DONOR PROTECTION: IRON SUPPLEMENT FOR FREQUENT BLOOD DONORS IN KOREA P‐120 EFFECT OF REGULAR DONATION ON SERUM LEVELS OF HIGH SENSITIVE C-REACTIVE PROTEIN IN BLOOD DONORS IN LAGOS, NIGERIA P‐121 IMPROVING IRON MANAGEMENT IN BLOOD DONORS P‐122 P‐123 ANALYSIS OF ADVERSE REACTIONS AMONG DONORS AGED 18 TO 24 WHO DONATE BLOOD AND ITS COMPONENTS AT THE REGIONAL BLOOD CENTER IN POZNAŃ, POLAND, IN THE YEARS 2014-2018 Blood Products: Processing, Storage, and Release of Blood P‐124 SELECTED MOLECULES AND PHAGOCYTOSIS OF MICRVESICULES RELEASED FROM STORED RED CELL CELLS UNDER BLOOD BANK CONDITIONS P‐125 THE STORAGE MODE OF SHEEP PLATELET CONCENTRATES DIFFERENTIALLY AFFECTS THE FORMATION OF MICROPARTICLES P‐126 EFFECT OF STORAGE SOLUTION ON OXYGEN DISSOCIATION FROM RBC DURING STORAGE P‐127 DUAL BLENDING STRATEGY FOR THE PRODUCTION OF PLATELET CONCENTRATES FROM 5 OR 6 BUFFY LAYERS P‐128 INHIBITION OF APOPTOSIS: A PROMISING APPROACH FOR COLD STORAGE OF APHERESIS PLATELET CONCENTRATES P‐129 HYPOXIA/HYPOCAPNIA IMPROVES THE STORAGE OF GAMMA IRRADIATED RED CELL CONCENTRATE P‐130 NON-INVASIVE MEASUREMENTS OF FLOW AND HEMATOCRIT OF THE IN VITRO BLOOD CIRCULATION WITH DOPPLER ULTRASOUND P‐131 EFFECT OF IRON OVERLOAD ON PLATELET ACTIVATION AND QUALITY DURING SEVEN-DAY STORAGE P‐132 PROLONGED PERIODS WITHOUT SHAKER ARE HARMFUL TO THE IN VITRO QUALITY OF APHERESIS PLATELS IN ADDITIVE SOLUTION P‐133 CONNECTIVE STUDY OF THE QUALITY OF THE PLATELET PRODUCT AFTER SEVEN DAYS OF STORAGE P‐134 P‐135 BIOMECHANICAL MEASUREMENTS AS A NEW QUALITY CONTROL TOOL FOR CELL BLOOD PRODUCTS P‐136 QUALITY ASSESSMENT OF PLATELET CONCENTRATES DERIVED FROM BUFFY LAYERS STORED OVERNIGHT P‐137 BUFFY COAT DOUBLE DOSE PLATELET CONCENTRATES PREPARED WITH IPP KANSUK POOLING AND LEUKODEPLETION SET P‐138 DOUBLE DOSES OF BUFFY COAT PLATELET CONCENTRATES PREPARED WITH FRESENIUS PT526AA PLATELET AGGREGATION AND LEUCODEPLETION SET, COMPOSTOP CI P‐139 ASSESSMENT OF QUALITY AND PERFORMANCE OF BUFFY-COAT DERIVED PLATELET PREPARED BY THE TACSI AUTOMATED SYSTEM IN THE IRELAND BLOOD TRANSFUSION SERVICE P‐140 P‐141 IMPROVEMENT OF BLOOD PROCESSING AND SAFETY THROUGH THE IMPLEMENTATION OF AUTOMATION TECHNOLOGY AND PATHOGEN REDUCTION IN THE BLOOD AND TISSUE BANK OF ARAGÓN P‐142 EVALUATION OF THE NEW IMUFLEX CRC COLLECTION SYSTEM WITH INTEGRAL LEUCOREDUCTION FILTER FOR Red Blood Cells P‐143 THE USE OF A NEW BLOOD COLLECTION KIT SUITABLE FOR DIRECT AND AUTOMATIC BLOOD SEPARATION DEVICE P‐144 THE QUALITY OF THE COMBINED PLATELET CONCENTRATE PRODUCED FROM THE PROVISIONAL UNIT OF PLATELETS OBTAINED BY AN AUTOMATED BLOOD COMPONENT SEPARATION SYSTEM P‐145 EFFECT OF ANTIOXIDANTS ON THE EXTENSION OF THE SHELF LIFE OF PLATELETS STORED IN COLD UP TO 12 DAYS P‐146 VALIDATION OF THE REVEOS AUTOMATED BLOOD PROCESSING SYSTEM AT THE INDONESIAN CENTRAL BLOOD TRANSFUSION SERVICE P‐147 P‐148 THE APPLICATION OF A MOTOR-DRIVEN BLOOD MIXER TO REPLACE MANUAL MIXING FOR THE PREPARATION OF BLOOD COMPONENTS P‐149 NOVEL WBC REDUCTION FILTER, SEPACELL(TM) RS2 WITH ADVANCED FILTRATION MEDIA, FOR IN-LINE RCC FILTRATION P‐150 MANAGEMENT OF THE PATIENT'S BLOOD: AN OPTIMIZED ADMINISTRATION OF THE "PLATELET RESOURCE" IN THE BLOOD BANK OF THE CARDARELLI HOSPITAL P‐151 WASTE OF BLOOD DERIVATIVES; DONATE AND SAVE A LIFE IS BETTER THAN WASTE P‐152 BLOOD SERVICE OF THE REPUBLIC OF KAZAKHSTAN AT THE CURRENT STAGE: REFORM EXPERIENCE AND DEVELOPMENT PROSPECTS P-153 LOSS OF PLATELET NUMBERS IN RECONSTITUTED PLATELET CONCENTRATES AT THE REGIONAL BLOOD CENTER IN POZNAŃ, POLAND P‐154 PURIFICATION AND CHARACTERIZATION OF PLATELET FACTOR 4 FROM HUMAN PLATELET CONCENTRATES BY IMMUNOAFFINITY CHROMATOGRAPHY blood components P‐155 EVALUATION OF RED CELL CONCENTRATES PRODUCED AFTER 7 DAYS - STORAGE OF WHOLE BLOOD WITHOUT LEUCODE P‐156 IgE SENSITIZATION PROFILES TO FOOD ALLERGENS, INHALANTS AND INSECT POISONS IN NORWEGIAN BLOOD DONORS MEASURED WITH MULTIPLE LINE-BLOT ENZYMOIMMUNOASSAY P‐157 DO THE DONOR'S ATTRIBUTES INFLUENCE THE QUALITY OF PLATELETS AFTER STORAGE? P‐158 STORAGE INJURY IN MINOR DONOR BETA-THALASSEMIA RED CELLS: PRELIMINARY RESULTS OF A COMPARATIVE ANALYSIS P‐159 USING NANOPARTICLE MONITORING ANALYSIS TO CHARACTERIZE MICROVESITES IN UNITS OF RED CELL CELLS: EFFECTS OF STORAGE ON MICROVESICLE SIZE AND CONCENTRATION P‐160 MANUAL METHOD FOR WASHING RED CELLS WITH SAGM SOLUTION P‐161 IN VITRO CHARACTERISTICS OF PLATELETS STORED AT 4–9°C P‐162 CRYOPRESERVED AND FRESH PLATELES: THE FIRST RESULTS OF THE COMPARATIVE STUDY AT THE BRNO UNIVERSITY HOSPITAL P‐163 PRODUCTION OF PATHOGEN REDUCED PLATELET UNITS USING REVEOS®DUAL INTERCEPT™ AUTOMATED BLOOD PROCESSING SYSTEM AND STORAGE PROCESSING SET P-164 FDA APPROVAL OF BIOMERIEUX BACT/ALERT®BPA AND LBW CULTURE BOTTLES FOR SECONDARY SAFETY TESTING TO PROLONG THE SHELF LIFE OF PLATELETS UP TO 7 DAYS P‐165 PATHWAYS OF UPGRADE OF PROTEIN-COATED MAGNETIC NANOPARTICLES IN HUMAN PLATELETS FROM PLATELET CONCENTRATES P‐166 FLOW CYTOMETRY ANALYSIS OF PLATELET POPULATIONS IN BUFFY-COAT PLATELET CONCENTRATES P-167 AUTOLOGOUS BLOOD TRANSFUSION AT A JAPANESE UNIVERSITY HOSPITAL OVER A PERIOD OF APPROXIMATELY 9 YEARS P-168 EFFECTS OF A 48-HOUR INTERRUPTION OF AGITATION ON THE IN VITRO QUALITIES OF WASHED PLATELETS SUSPENDED IN BRS-A P‐169 MONITORING THE QUALITY OF RESIDUAL WHITE AND RED CELLS IN MANUFACTURED BLOOD COMPONENTS USING A HEMATOLOGY ANALYZER P‐170 P‐171 SPECTRIN MATRIX OF RBC MEMBRANES DURING OXIDATION-REDUCTION PROCESSES P‐172 AFM STUDY OF THE MECHANICAL CHARACTERISTICS OF THE NATIVE MEMBRANES OF RED BALLOONS P‐173 P‐174 DISCARDED BLOOD COMPONENTS DUE TO REACHING THE EXPIRATION DATE: A THREE-YEAR EVALUATION OF A PORTUGUESE UNIVERSITY HOSPITAL BLOOD BANK P‐175 MICROSCANNER PLUS FOR THE DETERMINATION OF RESIDUAL LEUKOCYTES IN BLOOD COMPONENTS P‐176 IS HIGH LACTATE PRODUCTION BY STORED PLATELETS ASSOCIATED WITH HEALTH PROBLEMS? P-177 ASSESSMENT OF PLATELET QUALITY USING CYCLE VOLTAMETRY P‐178 NON-LINEAR FIT FOR DETERMINATION OF HEMOGLOBIN DERIVATIVES P-179 RATIONAL DEVELOPMENT BASED ON CELL DIFFERENTIAL OF AN OPTIMAL LEUKOCYTE RECOVERY SYSTEM FROM LR FILTERS plasma products P‐180 PLASMA FRACTIONATION CONTRACT: STRATEGIES FOR SELF-SUFFICIENCY OF PLASMA-DERIVED MEDICINES FROM VOLUNTARY UNREMUNERATED DONATIONS P‐181 PLASMA VERIFICATION SYSTEM: A VALUABLE TOOL FOR THE VALIDATION AND MONITORING OF PLASMA FREEZING. P‐182 ASSESSING THE MATCHING QUALITY OF BLOOD GROUP USING SIX SIGMA METRICS P-183 PRELIMINARY STUDY: TO IMPROVE FACTOR VIII STABILITY WITH LYOPHILIZED CRYOPRECIPITATE MINIPOOL FOR THE TREATMENT OF HEMOPHILIA A IN INDONESIA P‐184 EFFECTS OF AUTOLOGOUS PLATELET-RICH PLASMA ON THE HEALING OF PEPTIC ULCERS: A RANDOMIZED CONTROLLED TRIAL Pathogen inactivation P‐185 EVALUATION OF THE MIRASOL PRT SYSTEM AT THE CROATIAN INSTITUTE OF TRANSFUSION MEDICINE IN ZAGREB P‐186 REAL LIFE DATA ON THE THERAPEUTIC USE OF PLATELETS TREATED WITH AMOTOSALEN/UVA COMPARED TO CONVENTIONAL PRODUCTS P‐187 HOW CAN THE COMMUNITY OF MADRID PREPARE FOR A POTENTIAL OUTBREAK OF EMERGING PATHOGENS WITHOUT INCREASING THE COST OF PRODUCTION? P‐188 ANALYSIS OF UVC-TREATED AND GAMMA-IRRADIATED PLATELET-REDUCED PLASMA CONCENTRATES PREPARED FROM THROMA PHERESIS UNDER ROUTINE CONDITIONS P‐189 A COMPARISON OF THE EFFECT OF X AND GAMMA IRRADIATION ON THE STORAGE QUALITY OF RED CELLS P‐190 INFLUENCE OF THE USE OF THE 7-DAY PLATELET PATHOGEN INACTIVATED WITH AMOTOSALEN/UVA ON WASTE DUE TO EXPIRY IN THE HEMOTHERAPY AREA OF CASTILLA LA MANCHA (SPAIN) P‐191 IN VITRO EVALUATION OF SETS OF PHOTOCHEMICALLY TREATED PLATELET INTERMEDIATE UNIT SETS TO DELIVER TWO PATHOGEN-INACTIVATED PLATELET CONCENTRATES P‐192 EVALUATION OF THE QUALITY OF PATHOGEN INACTIVATED PLATELETS DERIVED FROM THE AUTOMATED WHOLE BLOOD PROCESSING SYSTEM P‐193 MEASUREMENT OF THE VIABILITY OF PLATELET CONCENTRATE SUBJECTED TO PATHOGEN INACTIVATION AFTER PHOTOCHEMICAL TREATMENT WITH AMOTOSALEN HYDROCHLORIDE AND ULTRAVIOLET LIGHT. CMN SXXI, MEXICO. P‐194 EFFICIENT INACTIVATION OF MERS‐CORONAVIRUS IN HUMAN APHERESIS PLATELETS WITH AMOTOSALEN AND TREATMENT WITH ULTRAVIOLET A LIGHT P‐195 EVALUATION OF A MEASURE OF ANTIOXIDANT POWER TO VALIDATE VIRO-INACTIVATED PLATELET CONCENTRATES BY INTERCEPT TREATMENT P‐196 EVALUATION OF A MEASURE OF ANTIOXIDANT POWER TO VALIDATE VIRO-INACTIVATED PLASMA UNITS THROUGH TREATMENT WITH METHYLENE BLUE P‐197 IN VITRO EVALUATION OF FROZEN PLASMA WITHIN 18H AND 19H OF APHERESIS AND WHOLE BLOOD EXTRACTIONS TREATED WITH INTERCEPT PROCESSING EQUIPMENT WITHOUT DEHP P‐198 IMPACT OF POOLING AND INACTIVATION OF THE PATHOGEN AMOTOSALEN/UVA ON THE CLOTTING FACTOR CONTENT OF HUMAN PLASMA P‐199 PATHOGEN INACTIVATION SYSTEMS IN BLOOD TRANSFUSION CENTERS IN POLAND new blood products P‐200 P‐201 Biotinylated Red Blood Cells: A Promising Approach for Monitoring Red Blood Cell Survival in Vivo in Clinical Trials P‐202 ANALYSIS OF THE NEONATAL AND ADULT HUMAN PLASMA AND PLATELET REGENERATIVE PROTEOME P‐203 INJECTABLE BIOTINYLATED PLATELETS FOR TRANSFUSION IN CLINICAL TRIALS P‐204 TREATMENT OF OPHTHALMIC PATIENTS PREVIOUSLY RESISTANT TO STANDARD THERAPY THROUGH THE USE OF AUTOLOGOUS BLOOD PRODUCTS – SINGLE CENTER EXPERIENCE P‐205 COMPARISON OF PLATELET CHARACTERISTICS OF WHOLE BLOOD STORED IN A NEW HYPOXIC PLATFORM WITH CONVENTIONAL STORAGE CONDITIONS P-206 A COMPARISON OF AUTOLOGOUS VERSUS ALLOGENIC SERUM EYE DROPS P‐207 PRODUCTION OF NON-TRANSFUSIONAL BLOOD COMPONENTS AT THE OSPEDALE MAGGIORE POLICLINICO OF MILAN P‐208 INVESTIGATION OF THE ANTIFUNGAL ACTIVITY OF PLATELETS IN CANDIDA ALBICANS P‐209 NATIONAL AND INTERNATIONAL COLLABORATION FOR THE SCREENING AND ACQUISITION OF RARE RED CELL CELLS P‐210 EVALUATION OF THE ABNORMAL TOXICITY TEST IN LYODRIED INFUSIBLE PLATELET MEMBRANE IN MICE P‐211 FROM THE BLOOD BANK TO THE MILK BANK – ANALYSIS OF POSSIBLE SYNERGIES BETWEEN BLOOD DONATION SERVICES AND HUMAN MILK BANKS P‐212 IN VITRO PROLIFERATION TEST FOR SERUM DROPS P‐213 ALLOGENIC SERUM EYE DROPS: 2 YEARS OF EXPERIENCE IN MANUFACTURING P‐214 P‐215 AUTOLOGOUS ARTIFICIAL TEARS USED IN THE 8-YEAR-OLD CHILD Transfusion-Transmitted Infections: ITT Screening Strategies P‐216 THE PREVALENCE OF NON-DISCLOSURE USE OF ANTIRETROVIRALS (ARVs) AMONG HIV-POSITIVE BLOOD DONORS IN SOUTH AFRICA P‐217 IMPORTANCE OF DONOR SELECTION AND PRE-DONATION COUNSELING TO PREVENT A HIGH RATE OF DONOR DIFFERENTIATION: A STUDY IN AN INDEPENDENT BLOOD CENTER P‐218 FOLLOW-UP PROGRAM FOR DEFERRED DONORS WITH DISCREPATING OR UNCONFIRMED MOLECULAR AND SEROLOGICAL TEST RESULTS TO ASSESS RE-ENTRY ELIGIBILITY IN DALIAN, CHINA P‐219 EVIDENCE OF DISCREPANT PRACTICES IN BLOOD SAFETY FOR HIV TESTING IN CAMEROON: A CALL FOR REGULATORY ACTIONS P‐220 RESPONSE TO POST-DONATION COUNSELING REMAINS A CHALLENGE AT THE BLOOD BANK, GENERAL HOSPITAL, MANDALAY, MYANMAR P-221 P‐222 VALIDATION OF THE DONOR HEALTH QUESTIONNAIRE: IS IT ABLE TO DIFFERENTIATE BLOOD DONORS WITH REACTIVE MARKERS OF INFECTION? P‐223 P‐224 VALIDATION OF ALINITY S ASSAYS FOR THE DETECTION OF HBSAG, HIV AG/AB, ANTI-HCV AND ANTI-HBC P‐225 P‐226 COMPARISON OF BLOOD DONOR SELECTION PATTERNS BETWEEN HOME BLOOD DONATIONS AND MEGA BLOOD DONATION CAMPAIGNS AND THEIR INFLUENCE ON DONOR SAFETY AND BLOOD SAFETY IN A TERTIARY CARE HOSPITAL IN INDIA P‐227 TRANSFUSION-TRANSMITTED INFECTION BETWEEN BLOOD DONORS AT THE NATIONAL BLOOD TRANSFUSION AND RESEARCH CENTER, SANA'A CITY - YEMEN, 2018 P‐228 AN EXPERIENCE OF NUCLEIC ACID TESTING FOR TRANSFUSION-TRANSMITTED VIRUSES IN BLOOD DONORS FROM PUNJAB P‐229 P‐230 P‐231 THE EFFECTS OF NUCLEIC ACID TESTING (NAT) FOR HBV, HCV AND HIV DETECTION IN VOLUNTEER BLOOD DONORS AT CHO RAY BLOOD TRANSFUSION CENTER, VIET NAM FROM 2015 TO 2018 P‐232 PERFORMANCE EVALUATION OF ELECSYS SEROLOGY ASSAYS IN A BLOOD ESTABLISHMENT P‐233 HEPATITIS B VIRUS INFECTION IN SIX MINIPOOL BLOOD DONATION AND INDIVIDUAL NUCLEIC ACID TESTING AT CHIANG MAI UNIVERSITY HOSPITAL P-234 ELECSYS VALIDATION®HBSAG II, ANTI‐HBC II, ANTI‐HCV II, HIV COMBI PT, HIV DUO, SYPHILIS, HTLV‐I/II, CHAGAS IMMUNOASSAYS FOR USE WITH CADAVERIC SAMPLES P‐235 NAT SCREENING OF BLOOD DONORS IN A GREEK BLOOD CENTER: YOUR CONTRIBUTION TO BLOOD SAFETY P‐236 USE OF NAT PCR FOR THE DETECTION OF TRANSFUSION TRANSMITTED CO‐INFECTIONS P‐237 VIRAL METAGENOMICS APPLIED TO BLOOD DONATIONS COLLECTED IN SUB-SAHARAN AFRICA AND THE BRAZILIAN AMAZON P‐238 EVOLUTION OF THE SEROPREVALENCE OF THE MAIN VIRAL MARKERS (HIV, HBSAG, HCV) BLOOD DONATION TO CONGO KINSHASA FROM 2013 TO 2017 P‐239 SAFETY OF BLOOD THROUGH MOLECULAR TECHNIQUES: PIONEERING NAT TECHNOLOGY IN EAST INDIA P‐240 INDUCTION HEATING: AN ADVANCED WASH TECHNOLOGY TO PRESERVE SAMPLE INTEGRITY IN ALINITY S, ALINITY I AND ARCHITECT I2000SR FOR TRANSFER TO NUCLEIC ACID ANALYSIS INSTRUMENTS P‐241 EVALUATION OF THE ABBOTT ALINITY S SYSTEM AND ESTIMATION OF THE SPECIFICITY OF THE NEW HBSAG, HIV AG/AB COMBO, ANTI-HCV AND HTLV-I/II ASSAYS VERSUS PRISM USING ROUTINE DONOR BLOOD SAMPLES FROM GREECE P‐242 HEV SCREENING SHOULD BE SYSTEMATICALLY INCLUDED IN BLOOD DONATIONS P‐243 P‐244 DEMOGRAPHIC SURVEILLANCE OF TRANSFUSION TRANSMITTED INFECTIONS AMONG CHINESE BLOOD DONORS P‐245 PREDONATION SCREENING TESTING, A NATIONAL INTERVENTION TO INCREASE THE SAFETY OF BLOOD AND BLOOD PRODUCTS IN IRAN P‐246 P‐247 P‐248 EVOLUTION OF VIRAL MARKERS (HIV, HBV, HCV) IN CÔTE D'IVOIRE BLOOD P‐249 P‐250 P‐251 PERFORMANCE OF NEW ASSAYS FOR HCVAB, HAVAB IGM AND HAVAB IGG ON THE FULLY AUTOMATED ABBOTT ALINITY SYSTEM®– A COMPARATIVE STUDY WITH ABBOTT ARCHITECT I2000SR® P-252 PERFORMANCE OF NEW HEPATITIS B ASSAYS ON THE FULLY AUTOMATED ABBOTT ALINITY S SYSTEM®– A COMPARATIVE STUDY WITH ABBOTT ARCHITECT I2000SR® P‐253 PERFORMANCE OF NEW ASSAYS FOR HIVAG/AB, SYPHILIS AND HTLV I/II IN THE FULLY AUTOMATED ABBOTT ALINITY S SYSTEM®– A COMPARATIVE STUDY WITH ABBOTT ARCHITECT I2000SR® P‐254 CONSECUTIVE POSITIVE RESULTS IN SCREENING FOR TRANSFUSION TRANSMITTED INFECTIONS: FAMILY HISTORY OF BLOOD DONORS ALSO IMPORTANT P‐255 EVALUATION OF SCREENING EFFICACY OF HBSAG AND ANTI‐HCV RAPID TEST KITS IN PAKISTAN P‐256 INCREASED SAFETY OF BLOOD TRANSFUSION IN THE AREA OF ACTIVITY OF THE REGIONAL BLOOD CENTER IN POZNAN, POLAND DUE TO THE MANDATORY TESTING OF DONORS FOR TREPONEMA PALLIDUM INFECTION P‐257 P‐258 COMPARATIVE STUDY OF ELISA AND VIRAL LOAD IN BLOOD DONORS REACTIVE TO HEPATITIS B AND C IN WEST INDIA P‐259 RELIABILITY OF SCREENING TESTS IN THE DETECTION OF MARKERS OF TRANSFUSION TRANSMITTED INFECTIONS IN BLOOD DONORS FROM THE DOBOJ REGION Hepatitis B (VHB) P‐260 P‐261 PERSISTENT ANTI-HBC NEGATIVITY IN ANTI-HBS-POSITIVE BLOOD DONORS WITH OCCULT HEPATITIS B INFECTION P‐262 CONFIRMED HEPATITIS B SURFACE ANTIGEN (HBSAG) POSITIVITY AFTER VACCINATION IN WHOLE BLOOD DONORS IN HUNGARY P‐263 ANALYSIS OF DONOR REENTRY TEST CASES FOR NON-DISCRIMINATED REACTIVE DONORS WITH DIFFERENT RESULTS FROM SCREENING OR ADDITIONAL TESTS P‐264 PREVALENCE OF HEPATITIS B VIRUS (HBV) MARKERS AND MOLECULAR CHARACTERIZATION OF ACTIVE HBV INFECTIONS IN BLOOD DONORS. P‐265 ANTI-HBCORE AND ANTI-HBS IN BLOOD DONORS: A PILOT STUDY IN NORTHERN GREECE P‐266 THE ANALYSIS OF BLOOD DONOR SCREENING FROM 2011 TO 2016 IN GUANGZHOU CHINA P‐267 Hepatitis C (VHC) P‐268 ANALYSIS OF RNA GENOTYPES AND QUANTITATIVE VALUES OF HCV-REACTIVE BLOOD DONORS NAT FROM KOREA P‐269 PHYLOGENETIC STUDY OF HEPATITIS C VIRUS ACCUMULATION IN BLOOD DONORS IN HUNGARY P‐270 P‐271 A STUDY OF THE RE-ENTRY PROCEDURE FOR HCV-REACTIVE DONORS IN CHINA P‐272 P‐273 DONOR BLOOD SCREENING FOR HEPATITIS C: HOW ACCURATE ARE CURRENT SCREENING TESTS IN UGANDA AND KENYA? HIV P‐274 MONITORING THE IMPACT OF POSTPONEMENT OF SEXUAL BEHAVIORS FOR THREE MONTHS AND SCOPE OF EVIDENCE FOR THE ASSESSMENT OF AN INDIVIDUALIZED RISK (FAIR) P-275 ESTIMATED RESIDUAL RISK OF HIV WITH A THREE-MONTH DEFERRAL FOR MEN WHO HAVE SEX WITH MEN IN CANADA P‐276 POSSIBLE HIV TRANSMISSION THROUGH BLOOD TRANSFUSION IN PUNJAB PROVINCE, PAKISTAN P‐277 ESTIMATES OF HIV PREVALENCE AND INCIDENCE AMONG BLOOD DONORS IN FIVE REGIONS OF CHINA P‐278 10-YEAR EVALUATION OF HIV FOLLOW-UP CASES IN SEROLOGY TESTING AMONG THAILAND BLOOD DONORS AT THE NATIONAL BLOOD CENTER, RED CROSS SOCIETY OF THAILAND P‐279 INTEROPERABILITY BETWEEN PUBLIC HEALTH SURVEILLANCE INFORMATION SYSTEMS (SIVIGILA) AND HEMOVIGILANCE SYSTEMS (SIHEVI-INS©) IMPROVES TRANSFUSION SAFETY bacteria P‐280 GROWTH AND DISTRIBUTION OF BACTERIA IN CONTAMINATED WHOLE BLOOD AND BLOOD-DERIVED COMPONENTS P‐281 SEPTIC PLATELET TRANSFUSION REACTIONS DUE TO ACINETOBACTER BAUMANII AND STAPHYLOCOCCUS SAPROPHYTICUS DESPITE NEGATIVE PRIMARY TESTS AND NEGATIVE RELEASE TESTS P‐282 ESTABLISHMENT OF THE FIRST INTERNATIONAL REPOSITORY OF REFERENCE STRAINS OF RELEVANT BACTERIA FOR RED CELL TRANSFUSION P‐283 DOES STORAGE TIME IN SAMPLOK SAMPLING KITS AFFECT BACTERIAL VIABILITY BEFORE BACTERIAL SCREENING? P‐284 TREATMENT WITH AMOTOSALEN/UVA MAY INACTIVATE ACINETOBACTER BAUMANII AND STAPHYLOCOCCUS SAPROPHYTICUS IN APHERESIS PLATELET CONCENTRATES IN 65% PAS/35% PLASMA UP TO DETECTION LIMIT AFTER 7 DAYS OF STORAGE P-285 BACTERIAL CONTAMINATION OF BLOOD PRODUCTS FOR TRANSFUSION IN THREE HOSPITALS IN THE DEMOCRATIC REPUBLIC OF THE CONGO P‐286 VOLUNTARY BLOOD DONORS WITH EARLY AND ACTIVE INFECTION BY TREPONEMA PALLIDUM IN HUNGARY 2015–2017 P‐287 RISK ANALYSIS OF BACTERIAL CONTAMINATION IN TRANSPLANT MATERIAL P‐288 ANALYSIS OF SEROPOSITIVE CASES OF SYPHILIS IN BLOOD DONANTS FROM THE FUNDAÇÃO PRÓ-SANGUE HEMOCENTRO DE SÃO PAULO FPS-HSP IN THE CITY OF SÃO PAULO P‐289 IMPROVEMENT OF BACTERIAL GROWTH BY PLATELETS DURING STORAGE AT ROOM TEMPERATURE: MITIGATION THROUGH REFRIGERATION P‐290 INVESTIGATION OF THE RESIDUAL RISK OF THE STERILITY TEST OF PERIPHERAL BLOOD PROGENITOR CELL PRODUCTS IN A BLOOD CENTER P‐291 QUANTIFICATION OF ENVIRONMENTAL BACTERIA IN AIR AND SURFACES IN THREE BLOOD BANKS IN THE DEMOCRATIC REPUBLIC OF THE CONGO USING CULTURE, ATP BIOLUMINESCENCE AND PARTICLE COUNTING P‐292 P‐293 P‐294 Emerging Pathogens and Other Transfusion Related Pathogens P‐295 GERMAN EXPERIENCES WITH FOUR YEARS OF ROUTINE SCREENING OF BLOOD DONORS FOR HEPATITIS E VIRUS P‐296 DISTRIBUTION OF ZIKA VIRUS IN THE BLOOD COMPONENT AND ADHESION OF ZIKA VIRUS TO RED BALLOONS OF DIFFERENT BLOOD TYPES IN WHOLE BLOOD P‐297 ESTIMATED RISK OF TRANSFUSION TRANSMITTED DENGUE INFECTION IN HONG KONG DURING THE 2018 OUTBREAK P‐298 EPIDEMIOLOGY OF HEPATITIS E VIRUS SPECIFIC ANTIBODIES AND ALTERNATURE LEVELS IN SERUM IN BLOOD DONORS FROM THE TWIN CITIES CAPITAL OF PAKISTAN P‐299 EPIDEMIOLOGY OF HEPATITIS E VIRUS INFECTION IN GUANGZHOU CHINA P‐300 INACTIVATION OF CELL-ASSOCIATED CYTOMEGALOVIRUSES IN HUMAN PLASMA USING THE THERAFLEX MB-PLASMA SYSTEM P-301 NAT SCREENING OF BLOOD, ORGAN, TISSUE AND STEM CELL DONORS IN CROATIA FOR WEST NILE VIRUS IN 2018 P-302 P-303 INACTIVATION OF RED BLOOD CELLS BY PATHOGENS BY ULTRAVIOLET C LIGHT Immunohematology ‐ Red blood cell immunology: Serology P‐304 ANTIGENS OF THE ABH HISTO-BLOOD GROUP IN SEMEN. ITS IMPACT ON THE REPRODUCTIVE HEALTH OF MEN P‐305 FLOW CYTOMETRIC SEMI-QUANTIFICATION OF SUBSTANCE H IN RED CELLS P-306 THE ROLE OF STRONG H ANTIGEN EXPRESSION IN ABO SEROLOGICAL IDENTIFICATION OF HEMOPATHIC PATIENTS P-307 ANTI-ABO TITRE IN ABO-INCOMPATIBLE KIDNEY TRANSPLANTATION: OUR EXPERIENCE IN A TERTIARY CARE HOSPITAL IN NORTH INDIA P-308 P‐309 THE INCIDENCE OF ABO DISCREPANCIES IN THE IH-500 AUTOMATED BLOOD BANK ANALYZER AND ITS SOLUTION STRATEGY P‐310 P‐311 ASSOCIATION OF ABO BLOOD GROUP ANTIGENS AND NEUROLOGICAL TUMORS P‐312 RHD EXPRESSION IS LINKED TO RHD/RHCE GENOTYPE P‐313 WRITING A LITTLE C DISCREPATING IN A DONOR RH:‐26 P-314 P‐315 STRATEGY FOR ATYPICAL OR DISCREPATING RHD TYPING RESULTS AMONG FIRST-TIME BLOOD DONORS IN A BLOOD CENTER IN NORTHERN GREECE P‐316 SEROLOGICAL WEAK D PHENOTYPES: EXPERIENCE OF THE CROATIAN INSTITUTE OF TRANSFUSION MEDICINE P-317 P‐318 PREVALENCE OF RH AND KELL BLOOD GROUP ANTIGENS AMONG SAUDI BLOOD DONORS IN JAZAN PROVINCE P‐319 P‐320 IMPORTANCE OF THE MONOCYTE MONOLAYER ASSAY IN PREDICTING THE CLINICAL SIGNIFICANCE OF ANTIGERBICH ANTIBODIES P-321 BLOOD GROUP DISCREPANCIES: DETECTION AND NEED FOR RESOLUTION P‐322 DIFFERENCES IN THE STABILITY OF UNEXPECTED ANTIBODIES TO RED CELL CELLS DETECTED AFTER REFRIGERATION OR FREEZING USING THE IH-500 AUTOMATED ANALYZER AND MANUAL IN-TUBE METHODS P-323 P‐324 ANTIBODY ELUTION TESTS: A DIFFICULT TASK IN A ROUTINE HIGH-THROUGH LABORATORY P‐325 EVALUATION OF THE EFFICACY OF MDMULTICARD FOR THE EXTENDED PHENOTYPE IN DIFFERENT STAGES OF PATIENTS TREATED WITH CYTOLYTIC ANTIBODIES DIRECTED TO CD38 P‐326 SUITABILITY OF DG GEL CARDS FOR ASSESSMENT P-327 SERIAL DETERMINATION OF KIDD, M AND S ANTIGENS ON THE PK 7300 BECKMAN COULTER AUTOMATED SYSTEM: THE EXPERIENCES OF THE CROATIAN INSTITUTE OF TRANSFUSION MEDICINE P‐328 IMMUNE HEMATOLOGICAL ASSESSMENT, TREATMENT AND OUTCOME OF AUTOIMMUNE HEMOLYTIC ANEMIA: EXPERIENCE FROM A PEDIATRIC SUPER SPECIALTY INSTITUTE IN NORTH INDIA P‐329 P‐330 IMMUNE HEMOLYTIC ANEMIA AND ACUTE RENAL FAILURE ASSOCIATED WITH ANTIBODIES TO DEXCHLORPHENIRAMINE P-331 IMPACT OF DARATUMUMAB ON THE TIME TO RESULT (TAT) OF SEROLOGICAL TESTS IN SINGAPORE P‐332 EFFICACY OF A TRANSFUSION PROTOCOL IN PATIENTS WITH MULTIPLE MYELOMA TREATED WITH DARATUMUMAB P-333 DARATUMUMAB (DARA) INTERFERENCE IN PRE-TRANSFUSION TESTS P‐334 DARATUMUMAB (ANTI‐CD38) INTERFERENCE WITH SEROLOGICAL TESTING: A CASE STUDY P‐335 OPTIMIZATION OF ANTIBODY SCREENING DURING PRE-TRAFUSION TESTING IN THE INDIAN SETTING: A PROSPECTIVE STUDY FROM A TERTIARY HEALTH CENTER P‐336 PREVALENCE OF IRREGULAR RED CELL ANTIBODIES AMONG HEALTHY DONORS IN HONG KONG: COMPARISON OF TWO AUTOMATED BLOOD GROUPING SYSTEMS P-337 RED CELL ALLOIMMUNIZATION IN TRANSFUSION-DEPENDENT THALASSEMIA: AN EXPERIENCE IN A SINGLE CENTER P‐338 P‐339 THE EFFICIENCY OF THE SELECTION OF BLOOD CELL DONORS USING ANTIGENS FROM THE RHESUS AND KELL SYSTEMS FOR THE PREVENTION OF ALLOIMMUNIZATION OF THE RECIPIENT P‐340 FREQUENCY OF ALLOIMMUNIZATION IN PATIENTS WITH LEUKEMIA, LYMPHOMA AND SICKLE CELL P‐341 RED CELL ALLOANTIBODIES AMONG BLOOD DONORS AT THE HARBIN BLOOD CENTER P‐342 ANALYSIS OF THE RESULTS OF IMMUNOHEMATOLOGICAL INVESTIGATIONS IN PATIENTS OF THE HEMATOLOGICAL CLINIC P‐343 P-344 ROOT CAUSE ANALYSIS (RCA) OF INCOMPATIBLE CROSSMATCH IN A TERTIARY CARE TEACHING HOSPITAL P‐345 DIAGNOSIS AND TRANSFUSION OF A PATIENT WITH MULTIPLE ALLOANTIBODIES (AND ONE ALLOANTIBODY AGAINST A HIGH FREQUENCY ANTIGEN) TREATED WITH ALLOGENIC BONE MARROW TRANSPLANTATION P‐346 THE CHALLENGE OF AN ALO ANTIBODY AGAINST AN ANTIGEN WITH A HIGH INCIDENCE IN THE KELL BLOOD GROUP SYSTEM: A CLINICAL CASE P‐347 TRANSFUSION MANAGEMENT OF A PATIENT WITH SICKLE CELL DISEASE WITH MULTIPLE ALLO ANTIBODIES P‐348 RARE JENU NEGATIVE DONOR IDENTIFIED THROUGH MISMATCHED CROSS MATCH P‐349 DELAYED HEMOLYTIC TRANSFUSION REACTION BY ANTI-JKA IN A PATIENT PREVIOUSLY TREATED WITH THE HIGH-AFFINITY CD47-TARGETING FUSION PROTEIN ALX148 SIRPΑ P‐350 SEROLOGICAL AND MOLECULAR STUDIES PERFORMED ON A PATIENT WITH SICKLE CELL DISEASE IN WHICH A DELAYED HEMOLYTIC REACTION TO TRANSFUSION IS SUSPECTED: HOW TO INTERPRET THE PRESENCE OF A JKA VARIANT ALLELE P‐351 CHALLENGE OF THE 3-DAY RULE: ONE CASE WITH RECENTLY IDENTIFIED ANTI-E AND ANTI-Jka WITHIN 3 DAYS OF COLLECTION, BEFORE THE EXPIRATION OF THE PRE-TRANSFUSION SAMPLE P‐352 ALLOIMMUNIZATION OF A PATIENT WITH PARTIAL DNB D ANTIGEN – A CASE REPORT P‐353 IDENTIFICATION OF ANTI-ARJ IN A CHINESE PREGNANT WOMAN P‐354 PANAGGLUTINATION IN THE INVESTIGATION OF IRREGULAR ANTIBODIES – A CLINICAL CASE Red Blood Cell Immunology: Molecular P‐355 THE FREQUENCY AND GENOMIC CHARACTERIZATION OF THE JK(A‐B‐) PHENOTYPE FOR BLOOD DONORS IN HARBIN, CHINA P‐356 ALLELE FREQUENCIES OF 10 BLOOD GROUP SYSTEMS IN KOREA P-357 SCREENING OF BLOOD MOLECULAR GROUPS IN DONORS FROM ARAB COUNTRIES USING HIGH-PERFORMANCE MALDI-TOF SPECTROMETRY AND PCR-SSP P‐358 A NEW A ALLELE AT THE ABO GENE LOCUS CHARACTERIZED BY THE DUPLICATION OF 21 BP IDENTIFIED IN POLISH INDIVIDUALS WITH SUBGROUP A WEAK AND B NORMAL PHENOTYPES P‐359 A NOVEL SINGLE NUCLEOTIDE SUBSTITUTION NEAR THE 5′ SPLICING SITE IN INTRON 5 OF THE ABO GENE LEADS TO A WEAK PHENOTYPE WITH A PSEUDOCHIMERIC PATTERN P‐360 P-361 MOLECULAR BASIS OF ABO GROUP DISCREPANCIES IN A COHORT OF 16 CLINICAL SAMPLES P‐362 CONGENITAL BLOOD CHIMERISM IN MONOCHORIONIC DIZYGOTIC TWINS OF TRIPLETS P‐363 ABO ALLELES WITH VARIANTS OF A SINGLE NUCLEOTIDE (I) P‐364 ABO ALLELES WITH VARIANTS OF A SINGLE NUCLEOTIDE (II) P‐365 ABO ALLELES WITH INTRON ENHANCER 1 VARIANTS P-366 P‐367 THE DISTRIBUTION OF FUT1 ALLELES FOR PARABOMBAY IN CHINESE INDIVIDUALS P-368 A NEW MUTATION IN A SINGLE NUCLEOTIDE OF THE ABO*A GENE LEADS TO DIFFERENT RESULTS IN THE MOLECULAR AND FORWARD/REVERSE BLOOD GROUP P-369 ABO CHIMERISM AS A LIMITATION OF ROUTINE GENOTYPING METHODS P‐370 RHD GENOTYPING IN D NEGATIVE CHINESE PATIENTS WITH ALLOANTI‐D P‐371 GENETIC CHARACTERIZATION OF THE RH HAPLOTYPE IN INDIVIDUALS CARRIERS OF THE RHD*46C ALLALELE OF P‐372 A NOVEL MUTATION AT THE RHD SPLICING DONOR SITE LEADING TO AN RHD-NEGATIVE PHENOTYPE P‐373 CHARACTERIZATION OF TWO NOVEL RHD VARIANT ALLELES P‐374 FROM GENOTYPING TO CLINICAL AND FUNCTIONAL INTERPRETATION OF VARIATIONS IN BLOOD GROUP GENES THROUGH INVESTIGATION OF PROTEIN STRUCTURE IN 3D: TWO NEW VARIANT ALLELES IN THE RHD GENE P‐375 P‐376 THE RHD ALLELE INVENTORY: LESSONS FROM HIGH-THROUGH GENOME DATABASES P-377 MOLECULAR CHARACTERIZATION OF D–/D–RARE VARIANTS IN INDIVIDUALS OF INDIAN ORIGIN P‐378 STUDY TO EVALUATE THE PERFORMANCE OF ID RHD XT AS A MOLECULAR TOOL FOR THE SCREENING OF THE RHD GENE IN COMBINED BLOOD SAMPLES FROM SEROLOGICALLY D-C/E+ DONORS P‐379 A NEW WEAK D 4.0 RELATED ALLELE AND RHCE*CECF DEFINES A NEW RH HAPLOTYPE IN AN AUTOLOGOUS DONOR WITH AN ANTIBODY AGAINST A HIGH FREQUENCY ANTIGEN P‐380 RHD ALLELIC VARIANTS IN CAUCASIAN DONORS SEROLOGICALLY CLASSIFIED AS D-NEGATIVE P‐381 CORRELATION BETWEEN SEROTYPES AND GENOTYPES OF D VARIANTS P‐382 NEW MISSENSE MUTATION IN THE RHAG GENE CAUSES THE FIRST RH DEFICIENCY PHENOTYPE REPORTED IN ARGENTINA P‐383 RHD POSITIVE AMONG SEROLOGICALLY D-NEGATIVE AND C/E+ BLOOD DONORS IN A GREEK TERTIARY HOSPITAL: A PROPOSED RHD GENOTYPING STRATEGY P‐384 WEAK D-TYPES IN THE IRANIAN POPULATION P‐385 P‐386 SEROLOGICAL GENOTYPING OF WEAK FORMS OF ANTIGEN D IN BLOOD DONORS FROM THE REPUBLIC OF SRPSKA P‐387 GENETIC CHARACTERIZATION OF RHD IN SAMPLES FROM RHD NEGATIVE BLOOD DONORS THAT RESULTED POSITIVE WITH THE NOVACLONE™ ANTI-D IGM+IGG MONOCLONAL MIXTURE IN INDIRECT ASSAY ON THE GALILEO NEO AUTOMATED ANALYZER P-388 P‐389 DETECTION OF RHD ZYGOSITY IN CHINESE: USING BASELINE SYBR GREEN I REAL-TIME PCR IN HIGH-RESOLUTION MELTING CURVE ANALYSIS P‐390 ID RHD XT, A SENSITIVE MOLECULAR TEST ON POOLED DNA SAMPLES P-391 INDIA SPECIFIC RHD GENOTYPING ASSAY FOR CHARACTERIZATION OF D VARIANTS P-392 RHD*WEAK D TYPE 3 AND ALO-ANTI-D PRODUCTION IN A PATIENT WITH SICKLE CELL DISEASE (SCD) P‐393 SILICO MODELING OF GLYCOPHORIN A AND HYBRID GLYCOPHORINS PREDICTS A 5-BETA BARREL ANTIPARALLEL BETA SHEET OB-FOLD TYPE STRUCTURE P‐394 ASSOCIATION OF THE GENE POLYMORPHISM OF THE DUFFY BLOOD GROUP WITH COLORECTAL CANCER P‐395 CHARACTERIZATION OF COMPLEMENT RECEPTOR 1 HAPLOTYPES IN INDIVIDUALS FROM ARGENTINA P‐396 P‐397 TWO LAN NULL INDIVIDUALS WITH NEW ABCB6 NULL ALLELES AND ONE COMPOSITE HETEROZYGOTE WITH AN EXTRAORDINARY COMBINATION OF KNOWN NULL AND WEAK ABCB6 ALLELES P‐398 CONFIRMATION OF A COMPOUND HETEROZYGOUS STATE FOR THE KEL GENE IN A PREVIOUSLY REPORTED KEL:‐36 SUBJECT WITH A PARTIALLY KNOWN MOLECULAR BACKGROUND P‐399 A NEW MUTATION IN THE KEL GENE CODING THE KMOD PHENOTYPE IDENTIFIED IN A JAPANESE BLOOD DONOR P‐400 A NOVEL OF NULL ALLELE IN BRAZILIANS P-401 IDENTIFICATION OF A SINGLE HOMOZYGOUS MUTATION IN THE B4GALNT2 GENE IN INDIVIDUALS LACKING THE SD(A) (SID) ANTIGEN ON THE RED CELLS P-402 P‐403 P-404 ASSOCIATION OF DUFFY BLOOD GROUP POLYMORPHISM WITH RBC CHEMISTRY DELETION P-405 SUCCESSFUL BLOOD MANAGEMENT BY ACUTE NORMOVOLEMIC HEMODILUTION IN A PATIENT WITH ANTI-PP1PK ANTIBODY P-406 MOLECULAR DETECTION OF HYBRID PHENOTYPES OF GLYCOPHORIN A AND B FOR THE PREDICTION OF MIA ANTIGEN P‐407 DETECTION OF THE CROM*12 ALLELE BY PCR-SSP IN THAI BLOOD DONORS P-408 COMPARISON OF ABO GENOTYPING METHODS: A STUDY OF TWO LOW RESOLUTION PCR ASSAYS IN A CLINICAL TESTING LABORATORY P-409 GENOTYPING OF THE RHD 1227G>A GENE BY SINGLE-TUBE PCR WITH TM-SHIFT PRIMERS P‐410 P‐411 THE BLOOD GROUP GENOTYPING APPROACH IDENTIFIES THE RARITY OF THE VARIANTS DETECTED IN THE KUWAITI POPULATION P‐412 USE OF THE METHOD BASED ON THE QUANTITATIVE MULTIPLE SHORT FLUORESCENT FRAGMENT POLYMERASE CHAIN ​​REACTION (QMPSF) TO INVESTIGATE HYBRID RHD‐RHCE GENES IN BRAZILIAN PATIENTS WITH SICKLE CELL DISEASE platelet immunology P‐413 P‐414 HUMAN PLATELET ANTIGEN ‐15 POLYMORPHISM IS ASSOCIATED WITH SERUM LAMININ LEVEL IN PATIENTS WITH CHRONIC HEPATITIS C P‐415 THE FUNCTION OF COATED PLATELETS IS RELATED TO THE BLEEDING PHENOTYPE IN PATIENTS WITH HEREDITARY THROMBOCYTOPENIA P-416 ESTABLISHMENT OF THE LUMINEX MICROBEADS METHOD FOR THE SIMULTANEOUS DETECTION OF HPA AND HLA ANTIBODIES P‐417 P‐418 P‐419 SUCCESSFUL PLATELET TRANSFUSION DESPITE 100% PANEL-REACTIVE SERUM ANTIBODIES P‐420 CHARACTERISTICS OF DIFFERENTIAL EXPRESSION OF THE ABO ANTIGEN ON PLATELETS IN THE CHINESE POPULATION OF ZHEJIANG PROVINCE P-421 P‐422 ANALYSIS OF PLATELET ANTIBODIES IN PATIENTS WITH REFRACTORITY TO PLATELET TRANSFUSION P‐423 A RARE CASE OF SEVERE REFRACTORY THROMBOCYTOPENIA IN A PATIENT WITH COMBINED HLA CLASS I, HPA-1A AND HPA-3A ANTIBODIES IN HEMATOPOIETIC STEM CELL TRANSPLANTATION P‐424 RESULT OF TRANSFUSION OF DIFFERENT TYPES OF PLATELET IN REFRACTORY PATIENTS BASED ON LARGE SAMPLE ANALYSIS granulocyte immunology P‐425 P‐426 ALLELE FREQUENCIES OF THE HUMAN NEUTROPHIL ANTIGEN AND ASSESSMENT OF THE RISK OF HNA ALLOIMMUNIZATION IN BLOOD DONORS AND RECIPIENTS P‐427 Maternal-fetal immunology P‐428 STUDY OF MATERNAL VARIANTS OF RHD THAT CAUSE INDETERMINATE RESULTS OF NON-INVASIVE FETAL RHD GENOTYPING P‐429 RHD GENOTYPING IN PREGNANT WOMEN WITH DOUBTABLE D PHENOTYPES P‐430 INCREASING THE PROPORTION OF CELL-FREE FETAL DNA TO MATERNAL DNA USING THE PIPPIN PREP GEL SORTING SYSTEM P-431 INADVERTED USE OF A VARIANT D CORD DONATION IN AN EQA SAMPLE WITH FETOMATERNAL BLEEDING: RESEARCH AND LESSONS LEARNED P‐432 NON-INVASIVE PRENATAL ANALYSIS OF BLOOD GROUP AND PLATELET ANTIGENS USING ALLELIC DISCRIMINATION PROTOCOL AND DIGITAL DROPLET PCR P‐433 USE OF NON-INVASIVE PRENATAL GENOTYPING OF FETAL BLOOD GROUPS IN THE MONITORING OF ALLO-IMMUNIZED PREGNANT WOMEN: THE EXPERIENCE OF THE FRENCH NATIONAL CENTER FOR PERINATAL HEMOBIOLOGY (CNRHP) P‐434 3 YEARS EXPERIENCE IN NON-INVASIVE PRENATAL TESTING OF FETAL RHD FOR DIRECTED ANTI-D IMMUNOPROPHYLAXIS IN POLAND P-435 PREGNANT SCD PATIENT WITH ANTI‐RH23 AMONG MULTIPLE ALLOANTIBODIES P-436 ENTRY OF TITLE SCORES DETERMINED BY AUTOMATED COLUMN AGGLUTINATION TECHNOLOGY IN THE MANAGEMENT OF PREGNANCY COMPLICATED BY ANTI-RH1 AND ANTI-RH4 IMMUNIZATION P-437 EIGHT-YEAR RETROSPECTIVE ANALYSIS OF FETOMATERNAL ALLOIMMUNIZATION AND OUTCOMES IN HEMOLYTIC DISEASE OF THE FETUS AND NEWBORN (HDFN) P‐438 ANTI-RH1 QUANTIFICATION ASSAY USING IH-500 (BIO-RAD®): PROMISING RESULTS FOR RH MONITORING:‐1 PREGNANT WOMEN P‐439 ERYTHROCYTE ALLOIMMUNIZATION IN PREGNANCY AT THE BRAGA HOSPITAL IN 2016-2017 P‐440 A CASE OF CHINESE TWINS SUFFERED FROM SEVERE HEMOLYTIC DISEASE OF THE NEWBORN BY ALOANTI-M P-441 EVALUATION OF THE PERFORMANCE OF THE AUTOMATED TITRATION OF ANTIBODIES TO RED CELLS USING COLUMN AGGLUTINATION TECHNOLOGY IN THE IH-500 SYSTEM P‐442 HEMOLYTIC DISEASE OF THE NEWBORN DUE TO ABO INCOMPATIBILITY: CASE REPORT P‐443 CASE REPORT OF ANTI-INDIAN B ANTIBODY IN PREGNANT WOMAN OF INDIAN ORIGIN P‐444 HEMOLYTIC DISEASE OF THE FETUS AND NEWBORN: RHESUS AND ABO INCOMPATIBILITY IN ALBANIA P‐445 SERIOUS CASE OF HEMOLYTIC DISEASE OF THE FETUS AND NEWBORN OCCURRING IN AN INFANT WHO HAS INHERITED A NEW RHD ALLELE ASSOCIATED WITH A “PARTIAL” RHD POSITIVE PHENOTYPE P‐446 P‐447 THE FIRST CASE OF ALLOANTIBODIES AGAINST HUMAN PLATELET ANTIGEN-15B IN CHINA P‐448 IS THERE REALLY A LIMIT BETWEEN CARE AND RESEARCH IN PLATELET IMMUNOLOGY EXPERT LABORATORIES? Clinical transfusion: neonatal and pediatric transfusion P‐449 RAISING AWARENESS OF THE POTENTIAL INCREASED SEVERITY OF HDFN IN DONOR EGG PREGNANCIES P‐450 P-451 ANALYSIS OF THE CLINICAL CHARACTERISTICS OF ALLERGIC TRANSFUSION REACTIONS IN CHILDREN P-452 HEMOLYTIC DISEASE OF THE FETUS AND NEWBORN: THE EXPERIENCE OF THE OSPEDALE MAGGIORE POLICLINICO OF MILAN P‐453 TRANSFUSION POLICY FOR PREMATURE NEWBORN IN THE OSPEDALE MAGGIORE POLICLINICO OF MILAN P‐454 DETERMINATION OF GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY AND CONSISTENCY OF HEMOGLOBIN S AND ALPHA THALASSEMIA IN UGANDAN BLOOD DONORS therapeutic apheresis P‐455 SUCCESSFUL KIDNEY TRANSPLANTATION IN HIGH-RISK HLA-SENSITIVE PATIENTS: REPORT OF 35 CASES FROM A TERTIARY HEALTH CENTER IN INDIA P-456 PROCEDURE FOR EXCHANGING PLASMA TO RED CELLS: A SAFE AND EFFICIENT WAY TO PERFORM EUVOLEMIC TRANSFUSION IN PATIENTS WITH VOLUME INTOLERANCE P-457 THE ROLE OF THERAPEUTIC PLASMA EXCHANGE FOR THE TREATMENT OF ALLOGRAFT REJECTION IN SOLID ORGAN TRANSPLANTATION: A SINGLE-CENTER EXPERIENCE P-458 EXTRACORPORESIS PHOTOPHERESIS: EX VIVO UV-C TREATMENT AS AN ALTERNATIVE TO TREATMENT WITH 8-METHOXYPSORALEN AND UV-A? P‐459 P‐460 THERAPEUTIC PLASMA EXCHANGE IN MEDICAL INTENSIVE CARE UNIT – A THREE YEAR AUDIT P-461 P‐462 P-463 EFFICACY OF PLASMA EXCHANGE IN MICROANGIOPATHIC HEMOLYTIC ANEMIA: EXPERIENCE FROM A TERTIARY CARE FACILITY IN NORTH INDIA P‐464 CLINICAL EFFICACY OF THERAPEUTIC EXCHANGE OF PLASMA IN A PATIENT WITH NEUROMYELITIS OPTICA – A CASE REPORT P‐465 HIGH-GRADE PARASITEMIA IN BABESIOSIS TREATED WITHOUT ADJUNCTED RBC EXCHANGE P-466 P‐467 COMPARISON BETWEEN THE EFFICIENCY OF CHRONIC PARTIAL RBC EXCHANGE AND AUTOMATED RBC EXCHANGE TRANSFUSION IN SICKLE CELL DISEASE: A FIRST TIME STUDY IN A PORTUGAL HOSPITAL P‐468 ROLE OF RED BLOOD CELL (RBC) EXCHANGE IN THE TREATMENT OF ACQUIRED METHEMOGLOBINEMIA IN A PATIENT WITH ANILINE DYE POISONING - A CASE REPORT P-469 EVALUATION OF CHANGES IN PH AND ELECTROLYTES DURING THERAPEUTIC EXCHANGE OF PLASMA PERFORMED IN PATIENTS WITH LIVER DISEASE: A RETROSPECTIVE ANALYSIS P‐470 CHALLENGES IN THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC PATIENTS - EXPERIENCE FROM A TERTIARY CARE FACILITY IN NORTH INDIA P-471 TREATMENT WITH ORAL ANTICOAGULANTS IN ELDERLY PATIENTS AT THE REGIONAL CENTER FOR TRANSFUSIONAL MEDICINE SHTIP P-472 EFFICACY OF CASCADING PLASMA PHERESIS IN REFRACTORY FAMILY HYPERCHOLESTEROLEMIA ‐CASE REPORT P-473 Practice of evidence-based transfusion medicine P-474 COMPARISON OF THE EFFICIENCY OF TRANSFUSION OF JOINT GLOBAL RED BASED ON ITS HEMOGLOBIN CONTENT VERSUS ROUTINE TRANSFUSION PRACTICE IN ELDERLY THALASSEMIA PATIENTS P-475 DONOR PREGNANCIES AND MORTALITY OF TRANSFUSION RECIPIENTS: A ROLE OF RED CELL STORAGE? P-476 REDUCTION IN THE RATE OF PREMEDICATION WITHOUT INCREASE IN ADVERSE TRANSFUSION REACTIONS IN OUTPATIENTS: A SINGLE CENTER EXPERIENCE P-477 GRANULOCYTE TRANSFUSION IN HEMATO-ONCOLOGICAL PATIENTS WITH FEBRILE NEUTROPENIA P‐478 NATIONAL AUDIT ON PATIENT BLOOD MANAGEMENT P-479 TRANSFUSION PRACTICE IN PATIENTS WITH AUTOIMMUNE HEMOLYTIC ANEMIA: LESSONS FROM A NATIONAL ENGLISH SURVEY P‐480 2018 NATIONAL COMPARATIVE REAUDIT OF THE USE OF GROUP O D NEGATIVE RED CELLS P-481 AUDIT AGAINST NATIONAL GUIDELINES FOR THE USE OF EMERGENCY NON-CROSSED OR RHD-NEGATIVE RED CELL CELLS IN AN AUSTRALIAN TERTIARY METROPOLITAN HOSPITAL OVER A SIX-YEAR PERIOD P‐482 P-483 P-484 RESPONSE TO PLATELET TRANSFUSION AND CORRELATION WITH PLATELET FUNCTION IN HEMATOLOGY PATIENTS P‐485 P-486 P‐487 ABO BLOOD GROUPS AND MALIGNANT DISEASES IN ALBANIA P‐488 THE EFFECT OF HYDROXYUREA ON BLOOD CLOTTING IN SICKLE CELL DISEASE IN PAKISTAN P-489 P‐490 P-491 RATIONALIZATION OF BLOOD TRANSFUSION IN ELECTIVE BREAST SURGERY: ANALYSIS OF JUSTIFICATION AND ECONOMICS P-492 DEVELOPMENT OF A DATA ENTRY PROGRAM FOR TRANSFUSION INDICATIONS AND ANALYSIS OF TRANSFUSION INDICATIONS THROUGH THIS PROGRAM IN A TERTIARY CARE HOSPITAL IN KOREA P‐493 DECREASED TRANSFUSION RATE IN CARDIAC SURGERY PATIENTS: A SINGLE CENTER ANALYSIS. P‐494 THE CLINICAL AND QUALITY OF LIFE IMPACTS OF IVIG AND SCIG THERAPY DIFFER IN PATIENTS WITH SECONDARY IMMUNODEFICIENCY COMPARED TO THOSE WITH PRIMARY IMMUNODEFICIENCY P‐495 INCREASED EXPRESSION OF PLATELET CD62P IN PATIENTS AFTER A TRANSFUSION OF PLATELET CONCENTRATE (PC) P-496 ANEMIA AND THE NEED FOR ALLOGENOUS BLOOD TRANSFUSION IN CARDIOSURGICAL PATIENTS IN ALBANIA P‐497 RELATIONSHIP BETWEEN THE FREQUENCY OF POSITIVE UNEXPECTED RED RED CELL ANTIBODIES AND THE CATEGORY OF THE DISEASE P‐498 APPLICATION OF INTRAVENOUS IMMUNOGLOBULIN IN THE TREATMENT OF REFACTORITY TO PLATELET TRANSFUSION IN HEMATOLOGICAL PATIENTS P‐499 EFFECTS OF ROTEM ON TRANSFUSION PRACTICES IN PEDIATRIC CARDIAC SURGERY P-500 P‐501 P‐502 P‐503 MYCOPLASMA PNEUMONIA ASSOCIATED WITH AUTOIMMUNE HEMOLYTIC ANEMIA IN A PATIENT WITH THALASSEMIA MAJOR Hemorrhage and massive transfusion P‐504 TIMING OF PLASMA TRANSFUSION AND ADVERSE MATERNAL OUTCOME IN WOMEN WITH PERSISTENT POSTPARTUM HEMORRHAGE: A NATIONWIDE COHORT STUDY P‐505 SAFETY AND VIABILITY FOR PATIENTS WITH CRITICAL BLEEDING UNDER TRANSFUSION OUTSIDE THE HOSPITAL IN THE EMERGENCY HELICOPTER OF CIUDAD REAL HOSPITAL P-506 EVERY MINUTE COUNTS: MISCAPES IN THE MANAGEMENT OF MAJOR BLEEDING, 3 YEARS OF PHOTOGRAPHIC DATA P-507 ANTENATAL BLOOD TRANSFUSION IN SOUTH AFRICA: INDICATIONS AND PRACTICE IN A HIGH HIV PREVALENCE SETTING P‐508 ROLE OF ARTERIAL BLOOD GAS ANALYSIS (ABG) AND THROMBOELASTOGRAPHY (TEG) AS POINT OF CARE (POC) TESTS IN MASSIVE TRANSFUSION CASES P-509 IMPEDANCE AGREGOMETRY AS AN INDEPENDENT PREDICTOR OF INCREASED PERIOPERATIVE BLEEDING IN CARDIAC SURGERY P‐510 HISTORY OF SEVERE BLEEDING IN HEMOPHILIA B CARRIER P-511 WHY EXCESSIVE TRANSFUSION WHEN LIMITED CAN WORK: AN EXPERIENCE FROM PAKISTAN P‐512 MANAGEMENT OF MASSIVE BLOOD TRANSFUSION IN SURGICAL PATIENTS IN A TERTIARY CARE ONCOLOGY CENTER P-513 EVALUATION OF VITAMIN K ANTAGONIST ORAL ANTICOAGULATION IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION P‐514 DEVELOPMENT OF A SHEEP MODEL OF HEMORRHAGIC SHOCK Adverse events, including TRALI P‐515 ALLOIMMUNIZATION OF RED CELLS IN PATIENTS WITH RENAL FAILURE AND RENAL REPLACEMENT THERAPY P‐516 ANALYSIS OF THE EFFECT OF THE INHIBITOR KIRS AND ITS LIGAND BETWEEN DONORS AND RECIPIENTS ON HEMATOPOIETIC STEM CELL TRANSPLANTATION P‐517 P‐518 CHARACTERIZATION OF IMMUNOMODULATORY MEDIATORS IN CONCENTRATES OF CONVENTIONAL AND CRYOPRESERVED SHEEP PLATELETS P‐519 CHARACTERIZATION OF IMMUNOMODULATORY MEDIATORS IN SHEEP COMPACT RED CELLS: DEVELOPMENT OF A ROBUST TRANSFUSION MODEL P‐520 DELAYED SEROLYTIC/HEMOLYTIC TRANSFUSION REACTIONS (DSHTR): CORRELATION OF LABORATORY FINDINGS WITH CLINICAL MANIFESTATIONS OF HEMOLYSIS P‐521 ADVERSE TRANSFUSION REACTIONS WITH NEUROLOGICAL SIGNS IN TRANSFUSION PATIENTS P‐522 TRANSFUSION DEPENDENCE IS ASSOCIATED WITH THE PRESENCE OF TOXIC IRON SPECIES AND LOWER SURVIVAL IN LOWER RISK PATIENTS WITH MYELODYSYSPLASIC SYNDROMES P‐523 TOWARDS UNDERSTANDING POST-TRANSFUSION IMMUNOMODULATION: IMMUNE RESPONSES OF SHEEP TO LIPOPOLYSACCHARIDES P‐524 TRANSFUSION REACTIONS IN THE CZECH REPUBLIC IN 2016-2018. Hemovigilance and transfusion safety P‐525 INCREASED SAFETY AND KNOWLEDGE OF RHD IMMUNOGLOBULIN THROUGH HEMOSURVEILLANCE REPORTS P‐526 PASSIVE HEMOSURVEILLANCE STUDY ON PRODUCTS TREATED WITH MIRASOL IN SPAIN P-527 ADVERSE TRANSFUSION EVENTS AND ERRORS/INCORRECT BLOOD COMPONENT TRANSFUSION (IBCT) IN GREECE 2012–2017 P‐528 CABIN-SIDE AUDIT OF BLOOD TRANSFUSION PRACTICES: AN EFFECTIVE TOOL FOR HEMOSURVEILLANCE. P‐529 THE INFECTIOUS RISK OF TRANSFUSION IN THE RECIPIENT: ISTARE DATA 2013-2016 P‐530 P‐531 TRANSFUSION REACTIONS IN PEDIATRIC PATIENTS P‐532 ANALYSIS OF ROOT CAUSES IN TRANSFUSION ERRORS OF NON-IRRADIATED COMPONENTS: HUMAN FACTORS AND LATENT FACTORS P‐533 IS SEVERE ANEMIA AN INDEPENDENT RISK FACTOR FOR TACO? CASE-BASED DISCUSSIONS BASED ON REPORTS FROM TACO A SHOT, THE UK HEMOSURVEILLANCE SCHEME P‐534 EVALUATION OF ADVERSE REACTIONS TO TRANSFUSION IN PATIENTS AT THE SARAJEVO UNIVERSITY CLINICAL CENTER P‐535 ADVERSE EFFECTS RELATED TO TRANSFUSION IN THE ELDERLY Alternatives to blood transfusion P‐536 OPTIMIZATION OF HEMOGLOBIN USING IV IRON P‐537 ALTERNATIVES TO TRANSFUSION; A CONVENIENT AND LOW-COST APPROACH TO IRON DEFICIENCY ANEMIA Cellular therapies: bank of stem cells and tissues, including umbilical cord blood P-538 TRANSCRIPTOMIC PROFILES OF MEGAKARYOCYTE DIFFERENTIATION FROM HUMAN CORD BLOOD CD34+IN VITRO CELLS P-539 PREOPERATIVE ANEMIA AND THE NEED FOR BLOOD TRANSFUSION DURING HIP AND KNEE SURGERY P‐540 P‐541 P-542 INVESTIGATE THE EFFECT OF THE ANTI‐CD36 MONOCLONAL ANTIBODY ON THE PROLIFERATION AND DIFFERENTIATION OF HUMAN CD34+HEMATOPOIETIC STEM (PROGENITOR) CELLS Collection, processing, storage and release P‐543 DIFFERENTIAL INFLUENCE OF HEPARIN ON GENE AND PROTEIN EXPRESSION IN STROMAAL CELLS OF DIFFERENT TISSUES P‐544 P‐545 P‐546 STANDARD AND LARGE VOLUME LEUKAPHERESIS (LVL) USING THE NEW CMNC SPECTRA OPTIA PROTOCOL P‐547 CD34 CALCULATION TOOL; A SIMPLE AND EASY TOOL FOR THE PERSONALIZED COLLECTION OF STEM CELLS P‐548 IMMUNOTHERAPY PRODUCTS: BLOOD PRODUCT, PHARMACEUTICAL OR A NEW CATEGORY ALL TOGETHER? P‐549 P‐550 CONTINUOUS MONONUCLEAR CELL COLLECTION ON THE SPECTRA-OPTIA DEVICE PROVIDES SIMILAR PERFORMANCE TO MONONUCLEAR CELL COLLECTION WITH LOWER COLLECTION VOLUME AT THE COST OF HIGHER AMOUNT OF WBC IN THE COLLECTION BAG P‐551 FACTORS INFLUENCING THE COLLECTION OF PERIPHERAL BLOOD STEM CELLS IN PEDIATRIC DONORS: A STUDY FROM THE QUATERNARY CENTER P‐552 APHERESIS COLLECTION OF MOBILIZED HEMATOPOIETIC STEM CELLS FROM PERIPHERAL BLOOD IN HEALTHY DONORS – 18 YEARS OF EXPERIENCE P‐553 PERFORMANCE EVALUATION OF THE NEWLY DEVELOPED BLOOD FILTER FOR DOMESTIC LEUKOREREDUCTION clinical applications P‐554 NANOFIBROUS SCAFFOLD FUNCTIONALIZED WITH PLATELET-DERIVED GROWTH FACTORS FOR SKIN TISSUE ENGINEERING P-555 LEUKOCYTE REDUCING FILTERS AS A SOURCE OF NEUTROPHILS FOR THE PURIFICATION OF α-DEFENSINS P‐556 DEDIFERENTIATION OF GRANULOSA CELLS INTO PLURIPOTENTIAL STEM CELLS INDUCED BY EXPOSURE TO EMBRYONIC STEM CELL EXTRACT P-557 P‐558 P‐559 P‐560 USE OF EXOSOMAL MICRORNAS DERIVED FROM MESENCHYMAL STEM CELLS IN DISEASE PROGRESSION Clinical immunogenetics: histocompatibility in stem cell transplantation P‐561 NEXT GENERATION SEQUENCING AS A METHOD TO DETERMINE HLA OF POTENTIAL BONE MARROW DONORS P‐562 ESTABLISHMENT OF A PRECISION SEQUENCING PLATFORM FOR THE HLA-I GENE BASED ON THE NEXT GENERATION SEQUENCING METHOD P‐563 COMPLICATIONS AND RESULTS OF ABO-COMPATIBLE AND INCOMPATIBLE HEMATOPOIETIC STEM CELL TRANSPLANTATION Histocompatibility in organ transplantation P‐564 FBS PRE-TREATMENT IMPROVES VIRTUAL CROSS MATCH FAQs Videos
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Summary of the 29th ISBT Regional Congress (1)

Link to Publisher's site

Vox sangJune 2019; 114 (Supplement 1): 5–240.

Published online June 7, 2019. do:10.1111/vox.12792

PMCID:PMC7169345

IDPM:31173375

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Local/Neighbors Day: Innovation in Austria

1A-01-01

SOUND OF MUSIC: QUANTUM MECHANICS OF INNOVATION IN AUSTRIA

gabriel1,2

1Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz2Institute of Traumatology, Ludwig Boltzmann Society, Vienna, Austria

Austria had for centuries a rich cultural history. The growing scientific community at the end of the century was highly concentrated in Vienna. Freud, Boltzmann, Schrödinger and Mach could be the first names to come across, whenever one quotes Austrian scientists. But more related to transfusion are Nobel Prize winners Max Perutz and Karl Landsteiner. Landsteiner's fate illustrates the brain drain that began in the early 1930s and intensified in 1939 with the "Anschluss", which led to the forced emigration of many scientists. A loss that was not regenerated in the postwar years and was further compounded by dubious and often unrevealed relationships and scandals in the Nazi era. Taken together, this leads to a serious loss of credibility and productivity of universities over decades. The opening of university access in the early 1980s and the intense historical work of scandals transformed Austrian universities into open and effective scientific institutions that drive innovation in the country.

Austria has achieved great economic achievement in recent decades, which was accelerated by EU membership in 1995. As a result of strong long-term economic performance, the country's gross domestic product (GDP) per capita is the eighth highest high among OECD countries and fourth in the EU28. Poverty levels and income inequality are below the OECD average. Investment in research and development (R&D) increased since EU accession, when Austria's R&D intensity (total R&D expenditure as a percentage of GDP) was well below the OECD average and significantly much lower than that of Switzerland, a country with which Austria prefers to compare itself. The EU target of 3% R&D intensity was met for the first time in 2014 and in 2018 it is the sixth highest among OECD countries and the second highest in the EU28. Austria showed the second highest increase in R&D intensity of all OECD countries, second only to Korea. The rapid expansion was accompanied by a similar increase in the human resources and scientific output of the universities. Austrian science in quantum mechanics, quantum communication and information is world renowned. Vienna is a major center for biotechnology, as is Linz for mathematics and mechatronics and Graz for automotive and production technologies. Austria has been a recipient of net resources in Horizon 2020 and the previous 7th Framework Programme. Small and medium-sized companies show a high propensity to cooperate with universities and other research organizations and are increasingly included in scientific grant schemes.

Vienna is the largest student city in the German-speaking world and consistently ranks among the world's best cities in quality of life indices. As Austria is home to world-renowned cultural attractions ranging from the famous Salzburg festival to Vienna's New Year's concert, its inhabitants are unaware of the progress being made in R&D and how thriving innovation is taking place in their country. They still love to show their cultural heritage and events and impress the world with a kind of Eternal Smiles and Tears.

1A-01-02

INNOVATION IN CELL THERAPY: EXCITEMENT AND HOPE

N Worel

Transfusion Medicine, Medical University of Vienna, Vienna, Austria

Patients with refractory B-cell malignancies such as non-Hodgkin lymphomas (NHL) resistant to standard therapies have a poor prognosis. The outcome is even worse in patients who relapse after an autologous stem cell transplant. Most of these patients do not qualify for allogeneic hematopoietic cell transplantation (HCT) due to refractory disease, lack of a suitable allogeneic donor, increased age, or cumulative toxicity from prior chemotherapy. Although patients who undergo allogeneic HCT typically benefit from a graft-versus-lymphoma effect, overall survival in patients with NHL after HCT remains short. A similar situation can be observed for patients with acute lymphoblastic leukemia (ALL). Therefore, new treatment modalities are urgently needed. Chimeric antigen receptor (CAR) T cells, a new class of cellular immunotherapy thatex-alivegenetic modification of T cells to incorporate an engineered CAR has been used in clinical trials. In most studies, B-cell malignancies treated with CD19 targeting CAR‐T cells were analyzed. Austria had the advantage of participating in two international trials in the past and is currently participating in additional CAR‐T studies.

Recently, results from CD19-directed CAR-T cell trials with increased patient follow-up led to the approval of tisagenlecleucel and axicabtagene ciloleucel by the FDA (Food and Drug Administration) and the EMA (European Agency for Food and Drug Administration). Medicines). Common adverse events (AEs) include cytokine release syndrome and neurological toxicity, which may require admission to an intensive care unit, B-cell aplasia, and hemophagocytic lymphohistiocytosis. These EAs are manageable when dealt with by a properly trained team following a set algorithm. In this presentation, we summarize the results of four large phase II CD19CAR‐T T cell trials for patients with NHL and ALL and focus on AEs.

1A-01-03

INFLUENCE OF ANEMIA ON OUTCOME IN PATIENTS WITH ORTHOTOPIC LIVER TRANSPLANTATION

d baron

Department of Anesthesiology and Intensive Care Medicine, Medical University of Vienna, Vienna, Austria

Preoperative anemia is a known risk factor for increased perioperative morbidity and mortality in patients undergoing major surgery. Previous studies have not only shown higher in-hospital mortality, but also longer length of hospital stay, higher rates of postoperative intensive care admission, and prolonged use of mechanical ventilation and intensive care resources in patients with anemia compared with those with normal preoperative hemoglobin concentrations. . About 30% of patients scheduled for major surgery suffer from preoperative anemia. This figure is even higher in patients requiring orthotopic liver transplantation, where up to 75% of all patients are diagnosed with anemia before surgery.

Transfusion of packed red blood cells (RBCs) is commonly used to correct anemic hemoglobin values. However, red blood cell transfusion has been associated with increased morbidity and mortality in patients undergoing cardiac, orthopedic, and abdominal surgery. Furthermore, red blood cell transfusion is associated with a higher incidence of postoperative acute kidney injury in patients undergoing orthotopic liver transplantation. Since preoperative anemia could increase the perioperative use of red blood cells, the negative effects observed after red blood cell transfusions could even be increased.

Data on the influence of preoperative anemia on morbidity and mortality after orthotopic liver transplantation are limited. Thus, we retrospectively analyzed the association of preoperative anemia and mortality in adult patients undergoing orthotopic liver transplantation at our institution. In addition, we examined the influence of anemia on perioperative parameters such as transfusion requirements, surgical complications, early allograft dysfunction, acute kidney injury, and the need for renal replacement therapy. Based on the results obtained in the retrospective analysis, an ongoing prospective randomized clinical trial was initiated.

Local/Neighbours' Day: Innovation in France

1B-02-01

TRANSFUSION DRUGS FOR SICKLE CELL PATIENTS: FROM BLOOD DONOR BANK TO GENE THERAPY

F Pirineos

Hospital Henri Mondor, French blood establishment, Créteil, France

The two stop treatments in sickle cell disease (SCD) are hydroxycarbamide, which induces functional HbF production, normally repressed at birth, and red blood cell (RBC) transfusion, a critical component of SCD management. However, red blood cell transfusion is not without its risks. Repeated exposure to allogeneic red blood cells can result in the development of red blood cell alloantibodies that can make it difficult to find compatible red blood cells for future transfusions. However, the main concern of alloimmunization is the development of a hemolytic transfusion reaction, with hyperhemolysis in the most severe cases, leading to multi-organ failure and death in 4% of cases. Prevention of this life-threatening condition must be based on risk factors. However, although some risk factors, such as alloimmunization, have been identified, much of the mechanism underlying DHTR remains a mystery, particularly in severe cases presenting with hyperhemolysis. Here we will describe current and future developments to prevent and treat this severe syndrome.

To decrease transfusion exposure in SCD but also improve the quality of red blood cells, some new products are developed. Oxidative damage is one of the parameters that could be decreased. Some work is also being done to prevent filter blockage during leukodepletion of valuable red blood cell units from Afro-Caribbean donors who carry sickle cell trait. Finally, in countries with higher risks of infectious disease transmission, the treatment of red blood cell units against infectious agents may be discussed.

The only current curative treatment for SCD is hematopoietic stem cell (HCS) transplantation. However, the occurrence, frequency, and effects of hematologic-immune complications in HCS remain and will be discussed. Finally, gene therapy holds true hope as a definitive curative treatment. Clinical trials are ongoing in France and will be discussed, as well as the remaining place of transfusion in this therapeutic.

1B‐02‐02

IMMUNOTHERAPY CART CELLS: FROM TARGET IDENTIFICATION TO THE CLINIC

ferrand1, in room1, F Larosa2, M Deschamps1

1Research, INSERM UMR1098 ‐ EFSBFC ‐ UBFC, BESANCON CEDEX2Clinic, Hematology, Besancon, France

Based on the clinical success of engineering chimeric antigen receptor T‐cells (CART) targeting CD19 in B malignancies such as acute lymphoid leukemia, lymphoma, but also now demonstrated in multiple myeloma, CART cell immunotherapy It has become one of the most promising alternatives. for patients with refractory/relapsed haematological diseases.

In the context of Chronic Myeloid Leukemia (CML), we have hypothesized that the quiescent Leukemic Hematopoietic Stem Cell (HSC) compartment, escaping current treatment with tyrosine kinase inhibitors (TKis), is partly associated with relapse. molecular, may be the target of CART cell immunotherapy. Gene expression profiling studies have established that a cell surface biomarker IL-1RAP is expressed in leukemics but not in normal CD34+/CD38-HSCs.

This talk will focus on the entire CART cell development process from immunizing mice with recombinant IL-1RAP protein to producing a specific monoclonal antibody (mAb), through proof-of-concept demonstration, before moving to the clinic. .

We produced and selected a specific anti-IL-1RAP mAb (clone #A3C3, Diaclone SA, Besançon, France). After molecular characterization of the antigen-binding domain, the nucleotide sequences were fused with third-generation T-cell activation coding sequences and cloned as a single strand in a lentiviral backbone comprising an iCASP9 safety switch suicide gene ( inducible caspase 9) and a cell surface monitoring/selection marker ∆CD19.

we demonstratein vitroand in alivemurine xenograft model in which IL‐1RAP CAR T cells can be activated in the presence of IL‐1RAP+ cell lines or primary CML cells, secrete proinflammatory cytokines, degranulate and specifically kill them. We also show that treatment with multiple TKIs over a 4-year period does not affect the transduction efficiency of CML patient T cells by the IL-1RAP CAR vector and that autologous CART cells can target IL-primary leukemic HSCs. 1RAP+.

"Off-tumor on target" toxicity prediction, by studying IL-1RAP expression in a tissue macroarray comprising 30 normal human tissues (3 donors), with #A3C3, detected various IL intensity stains -1RAP in only a few tissues. As for the healthy hematopoietic system, flow cytometry staining #A3C3 did not detect hematopoietic cells, except for monocytes that poorly express IL-1RAP. As expected, the monocyte subpopulation is targeted by autologous IL-1RAP CART cells (E:T ratio=1:1), but at a lower level than the IL-1RAP CML cell line.

In vivo investigation of specific toxicities of autologous CART IL-1RAP cells against HSCs and/or immune cells in a murine model NOG/grafted with human umbilical cord blood cells CD34+, but also using ain vitroThe CD34+ colony-forming unit assay did not reveal any significant toxicity in immunocompetent cell subpopulations, suggesting that healthy CD34+ HSCs are not affected.

Finally, to overcome potential toxicity, the functionality of iCASP9/Rimiducid®The kill switch was demonstrated in vitro but also in vivo in an NSG tumor xenograft model, demonstrating that when activated, the system is capable of killing more than 90% of CART cells after exposure to AP1903 .

In conclusion, based on the CML model, we demonstrate that IL-1RAP is an interesting target for CART cell immunotherapy, with limited predictable "on-target, off-tumor" toxicity. The next step will be to scale up the process to match human use in regards to regulatory requirements as well. This strategy may be applied, in the future, in other hematological malignancies.

1B-02-03

TRANSFUSION IN THE SETTING OF ACUTE BLEEDING: MASSIVE TRANSFUSION PROTOCOLS, INTRODUCTION OF NEW “OLD” BLOOD PRODUCTS SUCH AS WHOLE BLOOD

exposure S1, P. Tiberghien2, S Bruto2, S Begué2, T Pouget3, C Martinaud3

1Anesthesia, intensive care and emergency medicine, Val de Grâce military medical academy, Paris2EFS, San Dionisio3CTSA, Clamart, France

Mortality ranges from 20 to 30% for trauma victims with severe bleeding and is highly dependent on the transfusion therapy from which they may benefit. The nature of this therapy has an impact on prognosis with a halving of mortality when the plasma/pRBC ratio is greater than half and a decrease of about 20% when the proportion of platelets transfused is close to that of full blood. The speed with which such therapy is delivered also has a major impact, with mortality increasing by 5% for every minute delay in the availability of full therapy. This can be explained mainly by the fact that the probability of death of these patients is greater within minutes of hospital admission, with a median time to death of 2 hours after admission. To allow plasma, platelets, and pRBCs to be available in a timely manner, North American trauma centers have mandated that trauma centers have massive transfusion packs at the patient's bedside within 15 minutes. To further simplify and expedite the logistics from distribution to transfusion, several trauma centers now use whole blood stored at 4°C. This return of an "old" product is largely inspired by the military experience where whole blood is used primarily "warm" immediately after collection with convincing evidence of efficacy. Its return to civilian practice requires the ability to leukocyte it while preserving platelets and to store it while maintaining its hemostatic functions. Good quality data shows that this is feasible and several clinical studies are planned to start in the coming months. In France, the French Blood Establishment and the French Army are cooperating to initiate the prospective randomized non-inferiority trial STORHM (Sang Total pour la Réanimation des Hémorragies Massives) that will compare whole blood with separated blood components on a 1/1/1 basis. . proportion in trauma patients with severe bleeding. The primary end point will be a thromboelastographic parameter (peak amplitude) assessed at 6 hours after admission. Secondary endpoints will include overall and early mortality, lactate clearance (reflective of resuscitation efficacy), and 24-hour organ failure. This trial will recruit 200 patients in 6 French trauma centers and is scheduled to start in the second half of 2019.

Local/Neighbors Day: Innovation in Germany

1C-03-01

MESENCYMAL STROMAL CELLS FOR REGENERATIVE THERAPY

H Schrezenmeier*1, M Kalbitz2, E Amann1, R Lotfi1, M. Rojewski1

1Institute for Transfusion Medicine, Ulm Institute for Clinical Transfusion and Immunogenetic Medicine, GRC Blood Transfusion Service Baden-Württemberg-Hessen and Ulm University Hospital2Department of Hand Traumatology, Plastic and Reconstructive Surgery, Ulm University Hospital, Ulm, Germany

Mesenchymal stromal cells (MSCs) can be used for immunomodulatory and regenerative therapy. These Advanced Therapy Medicinal Products (ATMP) can be obtained from various tissue sources (bone marrow, adipose tissue, umbilical cord blood, placenta and others) and from various types of donors (autologous, allogeneic). We previously demonstrated that bone marrow-derived MSCs (BM-MSCs) are a powerful tool for in vivo bone formation and treatment of bone defects. However, adipose-derived stem cells (ASCs) appear to be more potent in the treatment of acute or chronic inflammation, especially when tissue degeneration (eg osteoarthritis) is involved. The evaluation of MSC in clinical trials has increased substantially over the past decade.

We will review the development of large-scale GMP-grade ex vivo expansion protocols for bone marrow MSCs (BM-MSCs) and adipose-derived stem cells (ASCs) that were developed, optimized, and standardized in various consortia within the Program of the European Commission (7th Framework Program: CASCADE, REBORNE; HORIZON 2020 Program: ADIPOA‐2; ORTHOUNION, MAXIBONE). A two-step protocol allows ex vivo expansion of >200×106cells (passage 1) within 2 to 3 weeks (Rojewski et al., Cytotherapy 2019, PMID 30926359). The protocols have been designed free of xenogenic components. MSC proliferation is stimulated by a growth factor preparation derived from human platelet concentrates (human platelet lysate; hPL) that is a rich source of the factors PDGF, TGF-ß, and bFGF that are essential for MSC growth. (Fekete et al, Cytotherapy 2012, PMID 22296115).

The BM-MSCs/ASCs obtained from these protocols have been characterized in detail in preclinical evaluations. Manufacturing licenses for MSC and ASC and a platelet-derived growth factor concentrate have been obtained and have been explored in several clinical trials for the treatment of bone defects (ORTHO‐CT1: EudraCT Number: 2011‐005441‐13; ORTHO‐ CT2: EudraCT Number: 2012-002010-39; MAXILLO1: EudraCT Number: 2012-003139-50). We will summarize the results of completed clinical trials that confirmed the feasibility and safety of autologous treatment of MSC/ASC and provided evidence of efficacy (Gjerde et al, Stem Cell Res. 2018, PMID 30092840; Gomez‐Barrena et al, Biomaterials 2019, PMID 29598897) ‐ also provides the rationale for ongoing prospective trials comparing MSC treatment with standard of care (ADIPOA2: EudraCT Number: 2015-002125-19 and ORTHOUNION: 2015-000431-32).

Finally, we will discuss the impact of donor type, the use of bioreactors for ex vivo expansion, and the preclinical evaluation of MSCs in new indications, e.g. for acute intervention in severe trauma (Amann et al., Cytotherapy 2018, PMID 29223534; Amann et al., PloS One 2019; e0216862).

1C‐03‐02

IN VITRO PRODUCTION OF MEGAKARYOCYTES

C Figueiredo, R. Blasczyk

Institute for Transfusion Medicine, Hannover Medical School, Hannover, Germany

Introduction:Megakaryocytes (MK) produced in vitro can serve as a source to produce platelets (PLT) ex vivo or in vivo. We have established a strategy to differentiate MKs from induced pluripotent stem cells (iPSCs) in bioreactors. This study aimed at large-scale production of MK using microcarriers to increase MK yield and to characterize its phenotype and functionality after irradiation as a method to decrease potential safety concerns associated with iPSC origin.

Methods:iPSCs were grown in aggregate form in the presence or absence of microcarriers using 50 mL shake flasks. Cells were differentiated into MK using TPO, SCF and IL-3 in APEL2 medium for a period of 22 days. Non-irradiated or irradiated iPSC-derived MKs were analyzed for polyploidy, phenotype, and proPLT production by flow cytometry and fluorescence microscopy. Furthermore, PLT production was investigated in vivo. Non-irradiated or irradiated MKs were transfused into NOD/SCID/IL-2Rγc–/– mice and blood was assayed for human PLTs.

Results:MK differentiation in the presence of microcarriers resulted in an 8-fold increase in MK by iPSCs compared to aggregates alone. This resulted in a mean total MK crop of 18.7±6.8×107in microcarrier-assisted bioreactors compared to 4.9±1.3×107MK collected from bioreactors containing only aggregates. Interestingly, MKs produced in microcarrier-assisted bioreactors showed a higher proPLT formation ability than MKs derived from aggregate bioreactors alone. The MK phenotype and DNA content were comparable between MKs derived from both types of bioreactors. MK irradiation did not affect their phenotype and ability to form proPLT or PLT after transfusion in NOD/SCID/IL‐2Rγc–/–mice.

Conclusion:Microcarriers were shown to significantly increase the yield of iPSC-derived MKs in stirred bioreactors to clinically relevant numbers. This may facilitate the use of iPSC-derived MK for ex vivo production of PLT, direct transfusion, or for innovative MK-based regenerative therapies.

Local/Neighbors Day: Innovation in Switzerland

1D-04-01

WE ARE STARDUST – WHAT'S NEXT TELL US ABOUT OUR ORIGINS

K Altwegg

Space and Planetology, University of Bern, Bern, Switzerland

Although the Rosetta Stone, found by Napoleon's troops in Egypt near the city of Rosetta (Rashid) contains only a small amount of text in three languages, it was key to deciphering the hieroglyphs. The Rosetta mission tried to do something similar: by observing a tiny body, its goal was to decipher the origin of the solar system, the planets, including Earth, and life. After more than 12 years, the Rosetta spacecraft gently crashed into the Churyumov-Gerasimenko comet on September 30, 2016. It has traveled billions of kilometers just to study a small black rock (4 km in diameter) called 67P/ Churyumov-Gerasimenko. The results of this mission now appear to fully justify the time and money spent over the past few decades on this effort. Where we are? Where we go? are we alone in the universe? These are some of the big questions. In this talk I will show what answers we got from Rosetta and Comet Chury. We follow the path of the material that makes up our solar system from a dark cloud to the solar nebula and finally to the planets and life. I will show that we are, in fact, the result of stardust and that what happened here can happen in other parts of the Universe.

1D-04-02

THE SKY IS THE LIMIT: NEXT GENERATION ENGINEERED CELL THERAPIES

jeker

Department of Biomedicine, University Hospital Basel and University of Basel, Basel, Switzerland

Cells, tissues, and entire organs can collectively be viewed as "living drugs." Genetically unchanged cells are commonly used in clinical practice to treat diseases as diverse as anemia, bleeding disorders, leukemia, and organ failure. Revolutionary advances in genomic and genetic engineering technologies are propelling cell therapies to the forefront of medical research and practice. The hematopoietic system is particularly suitable for genetic engineering because specific cell types can be purified based on the expression of specific surface proteins and the ability to grow and expand cells ex vivo.

The recent unprecedented clinical success of chimeric antigen receptor (CAR) reprogrammed killer T cells to target CD19-expressing tumor cells demonstrates the power of genetically engineered immune cell immunotherapy. However, given the rapid development of new genomic engineering and synthetic biology tools, it is likely that we are only at the beginning of a new era of engineered cell therapies. I will present recent advances in immune cell reprogramming, gene editing, safety issues, and remaining challenges such as manufacturing.

1D-04-03

CELL-FREE NUCLEIC ACIDS IN TRANSFUSION MEDICINE

S Waldvögel

Department of Medicine, University Hospital of Geneva, Geneva, Switzerland

Cell-free nucleic acids (CFNAs) circulate in the plasma of all individuals and are believed to be released into the circulation by the host and foreign cells. After fractionation by centrifugation, CFNAs can be extracted from the supernatant of whole blood samples or manufactured blood products. These DNA or RNA sequences can be of human, bacterial, viral or fungal origin. Most of them are double-stranded human DNA. Research on CFNA is increasing, thanks to technological advances in molecular biology. Some of its results are already implemented in clinical practice in the areas of prenatal diagnosis, oncology, and infectious diseases. The latest research is focused on exploring non-human CFNAs, the field of metagenomics. High-throughput sequencing associated with bioinformatics, so-called next-generation sequencing (NGS), has accelerated non-human CFNA investigations. This tool provides an opportunity to classify CFNAs into a human or non-human category and then identify them. Thus, it is possible to simultaneously explore the entire landscape of bacterial, viral, and fungal populations. Currently, NGS of human blood has already demonstrated its feasibility and value for identifying emerging viruses or investigating clinical cases of fever of unknown etiology. The CFNA NGS is also particularly effective for analyzing the different genotypes of a virus in case of a co-infection (for example, the hepatitis C virus). Therefore, studying CFNAs with new molecular technologies is of great importance in transfusion medicine, especially with regard to safety and clinical transfusion reactions. First, transfusion-transmitted infections are the most feared adverse complications. Second, non-hemolytic febrile transfusion reactions are also the most frequently reported adverse events in hemovigilance systems and their physiological mechanism, even if only one, is still unclear. Therefore, the investigation of CFNAs could improve our understanding and strategy with the goal of reducing these two adverse clinical events. Comprehensively studying the composition of circulating infectious agents in a blood product using NGS technology could be very interesting to investigate a severe febrile transfusion reaction. In addition, when testing costs are reduced, periodic prospective screening of all metagenomics of asymptomatic blood donors can be performed in addition to classical epidemiological surveillance. For example, in a study testing an NGS method on manufactured fresh frozen plasmas, an astrovirus (MLB2) was identified. Finally, it is the responsibility of transfusion physicians involved in the manufacture of blood products to ensure that CFNAs within a blood product do not have a clinical impact on the innate immunity of recipients. According to recent in vitro investigations, CFNAs purified from blood products can induce the transcription of inflammatory cytokines by mononuclear cells. Since non-human CFNAs have an effect on Toll-like receptors (TLR-linked inflammatory pathways), it would also be relevant to ensure that donor CFNAs do not have a significant effect on the recipient's immune system. In conclusion, CFNAs are highly diverse molecules that contaminate blood products. Technological progress now makes your research more accessible. In addition to being useful markers of infection in asymptomatic donors, their impact on the immunity of recipients needs to be further investigated.

Academy Day: Various Facets of Donor Management

2A-01-01

IMPACT OF BLOOD DONATION ON EXERCISE TOLERANCE

JW Helge

Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark

An active lifestyle and regular training are part of a healthy lifestyle and for many this includes participation in resistance exercise competitions at different levels. Therefore, it is very relevant to know how a blood donation affects exercise performance and how close it can be to an endurance competition. Endurance exercise performance is determined by many factors, but three of the main ones are maximal oxygen uptake, the relative load an individual can withstand over time, and finally, the efficiency of movement in the given discipline.

Over the years, several studies have sampled blood volumes ranging from 450 to 1200 mL and have applied different methodological approaches to measure maximal oxygen consumption during a recovery period ranging from 3 to 28 days. In general, the general finding is a reduction in blood hemoglobin and attenuated maximal oxygen consumption, as well as endurance performance after blood donation. In normal to well-trained men, maximal oxygen consumption and performance normalized after two weeks in one study following normal blood donation (450/470 mL), but remained attenuated after four weeks in another study, a even though the change in blood hemoglobin concentration was similar. and the design and methodology also similar in the two studies.

In addition to maximal oxygen consumption, the relative load that can be tolerated during exercise is probably also attenuated, through decreased arteriovenous oxygen extraction, but the available data are very limited. The first part of this talk will highlight the main findings and discuss some of the methodological issues that complicate interpretation and conclusions.

There are sex differences in circulating blood volume, hemoglobin concentration, hematocrit, and hormone levels, and therefore it is quite possible that there is a sex difference in the effect of donating blood on physical performance and recovery after blood donation. In addition to basic physiological sex differences, there is also a higher prevalence of iron deficiency in premenopausal women, physically active women, and women who donate blood. Therefore, we studied the influence of a standard 450 ml blood donation on maximal oxygen consumption and endurance performance and subsequent recovery in physically active women. We observed that in iron-sufficient women, blood hemoglobin concentration and maximal oxygen consumption returned to baseline 28 days after blood donation, but endurance performance already normalized after 14 days. The second part of this talk will discuss gender differences in the effect of donating blood on maximal oxygen consumption and endurance performance.

In general, the available data suggest that, with a careful and conservative approach, it takes 4 to 5 weeks after a normal blood donation to make a full recovery and be able to participate in endurance exercise competition.

2A-01-02

HOW DOES THE POSTPONEMENT AFFECT THE BLOOD DONOR?

has davison1, B lots2, C Gemini1

1Clinical Services and Research, Australian Red Cross Blood Service, Melbourne2School of Psychology, University of Queensland, Brisbane, Australia

More than one in ten attempts to donate blood result in a temporary postponement, due to concerns about the impact of the donation on the donor or recipient. There is well established evidence that temporary deferrals have a negative impact on donors, with a large proportion of deferrals not returning at the end of the deferral period. This presentation provides an overview of deferrals from the donor's perspective and describes the likelihood of receiving a deferral for different subgroups of donors. The impact of temporary deferrals on future donor giving will also be reviewed, taking into account both short-term and long-term giving patterns, highlighting which donors are most at risk of non-return after a deferral and what is known on the cumulative impact of multiple postponements on donors. Several hypotheses have been proposed to explain the strong negative impact of deferrals on donor behaviour, and there is preliminary evidence of psychological factors, such as emotional reactions, predicting the intention to return. Research is also beginning to emerge on the effectiveness of tailored interventions to mitigate the impact of deferrals on donor behaviour. The evidence for these preventive interventions and for strategies to reactivate donors once they have expired after deferral will be reviewed. Recommendations for blood centers will be made, as well as suggestions for future research to address continuing gaps in knowledge.

2A‐01‐03

THE GIFT OF LIFE - DOES IT APPLY TO THE RESEARCH DONATION?

V Raivola

Finnish Red Cross Blood Service, Helsinki, Finland

In his influential study “The Gift Relationship” (1970), Richard Titmuss coined the idea that voluntary, unpaid blood donation is the gift of life to a fellow citizen. This metaphor has been powerful in mobilizing donors (Busby 2004). It conveys a direct relationship between blood donation and the vitality of patients, as well as a difference between profits and costs. As a gift of life, blood donation is considered to symbolize pure altruism and promote solidarity among strangers. But can we apply the metaphor just as successfully to donating blood for research? We asked a group of Finnish blood donors what they would think if the FRC Blood Service invited them to give a blood sample and personal information for research. Blood donors were generally willing to contribute to research for the public benefit, because they saw great potential in science to create solutions to help patients in the future. However, based on data from our interviews and previous research, we suggest that the analogy between the gift of life and donating to research did not quite work. The metaphor does not address donor questions about new types of relationships, interests, and risks related to the use of personal data for research. If not answered, this could discourage research donations. Therefore, we argue that the gift of life metaphor is not applicable to donor recruitment in the context of research. In this presentation we want to look for a better metaphor for research donation that could be applied by blood services that collect research data.

Academy Day: Transfusion challenges in patients with sickle cell disease

2A-02-01

IMMUNOHEMATOLOGICAL CHARACTERISTICS OF PATIENTS WITH SICKLE CELL DISEASE

By tuna boat

CNRGS, National Institute of Blood Transfusion, Paris, France

Sickle cell disease (SCD) is the most prevalent genetic disorder in France, where it mainly affects people of African descent or people from the French West Indies. Many other countries are also affected, and more recently, with increased migration, SCD has become a global public health problem.

Transfusion remains a key treatment for patients with SCD; It is used as curative or preventive therapy. As a result, they are much more exposed to transfusions than the general population. In 2017, according to the French hemovigilance system, in the general population the transfusion rate was 0.78%. Different cohorts of SCD patients report significantly higher transfusion rates, ranging from 18% (in S/C or S/β+patients) to 98% (in SS or S/β0patients). Another difference, with the general population, is how early in life SCD patients are transfused.

Consequently, SCD patients are much more exposed to alloimmunization and delayed haemolytic transfusion reactions (DHTR), the latter being the most feared complication. In certain situations, defined as hyperhemolysis, the autologous red blood cells are also attacked and destroyed. This can put the patient in a life-threatening situation. Therefore, healthcare professionals should be familiar with the main immunohaematological features of patients with SCD and DHTR.

Alloimmunization occurs when there are discrepancies between the red blood cell phenotypes of the recipient and the donor. The typical phenotype of SCD patients is D+C−E−c+e+, K−, Fy(a−b−), Jk(a+b−), S−s+. The distribution of the alleles encoding this phenotype is nearly reversed in Africa and Europe. Some of the so-called low frequency antigens (LFA) should be considered as polymorphic antigens in the African population and these LFAs are not present in most commercial panels. The situation is even more complicated when recipients lack high-frequency antigens, the most common being Hr‐, HrB‐, Sec‐, Uneg, U+era, Js(b-), (Hy-), and Jo(a-). Finally, there is a high diversity of Rh among people of African descent. Because they harbor variant alleles and/or partial HR antigens, they are at risk of developing alloantibodies. In this context, the detection of partial HR antigens makes sense. The figures illustrating this diversity vary depending on the approach used. One of them is to take into accountright hand driveoRHCE*cevariant alleles. In various American studies, their prevalence was estimated to be 29-36% and 53-72%, respectively. Other kits take into consideration the partial antigens D, C and e. Their prevalence was estimated to be 8.4% to 14%, 12.5% ​​to 27.7%, 3.3% to 3.5%, respectively, and alloimmunization rates were 17.6%, 14 .3% to 30%, 7.1%, respectively.

As a result of these phenotypic discrepancies, patients with SCD are more likely to be alloimmunized. A general immunization rate of 2-6% is generally accepted in the general population. Depending on the unit selection policy and/or the study design, the immunization rate in SCD patients ranges from 7% to 76%, with the highest figures being established when an ABO/RH1-only matching policy is implemented. In a meta-analysis of 24 publications, overall alloimmunization rates were around 20%.

Alloimmunization is believed to be enhanced by an inflammatory state, which is often present in SCD patients. They are more likely to develop a new alloantibody. Using a stochastic model of alloimmunization, they have a 61% increased risk of producing additional antibodies versus 30% in the general population.

Autoantibodies have been identified as a risk factor for alloimmunization. As a result, patients with SCD often have complex mixtures of alloantibodies and autoantibodies. RH antibodies and those considered as irregular natural antibodies are present in a significant proportion.

Another feature of antibodies in SCD patients is their evanescence; up to 70% of alloantibodies become undetectable within a few years of their initial development. Relatedly, about one third of DHTRs are reported to occur in patients with no prior immunization history. Furthermore, one third of patients will not develop an antibody after a DHTR.

Identifying patients at risk of developing DTRD is key to managing them appropriately.

2A-02-02

MATCHING PHENOTYPES AND ALLELES: HOW FAR SHOULD WE GO?

C Folman1, Evan der Schoot2, M. de Haas1,3,4

1Immunohematology Diagnostics, Sanquin Diagnostic Services2Experimental Immunohematology, Sanquin Research and Landsteiner Laboratory, Amsterdam University Medical Center, Amsterdam3Clinical Research Center, Sanquin Research4Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands

Alloimmunization is a serious risk of red blood cell transfusion in patients with sickle cell disease (SCD) and can lead to severe (delayed) hemolytic transfusion reactions, exacerbation of clinical symptoms, and life-threatening hyperhemolysis. Once alloimmunized, the presence of alloantibodies in the blood of patients further complicates pre-transfusion testing and makes selection of compatible blood products difficult. Numerous studies have shown that patients with SCD are at relatively high risk of alloimmunization compared to the "general" population. This is not only explained by the large number of transfusions performed, but also by the increased exposure to foreign antigens as a result of differences in the antigen composition of SCD recipients and the blood donor population. Other factors involved in the immune response, such as age at first transfusion, inflammatory status, HLA typing, are under investigation and beginning to unravel.

Because blood transfusion remains one of the main treatment modalities for SCD and some patients have a lifelong transfusion dependency, it is important to minimize the rate of alloimmunization. Theoretically, full matching of all relevant blood group antigens would prevent alloimmunization. However, this is only possible when all donors are integral. Matching strategies must be developed to minimize alloimmunization while balancing patient needs and donor availability and cost-effectiveness. To develop a (preventive) matching strategy it is necessary to establish some factors; 1) what specificities of antibodies are clinically relevant 2) what antigens are most immunogenic 3) what is the availability of specific antigen types in the donor population 4) how should recipients (and donors) be typed, phenotypically and/or genotypically and what extent . The latter is especially important in patients with SCD since they are of African descent and the prevalence of genetic variations in this population is relatively high. RhD and RhCE variants are common and may go undetected when using serologic typing, but can be discovered with high-resolution molecular typing. Patients with partial Rh phenotypes are at risk of alloimmunization. Apart from special Rh phenotypes in individuals of African descent, the Fy(a-b-) phenotype related to the GATA-box mutation in theFYBallele and the U- or Uerathe phenotype resulting from genetic variations in the MNS alleles are also common.

Several studies have shown that in patients with SCD, antibodies directed against RhD, RhE, RhC, and K are found more frequently when mismatched transfusions are given. Preventive mating to these antigens has been shown to be successful in reducing alloimmunization. Extended matching for all Rh Fy(a), Jk(a) and Jk(b) antigens may further decrease the alloimmunization rate. Currently, different countries have preventive matchmaking strategies for this vulnerable group of patients. As genotyping becomes more widely available and affordable, optimal antigen typing approaches for patients and donors are being developed, combining serology and genetics. In this conference, various aspects of antigen typing approaches and preventive comparison strategies that will most benefit SCD patients will be discussed.

2A-02-03

MANAGEMENT OF DELAYED HEMOLYTIC TRANSFUSION REACTIONS AND HYPERHEMOLYSIS SYNDROME

trumpeter

No abstract available.

Academy Day: Artificial Intelligence and Ethics

2B-03-01

THE USE OF ARTIFICIAL INTELLIGENCE TO IMPROVE HEALTH CARE: WHAT DOES IT CONTRIBUTE TO TRANSFUSION MEDICINE?

B Geerts

Anesthesiology, Amsterdam UMC, Amsterdam, The Netherlands

Artificial intelligence has become a buzzword that will appear everywhere in the media. We can forget that AI, or the subfield in this field of computing, machine learning, has been around for over 50 years. Improvements in computing power, abundance of data, progress in computing, and the advent of affordable cloud solutions have now brought it into our daily lives.

In healthcare too, AI news has become ubiquitous. And some landmark papers have been published about algorithms outperforming (teams of) doctors in diagnosing all sorts of skin diseases, eye diseases from retinal scans, and cancer detection from CT scans. However, few of these solutions have appeared in our clinical practice yet.

In anesthesia, we work with the first algorithm that came to anesthesia practice; Hypotension during surgery is strongly associated with poor outcomes such as myocardial ischemia, surgical complications, renal failure, and even mortality. We work on a machine learning-trained algorithm that predicts hypotensive events using the blood pressure curve up to 15 to 30 minutes before the actual event.

However, to gain FDA and CE approval, a mere mathematical validation is required. This can be achieved in retrospective data sets. Actually, we need more before we can use these algorithms to support our decision making;

After the internal (retrospective) and external (prospective but passive use) validation steps, clinical validation (ie, RCT) is needed. In addition, we will also have to assess the economic impact. Ultimately, this tool has now made its way into clinical practice and is beginning to help us. move from a reactive hemodynamic management to a more proactive one.

Thus, we have started to work on machine learning tools to predict the incidence of specific types of patients admitted to the ED and to predict infections after surgery.

We'll discuss our approach, essentials for getting started with machine learning, how-tos. We will also discuss a first project design to use machine learning in the management of bleeding patients to obtain the best therapy advice for the use of blood products such as plasma, fibrinogen, etc. How can we start using this tool in unison with our existing tools to improve science and clinical practice in our respective (bio)medical fields?

2B‐03‐02

BLOOD DONATION: INCENTIVES AND INCENTIVES: WHERE TO DRAW THE LINE?

P Flanagan

New Zealand Blood Service, Wellington, New Zealand

The ISBT Code of Ethics (the Code) identifies that blood donation must be voluntary and non-remunerated (VNRD). The Council of Europe definition of VNRD contained in the Code states that "A donation is considered to be voluntary and unpaid if the person donates blood of their own free will and is not paid for it, either in cash or in kind that can be considered a substitute for money. This would include time off work not reasonably necessary for the donation and travel. Small tokens, soft drinks, and direct travel expense reimbursements are compatible with voluntary unpaid donation.. In practice, however, Blood Services must ensure that there are enough suitable donors available to meet the clinical needs of the patients and hospitals they support. In an increasingly busy world, blood services must compete with other organizations that promote community health and wellness to achieve this. Promotional and marketing activities are used both to attract new donors and to encourage repeat donations from regular donors. Care must be taken to ensure that these activities do not inadvertently violate the principles that underpin the VNRD. The question of when an activity ceases to be a stimulus to altruistic donation and provides the potential donor with a benefit that acts as an incentive for them to donate, then arises. The Nuffield Council on Bioethics in their publication on ‘Human Bodies: Donation for medicine and research'has developed an "intervention ladder" to help answer this question. The ladder comprises six categories of interventions (rungs) designed to increase the likelihood that a person will give and ranks them in order of ethical complexity from providing information (rung 1) to providing financial incentives (rung 6). In doing so, they also identify that 'how individuals respond to such inputs will clearly vary from person to person, and indeed there will inevitably be some degree of overlap in how people respond to neighboring rungs.'. This suggests that there is no easy or clear limit to identify what might be acceptable and that some activities might be acceptable to one sector of the population but not to others. This presentation will explore some of these boundary issues and help develop some principles to help manage the dilemmas.

Academy Day: Transfusion-Related Issues in Babies and Children

2B-04-01

TRIGGERS OF PLATELET TRANSFUSION IN NEONATES

and lopriore

Neonatology, LUMC, Leiden, The Netherlands

Thrombocytopenia is a very common hematologic abnormality found in newborns, especially premature infants. Two subgroups can be distinguished: early thrombocytopenia, which occurs within the first 72 hours of life, and late thrombocytopenia, which occurs after the first 72 hours of life. Early thrombocytopenia is associated with intrauterine growth restriction, while late thrombocytopenia is mainly caused by sepsis and necrotizing enterocolitis.

Platelet transfusions are the hallmark of treatment for neonatal thrombocytopenia. Most of these transfusions are prophylactic, meaning they are given in the absence of bleeding. However, the effectiveness of these transfusions in preventing bleeding has never been proven. Furthermore, the risks of platelet transfusion appear to be more pronounced in preterm infants. Due to the lack of data, platelet transfusion guidelines differ widely between countries.

In a recent randomized controlled trial (Planet‐2/Matisse study) among preterm infants with severe thrombocytopenia, we found that those randomized to receive platelet transfusions at a platelet count threshold of 50 × 109/L had a significantly higher rate of death or major bleeding within 28 days of randomization than those who received platelet transfusions at a platelet count threshold of 25 × 109/l

This presentation summarizes the current understanding of the etiology and treatment of neonatal thrombocytopenia.

2B-04-02

TACO DIAGNOSIS IN CHILDREN

F. Gauvin

Pediatrics, CHU Sainte-Justine, Montreal, Canada

Transfusion-associated circulatory overload (TACO) is a serious adverse transfusion reaction that is associated with increased mortality and morbidity. The incidence of TACO in adults ranges from 1% to 8%, but it probably goes unreported and undiagnosed. The incidence in the pediatric population is undetermined.

TACO usually occurs in patients receiving a large volume of blood products in a short period of time. It is more common in patients with known risk factors such as cardiovascular disease, renal failure, and older or younger age (>60 years or <3 years). Hospitalized patients and intensive care patients are also more at risk.

The typical presentation of TACO is respiratory distress (dyspnea, tachypnea) occurring within 12 hours of a blood transfusion. Associated signs and symptoms are hypoxia, hypertension, tachycardia, positive fluid balance, elevated central venous pressure, and acute or worsening pulmonary edema on chest radiograph. Echocardiography and measurement of brain natriuretic peptide (BNP) or its N‐terminal prohormone (NT‐proBNP) are helpful for diagnosis.

Several definition criteria for TACO have been proposed, but none are adapted for children, particularly critically ill children who are most at risk. This is probably the main reason why TACO is still further underdiagnosed and underreported in the pediatric population. In a recent study, we compared the incidence of TACO in a pediatric intensive care unit using the International Society for Blood Transfusion (ISBT) criteria, with two different ways of defining abnormal values: 1) using normal pediatric values ​​published in the Nelson's Textbook of Pediatrics; and 2) use the patients as their own controls and compare values ​​before and after transfusion with a difference threshold of 10% or 20%. We monitor the TACO up to 24 hours after the transfusion. A total of 136 patients were included. The incidence of TACO ranged from 1.5% to 76%, depending on the definition used. With such wide variability, it is concluded that a more operational definition of TACO in pediatrics is needed, particularly for critically ill children.

The differential diagnosis of other adverse transfusion reactions associated with dyspnoea (eg, transfusion-associated lung injury, anaphylaxis) is important because treatment differs, as do blood bank guidelines. The treatment of TACO is similar to that of any other cardiogenic pulmonary edema: oxygen, diuresis, ventilatory support. Prevention is possible by avoiding unnecessary transfusions, transfusing only the necessary amount of blood product, avoiding rapid transfusions, and using diuretics.

2B-04-03

APPLICATION OF PRINCIPLES OF PATIENT BLOOD MANAGEMENT (PBM) IN PEDIATRIC PATIENTS

G Crighton1,H New2, Stanworth3

1Haematology, Royal Children's Hospital, Melbourne, Australia2Hematology Centre, Imperial College, London3Clinical Hematology, John Radcliffe Hospital, NHS Blood and Transplant Oxford, Oxford, UK

Globally, children under five years of age have the highest prevalence and the most severe degrees of anemia. Iron deficiency is the major contributing cause of anemia in children, and children are the population group most vulnerable to the detrimental long-term effects of anemia and iron deficiency.

Patient blood management (PBM) refers to an evidence-based package of care that aims to improve patient outcomes through optimal use of transfusion therapy, assessment, and treatment of anemia, optimization of hemostasis and the use of blood conservation strategies. Patient blood management is now internationally endorsed as a standard of care and PBM interventions are well established in adults, but implementation in pediatric settings lags behind. This is partly because pediatricians are not familiar with the term PBM, and also because definitions, guidelines, and implementation strategies developed for adults are not always applicable to neonates, infants, and children. There is also a paucity of literature specifically examining pediatric blood management. This article discusses a number of important key elements in pediatric PBM and how PBM principles can be applied to pediatric settings.

Academy Day: Managing Transfusion-Transmitted Infections

2C-05-01

A RISK-BASED DECISION-MAKING FRAMEWORK FOR BLOOD SAFETY: WHAT IS THE CASE FOR ZIKA?

E Bloch

Pathology, Johns Hopkins University School of Medicine, Baltimore, United States

Risk-Based Decision Making (RBDM) is a decision-making approach that weighs the complex interplay of all the factors that influence policy related to a given health threat. RBDM strives to minimize risk, optimize results, and prioritize resources for the greatest good. In the context of blood transfusion safety, RBDM arises from a growing awareness that the current paradigm of achieving "safety at any cost" is unsustainable and unbalanced. This has been unduly shaped by historical failures, mostly revolving around the HIV response in the 1980s. By contrast, RBDM strives to assess all input objectively. The global assessment encompasses scrutiny of the best available scientific data at the time of decision-making, broad participation of key stakeholders, and careful consideration of ethics, social values, politics, economics, and historical precedents. both for and against intervention. RBDM emphasizes proportionality. It should also allow for the review of decisions in the light of new data, with the scope to modify accordingly, recognizing that the merits of a given policy may change based on new findings. Zika virus, a previously unknown mosquito-borne flavivirus, emerged rapidly in 2015, sparking an international public health emergency. The response in the United States (US) offers an illustrative case study of the challenges surrounding intervention for transfusion-associated infections. Demonstration of serious clinical complications in selected patient subgroups (ie, fetuses), large number of travel-acquired cases, and rare cases of autochthonous transmission, evidence of viraemia in blood donors, and plausible transfusion transmissibility prompted mandatory testing adoption. donor nucleic acid (ID ‐NAT), a political decision that remains controversial. The Zika pandemic has abated with low numbers of cases reported in the continental US in 2018, all of which were acquired through travel. Four years after the appearance of Zika in the Americas, no clinical cases have been attributed to blood transfusions. The modeled cost‐utility of ID‐NAT in the US and US territories (eg, Puerto Rico) is $341 million per quality-adjusted life year. The gross cost of testing is $137 million per year. Blood collection agencies are under financial pressure, discouraging investment in strategies to deal with infectious risks that, unlike Zika, have demonstrated risk to the blood supply (e.g., bacterial contamination,Babesia). However, while the decision to test US blood donors for Zika might be viewed unfavorably, in many ways it has been faithful to RBDM. This highlights the many challenges of RBDM, whereby decisions must balance historical precedent, disparate stakeholders, public perception, culture, and national politics, all of which have a significant impact on decision making. The challenge is to reconcile these factors to restore proportionality and room for review.

2C‐05‐02

SCREENING STRATEGIES TO MINIMIZE THE RISK OF TT-HEV INFECTIONS

Vollmer, C Knabbe, J Dreier

Institute for Laboratory Medicine and Transfusion, Heart and Diabetes Center North Rhine-Westphalia, University Clinic of the Ruhr University Bochum, Bad Oeynhausen, Germany

Bottom:The risk and significance of transfusion-transmitted hepatitis E virus (TT‐HEV) infections from contaminated blood is currently a controversial issue in transfusion medicine. In particular, the infectious dose is an amount not ultimately determined. Different countries have chosen different approaches to deal with this pathogen. A central issue is the need for individual NAT (ID) versus minipool NAT (MP) screening approaches to identify all relevant viraemias in blood donors.

Goals:Comparison and evaluation of the available screening strategies in relation to the infectious dose to minimize the risk of TT‐HEV infections.

Methods:We systematically reviewed currently known cases of TT‐HEV infections and available NAT screening assays. In addition, blood donation screening strategies for HEV EHEV in force in the European Union were compared. We also describe our own HEV screening experiences using a donor screening algorithm based on ID‐NAT compared to MP‐NAT in pools of 96 samples. From November 2017 to January 2018, a total of 10,141 blood donations were tested for the presence of HEV RNA using an MP‐NAT (in house, RealStar HEV RT‐PCR Kit) and an ID‐NAT (platform cobas 6800).

Results:The review of the literature revealed a significant variation in terms of the infectious dose causing hepatitis E. In the systematic review of cases, all components with a viral load (CV) greater than 5.00E+04UI caused infection (definitive infectious dose (DIFD).The infectious dose resulting in overall observed TT‐HEV infection was 7.05E+03IU (minimum infectious dose (MIFD). The infectious dose of different blood products is mainly influenced by the remaining plasma content .

Our data comparing the two different HEV detection algorithms revealed eight HEV RNA positive donations by MP‐NAT (incidence 1: 1,268), while ID‐NAT identified 17 HEV RNA positive donations (incidence 1: 597). ; all ID‐NAT positive donations only had VL < 25 IU/ml.

Summary/Conclusions:Taking into account current knowledge about the required MIFD, DIFD, and analytical sensitivities of detection methods, we extrapolated the detection probability of HEV-RNA positive blood donors using different testing strategies (NAT assay, ID vs. minipool with different pools). sizes). We also consider the amount of plasma in the different blood products and calculate the infectious doses needed to be detected. ID tests alone would be sufficient to detect the minimal VL in the donor to avoid TT‐HEV infections according to the currently known MIFD, but a highly sensitive MP‐NAT should be suitable as a routine screening assay to identify highly viraemic donors. and avoid TT ‐HEV infections according to the DIFD. We also found that the incidence of HEV infection was approximately 50% higher if ID‐NAT was used. However, the CV was below 25 IU/ml and would most likely not lead to TT‐HEV infection based on the currently known MIFD or DIFD. The clinical relevance and need for identification of these HEV-positive low-level donors still require further investigation.

2C-05-03

UPDATE ON PATHOGEN INACTIVATION TECHNOLOGY

M Lozano, J Cid

Hemotherapy‐Hemostasis, Hospital Clínico Universitario, Barcelona, ​​Spain

In the last 25 years several pathogen inactivation (PI) technologies have been developed to be applied to blood components. Technologies to inactivate pathogens in plasma and platelets are available in the European Union, and some others are currently under development. The first IP technology introduced to the market was by plasma, and it was based on the addition of methylene blue and illumination with light (Theraflex MB‐Plasma, MacoPharma and Grífols). For platelets and plasma, two technologies are licensed, one based on the addition of amotosalen and illumination with ultraviolet (UV) light (Intercept®, Cerus) and the other combines the addition of riboflavin (vitamin B2) and illumination with UV light (Mirasol®, Terumo BCT). Another technology for platelet inactivation is currently under development, based on illumination with UVC light and strong shaking (Theraflex, MacoPharma). For red blood cells, a technology based on the addition of a molecule (amustalin, Cerus) is being developed. The mechanism of action and the spectrum and level of inactivation of pathogens varies between the different technologies. Furthermore, the number of studies with clinically relevant endpoints and the number of patients included in the studies is not homogeneous. There is published evidence for most of them showing that the treated blood components are safe and effective for patients although, for the treated platelet concentrates, there is some decrease in post-transfusion recovery and survival of transfused platelets, with differences between the different technologies. However, the accumulated experience on the routine use of some of the technologies over almost 20 years supports the concept of safety and efficacy of blood components treated with pathogen-inactivation technologies without a significant increase in use. The use of pathogen inactivation for blood components is not widespread. Differences in epidemiology between countries, perception of infectious risk, concerns about possible adverse effects associated with its use, and economic considerations could explain the observed differences in its implementation.

Academy Day: Immunohematology

2C-06-01

P1PK: A BLOOD GROUP SYSTEM WITH IDENTITY CRISIS

Oh Hellberg

Division of Laboratory Medicine, Office of Medical Services, Clinical Immunology and Transfusion Medicine, Lund, Sweden

The history of the P1 and the Pkantigens is complicated and sometimes confusing due to various changes in nomenclature. The association between antigens and their genetic home has raised many questions, as well as the long-standing enigma about the molecular mechanism underlying the common P1 and P2 phenotypes.

The system (ISBT no. 003) currently includes three different antigens, P1, Pkand NOR. The P1 antigen was discovered as early as 1927 by Landsteiner and Levine while Pkand NOR were described in 1951 and 1982, respectively. As for the ABO system, natural antibodies of the IgM and/or IgG classes can be formed against the missing P1/P.kcarbohydrate structures. Anti‐P1 is usually a weak, cold‐reactive antibody that is very rarely implicated in haemolytic transfusion reaction (HTR) or haemolytic disease of the fetus and newborn (HDFN). However, some antibodies to P1 have been reported to react at 37°C, bind complement, and cause both immediate and delayed HTRs. the pkantibodies can cause HTR and anti‐NOR is considered a polyagglutinin of unknown clinical significance. A higher frequency of spontaneous abortion is observed in women with the rare p and P1 phenotypesk/P2k. Fetal and newborn red blood cells express low amounts of P1, P, and Pkantigens, but the placenta shows high expression and is therefore a potential target for antibodies and the cause of spontaneous abortions. the pkand P1 antigens have wide tissue distributions and can act as host receptors for various pathogens and toxins. Furthermore, the altered expression of PkThe antigen has been described in various forms of cancer.

A long-standing question has been why individuals with the p phenotype do not just lack Pkand expression of P but also of P1. It was recently clarified that the sameA4 gallonThe encoded galactosyltransferase synthesizes both P1, Pkand NOR antigens and, furthermore, the P1 and P2 phenotypes were confirmed to be caused by transcriptional regulation. Transcription factors selectively bind toPAG1allele in the 5' regulatory region ofA4 gallon, which enhance gene transcription.

It has been debated whether the Pkand P1 antigens exist on human red blood cell membrane glycoproteins or whether glycolipids are the only membrane components that carry these epitopes. A recent publication shows that the P1 antigen can be detected on human red blood cell glycoproteins and therefore glycosphingolipids can no longer be considered as the sole carriers of the antigens.

The blood group system that started with one antigen, P1, has now gained two more members, namely Pkand NOR. Step by step the biochemical and genetic basis underlying the antigens expressed in this system has been revealed, but many questions remain to be resolved.

2C‐06‐02

WHY ARE THE GATA AND KLF REGULATORY GENES INCLUDED IN THE BLOOD GROUP TABLES?

N Nogués

Immunohematology, Blood and Tissue Bank, Barcelona, ​​Spain

Neither GATA1 nor KLF1 represent a blood group system, but mutations in the genes encoding these transcription factors (TFs) have been shown to result in co-impaired expression of blood group antigens in certain rare blood group phenotypes. In particular, mutations in the KLF1 gene are responsible for the dominantly inherited In(Lu) phenotype, commonly referred to as Lu(a-b-) due to the greatly reduced expression of Lutheran antigens. However, red blood cells from In(Lu) individuals have also weakened the expression of other blood group antigens, such as the high incidence antigen AnWj, the Indian blood group system antigens (CD44), and P1, among others. . Since the first description of KLF1 variants associated with the In(Lu) phenotype, many other variants of this gene with an impact on blood group antigen expression have been reported and are listed in the KLF1 table of blood group alleles. . Apart from KLF1, a mutated GATA1 gene associated with the X-linked form of the Lutheran-mod phenotype has also been found and has also been recorded in the GATA1 allele table. In addition to the effect of TF variants on blood group antigen expression, transcription factor binding site polymorphisms exist in the regulatory regions of blood group genes, which also have an impact on the expression of encoded antigens. in red blood cells. The first example of this type of polymorphism was described in 1995, when it was discovered that the interruption of a GATA motif in the promoter of the ACKR1 gene abolished the expression of the erythroid gene in Fy(a-b-) individuals of African descent. The impact of mutations affecting GATA1 binding sites has also been described in some ABO subgroups, such as the Am and Bm phenotypes. A regulatory element with GATA-binding sites in the first intron of the ABO gene has been found to be altered in individuals with these phenotypes, either by deletion or by a point mutation that disrupts the GATA motif.

Recent findings have also revealed that Xga expression in red blood cells is dependent on GATA1 binding to a control element located 3.7 kb upstream of the XG gene. A single nucleotide polymorphism (SNP) within this region was shown to correlate very well with the expected distribution of the Xga negative phenotype in different populations. Subsequent work has shown that this G>C SNP disrupts a GATA1 binding site and consequently suppresses Xg expression in erythrocytes. Overall, these investigations have elucidated the underlying genetic basis for Xga expression and made Xga genotyping possible. Like Xga, the P1 antigen has long been known to be determined by the A4GALT gene, but the molecular basis underlying the common P1/P2 phenotypes has remained unknown until recently. Several cis-regulatory SNPs were identified in non-coding sequences around exon 2a, which showed a very good correlation with the expression of the P1 antigen. Interestingly, potential binding sites for several hematopoietic TFs were identified in the same region. Finally, recent investigations have demonstrated the role of RUNX1 TF in the expression of the P1 antigen, through selective binding to a regulatory site present in the P1 alleles but not in the P2 alleles. In summary, variation in blood group antigen expression may be due to mutations or polymorphisms in the regulatory region of blood group genes. Recent reports have revealed the molecular mechanisms underlying the expression of P1 and Xga blood group antigens, implicating the binding of TF to allele-specific regulatory elements. Similar mechanisms may also regulate antigen expression in other blood group systems.

2C‐06‐03

CELL-FREE FETAL DNA FOR FETAL BLOOD GROUP GENOTYPING: NON-INVASIVE PRENATAL TESTING

FB Clausen

Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark

Since the discovery of cell-free fetal DNA (cffDNA) in the blood of pregnant women, the development of non-invasive prenatal tests (NIPT) has provided new diagnostic applications in prenatal care. In transfusion medicine and clinical immunology, cffDNA is extracted from maternal plasma to predict fetal blood groups for the purpose of 1) guiding targeted Rh prophylaxis in nonimmunized RhD-negative women and 2) assessing the risk of hemolytic disease of the fetus and the patient. newborn (HDFN) in immunized women. I will give an overview of non-invasive prenatal testing for fetal blood groups. Based on the literature, I will summarize the current experience with non-invasive prenatal testing for fetal RHD and other blood groups. For RhD-negative pregnant women, routine clinical testing is available in several countries around the world to assess HDFN risk in D-immunized women, and routine testing to guide Rh prophylaxis is now implemented as a national service in 6 or 7 European countries. Non-invasive prenatal tests for fetal RHD are highly accurate with sensitivities of 99.9%, as reported by clinical programs. In general, sensitivity is challenged by low amounts of cffDNA, especially in early pregnancy. Specificity is challenged by the Rh polymorphic blood group system, where careful attention is needed to navigate among the many RHD variants. RHD variants can complicate cffDNA analysis and interpretation of results, especially in ethnically mixed populations. Despite these challenges, fetal RHD testing is highly feasible when implemented with careful attention to these issues. For blood groups that are determined by SNPs, such as KEL or Rhc, the main challenge has been interference from maternal DNA when analyzing fetal DNA, resulting in low precision and lower sensitivity when using qPCR. With the application of newer techniques such as next generation sequencing and digital droplet PCR, accurate non-invasive prediction of these fetal blood groups has been demonstrated. The success of fetal RhD prediction and its successful clinical implementation in national programs should encourage widespread use of cell-free DNA-based testing. Future work on non-invasive prenatal testing of SNP-determined fetal blood groups may consolidate the application of cell-free DNA testing for such targets, including human platelet antigens. At ISBT, the newly formed cfDNA subgroup of the Red Blood Cell Immunogenetics and Blood Group Terminology Working Group will work to facilitate clinical applications, implementation, and evaluation of cell-free DNA tests.

Academy Day: New technologies for transfusion medicine

2D-07-01

IT IN BLOOD BANKS, PRESENT AND FUTURE. A NORDIC PERSPECTIVE

Jensen

Aarhus University Hospital, Department of Clinical Immunology, Aarhus N, Denmark

Blood banks in most of the Nordic countries share a vein-to-vein approach which, in short, means that blood collection, blood component preparation, testing/release and storage are handled by a single actor. On top of that, recipient and donor blood grouping, crossmatching, delivery, registration of the transfusion and of any complications are usually handled in a single blood bank information system (BBIS). This means that blood banks in the Nordic countries are traditionally operated by a single provider.

Process control needs in a single-vendor BBIS, current solutions, unresolved challenges, and untapped possibilities to simplify processes have been discussed with the intent of describing separate processes and acquiring the best IT systems for your business. class or suite. Aiming for integrations, rather than building an integrated IT system, to support the need for a vein-to-vein process is a precondition in the Nordic countries.

With multiple IT systems supporting siled processes, we intend to facilitate siled process development and also increase flexibility throughout the process.

We set out to disclose any existing knowledge in the literature on IT vendor strategies for blood banks, but failed to identify any relevant literature. However, a systematic review of the literature on provider strategies when choosing Health IT was based on the PRISMA method and identified 837 studies, but only 10 were eligible for full-text review and 5 met the inclusion criteria.

Even this larger literature survey reveals very little evidence. Two studies find single-vendor strategies poor and conclude that "best-of-suite" solutions are optimal. One study was unable to correlate vendor strategies with researched productivity, but concludes that best-in-class and suite strategies require larger organizational changes than a single-vendor strategy.

In short, the existing research is contradictory.

This work adds basic knowledge to break down blood bank process control into smaller processes. This adds the ability to identify best-in-class or best-suite vendors, rather than relying on single-vendor IT solutions. Furthermore, it is a call for more research in the field of supplier selection strategies that this study failed to identify.

2D-07-02

APPLYING DRONES TO SUPPLY BLOOD TO REMOTE AREAS: THE RWANDAN EXPERIENCE

S Gate

Biomedical Services, Rwanda Ministry of Health, National Blood Services, Kigali, Rwanda

Bottom:In Rwanda, blood transfusion services began in 1976. During the 1994 genocide against the Tutsis, almost all of Rwanda's socioeconomic fabric was destroyed, as was its health infrastructure. The health system was taking a hit, and there were health inequalities between urban and rural areas, including access to blood for transfusions. Starting in 1995, the government began to rebuild all the courses of life, including the health system and, in particular, the blood service. The National Center for Blood Transfusion (NCBT) was then mandated to provide safe, effective and appropriate blood and blood components to all patients in need. This was critical to achieving health-related MDGs 4, 5 and 6.

Today, Rwanda has an ambitious vision of putting all 12 million citizens within 30 minutes of any essential medical product. While every second counts in emergency management, the use of drones was the perfect solution to many of the last mile challenges that have traditionally been difficult to overcome. It is impossible to accurately forecast even the need for a single patient. The government has provided an easy solution by centralizing supply and providing on-demand emergency medical deliveries via drones.

Physicians are now empowered to provide quality care with all available supplies, patients can now receive treatment close to home, and we eliminate the waste of potential overstock when healthcare workers know they have a quick and reliable source of supply. reliable.

Description:In 2016, the Rwandan government began operating the world's first national drone delivery program for blood and other life-saving medical products. These drones can transport two to six units of blood at a time and deliver them in 15 to 45 minutes, depending on the location of the hospital. The average duration was 2 to 4 hours round trip with the vehicle system, before the use of Drones. The drones are currently delivering blood to 25 health centers across the country and are expected to reach 90% of transfusion health centers outside of Kigali by the end of the year.

During the first year, health workers saved an average of 3.1 hours per delivery and a total of 10,115 hours of wasted time in roadside pickup that could be spent on patient care. As of March 2019, more than 11,000 deliveries have been made, of which 30% are emergency deliveries. A total of more than 19,500 units of blood have been delivered. In February 2018, Zipline earned the highest rating of healthcare facilities served in a performance evaluation conducted by the National Center for Blood Transfusion.

When a doctor or medical staff member needs blood, they place an order through the hemovigilance order portal. They are then sent a confirmation message saying that a drone is on its way. The drone flies to the health center at a speed of up to 100 km/h. When you are within five minutes of the destination, medical personnel receive a notification. The drone then drops the package, attached to a parachute, into a special drop zone.

Conclusion:Supply is not a developing country problem, it is a global problem. Rwanda was just the first to recognize the potential of this technology and decided to do something about it first and fast, to ensure universal access to all blood products.

2D-07-03

NEW CHALLENGES IN BLOOD INVENTORY MANAGEMENT AND CABIN-SIDE TRANSFUSION

logia L

Scottish National Blood Transfusion Service, Edinburgh, UK

Supporting the provision of viable blood transfusion services in remote/rural areas is more than just a geographic challenge. Limited qualified blood bank resource; small production volumes; increased regulation are just three of the additional factors that are combining to threaten the safe and sustainable provision of blood transfusion services. Inventory management and after-hours service delivery were identified as essential areas where it was thought that technology, in the form of a remotely controlled blood fridge, could provide a key element of the overall solution. A radio frequency identification (RFID) refrigerator shelf system was installed in a standard blood bank refrigerator and connected to the laboratory information management system (LIMS) common to the remote and central blood bank. The central blood bank was able to analyze patient samples from the remote laboratory, identify the appropriate components located in the remote refrigerator for the patient, and enable correct delivery of the components, even when qualified personnel were not available at the remote laboratory. Testing has concluded that the installation of remote refrigerator management can play an important role in helping to maintain a remote inventory that enables the delivery of patient-friendly components. By keeping transfusion services in remote communities, we can avoid transporting patients requiring transfusion support to locations miles from home.

Academy Day: Platelet and Granulocyte Immunology

2D-08-01

WORK IN THE CASE OF GRANULOCYTE ANTIBODIES

carne bk

Laboratorio de Inmunogenética / HLA, DRK Blutspendedienst West, Bad Kreuznach, Alemania

Bottom:Granulocyte autoantibodies and alloantibodies have been implicated in a variety of clinical conditions, including primary and secondary autoimmune neutropenia, alloimmune neutropenia, and febrile and severe pulmonary transfusion reactions such as transfusion-related acute lung injury (TRALI).

Goals:To provide a study in case of antibodies against granulocytes.

Methods:An overview of clinical conditions, methods for antibody testing, typing, and antibody specificities related to different diseases will be provided.

Results:Autoimmune neutropenia occurs as a primary form in infants under three years of age or secondary to infections, malignancies or other autoimmune diseases mainly in adults and is associated in most cases with antibodies against HNA‐1a. Antibodies against HNA‐1b, FcgRIIIb and HNA‐2 have also been reported. Neonatal alloimmune neutropenia results from transplacental transfer of maternal antibodies to the fetus and is caused by all known specificities of HNA antibodies, i.e., HNA-1a, -1b, -1c, -1d, HNA-2, HNA-3a, ‐3b, HNA‐ Specificity 4a, -4b and HNA-5a. HNA and HLA antibodies can induce mild febrile transfusion reactions and TRALI. Since the introduction of the male-only plasma strategy, in many countries the incidence of TRALI has decreased, but it remains one of the most common causes of serious transfusion reactions. Especially plasma containing HNA-3a antibodies from female donors is responsible for serious or even fatal reactions. But HNA-1a, -1b, HNA-2, and HLA class I and class II antibodies were also reported. The latter activate monocytes to secrete soluble factors that act on primed neutrophils in narrowed pulmonary capillaries.

Lab test:The laboratory study requires knowledge of the patient's clinical condition and the appropriate methods to detect the relevant antibodies. The classical granulocyte agglutination test (GAT) in combination with the granulocyte indirect immunofluorescence test (GIFT) can detect almost all relevant antibodies. HNA-1, -2, -4, -5 and HLA class I antibodies are clearly detectable in GIFT whereas HNA-3 antibodies strongly agglutinate neutrophils in GAT. The Granulocyte Antigen Monoclonal Antibody Specific Immobilization Test (MAIGA) detects all HNA antibodies except HNA-3 with high specificity and glycoprotein sensitivity, but is time consuming and requires highly skilled personnel. For TRALI diagnosis, laboratory tests are completed with methods such as lymphocyte indirect immunofluorescence test (LIFT) or ELISA for HLA class I antibodies and ELISA specific for HLA class II. For several years, assays based on fluorescent beads (Luminex) allow faster and more automated detection of HNA antibodies, but to date not all specificities, especially HNA-3, can be detected reliably, so even the classic GIFT and GAT have to complete the methodological spectrum. Current serologic typing is confined primarily to determination of HNA-2 in the GIFT because the molecular reason for the HNA-2 null phenotype is not fully understood. Establishing only one PCR‐ASP reaction for the CD177*787A>T major polymorphism would risk missing other molecular causes. However, for all other HNAs, the first choice is aleotization by PCR methods.

Summary/Conclusions:Granulocyte serology today is still largely based on a variety of manual methods and will be reserved for specialized laboratories, as it requires experienced laboratory personnel and in-depth knowledge of granulocyte immunobiology.

2D-08-02

OPTIMAL ALGORITHMS FOR MOLECULAR AND SEROLOGICAL TYPING IN RESEARCH ON PLATELET ALLOANTIBODIES

awls

Norwegian National Unit for Platelet Immunology, Laboratory Medicine, University Hospital of Northern Norway, Tromso, Norway

Maternal alloantibodies to human platelet antigens can cause severe thrombocytopenia and bleeding in the fetus or newborn, identified as fetal/neonatal alloimmune thrombocytopenia (FNAIT). Although in most cases thrombocytopenia resolves spontaneously within the first 2 weeks of life, some infants have bleeding symptoms and therefore require a platelet transfusion. A set of laboratory tests is required to confirm the FNAIT diagnosis. In addition to guiding the affected newborn to match platelets, correct diagnosis will be valuable in assessing the risk of FNAIT in subsequent pregnancies.

In addition, antiplatelet alloantibodies can also complicate platelet transfusions by immune-mediated platelet refractoriness and require proper identification of patient antibody specificities prior to selection of donor platelets. The algorithm for laboratory investigations includes both serological and molecular assays, and depends on the objective and timing: whether there is an urgent need for platelet transfusion, monitoring of a known-risk pregnancy, or large-scale laboratory testing to confirm diagnosis. Molecular genotyping should include all HPA systems relevant to the local population (in Caucasians HPA-1, -2, -3, -5, and -15), preferably with optional extended panels for systems for low-frequency populations due to immigration/ motility and for less frequently observed alloantibodies (HPA‐4, ‐6 to ‐11 are included more frequently). Serologic evidence for antibody binding to platelets is often initially tested by flow cytometric analysis (direct match and/or cross match). However, the detection of platelet-specific antibodies is often complicated by the presence of anti-HLA class I antibodies and therefore requires sensitive platelet-specific glycoprotein assays. Serologic tests for platelet-specific antibodies include at a minimum antigen panels at GPIIb/IIIa, GPIb/IX, GPIa/IIa, and CD109 and preferably additional targets for populations of Asian/African origin. There are several methods available; that is, bead-based assays and ELISA-based methods. However, variants of the monoclonal antibody immobilization of platelet antigen (MAIPA) test are performed by most reference laboratories, as reported by the 19th ISBT International Workshop on Platelet Immunology (2018). Investigations also include measurement of anti‐HPA‐1a by quantitative MAIPA, if present, as this is reported to potentially predict the severity of FNAIT. For pregnancies with known risk of FNAIT, methods are available to perform noninvasive prenatal typing from maternal plasma. The most feasible and so far appropriate for routine testing is HPA-1 fetal typing with quantitative RoPCR using melting curve analysis. Other sophisticated but resource-demanding techniques have also been reported recently, which is important for the typing of other HPA systems as well.

2D-08-03

MOLECULAR BASIS OF HNA-2 EXPRESSION

Bayat B

Justus Liebig University, Institute for Clinical Immunology and Transfusion Medicine, Giessen, Germany

Human neutrophil antigen 2 (HNA-2) is a neutrophil-specific antigen located on the GPI-anchored glycoprotein CD177 (also known as NB1). HNA-2 is absent from the surface of neutrophils in 3 to 5% of healthy individuals, dividing the population into HNA-2 positive and HNA-2 null individuals. Exposure of HNA-2 null individuals to HNA-2 positive neutrophils during pregnancy, after transfusion, or transplantation induces immunization against HNA-2 and consequently isoantibody production. HNA-2 isoantibodies are involved in the mechanism of neonatal alloimmune neutropenia (NAIN), transfusion-related acute lung injury (TRALI), and graft failure after bone marrow transplantation.

The presence of CD177 on a neutrophil surface from HNA-2 positive individuals follows a bimodal expression that classifies circulating neutrophils into HNA-2 positive and negative subsets. The CD177 gene contains 9 exons that code for a protein of 437 amino acids. The lack of HNA-2 (in HNA-2 null individuals) is associated with the presence of a missense mutation, CD177*c.787A>T in exon 7 of the CD177 gene that induces a premature stop codon in the gene. codon 263. This mutation alone or in combination with CD177*c.997delG has been introduced as the major reason for the absence of CD177 in HNA-2 null individuals.

Un pseudogen (CD177P1) highly homologous to exons 4–9 of the CD177 gene is located downstream of the CD177 gene. Conversion of exon 7 of CD177P1in the CD177 gene is responsible for the generation of the CD177*c.787A>T missense mutation.

In addition, the heterozygosity or homozygosity of CD177*c.787A>T is taken into account for the regulation of HNA-2 positive and negative neutrophil subpopulations. Genotyping has revealed HNA-2 null individuals, heterozygous for the CD177*c.787A>T mutation without CD177*c.997delG, indicating the presence of a complementary mechanism that regulates CD177 expression. Recently, a polymorphism CD177*1291G>A in combination with CD177*787A>T has been described in individuals null for HNA-2 and individuals with atypical expression of CD177.

Altogether, these data indicate one or more complex compound mechanisms for the regulation of CD177 expression on the surface of neutrophils.

This presentation will summarize recent findings on CD177 expression and highlights potential genotyping methods for genetic evaluation of donor and patient CD177 expression.

Clinical - Clinical Transfusion I

3A‐S01‐01

BECOMING WISE WITH KIDNEY TRANSPLANTATION RELATED TO AN ABO INCOMPATIBLE LIVING: AN EXPERIENCE IN A TERTIARY CENTER

S. Agrawal, M Chowdhry, S Gajulapalli, M Avel

Transfusion Medicine, Indraprastha Apollo Hospital, New Delhi, India

Bottom:There is substantial growth in ABO-incompatible (ABOi) kidney transplants worldwide. Desensitization using a combination of apheresis and immunosuppression protocols has led to a greater number of donors and has reduced the number of patients waiting for a kidney transplant.

Goals:To determine the efficacy of ABO titer reduction by two different apheresis techniques and to analyze the parameters that influence the graft outcome.

Methods:All consecutive ABOi kidney transplants performed in our center from February 2012 to January 2019 were retrospectively reviewed. Those with follow-up data of at least one year were included for analysis. Immunosuppression included rituximab (375 mg/m2) followed by steroids, mycophenolate mofetil, and tacrolimus.

Conventional therapeutic plasma exchange (cTPE) for 1–1.5 plasma volumes was performed before and after transplantation (based on graft function/increasing titers) in Haemonetics MCS + cell separator (Braintree, MA, USA) using 5% albumin and 2 units of Group AB FFP (fresh frozen plasma). Pre-transplant immunoadsorption (AI) was performed by processing 8 volumes of plasma in one session using an antigen-specific immunoadsorbent column (Glycosorb ABO, Glycorex Transplantation, Lund, Sweden) on Terumo BCT's Spectra Optia.®. The goal was an ABO titer (IgM+IgG) before transplantation of ≤8. Patient and graft survival at 1 year was evaluated.

Results:Of the 104 transplants performed, 82 patients with a 1-year follow-up were included for analysis. All combinations of ABO incompatibilities were accepted. The mean age was 38.45 ± 14.79 years. There were 67 men and 15 women. Seventy-one patients underwent cTPE only and the remaining 11 underwent AI ± cTPE for desensitization.

The median initial titer was 32 (16-1024). The median titer at transplant and discharge was 2 (1-8) for all patients. Mean serum creatinine at discharge was 1.3±0.97mg/dl. The mean number of cTPEs performed was 3.6 ± 2.3 per patient in the pre-transplant period for those who received cTPE only. The mean number of AI and cTPE performed in patients with AI ± cTPE is 1.7 ± 0.47 and 2.4 ± 2.6, respectively. The mean reduction in serial dilution titers was 4.9 ± 2.0 in these patients, which was statistically greater than in those who underwent cTPE alone (3.4 ± 2.1, P = 0, 04). The number of procedures required to reach the target titer was not significantly different for anti-A and anti-B (p = 0.5). The mean post-transplant cTPE performed was 1.3±2.3. There was graft dysfunction in 8 patients (9.75%) of whom 3 (37.5%) were saved and 1 dropped out against medical advice. Graft survival was influenced by the titer at the time of transplantation (P=0.016). Overall patient survival at one year was 91.46% and death-censored graft survival was 92.1%.

Summary/Conclusions:The net reduction in ABO titer after apheresis is better with the use of AI. Titer at transplant affects graft outcome regardless of the method used to achieve this goal. Furthermore, the result is independent of the titer being monitored (anti-A or anti-B).

The use of plasmapheresis and immunosuppression make the outcome of ABOi renal transplantation acceptable and comparable with its Western counterparts.

3A‐S01‐02

DEVELOPMENT OF DETAILED TRANSFUSION EXPOSURE INFORMATION FROM PATIENT ELECTRONIC MEDICAL RECORDS USING NATURAL LANGUAGE PROCESSING

BI Whitaker1, Williams1, J Duque2, R. Boyd2K Natarajan3, S Anderson1

1Office of Biostatistics and Epidemiology/CBER, US Food and Drug Administration, Silver Spring, MD2Health Informatics and Analytics, Georgia Technology Research Institute (GTRI), Atlanta, GA3Columbia University, New York, New York, United States

Bottom:Extraction and use of individual ISBT-128 tagging codes from the electronic health record (EHR) provide valuable identification of patient exposures to blood components within an institution. However, to accurately relate blood component exposures to subsequent adverse events, accurate information on timing of transfusion and vital signs is often needed.

Goals:Observation of transfusions by nursing staff is standard practice in the US. Transfusion notes typically contain information on blood products, transfusion start and end times, a vital sign flowchart, and documentation of any transfusion reaction. We apply Natural Language Processing (NLP) to capture this important supplementary information.

Methods:Nursing notes containing unstructured data from New York Presbyterian Hospital were used in a three-stage process to extract pertinent information about transfusion events. Columbia University Medical Center (CUMC) took advantage of a Python-based NLP platform, ClarityNLP, developed by the Georgia Technological Research Institute (GTRI). Prior to implementing the tool in the CUMC setting, a representative set of 15 de-identified transfusion nursing notes was submitted to GTRI for use as training cases for the NLP extraction tool. In addition to the extraction of existing information, the NLP tool created derived information; for example, a derived field was created for the total transfusion time in minutes and also for the times from the start of the transfusion to each set of vital signs taken. After GTRI enabled the NLP tool, it was installed within the CUMC environment for use. A separate set of transfusion nursing notes was used to test ClarityNLP within the CUMC environment. The parser was able to accurately extract all the intended information from the semi-unstructured notes and output it in a structured format. Accurately filled in fields likestart of transfusion, end of transfusion, elapsed minutes, reaction, ordered blood product, date and time, hour delta minutesas well as baseline vital signs and subsequent measures taken during the transfusion.

Results:As a final performance evaluation, ClarityNLP ran on approximately thirty-four thousand transfusion notes. The output of this run included information on the blood products ordered, the start and end times of the transfusion, whether patients experienced a transfusion reaction, as well as vital measures taken before and during the transfusion, including temperature, oxygen level, blood pressure and heart rate. For the validation process, 100 transfusion nurse notes were sampled and reviewers assessed the accuracy of the information regarding 1) the requested blood product, 2) whether the patient experienced a reaction, and 3) the onset times. and completion of the transfusion. For each of these fields in the 100 sampled notes, the ClarityNLP tool reproduced these data points with 100 percent accuracy. In addition, the tool provided transfusion completion times for numerous structured records that were missing this key data point.

Summary/Conclusions:ClarityNLP can very efficiently digest a large number of transfusion nursing notes simultaneously and also does an excellent job of extracting the main characteristics of a transfusion, which can be used in association with structured data to produce a more accurate and complete picture of transfusion. patient transfusions.

3A‐S01‐03

RHD IMMUNOGLOBULIN: ARE WE DOING IT RIGHT IN OBSTETRICS?

Bielby1, B Glazebrook1, pastry chefs1, P Beard1, Bastin K.1, J Daly2

1Blood Matters, Department of Health and Human Services, Australian Red Cross Blood Service, Melbourne2Pathology Services, Australian Red Cross Blood Service, Brisbane, Australia

Bottom:The Blood Matters Serious Transfusion Incident Reporting (STIR) program (Australia) has been collecting RhD immunoglobulin (RhDIg) incidents since 2015. STIR receives reports from four jurisdictions with 93 registered health services.

Although the number of reports was small, worrying trends were emerging. To better understand the use of RhDIg, Blood Matters conducted an audit comparing use with the Australian RhDIg Guidelines (2015).

Goals:To review:

  • Health services policies and procedures on the use of RhDIg

  • Compliance with current guidelines for the use of RhDIg in obstetrics in Australia

Methods:Health services with level 2 or higher maternity services (providing antenatal, intrapartum, and postnatal care) were invited to participate in a two-part audit (n = 79).

Part 1: Policy for the use of RhDIg in obstetrics.

Part 2: Clinical practice audit of 30 RhD negative women who gave birth during the period July 2017 to June 2018.

Results:Part 1: The policy was reported by 48 (61%) sites. Of these, 43 (90%) had a policy for the use of RhDIg, and all specified that RhDIg should be administered at 28 and 34 weeks, with sensitization events, and at delivery for all women at risk. Documented consent was required at 44 (92%) sites, with 23 specifying that one consent covered all administrations (prenatal, delivery, and sensitization events), 17 requiring consent at each administration, and 4 separate consent for routine administration versus events. awareness. No specific educational requirements were required for personnel ordering or administering RhDIg at 15 (31%) sites.

Despite 11 (23%) health services reporting 36 administration errors in 12 months, STIR received only 9 reports during this time.

Part 2: There were 939 individual practice audits returned from 43 (54%) sites. Of these 19 women refused or did not require antenatal prophylaxis, leaving 920 women in the audit. There was no documented prophylaxis or rejection in 42 (4.6%) women, and 45 (4.9%) received only one of the two recommended doses. Prenatal dosing was not given at the correct dose and time for one or both doses in 248 (27%) women.

Sensitization events were reported in 104 women, with 26 (25%) not receiving the recommended dose of RhDIg.

At delivery, 604 women had an RhD-positive baby, 593 (98%) received postnatal prophylaxis, leaving 11 women at risk, and 514 (85%) had quantified fetomaternal hemorrhage. Of the 265 women in the audit who gave birth to RhD-negative children, 12 (5%) received RhDIg. (The remaining 51 infants had unknown RhD status.)

Overall, 261 (28%) of the women audited missed at least one dose, received a dose less than recommended, or administered at the wrong time, putting them at risk of developing antibodies. Three women did not receive RhDIg during pregnancy with no indication of rejection.

Poor documentation was a limitation in this audit with implications for patient care and traceability.

Summary/Conclusions:RhDIg administers well against postnatal guidelines (98%). Antenatal dosing for routine prophylaxis and priming events was suboptimal in 28% of women, increasing the risk of immune priming and hemolytic disease of the newborn in future pregnancies.

3A‐S01‐04

THE EFFECT OF INTRAUTERINE TRANSFUSION ON FETAL RETICULOCYTE COUNT AND OUTCOME IN ALLIOMMUNE HEMOLYTIC DISEASE OF THE FETUS AND NEWBORN

i am ree1,2and Lopriore2, C Zwiers3, M. Janssen2, M. de Haas4,5,6

1Transfusion clinical research, Sanquin2neonatology3Obstetrics, Leiden University Medical Center4Transfusion Clinical Research Center, Sanquin5Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden6Diagnostic Immunohematology, Sanquin, Amsterdam, The Netherlands

Bottom:Red blood cell alloimmunization can lead to hemolytic disease of the fetus and newborn (HDFN). Fetuses with severe HDFN may require treatment with intrauterine red blood cell transfusions (IUTs) to treat fetal anemia. After birth, these babies often require postnatal red blood cell transfusions due to persistent anemia. Preliminary research shows that the absolute reticulocyte count at birth in infants with IUT is significantly lower compared with infants without IUT treatment, suggesting that IUT treatment may suppress erythropoiesis and lead to increased transfusion dependency. postnatal. The effect of the amount of IUT on fetal reticulocyte counts and neonatal outcomes is unclear.

Goals:Our objective was to quantify the effect of one or multiple IUTs on the fetal reticulocyte count in a population of fetuses with severe HDFN, referred to our institute between January 2005 and December 2018.

Methods:Observational study of all 190 consecutive infants with HDFN caused by D-antibodies treated with one or more IUTs and born at Leiden University Medical Center (LUMC) between January 2005 and December 2018. Data were extracted from archives maternal and neonatal physicians. including laboratory samples before and after IUT procedures and neonatal results. The primary outcome was adjusted using a generalized estimating equation (GEE) model to account for potential interrelationships between the outcomes of multiple TUIs in the same fetus, including gestational age at the time of the TUI.

Results:[preliminary] The median number of TUIs per fetus was 2 (interquartile range [IQR] 2–4), the first TUI was performed at a median gestational age of 29.0 weeks (IQR 24.6–32.1 ) weeks. For TUI, the median hemoglobin level before TUI procedures increased according to gestational age from a median of 6.9 g/dL (IQR 5.3–8.5) to 8.5 g/dL dl (IQR 7.4–9.7) after 5 IUT (P<0.001). Median reticulocyte count showed a significant decrease over the course of multiple IUTs, falling 72% from 296*109/L (IQR 234–388, or 177‰ [IQR 121–242]) before the first IUT at 83*109/L (IQR 5–175, or 34‰ [IQR 2–72]) before the second IUT, with a further 26% decrease to 7*109/L (IQR 4–136, or 3‰ [IQR 2–56]) before the third and subsequent IUTs (P<0.001). The number of IUT was related to the median reticulocyte level at birth, decreasing significantly from 140*109(IQR 13–237, or 58‰ [IQR 45–83]) after 1 IUT at 8*109(IQR 3–18, or 2‰ [IQR 1–5]) after 5 IUT (P=0.002). Although not statistically significant, the number of TUIs may also be related to the proportion of infants requiring postnatal transfusions, ranging from 88% to 100% (P=00.596), and the number of postnatal transfusions per infant, which ranges from a median of 2 (IQR 2-3) to 3 (IQR 2-4) after 5 IUT (P=0.327).

Summary/Conclusions:In severe HDFN, IUT treatment causes a decrease in fetal and neonatal reticulocyte counts. Already after two IUTs, only 2% of the initial fetal reticulocyte count remains, and recovery appears to be slow, as a greater proportion of infants develop persistent hyporegenerative anemia requiring multiple postnatal transfusions.

3A-S01-05

IDARUCIZUMAB FOR DABIGATRAN REVERSAL: A SINGLE CENTER ANALYSIS OF TWO YEARS EXPERIENCE

to Sarmento1,Pinto BL2, D Cybeles2, L Gonçalves2, F Araujo2,C cook2

1Centro Hospitalar do Baixo Vouga, E.P.E., Aveiro2Department of Transfusion Medicine and Blood Bank, Center for Thrombosis and Hemostasis, Centro Hospitalar e Universitário de São João, E.P.E., Oporto, Portugal

Bottom:Idarucizumab is a humanized monoclonal antibody fragment developed to reverse the anticoagulant effect of Dabigatran. It has been used more frequently since its approval in late 2015. Previous studies reporting the results of clinical trials have shown its efficacy and safety, and data from real-life experience related to its use has been increasing. since then.

Goals:To evaluate the use of idarucizumab in our center, Centro Hospitalar Universitário de São João, over a 2-year period, in terms of its effect on coagulation assays and clinical outcomes, in patients who received idarucizumab.

Methods:We performed a retrospective analysis of the use of idarucizumab in 33 patients, between January 2017 and December 2018, who presented with severe active bleeding (group A, 20 patients) and patients who required urgent procedures (group B, 13 patients).

Results:After reversal therapy with idarucizumab, all patients had a normalized free dabigatran concentration of less than 30 ng/mL, despite being treated with the standard dose of 5 g intravenous idarucizumab (45% of all patients) or with a single dose of 2.5 g.

Transfusion support, with packed red blood cells, was required in 33% of all patients; 6% received pooled platelet transfusions; 6% received fresh frozen plasma; 6% received activated or non-activated prothrombin complex concentrate.

Patients in group A, excluding patients with intracranial haemorrhage, had impaired renal function, with a mean serum creatinine concentration of 1.9 mg/dl. Group B patients presented worse renal function (mean serum creatinine concentration of 3.27 mg/dl).

None of the patients presented thrombotic events in the 60 days following the administration of the reversing agent.

The overall 30-day mortality rate was 24% among all patients. None of the deaths were due to ongoing bleeding or thrombotic events.

Summary/Conclusions:Idarucizumab completely reversed the anticoagulant effect of dabigatran without causing a prothrombotic state in patients within 60 days.

The decision to administer a single 2.5 g dose of idarucizumab to some patients was due to the limited availability of idarucizumab. However, our results show that it may be reasonable to individualize dosing for selected patients with lower dabigatran concentrations and normal renal function.

3A-S01-06

REDUCTION OF PATHOGENS FROM FROZEN PLATELETS

D Kutac1,2, M. Bohonek1,3, L Landova1, B. Kostrouchova1and Staskova1, M. Blahutova1, of streams4

1Department of Hematology and Blood Transfusion, Prague Central Military Hospital, Prague2Faculty of Military Health Sciences, Hradec Kralove Defense University, Hradec Kralove3Faculty of Biomedical Engineering, Czech Technical University in Prague, Czech Republic4First Charles University Medical Faculty of Prague and Prague General University Hospital, Prague, Czech Republic

Bottom:Platelet shortages can be mitigated by creating a cryopreserved (CP) platelet inventory. This strategy has been used successfully in both military and civilian medicine in support of a massive transfusion protocol. With emerging infectious threats, pathogen reduction is promoted in civilian and military transfusion medicine. Many studies for the evaluation of frozen platelet (PLT) quality parameters are ongoing or have been published. However, few have evaluated the impact of modern pathogen reduction technology on frozen platelets.

Goals:Pathogen Reduction Technology (PRT) methods are used successfully to treat plasma, fresh platelets, and fresh whole blood. This study explores the impact of pathogen reduction technology on subsequent platelet freezing. The aim of this study was a comparison of in vitro quality parameters between PRT-treated and untreated platelets.

Methods:A comparative study of CP, PRT treated (T‐CP) and untreated (C‐CP) was carried out. Both study arms were collected as type O PLT apheresis on a Haemonetics MCS+ machine (Haemonetics corp., USA) and processed according to standard procedures. Type O PCs were processed with 6% DMSO, frozen at -80 °C, and reconstituted in thawed AB plasma. 16 units were treated with PRT (Mirasol, Terumo BCT, USA) before freezing and 15 PCs from the control group were left untreated. After PC reconstitution, the following laboratory tests were performed: blood cell count, PLT, MPV, PLT recovery, glucose, lactate, pH, pO2, pCO2, HCO3, TEG, TGT, CD41, CD42b, Annexin V, CCL5, CD62P, Kunicki score and presence of aggregates >2mm.

Results:No significant differences were found between both groups for the following parameters: number of PLT/unit, recovery, MPV, pH, TGT – Peak, CD41 and Annexin V. T‐CP showed a significantly higher TEG, TGT – tLag coagulation index with faster tPeak, speed index and ETP, as well as metabolic markers increased, evidenced by higher pO2, pCO2, glucose, lactate, and HCO3. Expression of CCL5 and sCD62P was elevated in T‐CP compared to C‐CP. The morphological changes assessed by the Kunicki score were greater in the T‐CP. All the T-CP units contained visible aggregates, with a tendency to increase over time, while in C-CP no aggregates were observed.

Summary/Conclusions:T‐CPs showed better in vitro haemostatic activity with fewer morphological changes than their untreated counterparts. T‐CPs appear to be more metabolically activated than C‐CPs, however platelet functionality did not appear to be impaired. On the other hand, the occurrence of aggregates in T‐CPs probably needs further investigation or adaptation of the preparation procedures. Meanwhile, T‐CTs should be given soon after thawing with active hemovigilance.

Immunobiology - Blood group genomics: a debate

3A‐S02‐01

PHENO- AND GENOTYPE IN THE TYPING OF BLOOD GROUPS – TWO SIDES OF THE COIN – PART I

CM Westhoff

Immunohematology and Genomics, New York Blood Center, New York, United States

Antibody-based typing, with a positive result reflected in red blood cell (RBC) agglutination, has served the profession for nearly a century, enabling safe and effective transfusion therapy. The power of red blood cell typing by serological methods lies in the availability of standardized antibody reagents that target many of the specificities of importance for transfusion and the ability to directly detect antigen expression on red blood cells. Historically, hemagglutination has been relatively inexpensive, particularly for ABO and RhD as the most important blood groups in most populations. Red blood cell serologic typing is reliable, does not require sophisticated equipment, is generally simple to perform, and is rapid, requiring less than 1 hour to obtain results. Therefore, antibody-based tests have been considered the "gold standard" for blood group typing.

With the age of genomics, DNA-based genotyping is increasingly used as an alternative to antibody-based methods. Most antigens are associated with single nucleotide changes (SNPs) in the respective genes. Genotyping has been validated by comparison with antibody-based typing and has been shown to be highly correlated. The power of red blood cell genotyping lies in the ability to test for antigens for which there are no serological reagents and to type numerous antigens in a single assay using automated DNA arrays. This increases precision and weak antigen expression can be revealed. Fresh red blood cell samples are not required for DNA extraction, and there is no interference from transfused red blood cells or IgG bound to the patient's red blood cells. DNA-based typing is inexpensive because it provides much more information, but the tests require special equipment, training, and a 24-hour turnaround time.

What is then the best approach to use? Will serological typing be replaced by DNA-based typing? Indeed, genotyping will be increasingly used in the practice of transfusion medicine, especially with the growth of whole genome sequencing (WGS). However, because serological typing for ABO and RhD is fast and accurate and is often used for sample identification, genotyping will not be the only means of routine typing. Genomic sequencing approaches will certainly reveal unrecognized changes and genetic variability in red blood cell membrane proteins, but not all variations will be immunogenic. A genetic polymorphism must be associated with the production of antibodies to be considered a blood group antigen. The importance of an antibody and the reactivity of the antibody will continue to be the central principle that defines transfusion. Like the two sides of a coin, both are key to safe and effective transfusion therapy.

3A‐S02‐02

PHENOTYPE AND GENOTYPE IN THE TYPING OF BLOOD GROUPS – TWO SIDES OF THE COIN – PART II

C Gassner

Independent Researcher, Zurich, Switzerland

Since the mid-1980s, research on the molecular basis of the structural and functional aspects of the proteins that carry and produce antigens has led to an improved and modern understanding of blood group variation. More commonly, basic single nucleotide polymorphism (SNP)-based molecular typing techniques were used to test new findings in a smaller subset of samples, resulting in overall concordant serotyping and genotyping results. Very commonly, however, a small number of all samples returned inconsistent results, prompting consecutive rounds of analysis and resolution, ultimately resulting in better insight regarding the underlying blood group variation. Such rounds of iterations represented the synergistic incremental process of learning, learning for serologists and molecular biologists. Heredity from the public, the presence of high or low frequency or partial antigens and the notice of weakly expressed or nearly undetectable antigens set the path for incremental learning and can best be exemplified by discoveries within ABO blood group systems, RhD and Kell.

The naming of phenotypes and genotypes coevolved along with the ongoing discovery of new antigens. Today, antigens and their antithetic counterparts (if tested and if they exist) are more frequently reported independently, as shown by way of example for the following Kell phenotype consisting of three pairs of antithetical antigens: kk, Kp(a+b+), Js(a +b+). Alternatively, the same phenotype could be stated as: KEL:‐1,2,3,4,(5),6,7. Genotypes, on the other hand, rather reflect the actual biological background, e.g. show the two parental alleles (or "haplotypes") present in a sample of individuals. The genotype of the example mentioned above would be:KEL*02.03/02.06(on italic). In an idealized diagnostic setting and for most protein-encoded blood group systems, each individual blood group allele would be defined by its complete genomic sequence, derived from a parental chromosome (including "some" 5' and 3' regions). not translated). Thus, each such "ideal allele" would fully state the presence or absence of all of its high- and low-frequency public antigens and would possess its "ideal name." By trend, biallelic SNPs and their immediate relationship to antithetical antigen pairs might have distracted attention from the original meaning of "blood group alleles" more recently. Finally, genotypes that only depend on the names of the alleles (ideals), and considering Mendelian inheritance patterns (dominant, recessive), would allow fully comprehensive phenotype predictions.

More recently, blood group serology, e.g. the "second side of the coin" seems to gain momentum. Since the advent of whole genome sequencing and access to more than 1,000 human genomes, dozens of new blood group alleles seem to be discovered almost daily. In addition to the challenge of naming this multitude of alleles, the respective discoveries are frequently made in samples lacking prior phenotypic blood group values. Clear procedures will be needed to address the naming and analysis of phenotypes resulting from previously unknown alleles. As a consequence, the questions asked 30 years ago have changed: Today, molecular biologists analyzing hundreds of newly discovered blood group alleles no longer ask serologists, "Can you confirm my serology?" ask their question to the experts for blood group phenotyping: “Can you confirm my genotype?”

3A-S02-03

REFERENCE DATABASE: THE COMPLETE DATABASE FOR RHD VARIANTS

y floch1,2, S Telechea3, F Pirineos1,2, C Tournamille1,2, the one from Brevern2,4

1INSERM (French National Institute for Health and Medical Research) - U955 Team 2 - IMRB - UPEC, French Blood Agency, Creteil2Labex GR‐Ex, Paris3CNRS UMR 6286, UFIP - University of Nantes, Nantes4INSERM UMR_S 1134, University of Paris, University of Reunion Island, INTS (Institut National de Transfusion Sanguine), Paris, France

Bottom:Since the discovery of the molecular basis of the HR blood group system in the 1990s, hundreds of articles have been published describing newright hand drivealleles or adding to the knowledge of known alleles. These works present heterogeneous data: molecular, serological, etc. Existing allele lists (ISBT allele tables, Rhesus database website) are valuable but have a limited number of features.

Goals:Develop a comprehensive and elaborate database forright hand drivealleles that allow complex queries and link all relevant data.

Methods:We have developed a modern database, called RHeference, based on BioDjango, an open Python framework for bioinformatics. Contains all published information about in the frameworkright hand drivealleles, thanks to an exhaustive study of the scientific literature.

RHeference contains the nucleotide and amino acid sequence for each published Rh1(D) variant, all nomenclatures, Rh antigen expression, ISBT classification (weak D, partial D, Del), data on anti-Rh1 antibody formation. .. Sources and citations for all information are included in the alleles tab.

Results:The novelty and greatest strength of RHeference is allowing easy navigation through pre-calculated queries: from molecular data (presence or absence of mutations in specific positions), name, antigen expression, citation... The data can be navigated horizontally through dedicated links.

Summary/Conclusions:With several hundred citations and 443right hand drivealleles (to date), RHeference provides an overview of current knowledge about theright hand drivegene. It is an invaluable tool thanks to its features and endless query options. The database will continue to grow as our knowledge expands and new articles are published. New features will be included in the future, especially regarding the 3D structure.

3A-S02-04

AUTOMATED TYPING OF HR COMPLEX GENOTYPES FROM GENOME WIDE SEQUENCES

Carril W1,2, J Salas1,2,3, S Vegeta4, D Simmons1,2, B. Bujiriri1, H Mah1, P Kumar5, why1,2,5,6, C Westhoff4

1Patología, Brigham and Women's Hospital2Harvard Medical School3Pathology, Beth Israel Deaconess Medical Center, Boston4New York Blood Center, New York5Partners Personalized Medicine6Laboratory of Molecular Medicine, Boston, United States

Bottom:Rh is one of the most diverse and complex blood group systems. Although serologic methods satisfy most routine Rh typing needs, serology cannot fully resolve all important clinical phenotypes. Weak and partial phenotypes often require DNA-based methods such as SNP and/or Sanger sequencing. Recently, the use of next-generation sequencing (NGS) for blood group typing, including complex Rh phenotypes, has been reported, but the analysis is not straightforward and often requires interpretation by experts in the field.

Goals:We recently developed automated software (bloodTyper) capable of determining RBC antigens from whole genome sequencing (WGS), including validation of common Rh antigens. Here we seek to design and validate bloodTyper for the interpretation of samples with complex Rh variations.

Methods:Twenty samples with SNPs and Sanger sequencing based onright hand drivegenotyping and two withRHCEgenotyping were selected to represent a diverse set of complexesright hand driveyRHCEalleles, including hybrids. Archived DNA was subjected to WGS followed by blind evaluation using bloodTyper interpretive software. Structural variations (SVs) were determined by a combination of three independent detection methods, including: sequence read coverage depth, split reads, and paired reads.

Results:In this specific data set, bloodTyper was able to correctly identify D negative (right hand driveerased andRHD*psi), D weak (RHD*weak D Types 1,2, y3), partial D (RHD*weak partial D 4.0,*BUT,*DOL,*DIIIa,*Diva,*DAU0,*DAU3,*DVI types 1y2), compound heterozygotes [RHD*weak partial D 4.0/*Psi,*Weak partial D 4.0/*DIIIa‐CE(4‐7)‐D,*DIIIa/*DIIIa‐CE(4‐7)‐D,*D/*DIIIa‐CE(4‐7)‐D,*DAU5/*DIIIa‐CE(4‐7)‐D, y*DAU5/*486+1a(Del)], and partial RhCE (RHCE*CeRN/* ce,* cehar/*CE). Accurately Determined Sequence Read Depth SV Methodsright hand drivezygosity and detected the presence ofright hand drivehybrids [RHD*DIIIa‐CE(4‐7)‐D,*DVI type 1, y*DVI type 2].RH*Ccould be detected by a read-depth analysis of sequences looking forright hand driveconversion of exon 2 gene toRHCE, as previously reported; however, we also show that C antigen can be detected by split-read SV methods containingright hand drivesequences of intron 2 followed by the unique insertion feature of 109 bp ofRH*C.right hand drivehybrids andRH*Ccould also be confirmed by detecting paired reads spanning the two intronic breakpoints with a read mapped toright hand driveand the other toRHCE.RHCE*CeRNy* ceharwere detected using a paired read SV approach with misaligned to rearranged read mappingright hand driveexon and the other toRHCEintronic region encompassing the breaking point.

Summary/Conclusions:Automated interpretation of WGS data enabled precisionright hand drivegenotyping, including zygosity, using a combination of SV approaches. This approach also successfully interpretedright hand driveyRHCEcomplex compound heterozygotes. Such automated analysis would be scalable and could become a routine part of large genomic sequencing projects, allowing for the determination of complex Rh genotypes in unprecedented numbers of donors and recipients and assisting during difficult alloantibody analyses.

Adverse events: safety of blood from a virome perspective

3A‐S03‐01

METAGENOMICS AND BLOOD DERIVED PRODUCTS

S Waldvogel-Abramowki, S Taleb,O Preynat‐Seauve

University Hospitals of Geneva, Geneva, Switzerland

Transfusion-transmitted infections remain a permanent threat in medicine. It carries the burden of the past, marked by severe transfusion-borne infections, and is constantly threatened by emerging viruses. The overall increase in immunosuppression among patients undergoing frequent transfusions exacerbates this problem. During the last decade, the criteria for donor selection have become increasingly stringent. Although routine nucleic acid tests (NATs) for the specific detection of viruses have become more sensitive, these safety measures are only of value for a limited number of selected viruses. However, the scientific approach to this is changing, with the goal of trying to identify infectious agents in donor units as soon as possible to mitigate the risk of clinically relevant infection. To this end, and in addition to epidemiological surveillance of the general population, researchers are adopting new methods to discover emerging infectious agents, while detecting a greater number of viruses in donors. Next-generation sequencing (NGS) offers the opportunity to explore the entire viral landscape in blood donors, so-called metagenomics, to investigate severe transfusion reactions of unknown etiology. In the not too distant future, one could envision this platform being used for routine testing of donated blood products. This presentation summarizes current knowledge in this area, with a special focus on the viral landscape described in red blood cells, platelets, and plasma for transfusion.

3A-S03-02

MOLECULAR AND IMMUNOMAGNETIC AGGLUTINATION ASSAYS IN A SINGLE ANALYTICAL PLATFORM: APPLICATION TO THE DIAGNOSIS OF ARBOVIRAL INFECTIONS

F Leon1, E. Pinchón1, N Temurok2, Jean‐F Cantaloube1, P Gallian3, V Foulongne1, M Clos2, P. Van de Perre1, A Daynes2, J‐P Molès1,C Fournier‐Wirth1

1UMR PCCI Pathogenesis and Control of Chronic Infections (EFS - Inserm - University of Montpellier), French Blood Establishment2Department of Innovation and Technology, HORIBA Medical, Montpellier3French blood establishment Alpes‐Mditerranée, Marseille4UMR PCCI Pathogenesis and Control of Chronic Infections (EFS - Inserm - University of Montpellier), University Hospital of Montpellier5UMR PCCI Pathogenesis and Control of Chronic Infections (EFS - Inserm - University of Montpellier), Inserm, Montpellier, France

Bottom:Screening of blood donors and travelers returning from areas of active transmission has highlighted the importance of diagnosis of acute arboviral infections. In the context of coinfections and similar clinical signs in endemic areas, the differential diagnosis of arboviruses is essential to discriminate the causative agent. Detection of viral nucleic acids in serum or plasma provides a definitive diagnosis; however, in most cases, viremia is transient in less than 2 weeks after the onset of clinical disease. Furthermore, cross-reactivity due to the high degree of structural and sequence homology between ZIKV and other flaviviruses is a major concern. The combination of molecular (identification of viral genomes) and immunological (detection of the immune response) assays is a key challenge to follow the natural history of these infections and improve patient management and epidemiological surveillance.

Goals:In this context, we have developed an innovative platform based on the agglutination of covalently grafted superparamagnetic nanoparticles (NPMag) with nucleic or protein probes to address the continuous emergence of arboviruses.

Methods:Dengue (DENV) and ZIKA (ZIKV) viruses are selected as models in this study. A pan‐flavivirus RT-PCR is used for the molecular assay to amplify viral genomes. Biotinylated viral amplicons are then specifically captured on complementary parent polythiolated probes coated with NPMag. For the immunological assay, NPMag are engrafted with NS1 viral proteins to capture anti-DENV or anti-ZIKV antibodies potentially present in the plasma samples. Both tests are performed in disposable cuvettes in a homogeneous format. A magnetic field generated by an electromagnet is applied to the reaction medium to align the NPMag in chains to improve the capture of targets between two NPMags. The formed aggregates are detected when the field is off. The optical density is measured in real time at 650 nm during several magnetization/relaxation cycles.

Results:In this study, molecular analytical performances were evaluated in human samples from blood donors with no history of infections as negative controls, in viral standards, and in clinical samples. Using viral reference standards, we have observed sensitivities of 10 ‐ 102TCID50/mL for ZIKV and DENV (serotypes 1/2/3/4) after a detection phase of about 5min. Initial results obtained on 16 ZIKV(+) clinical samples previously tested by commercial real-time PCR (Ct<36, Altona) showed an 88% correlation between the two detection methods. No false positive results or cross reactions were observed. Regarding immunological assays, commercial human plasma from donors who tested positive for antibodies against DENV or ZIKV was detected positive with our innovative approach in less than 10 minutes (sampling + detection) instead of 2 hours with classical ELISAs. Further trials in clinical samples are planned to confirm these preliminary results.

Summary/Conclusions:This innovative strategy combining molecular assays and immunoassays on the same analytical platform offers new opportunities for rapid blood testing to improve surveillance and prevention of arboviral infections.

3A‐S03‐03

INCIDENCE OF ZIKA, CHIKUNGUNYA AND DENGUE VIRUSES IN BLOOD DONORS IN BRAZIL 2016–2018

B Custer1, T. Gonzalez1, D. Brambilla2, K Gao3, L. Amorim4, in Carneiro Proietti5, A MendroneJr6, P. Lorenzo7, L Capuani8, C Aléncar9, Piedra M1, C McClure2, lines J3, M. Busch1and Sabino9, B for the REDS-III International Component10

1Vitalant Research Institute, San Francisco2RTI, International, Rockville, MD3Grifols, San Diego, CA, United States4Hemorio, Rio de Janeiro, RJ5Hemominas, Belo Horizonte, MG6Fundación Pro‐Sangue, São Paulo, SP7Hemope, Recife, PE8FMUSP9USP, Sao Paulo, SP, Brazil10National Heart, Lung, and Blood Institute, Bethesda, MD, United States

Bottom:With the exception of surveillance based on the diagnosis of clinical cases, data on the incidence of Zika (ZIKV), Chikungunya (CHIKV) and Dengue (DENV) arboviruses in the population are not available in Brazil.

Goals:The objective of this study was to evaluate the contemporary incidence of these agents in donors in 4 large, geographically dispersed blood centers located in the southeast and northeast of Brazil.

Methods:In the Brazilian public blood bank system, NAT screening for HIV, HCV and HBV is carried out in minipools (MP of 6 donations – MP6). The residual volume of MP6 plasma, 0.35 to 0.45 mL, is routinely discarded. From April 2016 to present, 4 blood centers saved ~67 MP6 per week for retrospective testing using a qualitative research transcription-mediated amplification (TMA) triplex assay for ZIKV, CHIKV, and DENV developed by Grifols/Hologic. The MPs were shipped to the US and batch tested at Grifols. Testing was performed using the MP6 diluted with pooled plasma from US donors to achieve an equivalent test volume at pool sizes of 18 or by pooling 3 MP6 samples in MP18. Clusters were classified as negative or positive based on singleton tests. To estimate the percentage of viremic donors per month, each denominator was adjusted to account for the number of donations included in each group each month, and 95% confidence intervals (CI) were calculated using the method developed by Biggerstaff (not shown). show the data).

Results:This summary reports on testing conducted between April 2016 and January 2018 with donations from 106,014 donors. The 3 arboviruses were detected in donors in different geographical locations in Brazil during the last rainy season of 2016 (April to June). DENV viraemia was found in Sao Paulo, Belo Horizonte, and Rio de Janeiro in 2016 with an estimated monthly peak viraemia of 416 per 100,000 donors in Belo Horizonte. CHIKV viremia was found in Sao Paulo and Recife in 2016 with a monthly viremia peak of 426 per 100,000 donors in Recife. CHIKV was also detected in Rio de Janeiro in 2017 and in Recife in January 2018. ZIKV viremia was found in Belo Horizonte and Rio de Janeiro in 2016 and 2107 with a monthly peak viremia of 638 per 100,000 donors in both locations. ZIKV viraemia was detected in PM samples from donors tested in Rio de Janeiro in 12 of 19 months, including in January 2018 with 116 per 100,000 donors, and was also detected outside of the seasonal rainy season in both 2016 and 2017.

Summary/Conclusions:All three arboviruses were circulating in Brazil at the same time in 2016. The ZIKV test in this study was performed after the main outbreak in the northeastern part of Brazil had subsided and this probably explains why we did not detect ZIKV in Recife during the period of study. . The pattern of ZIKV detection in Rio de Janeiro suggests that non-mosquito routes of transmission, such as sexual transmission, may keep the virus circulating for longer periods of time.

3A-S03-04

VECTOR-BORNE DISEASES AND SAFETY IN BLOOD TRANSFUSION: A EUROPEAN PERSPECTIVE

M. Janssen, R. Lieshout,R Garzon Jimenez

Donor Medicine Research, Sanquin, Amsterdam, The Netherlands

Bottom:Arboviral infectious diseases have been identified as a threat to human health. In 2002 they also became a concern for the safety of blood transfusions. Despite the implementation of safety measures to prevent transmission by blood transfusion, there is great variation in the perception of the need for such measures. This variation may be due to a lack of understanding of the risk of transmission by blood transfusion.

Goals:Estimate the risk of transfusion-transmitted arboviruses in donors traveling to affected areas within Europe and identify risk perception among powerful stakeholders.

Methods:An integrated EUFRAT-based model was developed to estimate the risk of transfusion transmission for West Nile virus (WNV), chikungunya, and Zika outbreaks in Europe. Data on the characteristics of the blood supply of the countries of Europe were obtained from the 2013 to 2015 reports of the Council of Europe. In addition, information on inter-European travel from 2013 to 2016 was obtained from EUROSTAT. A European mean number of blood transfusion transmissions per observed infectious case was estimated for arbovirus outbreaks.

In collaboration with the European Blood Alliance, 13 participants from 12 different organizations involved in decision-making on blood safety were invited to a semi-structured interview. The selection of the participants was based on membership of the stakeholder group, the activities carried out or the country of origin (endemicity of the viruses). Comparisons of primary (within groups) and secondary (between groups) data were performed to identify similarities and differences in risk perception and the factors that influence these perceptions.

Results:The traveling donor (R0) transmission rate of European WNV was estimated to be 7.1E‐03 infected individuals per observed neuroinvasive case. The required number of infections to obtain a blood product infected in Europe with chikungunya and WNV were respectively 6238 and 140.

The qualitative study showed that the perception of risk of arbovirus transfusion transmission is low for WNV and very low for chikungunya and Zika virus. This perception is predominantly influenced by 5 factors: (1) the presence of a competent vector and viral circulation; (2) evidence of being a transfusion-transmissible disease; (3) health complications associated with the disease; (4) availability of prevention and control measures; and (5) influence and interaction between the actors involved in the process.

Summary/Conclusions:Despite the low perception of the risk of blood transfusions among the actors, the lack of active participation of some of them in the decision-making process generates differences in the implementation of the directives and recommendations on blood safety. The use of scientific evidence in decision-making processes becomes more important as this can lead to greater transparency and uniformity in the decisions made. The developed model can be easily applied to determine the risk of blood transfusions across Europe due to traveling donors, but it also provides decision makers with more evidence for a rational approach to managing blood safety.

3A-S03-05

APPLICATION OF A ZIKA VIRUS SEROLOGICAL ASSAY TO ASSESS INFECTION RATES IN DONORS AFTER THE 2016 EPIDEMIC IN PUERTO RICO

Simmons1,2, Piedra M1,2, C Cheng1, P Williamson3,Busch1,2

1Vitalant Research Institute2Laboratory Medicine, University of California, San Francisco, San Francisco3Creative Testing Solutions, Tempe, United States

Bottom:Zika virus (ZIKV) caused a dramatic epidemic in Puerto Rico (PR) during 2016, with up to ˜2% of blood donors reactive for ZIKV RNA on ID‐NAT testing at its peak in June 2016. 2016.

Goals:Perform a serologic survey for anti‐ZIKV IgG using six panels of 500 donor specimens, each collected in March 2015, at the beginning, peak, and end of the 2016 epidemic, and between March 2017 and April 2018.

Methods:We employed a commercially available ZIKV IgG ELISA antibody (Ab) assay based on Bio-Techne's ZIKV NS1 antigen to characterize ZIKV seroprevalence in the 6 × 500 cross-sectional sample sets (anonymized with selected demographic information).

Results:500 PR donor samples collected in April 2015 were initially tested using the manufacturer-provided cutoff to confirm that ZIKV Ab results were largely negative (3 positive, 3 equivocal) despite high dengue virus seroprevalence (>90%) in PR which could potentially lead to false positive ZIKV Ab results. We then use this dataset, along with known positives collected 1-3 months after ZIKV NAT performance donor screening, to establish a population-specific cutoff based on recipient operating characteristic curve analysis. (ROC). This cut-off value yielded sensitivity and specificity values ​​of >99% and an area under the curve (AUC) of 0.999, demonstrating a highly precise assay. We used this new cutoff to calculate the final seroreactivity rates in the 5 additional sample sets (2500 samples) and estimate the seasonal incidence. Reactivity rates, along with mean net OD for reagents only (shown in parentheses), were calculated for each set of samples: March 2015: 0.6% (0.4); April 2016: 4.1% (1.6); June 2016: 9.0% (1.6); October 2016: 17.8% (2.0); March 2017: 23.0% (1.3); and April 2018: 16.2% (0.7).

Summary/Conclusions:The peak seroprevalence of 23% shortly after the epidemic (March 2017) is consistent with our estimate of a 22% seasonal incidence in PR during the 2016 outbreak derived from the performance of ZIKV RNA-reactive blood donors and the duration of the NAT detection period (Chevalier et al. al. Emerg Infect Dis (2017) 23:790; Williamson et al., submitted). Another interesting finding was the rapid decline of ZIKV Abs between 2017 and 2018, both in terms of percentage of reactive donations and mean OD signal in reactive samples. These findings have implications for conducting serologic surveys in other populations and for the potential risk of ZIKV reinfections in donors and pregnant women during recurrent outbreaks.

Blood products: problems with blood components

3A‐S04‐01

BENEFITS OF THAWED PLASMA IN BLOOD SUPPLY MANAGEMENT

JJ Zwaginga1,2

1Immunohematology and Blood Transfusion, Leiden University Medical Center2Sanquin‐ LUMC Center for Clinical Transfusion Research, Sanquin Research, Leiden, Países Bajos

Although in trauma patients significant blood loss still represents 30-40% of premature deaths and postpartum hemorrhage represents 1/5 of maternal deaths, it is extremely important to optimize transfusion support. Patients with bleeding in this regard should be evaluated immediately if they are at risk or already have massive blood loss with associated morbidity and mortality. If so, it seems justified to start massive transfusion protocols (MTP) as soon as possible to preserve its hemostatic capacity with the possibility of limiting blood loss and mortality. Ideally, initiation of transfusions in trauma patients should take about 20 minutes, however in most patients this will take more than an hour. In addition to the associated delay in damage control intervention, this delay in the start of transfusion will add to morbidity. Meanwhile, the preservation of hemodynamics mediated by colloids and crystalloids, that is, will dilute the hemostatic system compromised by other factors as well. In this regard, solutions related to blood products are also justified to address this problem.

In this context, we will first give guidelines as to which bleeding patients justify starting with MTP and which product (ratios) should be best administered. Second, we will review the evidence on the mortality-modifying effect of early initiation of such protocols. Third, in addition to the storage and associated direct availability of blood products in the trauma room and operating room, the current evidence and ratio for arranging for prehospital use of fibrinogen or cryopreserved or lyophilized plasma will be discussed.

3A-S04-02

CHALLENGING THE 30 MINUTE RULE FOR THAWED PLASMA

S Ramirez-Arcos1, J. Allen2Devotee3, L Bower4, Cardigan R4, M Girard5, A Howell6, Course Y1, C McDonald2, M. Nolin5, D Sawicka4, W. Sheffield3

1Innovation Center, Canadian Blood Services, Ottawa, Canada2NHS Blood and Transplant, London, UK3Innovation Center, Canadian Blood Services, Hamilton, Canada4NHS Blood and Transplant, Cambridge, Reino Unido5Hema-Quebec, Quebec6Innovation Center, Canadian Blood Services, Edmonton, Canada

Bottom:Frozen plasma (FP) is manufactured within 24 h of blood collection and stored at ≤‐18°C for up to 12 months. Thawing of FP is performed prior to transfusion. In Canada and the United Kingdom, thawed plasma is stored for 5 days at 1–6°C y 2–6°C, respectively. The "30 minute rule" for red blood cells (RBCs) requires discarding units that have been exposed to uncontrolled temperature for more than 30 minutes during storage. This rule applies to other products, including FP, without evidence-based data, leading to product wastage. The 30 minute rule for RBC has recently been expanded to a 60 minute rule in Canada and the UK.

Goals:To determine the effect of temperature excursions on the quality and safety of thawed plasma during 5-day storage.

Methods:A multicenter study was conducted with quality and sterility arms, each conducted at NHS Blood and Transplant, Héma‐Québec, and Canadian Blood Services. Pools of four units of ABO compatible plasma were pooled, divided, and stored at ≤‐18°C for ≤90 days. Each group of units comprised two test units (T30 and T60), which were exposed to room temperature (RT) for 30 or 60 min, respectively, on day 0 (thawing day) and day 2 of storage; a negative control (NC) unit, which remained refrigerated for 5 days; and a positive control (PC) unit, which was stored at RT for 5 days. On day 5, units T30 and T60 were exposed once to RT for 5 h. Plasma samples were taken for analysis before each challenge. For quality assays, the stability of the coagulation factors FV, ​​FVII, FVIII, fibrinogen, and prothrombin time was measured. Bacterial growth experiments were performed in units of thawed plasma inoculated with ˜1CFU/ml or ˜100CFU/ml ofmarchitamiento serratia,Serratia liquefaciens, Pseudomonas putidaoStaphylococcus epidermidison day 0 and then stored under different conditions as described for quality tests. Statistical analyzes were performed to compare the results between conditions at each test site.

Results:Quality assays showed no significant difference between T30 and T60 units for any of the coagulation factors in samples taken after a 5-h exposure to RT on day 5. Bacterial growth was observed in PC units inoculated with either of the concentrations for all species. The exception wasp putida,that was self-sterilized in all units tested in Héma‐Québec. The NC, T30 and T60 units inoculated with 100CFU/ml showed bacterial survival but no proliferation during 5 days of storage, while the units inoculated with 1CFU/ml showed variable survival and self-sterilization within the three sites. There was no difference in bacterial concentration between the T30 and T60 units for any of the species at any of the test sites.

Summary/Conclusions:Multiple 30- or 60-min RT exposures do not affect the stability of coagulation factors or promote bacterial growth in thawed plasma stored for 5 days, even in the worst case after a 5-h RT exposure. These data suggest that it is safe to expose thawed plasma to uncontrolled temperatures for periods of 60 minutes, as demonstrated for RBCs.

3A-S04-03

SEX HORMONE INTAKE IN FEMALE BLOOD DONORS MODULATES THE SUSCEPTIBILITY OF RED CELL CELLS TO SPONTANEOUS AND STRESS-INDUCED HEMOLYSIS DURING COLD STORAGE

Fang F1, K Hazegh2, D Sinchar3, Y Guo1, Page G4, a mast5, S. Kleinman6, M. Busch7,T Kanias2

1Division of Biostatistics and Epidemiology, RTI International, Durham2Vitalant Research Institute, Vitalant, Denver3Institute of Vascular Medicine, University of Pittsburgh, Pittsburgh, PA4Division of Biostatistics and Epidemiology, RTI International, Atlanta, GA5Blood Research Institute, Wisconsin Blood Center and Department of Cell Biology, Neurobiology and Anatomy, Medical College of Wisconsin, Milwaukee, USA6Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada7Vitalant Research Institute, Vitalant, San Francisco, CA, United States

Bottom:Sex hormone intake in blood donors occurs in three demographic groups: premenopausal women taking contraceptive medications (progestins with or without estrogens), postmenopausal women receiving estrogen replacement therapies that may be combined with progestins, and testosterone therapies in men. We hypothesize that sex hormone therapies can modulate the quality of red blood cell (RBC) products through alterations of RBC function and predisposition to hemolysis during cold storage.

Goals:The objectives of this study were to assess the association between sex hormone intake and red blood cell hemolysis measurements, and to examine the possible mechanisms by which sex hormones interact with red blood cells.

Methods:Self-reported sex hormone intake and menstrual status were assessed in 6636 female blood donors from the National Heart, Lung, and Blood Institute RBC‐Omics study. Associations between hormone intake and donor scores for spontaneous storage, osmotic or oxidative hemolysis were determined in all women and by menstrual status. Interactions between sex hormones and red blood cells were determined by the potency of sex hormones (progesterone, 17β-estradiol, or testosterone) in inhibiting calcium entry or hemolysis during incubation or cold storage. The calcium fluorophore, Fluo‐3AM, was used to define calcium influx into red blood cells in response to sex hormone treatments or drugs that modulate transient receptor potential cation (TRPC) channel activity, including Hyp9 (a selective activator of TRPC6).

Results:Sex hormone intake by menstrual status was higher in premenopausal women (25.3%) than in postmenopausal women (7.4%). Female hormone intake was significantly (all P<0.0001) associated with reduced storage hemolysis in all women (0.32±0.16% vs. 0.35±0.29% in controls ), increased susceptibility to oxidative hemolysis (37.9±9.3% vs. 35.8±9.9% in controls) and reduced osmotic hemolysis in postmenopausal women (23.1±10.2% vs. 26.8 ±12.0% in controls). In vitro, supraphysiological levels of progesterone (10 or 20 μmol/L), but not 17β-estradiol or testosterone, inhibited Hyp9-induced or spontaneous calcium entry into red blood cells and were associated with lower spontaneous hemolysis after of 30 days of cold storage (0.95 ± 0.18%). versus 1.85±0.35%, progesterone 10 μmol/L versus solvent control (dimethyl sulfoxide, 0.1%), P < 0.0001). Coincubations (2.5 h, 37 °C) of red blood cells in the presence of progesterone and a TRPC6 activator (Hyp9, 25 μmol/L) suggested that progesterone protected against Hyp9-induced hemolysis (1.45 ± 0.13 % and 1.01 ± 0.09% vs. 2.63 ±0.19%; Hyp9+progesterone at 10 or 20 μmol/L versus Hyp9 alone, P<0.05 by one-way ANOVA).

Summary/Conclusions:This study revealed that the intake of sex hormones in blood donors is capable of modulating the predisposition of red blood cells to hemolysis and led us to propose new mechanistic pathways through which progesterone regulates calcium entry and hemolysis in blood cells. human reds. Pre- and postmenopausal women respond differently to hormone intake and its effects on red blood cell responses to osmotic or oxidative stress. Progesterone modulates calcium entry into red blood cells through a mechanism that may involve interactions with membrane TRPC6 channels, the activation of which is associated with prehemolytic events such as senescence and eryptosis.

3A‐S04‐04

THE DEHT PLASTICISER PRESERVES THE QUALITY OF RED CELLS WELL DURING STORAGE IN PVC BLOOD BAGS

larsson1,2, S. Ohlsson1, J. Derving1, P. Sandgren1,3, M Uhlin1,2

1Department of Clinical Immunology and Transfusion Medicine, Karolinska University Hospital2Department of Clinical Science, Intervention and Technology (CLINTEC)3Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden

Bottom:Polyvinyl chloride (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) has been the material of choice for commercial blood bags since the mid-20th century. Plasticizers are essential for the flexibility of the material. Furthermore, DEHP is favorable for the storage of red blood cells (RBCs). Historically, the removal of DEHP from blood bags has been linked to unacceptable levels of hemolysis during storage.

However, concerns are raised about the potential toxicity of DEHP. The forthcoming stricter regulations from the European Commission, allowing a maximum of 0.1% DEHP in medical devices, increase the urgency of finding a replacement plasticizer for DEHP that does not compromise the quality of red blood cells. Di(2‐ethylhexyl) terephthalate (DEHT) is a suggested substitute.

Goals:The objective of this study is to compare PVC-DEHT with PVC-DEHP blood bags using two different additive solutions (SA) to determine if DEHT-plasticized blood bags can maintain acceptable red blood cell quality over time. over time.

Methods:Sixty-four leukoreduced red cell concentrates were produced from 450 mL (±10%) of whole blood collected directly into DEHT or DEHP plasticized PVC blood bag systems (Macopharma, Mouvaux, France). Using a mix-and-split study design, pairs of identical red blood cell content were created within each plasticizer arm. One of the divisions was assigned AS saline-adenine-glucose-mannitol (SAG-M) for storage, and the other phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGS-M), generating four arms of study: DEHT/SAG-M, DEHT/PAGGS-M, DEHP/SAG-M and DEHP/PAGGS-M (N=16 per arm). Bags of different plasticizers were handled separately and did not touch anything containing the other plasticizer during the entire study.

For 49 days, RBC concentrates were sampled weekly to assess RBC storage injury by analysis of hemolysis, mean corpuscular volume (MCV), pH, and extracellular potassium (K) concentrations.+), extracellular sodium (Na+), ATP, glucose and lactate. The mean ± standard deviation was calculated and statistical significance was tested by repeated measures 2-way ANOVA.

Results:Hemolysis was greater in DEHT than in DEHP from day (d) 14 onwards (P<0.01), without influence of AS until d28. As of day 35, the four arms of the study differed (P<0.05), with greater hemolysis in SAG-M than in the corresponding PAGGS-M arm. At the end of storage, day 49, DEHT/SAG-M showed the highest hemolysis, 0.39 ± 0.03%. DEHT/PAGGS-M reached 0.27±0.03%, while DEHP/SAG-M, the current reference blood bag in most European countries, reached 0.23±0.04%. DEHP/PAGGS-M was the lowest, 0.18 ± 0.04%.

k+the concentration remained lower in DEHT than in DEHP regardless of AS from day 28 onwards (P<0.01). Concentrations at day 49 were 45.5±1.4 (DEHT/SAG-M), 44.7±1.7 (DEHT/PAGGS-M), 48.4±1.7 (DEHP/SAG-M ) and 48.7±1.45 (DEHP/PAGGS‐M) mmol/L respectively. backwards, na+it had a clearer relationship with AS than with the plasticizer.

Neither pH, MCV, glucose, lactate nor ATP were affected by the choice of plasticizer (ns). However, a higher metabolism rate was observed during storage in SAG-M.

Summary/Conclusions:Our study demonstrates that DEHT-laminated PVC blood bags provide adequate red blood cell quality. Hemolysis levels remain well below the EDQM limit (0.8%) even after 49 days of storage, both in SAG-M and PAGGS-M. The lower extracellular K+Levels during storage compared to PVC‐DEHP strengthen the satisfactory conclusion.

We conclude that DEHT is a strong future candidate to replace DEHP in RBC storage.

3A-S04-05

PROTEAsome MODULATION IN STORED RBC: STORAGE AGE AND DONOR EFFECTS

V Tzounakas1, M. Dzieciatkowska2, Anastasiadi1, D Karadimas1, A Vergaki3, P. Siourounis3, I Papassideri1, of Kriebardis4, A D'Alessandro2, M. Antonelou1

1Department of Biology, Faculty of Science, National and Kapodistrian University of Athens, Athens, Greece2Department of Biochemistry and Molecular Genetics, University of Colorado Denver, School of Medicine, Aurora, CO, Colorado, USA3Regional Blood Transfusion Center, Nikea “Agios Panteleimon” General Hospital, Piraeus4Department of Biomedical Sciences, Faculty of Health and Care Sciences, University of West Attica (UniWA), Egaleo City, Greece

Bottom:The proteasome is a fundamental multicatalytic enzyme complex in the protein homeostasis system. It affects responses to stress, cellular aging, and lifespan. Proteasomes are retained within red blood cells during maturation and display activity.in vitro. However, the physiological function of RBC proteasomes and their modulation by genetic factors and aging, bothliveand in units of red blood cells have not been studied in depth.

Goals:The objectives of this study were to obtain information on the composition, activity, and subcellular/extracellular distribution of RBC proteasomes, and their variation during storage of RBCs from genetically distinct donor groups.

Methods:Red blood cells from sixteen male donors (6 with G6PDH deficiency, class II Mediterranean variant) were studied before and during storage in leukoreduced CPD‐SAGM units. Components of the proteasome were analyzed by proteomics and immunoblotting of RBC membrane and extracellular vesicles. Assays for proteasome activity were performed on membrane, cytosol, and plasma samples and under conditions mimicking transfusion using fluorogenic peptide substrates. Oxidative stress was measured by fluorometry. Statistically significant correlations of proteasomal factors were topologically represented in undirected networks.

Results:Thirty-eight different proteasome-associated components were identified by proteomic analysis on the stored red blood cell membrane. The 20S components (including the b1, b2 and b5 catalytic subunits) were predominant and showed elevated levels at mid-storage. There was a trend for higher and earlier membrane binding of proteasomal components in G6PD.against control RBCs throughout the storage period. Analysis of individual donors revealed substantial inter-donor differences in membrane association levels and a trigger effect for storage. LLVY (b5, chymotrypsin-like) and LRR (b2, trypsin-like) were the predominant proteasomal activities in the control cytosol, which decreased after half storage, in contrast to LLE (b1, caspase-like) activity. which was is not affected by storage. A different pattern was present in the G6PDcytosol, with higher levels of LLVY and LRR but a storage-driven drop in LLE activity. Membrane levels of proteasome activities were not affected by storage in control red blood cells. in G6PDHowever, higher levels of LLVY and LLE were detected in mid-storage compared to control cells or late storage. Higher membrane LLE activity was found versus cytosol in control and G6PDred blood cells shortly after storage. However, G6PDH deficiency was associated with elevated levels of membrane rather than cytosolic activity, which had strong correlations with the metabolites of the glycolysis pathways, PPP and GSH. Extremely low LLVY activity was detected extracellularly, which increased, however, in proportion to storage time in both groups, with higher activity measured in G6PD.floating. When reconstituted with healthy plasma under conditions mimicking transfusion, stored RBCs exhibited increased LRR and LLE cytosolic activities (and lower ROS) compared to baseline (RBC unit), but lower LLE activity in the membrane compared to the cytosol.

Summary/Conclusions:The intracellular distribution of proteasomal proteins and levels of proteasome activity are modulated in red blood cells as a function of the extracellular environment (temperature, antioxidant status, plasma vs. supernatant), age of storage, and G6PDH deficiency, in close association with factors metabolic and proteomic stress.

Donors and Giving: Reach and retain donors in low-, middle-, and high-income settings

3A‐S05‐01

REACH AND RETAIN DONORS IN UNDER-RESOURCED CONTEXTS

L Indermuehle

International Cooperation, Swiss Red Cross, Wabern, Switzerland

Bottom:Red Cross and Red Crescent Societies were playing an important role in establishing blood transfusion facilities in many low-resource countries. By the mid-1970s, the Red Cross was actively involved in national blood programs in approximately 95% of the countries, primarily in the recruitment and education of blood donors. Today, the major organizational developments in blood transfusion services have been in high-income settings, where nearly 50% of all donations worldwide take place (home to only 17% of the population). WHO data shows that the average annual rate of blood donation in high-income countries is 3.21% of the population compared to 0.46% in low-income countries. The factors for this low participation are multi-layered, but it is well known that most low-resource settings suffer from a low rate of regular donors and challenges in establishing and financially maintaining a national blood donation program. Red Cross and Red Crescent (RC) Societies play a key role in reaching and retaining donors in communities and contributing significantly to better blood safety and availability. International partnerships and collaboration, such as the Swiss Red Cross (SRC) programme, aim to strengthen national structures to improve blood safety and meet today's epidemiological, demographic and technological challenges.

Goals:The present work aims to review the role, mandate and impact of RC Societies in improving blood safety through the systematic programming of "Voluntary Non-Remunerated Regular Blood Donors" (VNRBD) and international associations. .

Methods:Data and evidence is drawn from SRC's international cooperation projects over the last 30 years, more specifically from the partnership with three CR Societies, and data from the IFRC's Global Advisory Panel (GAP), including its Global Mapping of 2018.

Results:The promotion of VNRBD has been a specific objective in all programs supported by SRC. Through the involvement of the RC Society, the training of volunteers and the partnership with health authorities, the projects significantly increased the rate of blood donors by recruiting and retaining donors from the communities. For example, RC Societies increased total giving by 25% in Lebanon; VNRBDs at 71% per year in Kirgizstan, and from practically zero to 3,588 in South Sudan. The importance of RC Societies was also underlined in the global GAP mapping published in 2018, which showed that 36 (19%) of them provide level A (Full Blood Service), 75 (39%) are Level B (Recruitment systematic collection of blood donors) and 47 (25%) are level C blood services (VNRBD Blood Promotion). GAP has also started a new three-year VNRBD support program aimed at establishing tools and materials for National Societies.

Summary/Conclusions:The Red Cross and Red Crescent Movement has a unique mandate and position to improve blood safety globally at all levels; With its huge network of volunteers, even blood donors in remote communities can be contacted and retained. RC Societies in low-resource settings with a Tier B or Tier C role should further capitalize on partnerships with local and international actors to leverage technical assistance and funding for their activities.

3A‐S05‐02

RECRUITMENT OF FUTURE BLOOD DONORS TO SUPPLY THE SAFER BLOOD AND NATIONAL SELF-SUFFICIENCY OF BLOOD SUPPLY

Tilbars1, J. Anagnan2, M. Jankulovska2, you are Jesus2, P. Heimer2, N. Solaz2, D Yuce2, a Ilisul2, M. Piskin2, J. Jankulovski2, north of Togo2, S. Guzel3, B. Durmus3, M Kocakoglu3, year3, S. Canpolat4, M Calenda4, L Sagdur4, S Ozden5and Kodaloglu Temur1, N Ertugrul Sun6, M Ozturk1, The Kapuagasi1

1General Directorate of Health Services, Ministry of Health2WYG Türkiye Consulting3General Directorate of Secondary Education, Ministry of National Education4General Directorate of Blood Services, Turkish Red Crescent5General Directorate of Health Promotion, Ministry of Health6MoH Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Türkiye

Bottom:Motivating and encouraging the public to donate blood and to be willing to help save lives is essential to maintaining a safe and adequate national blood supply.

Goals:The project "Technical Assistance for the Recruitment of Future Blood Donors (EuropeAid/132420/D/SER/TR)" aimed to avoid problems in the supply of safer blood to contribute to the improvement of public health (i) increasing schoolchildren's knowledge about blood donation, (ii) sensitizing school directors and teachers about voluntary non-remunerated blood donation (VNRD), (iii) motivating students' relatives to donate blood blood and (iv) create public awareness through the media.

Methods:Effective coordination is established between the Ministry of Health (MoH), the Ministry of National Education (MoNE) and the Turkish Red Crescent (TRC). Existing primary and secondary school curricula and textbooks were revised and revised, and corresponding materials on the importance of blood donation were created. Human resource capacity of MoH, MoNE and TRC was developed to support blood donation awareness. To raise public awareness of blood donation throughout the country, education and recruitment campaigns were organized in 500 pilot schools. In addition, communication and public relations campaigns on blood donation were organized throughout the country.

Results:(1) Existing curricula and textbooks related to the promotion of blood donation were examined, revised, and reported to the Board of Education of the Ministry of Education. (2) Corresponding educational materials for students and teachers were developed and distributed. (3) Blood donation clubs were established in 500 pilot schools. (4) Training was carried out for 688 members of the Ministry of Health and TRC personnel on blood donation regarding their responsibilities. (5) Cascade training was conducted for 3,218 blood establishment officials and 4,399 school principals in 81 provinces. (6) Informative seminars were given to 251,475 students and 15,739 teachers and students' families during school campaigns. (7) Four animated films about blood donation were produced and broadcast on the national television channel (TRT). (8) Three different computer games targeting different age groups were developed and uploaded to the project web portal and distributed to the pilot schools. (9) 3,851 advertising spots were produced and broadcast on 33 different TV and Radio channels. (10) Posters and brochures were prepared and distributed in 81 provinces to sensitize the population. (11) Advertisements about the project and the importance of VNRD were featured 386 times in national and local newspapers, 1,117 times in online news, and broadcast on 6 national TV channels. (12) During the campaigns, 28,310 units of whole blood were collected in pilot schools. (13) Visibility kits to recruit future blood donors are prepared and distributed throughout the project activities. (14) The level of awareness and knowledge of students and their teachers/parents about the importance of blood donation is increased to 32.07% and 35.99% respectively, evaluated by pretest and posttest. The voluntary non-remunerated donation rate of the national demand increased from 73.66% to 82.54 in two years.

Summary/Conclusions:Training programs and campaigns successfully increased awareness about blood donation. To achieve a nationally self-sufficient safe blood supply, recruitment efforts must continue.

3A‐S05‐03

EFFECTIVE METHODS TO REACTIVATE INACTIVE BLOOD DONORS: A RANDOMIZED STRATIFIED CONTROLLED STUDY

J Ou‐Yang1, CBei2, H Liang2, B he2, J Chen2, X largo2, yup2

1Blood Source Management Department2Guangzhou Blood Center, Guangzhou, China

Bottom:Blood donation is the only source of blood products so recruiting enough blood donors is vital for all countries.

Goals:In this study, the efficacy and cost-effectiveness of phone calls and SMS reminders for the re-recruitment of inactive blood donors was evaluated.

Methods:This single-center, unblinded, parallel randomized controlled trial in Guangzhou, China, included 11,880 inactive blood donors whose last donation was between January 1 and June 30, 2014. Donors were randomly assigned to one of two intervention groups (telephone reception or short message service [SMS] communications) or a control group without intervention. SMS messages with a purely altruistic appeal were adopted in the SMS group; In addition to the altruistic appeal, the telephone group also asked the reasons for the postponement of donating blood. All participants were followed for 1 year. The primary outcome was re-donation rates, compared using intention-to-treat (ITT) and according-to-treatment (AT) analyses. Secondary outcomes were self-reported deterrents. Other outcomes included the redonation interval, the efficacy of each intervention, and the cost-effectiveness of phone calls versus SMS reminders at readmission.

Results:The ITT analysis found no significant differences in the turnover rate between the three groups. However, the AT analysis showed that the redonation rate was significantly higher in the telephone group than in the SMS group (11.7%contra. 8,6%, P=0.002) and in the control group (11.7%contra. 7,4%, P<0.001). Donor return behavior was positively associated with successful receipt of reminders (odds ratio: 1.56, 95% confidence interval [CI]: 1.30–1.88, P<0.001), age (1.03, 95% CI: 1.02–1.04, P<0.001) and donation history (1.08, 95% CI: 1.06–1.10, P<0.001). The SMS reminder prompted donors to return earlier than no reminder within 6 months (P=0.006), and it was much more profitable than phone calls (71.7 times cheaper). Time constraints, medical problems, and group-sponsored donation were the main causes of self-differentiation in the telephone group. The altruistic appeal had a positive effect among donors who indicated lack of time as the reason for the postponement.

Summary/Conclusions:Interventions to reactivate inactive blood donors can be effective, as phone calls encourage more donors to return, but at a higher cost than SMS messages. The SMS reminder with a purely altruistic appeal can urge donors to donate again sooner than no reminder at all.

3A‐S05‐04

PROMOTING VOLUNTARY BLOOD DONATIONS IN PAKISTAN THROUGH FACEBOOK'S BLOOD DONATION FEATURE

H Zaheer, U Waheed, S Tahir, K Nasir

Safe Blood Transfusion Program, Ministry of National Health Services, Government of Pakistan, Islamabad, Pakistan

Bottom:Despite 70% of Pakistan's population being under the age of 29, only 10% of blood supplies come from voluntary donors, while the remaining blood is collected from "Family Replacement Donors". In Pakistan, the system has outsourced the mobilization of blood donors to the families of patients. As a result, many people are turning to their networks, including Facebook, to locate blood donors. There are thousands of posts every month in Pakistan looking for blood donors on Facebook.

To help families in need, the global social media giant Facebook has launched a special blood donation feature for Pakistan in collaboration with SBTP, Pakistan. The feature makes it easy for people to sign up to become blood donors and helps connect these willing donors with people and organizations in need of blood.

Facebook has launched similar features in India, Bangladesh and Brazil to address the blood shortage problem in those countries. However, among these four countries, Pakistan is uniquely positioned due to the existence of a national counterpart, SBTP, which can assist Facebook in promoting its feature and provide feedback on the impact of this innovative effort for continuous improvement of Facebook. the function.

Goals:To promote voluntary blood donations and blood safety in Pakistan through Facebook.

Methods:The Facebook and SBTP teams launched a pilot to study the impact and effectiveness of Facebook's blood drive feature as a community engagement tool. A six-month plan has been drawn up to measure the impact of this tool in five selected blood centers. A checklist called “P0 Checklist” was shared with these blood centers to fulfill some basic requirements for an official blood bank page, including display image, cover photo, contact information, addresses , etc. Regular Skype meetings are held between the SBTP teams, Facebook (San Francisco and Singapore) and the blood centers to monitor the progress of the Pilot and generate feedback.

Results:Facebook's blood donation feature has recorded remarkable success with over a million registrations in a few months in Pakistan. Blood centers participating in the Pakistan study experienced an improvement in the voluntary blood donation trend with 3 to 10 walk-in donors and an average of more than 20 voluntary blood donation phone inquiries per month in each center. The trend is gradually increasing as the feature is refined based on feedback received. The pilot will end in June 2019. The statistics generated since January 2019 are very encouraging and underscore the importance of social media in reaching potential untapped blood donors. The study will be used to plan an effective national strategy to increase donor mobilization, recruitment and retention.

Summary/Conclusions:Pakistan's Facebook feature for voluntary blood donations can go a long way in shifting the system's current reliance on family donors to internationally recommended voluntary blood donors. This paradigm shift in Pakistan can be emulated in other developing countries facing a shortage of voluntary donors. Pakistan's experience can potentially change global donor mobilization strategies in the future in the most cost-effective way.

3A‐S05‐05

RECRUITMENT OF NON-CAUCASIAN BLOOD DONORS: THE EXPERIENCE OF A SWITZERLAND BLOOD DONATION CENTER

the children1,2,T. Ruefli1, V. Pehlic1, M. Argast1, H Luescher3,N borer1, C Nobs1, S Arnold1, a holbro1,2, a busero1

1Swiss Red Cross Blood Donation Center Basel2Hematology Division3University Hospital, Basel, Switzerland

Bottom:In our region, a growing number of patients of African or Asian origin with sickle cell disease (SCD) or transfusion-dependent thalassemia (TDT) require red blood cell (RBC) transfusions, and many have RBC alloantibodies. Selection of optimally matched RBC units for these patients is essential to prevent not only acute hemolysis but also further alloimmunization. In addition to antigen matching for ABO, Rh D, C, c, E, e, and K, patients with SCD and TDT should ideally receive matching RBC units for M, S, s, Fya, Fyb, Jka, and Jkb as well. (extended phenotype). This is the policy of our center, which currently provides RBC products to 31 patients with hemoglobinopathies.

Because the vast majority of our blood donors are Caucasian, selecting compatible red blood cell units for patients of different ethnic origins can be difficult. Therefore, there is an increasing need to expand the number of available African and Asian blood donors.

Goals:The strategy for recruiting non-Caucasian blood donors implemented in our center is described below, and the results obtained over six years are reported.

Methods:As of 01/01/2013, whenever a non-Caucasian first-time blood donor registers, an alert is entered into the donor file to trigger extended RBC phenotyping in conjunction with routine testing. The determination of the RBC antigen is carried out in our laboratory with serological methods. In selected cases (ie, suspected RhD or RhCE variant), samples are submitted for molecular analysis (SSP PCR). Rare RBC phenotypes in relation to ethnicity include, among others, Fy (a‐b‐), S‐ s‐, Lu (b‐), and those with rare Rh phenotypes. If a rare RBC phenotype is detected, a coded comment is entered into the donor data and the donor is included in the national rare donor file.

Results:From 01/01/2013 to 03/01/2019, an expanded determination of RBC antigens was performed in 352 subjects who presented for blood donation. Twenty-nine rare donors (8%) were identified and included in the rare donor file: 25 Fy(a‐b‐), 1 Lu(a‐b‐), 1 Lu(b‐), 1 Fy(a‐b ‐ ) and S‐, 1 CCddee (r'r'). Overall, these 29 donors provided 105 units of red blood cells (range 1-26). To date, all donors are still active and 14 are reserved for dedicated donations. The internal price of the RBC antigen test per donor is approximately CHF 100.‐ resulting in a total financial effort of around CHF 35,200.‐ in the time elapsed since the project started.

Summary/Conclusions:In our experience, a “passive” recruitment of non-Caucasian blood donors based on ethnicity has low overall logistical and financial efficiency. In addition, African and Asian blood donors may require screening for hemoglobin variants and malaria serology in addition to routine testing. However, a specific determination of the extended RBC antigen phenotype allows identification of individuals with rare phenotypes. Currently, our center is implementing measures for the active recruitment of potentially rare blood donors. After a pilot phase, a draft recruitment strategy will be developed at the national level. Another objective is to build a national registry of patients with hemoglobinopathies requiring transfusions.

Plenary Session - Closing the Gap

PL‐01‐01

TRANSFUSION AND TREATMENT OF SEVERE ANEMIA IN AFRICAN CHILDREN TRIAL (TRACT)

Maitland1,2

1KEMRI Wellcome Trust Research Program, Kilifi, Kenya2Imperial College, London, UK

Bottom:In sub-Saharan Africa, where infectious diseases and nutritional deficiencies are common, severe anemia is a common cause of pediatric hospital admission, although treatment options are very limited. To avoid excessive use of blood products, the World Health Organization advocates a conservative transfusion policy and recommends iron, folate, and anthelmintics at discharge. The results are unsatisfactory with high in-hospital mortality (9-10%), 6-month case fatality, and relapse (6%) rates justifying a definitive trial to establish the best transfusion and treatment strategies to prevent early mortality and relapse. and late

Goals:We conducted a multicenter randomized controlled trial (Transfusion and Treatment of African Children trial; TRACT) in 3954 children aged 2 months to 12 years admitted to hospital with severe anemia (hemoglobin <6 g/dL). The children were enrolled at 4 centers in Uganda and Malawi and were followed for 6 months. The trial simultaneously evaluated (in a factorial trial with a 3 × 2 × 2 design) three ways to reduce short- and long-term mortality and morbidity after hospital admission with severe anemia in sub-Saharan Africa. Test Record: Current Controlled Tests ISRCTN84086586.

Methods:The trial compared (i) R1: liberal transfusion (30 ml/kg whole blood) versus conservative transfusion (20 ml/kg) versus no transfusion (control). Control is only for children with severe uncomplicated anemia (hemoglobin 4-6 g/dl); (ii) R2: post-discharge multivitamin and multimineral (MVMM) supplementation (including folate and iron) versus usual care (folate and iron) for three months; (iii) R3: cotrimoxazole prophylaxis after discharge versus no prophylaxis for three months. All random assignments were open. Enrollment in the trial began in September 2014 and the last patient was followed up in December 2017. The primary outcome is cumulative mortality at 4 weeks for the transfusion strategy comparisons and at 6 months for the support comparison. nutritional/antibiotic prophylaxis. Secondary outcomes include mortality, morbidity (haematological, nutritional, and anti-infectious correction), safety, and cost-effectiveness.

Results:The results of the two transfusion randomizations will be presented at the meeting. The two manuscripts related to these randomizations are currently under review and we expect them to be published before the conference. Discussion If confirmed by the trial, a 'package' of cheap and widely available effective interventions, targeting the immediate and later consequences of severe anemia, would lead to substantial reductions in mortality in a substantial number of children in Africa hospitalized with severe anemia. every year. and lead to revisions in World Health Organization guidelines.

PL‐01‐02

GLOBAL PERSPECTIVE OF ETHICS IN THE HEALTH SUPPLY – CRITICAL APPRAISAL

S Hurst Maine

No abstract available.

PL‐01‐03

Transfusion in locations with limited infrastructure

a garbanero1, T Nwagha2, A mountain2, D Gwarzo3, A hero3

1University Medicine, Institute for Immunology and Transfusion Medicine, Greifswald, Germany2Department of Hematology and Immunology UNTH Ituku, Ozalla3Department of Hematology, Kano University Hospital, Kano, Nigeria

Blood transfusion is an essential treatment. Transfusion safety consists of several components. Although all are important, in the richest countries in ions, the order of priority is usually: 1.) Avoid transfusion-transmissible infections; 2.) Blood product quality with a strong focus on component therapy; 3.) Prevention of serious transfusion reactions; 4.) Prevention of administrative errors; 3.) Sufficient availability of blood.

The key note from this conference will be that the order of priorities in transfusion safety should probably be different in resource-constrained settings. 1.) Sufficient availability of blood and proper utilization; 2.) Avoid transfusion-transmissible infections; 3.) Avoid clerical errors; 4.) Prevention of serious transfusion reactions; 5.) Quality of the blood product.

Most importantly, in resource-constrained regions, patients suffer from insufficient transfusions because not enough blood is available. Every effort should be made to reduce the waste of available blood, whether through improper storage or handling, or unindicated transfusions. Furthermore, the prevalence and number of transfusion-transmissible pathogens is much higher than in wealthier parts of the world. This is compounded by the fact that rejection of blood donors based on their history is problematic when the blood bank is empty.

The goal of developing centralized national blood services with few cost-effective high-quality blood product manufacturing sites (low personnel costs), which are distributed to regional hospitals, does not match the reality of infrastructure, government support, and functionality. In resource-constrained health systems, available personnel (hands) are generally not a problem, while reagents, equipment, and even electricity are precious resources.

The conference will propose to focus on the training and education of personnel, establishing transfusion services in local hospitals, which provide the blood products for the region, based on donor recruitment campaigns adjusted to the available technology, the local culture, including the programs of replacement donors, with retention of safe donors as a top priority. Fractionation of blood into components has been standard in transfusion medicine, but recently whole blood has experienced a resurgence for patients with acute blood loss. Given the main indications for transfusion, such as postpartum hemorrhage or severe trauma, in regions with limited infrastructure, whole blood might be the most appropriate product. Most patients requiring transfusions in these regions are younger, and whole blood volume overload is not a major problem. In addition, frequent power outages do not allow for long-term storage of plasma at -20°C (hence most of it is wasted), although this problem can be solved with solar-powered freezers. Ideally, whole blood should be pathogen inactivated, for which two methods are currently available.

To reduce the frequency of acute hemolytic transfusion reactions, education and training to minimize clerical errors in the transfusion process are very important. Extended testing for other Rhesus and K antigens in addition to ABO and Rh-D in patients with transfusion-dependent hemoglobinopathy may help reduce late hemolytic transfusion reactions.

At present, a pathogen-inactivated whole blood product devoid of leukocytes could primarily meet blood transfusion needs in regions with limited infrastructure. The developed world should invest research efforts to make such a product available at affordable costs.

Immunobiology - Genotyping

3C‐S06‐01

HLA TYPING AND BLOOD GROUPS WITH NGS – ONE-STOP SHOP

G Schöfl

No abstract available.

3C‐S06‐02

A complete and customizable sequencing panel for genotyping of red blood cells, platelets and neutrophils

y Roll1, E Schoeman1, M Hobbs2, T Powley3, R flor1, C Hyland1

1Clinical Services and Research, Australian Red Cross Blood Service, Kelvin Grove2Garvan Institute for Medical Research, Sydney3Red Blood Cell Reference Laboratory, Australian Red Cross Blood Service, Kelvin Grove, Australia

Bottom:In modern transfusion medicine, serological investigations of blood cell antigens are complemented by array genotyping and PCR assays. While these platforms are informative in most baseline research, they have limited ability to define nucleotide variants associated with rare antigens and cannot detect novel variants that might affect antigenicity. Next-generation sequencing is increasingly employed in reference settings, providing information that cannot be obtained through these methods.

Whole genome and whole exome sequencing has been used successfully in many investigations of new and rare antigens; however, concerns remain regarding the collection of genomic data unrelated to baseline investigations and the reporting of clinically significant incidental findings. These concerns can be addressed through the use of specific sequencing panels. We report the design, testing, and efficacy of a panel that provides a complete genotyping profile for red blood cell, platelet, and neutrophil antigens in a single test.

Goals:Design a custom targeted exome sequencing panel for red blood cell, platelet, and neutrophil antigen genes, and compare efficiency against a commercial medical sequencing panel (Illumina TruSight One - TSO).

- Test the internal and panel genotype prediction script on the sequence results of 51 samples with known genotypes and phenotypes of red blood cells, platelets, and neutrophils and determine if the predictions are concordant.

Methods:The panel was designed with 2654 probes covering exons of 64 genes associated with red blood cell, platelet, and neutrophil antigens.

Using Illumina Nextera's rapid capture technology, 51 samples were analyzed over five sequencing runs, in standard and micro chemistry, to determine the optimal sample complexity per standard run and the efficiency of smaller flow cells for smaller applications. performance.

An internal Python script was used to predict stellar allele genotypes based on variants listed in the ISBT and EMBL databases. These predictions were compared with the results of serology, SNP array, and previous TSO data.

Results:Consistently averaged coverage >250×, with 94% of target at Q30 quality. The optimal sample complexity for a standard run was determined to be 14 samples, allowing sufficient coverage of all clinically significant variants. For RBC samples with prior typing data (excluding RH structural variants), the script correctly predicted 99.5% of SNP-based RBC genotypes. The script predictions were 100% concordant for platelet genotypes and four of five neutrophil antigen genotypes. HNA2 genotypes defined by CD177 could not be reliably determined.

The increased target coverage of the panel allowed the detection of a clinically significant heterozygous variant in the Scianna system, which had previously gone undetected by the TSO panel due to extremely low coverage. In addition, a variant defining a potentially novel null allele was detected in the P1PK system.

Summary/Conclusions:The panel demonstrates significantly higher coverage, quality, and throughput compared to TSO and enables detection of variants that were previously overlooked due to low sequencing coverage. Up to 14 samples can be reliably sequenced in a single run. Our script correctly predicts over 99% of alleles based on SNPs; however, structural HR variants require additional manual analysis.

3C‐S06‐03

DONOR CHARACTERIZATION: A NEW PLATFORM FOR INTEGRAL GENOTYPING, RESULTS OF A LARGE-SCALE STUDY

N Gleadal1,2

1Hematology, University of Cambridge2NHS Blood and Transplant, Cambridge, UK on behalf of the Blood transfusion Genomics Consortium

Bottom:To ensure the safety of a transfusion, it is essential to identify the blood type of both the donor and the recipient. Serologic methods to type ABO, RH, and KEL use monoclonal antibodies; however, rare blood group typing reagents are expensive, unavailable, or unreliable. DNA-based identification of human blood groups has been used to overcome these limitations and its application has reduced alloimmunization rates in chronically transfused patients. However, to date, the cost per sample has prevented the universal application of DNA-based donor typing.

Goals:To achieve universal adoption of DNA-based donor typing, the Blood Transfusion Genomics Consortium (BGC) set out to develop an affordable DNA-based platform capable of typing all red blood cell antigens, HLA class I and II and human platelet antigens.

Methods:The UK Biobank Axiom matrix, previously used to type 600,000 UK citizens, has been redesigned for donor typing using three approaches: i) Transfusion medicine knowledge mining, e.g. ISBT allele tables; ii) Inclusion of loci associated with the health of the donor; iii) Extraction of all coding variants in relevant genes with a frequency > 1:20,000 identified in large-scale sequencing data. Samples from NHSBT and Sanquin blood donors (n = 7871) were used for performance evaluation. Red cell and platelet antigens for each donor were inferred from genotypes using the bloodTyper algorithm and assessed for agreement with clinical serologic typing results.

Results:The agreement between the results of genotypic and serological typing was 99.9% for 95,022 comparisons; 29 of the 89 mismatches were serologically negative and genotypically positive for a given antigen (K/k, Fy[a/b], Lu[a/b]). In all cases, DNA variants known to modify or weaken antigen expression were detected, demonstrating the power of genotyping to detect "weak antigen" variant expression. For 48 antigens for which serology was available, genotyping provided a 3.6-fold increase in the number of typing results available per donor (47.9 vs. 13.2). In addition, genotyping provided data on an additional 224 clinically relevant antigens, allowing the identification of antigen-negative donors and the identification of blood groups for which antibodies are not commercially available. The power of a genotyped panel of donors to support patient management was demonstrated by a retrospective analysis of case reports submitted to the NHSBT. From 3146 patient references with >3 alloantibodies between 2014 and 2018, 772 unique alloantibody profiles were identified. We found that there was a 2.6 times higher probability of finding O-negative matched donors for these patients when using genotyping data from the 4721 NHSBT donors. Importantly, the number of alloantibody combinations for which an antigen-negative match could not be identified was reduced from 293 to 246, representing an additional 164 patients who could be provided with directly matched blood from the same donors. .

Summary/Conclusions:Through the efforts of BGC, an affordable, fully automated genotyping platform has been developed, including processes for quality control and data analysis. In addition, we have demonstrated the real-world benefits that more extensive donor characterization can provide when selecting blood for patients with multiple antibodies. The results of this international collaboration provide opportunities to introduce fully automated genotype-based donor typing in a safe and cost-effective manner to blood supply organizations.

3C‐S06‐04

PROFILE OF THE GENOTYPE OF THE WHOLE BLOOD GROUP BY SEQUENCING ANALYSIS OF THE WHOLE GENOME OF THE NATIONAL BIOBANK

P Wu1, Y Chang2, Y Lin3, P Chen3, Chen M.2, S Father1

1Technical Division2Testing Laboratory Department, Taipei Blood Center3Graduate Institute of Medical Genomics and Proteomics, National Taiwan University, Taipei, Taiwan - China

Bottom:In transfusion practice, accurate antigen typing and matching is essential, especially for transfusion-dependent patients. Providing patients with antigen-compatible blood can greatly reduce alloimmunization and improve transfusion outcome. However, antigen tests are primarily limited to antigens within the first 10 systems due to lack of antiserum. Furthermore, antigen typing can be difficult due to altered or weak expressions. Therefore, many blood banks and centers incorporate blood group genotyping to complement serotyping.

There are currently 36 blood group systems comprising more than 300 antigens, with published phenotypic changes associated with genetic variations. Therefore, antigen expression can be predicted by analyzing blood group gene sequences. Taiwan Biobank performs whole genome sequencing (WGS) of individuals throughout the country. These data are suitable for allele frequency analysis to demonstrate gene expression and genetic profile in our population, in addition to estimating the importance of each antigen in transfusion practice.

Goals:Our goal is to provide and verify population-based blood group antigen profiling using WGS and Taiwan Biobank DNA samples.

Methods:Nearly 1500 WGS and demographic data were analyzed. Blood group antigen annotations were made according to the variants of the ISBT allele tables, including 2 transcription factors; variants for the Lewis system were obtained from previous studies. Blood group variant annotations were verified with 4 DNA samples using targeted sequencing on the Illumina MiSeq, and specific variants were verified with 40 DNA samples using the commercial genotyping kit or Sanger sequencing. Allele frequencies from the WGS analysis were compared to population serological data using the two-proportion z-test.

Results:Blood group antigens from the entire population were analyzed and detailed antigen expression profiles in all systems (except CH/RG) were revealed. WGS antigen frequencies were similar compared to published serology data, except for the antigens and possible explanations listed below, 1) M, N: insufficient sequencing reads, 2) C, c: identicalRHCEexon 2 withright hand driveexon 2 forCallele, 3) Mur: insufficient read length/depth forPIPELINE/GYPBhybridization call and individuals of high prevalence of Mur antigen in aboriginal tribes were not enrolled. Blood group antigen predictions and WGS variants agreed with DNA verification. Additionally, 13 systems showed no genetic variation, predicting uniform antigen expression in our population, and we can manage transfusion with minimal concerns for antigen mismatch in these systems. Furthermore, we found weak and null alleles in our population for blood group systems of which we had no prior knowledge, such as LAN, JR, and VEL. These variants served to identify a patient with anti‐Jracarrying jr homozygousanull alleles.

Summary/Conclusions:Taiwan Biobank WGS is suitable for whole blood group antigen profiling with few adjustments needed for specific antigens. The population antigen allele frequency provides valuable information about the importance of antigen in transfusion practice, the matching strategy for our patients, and the estimation of the probability of obtaining population-specific antigen-negative blood en masse. In addition, the genetic variants revealed in this study can help us locate rare donors and integrate variations into routine donor blood group screening to efficiently provide suitable blood at a low cost.

3C-S06-05

GENOTYPING OF THE EXTENDED BLOOD GROUP OF THE BEL-A2 IMMORTALIZED ERYTHROID CELL LINE USING NEXT GENERATION WHOLE EXOME SEQUENCING

R Javed1,2, L.Tilley3, J. Frayne1, crew V3

1University of Bristol, Bristol, UK2Clinical Hematology and BMT, TATA Medical Center, Kolkata, India3International Reference Laboratory for Blood Groups, NHS Blood and Transplant, Bristol, UK

Bottom:Providing adequate amounts of safe and well-matched blood to meet the demands of an expanding and aging patient population presents a challenging global problem. For these reasons, sustainablein vitroRed blood cell sources may offer a desirable alternative to dependence on donor blood. The first stable cell line of immortalized early adult erythroblasts, BEL-A2, has been shown to efficiently differentiate into mature and functional reticulocytes (Trakarnsangaet al., Nat Commun. 8:14750, 2017) and thus could provide a readily available tool for diagnostic use and proof of principle for future therapeutic use.

Goals:In IBGRL, next-generation whole exome sequencing (WES) has previously been used to accurately predict blood group phenotype in various blood group systems, including ABO, Rh, and MNS (Tilley & Thornton, Transfusion Medicine 27 (Suppl .2): 42, 2017). Here we have used it to analyze and document genotypes related to the BEL‐A2 blood group and predict blood group phenotypes. Additional genes involved in cell growth and enucleation were also analyzed to further elucidate the characteristics of the BEL-A2 cell line.

Methods:BEL-A2 cells (day 196) were grown in expansion medium and genomic DNA (gDNA) was isolated from 1×106cells on day 5. For WES, gDNA libraries were prepared using Nextera®Rapid Capture Exome Enrichment and Sequencing at Illumina®MiSeq. Sequence alignments for 41 genes encoding all 36 known blood group systems and an additional 12 genes encoding transcription factors and cell enucleation-associated proteins were visualized using the Integrative Genomics Viewer, while Illumina®Variant Studio was used to identify the observed mutations. Mutations in the coding regions were used to determine the BEL-A2 genotype and the predicted phenotype.

Results:Good coverage of most of the selected genes was achieved. Homologous blood group gene alignment includingright hand drive/RHCE,PIPELINE/GYPByC4A/C4Bwas problematic and further analysis of the coverage of these genes was required for accurate interpretation. Despite a number of polymorphisms observed in the analyzed genes, BEL-A2 did not express any new or rare blood group antigens. The genotyping results predicted a common antigenic profile, in agreement with previous genotyping and serological results when available. Although several nonsense single nucleotide variations were detected in the analyzed genes, includingCR1,CDAN1yTMX4,these were common polymorphic variants and are unlikely to have any functional significance.

Summary/Conclusions:WES was used to determine the BEL-A2 genotype in relation to blood group genes and selected genes encoding transcription factors and proteins associated with cell enucleation. WES allowed accurate prediction of blood group phenotypes, showing complete agreement with available serological data (Trakarnsangaet al, 2017). A small number of mutations have been identified that are of unknown significance and require further work to determine any potential phenotypic effects. This comprehensive BEL-A2 blood group-related exome record will enable reliable gene editing strategies for future diagnostics and treatments. In addition, knowledge of the whole cell line exome will allow analysis of any emerging genes of interest and provide a better understanding of the mechanisms of erythroid differentiation and enucleation.

Clinical: focus on pediatrics

3C-S07-01

TREATMENT OF ITP IN PEDIATRIC PATIENTS

S Holzhauer

No abstract available.

3C‐S07‐02

INTERNATIONAL VARIATION IN PLATELET TRANSFUSION PRACTICES IN CRITICALLY ILL CHILDREN

nellis1, R Goel2, oh Karam3, Stanworth4

1Pediatrics, Weill Cornell Medicine, New York2Simmons Cancer Institute at SIU School of Medicine, Springfield3Pediatrics, Virginia Commonwealth University, Richmond, USA4John Radcliffe Hospital, Oxford, UK

Bottom:Emerging evidence, especially in neonates, has shown potential harm associated with liberal platelet transfusion strategies. There is very little evidence regarding optimal platelet transfusion thresholds in critically ill children. Randomized controlled trials can be difficult due to the lack of balance of providers. If there is regional variation in practice, comparative effectiveness studies may be an alternative approach.

Goals:Describe regional variation in platelet transfusion practices in critically ill children.

Methods:Secondary analysis of a prospective observational study. Subjects were grouped by region (North America, Europe, Middle East, Asia, and Oceania) and nation. Transfusions were analyzed as prophylactic (given to prevent bleeding) or therapeutic (given to treat bleeding). The primary outcome was total platelet count (TPC) before transfusion. Subgroup analyzes were performed on children with an underlying cancer diagnosis and those receiving extracorporeal life support (ECLS). Dosing and processing of platelet transfusions were analyzed as secondary outcomes.

Results:A total of 549 children from 16 countries were enrolled (67% North America, 17% Europe, 7% Oceania, 5% Asia, and 4% Middle East). Overall, the median CPR (IQR) before prophylactic transfusions (n=360) differed significantly by region (P=0.04) and ranged from 12 (8–41) x109cells/L in the Middle East at 45 (20–66) x109cells/L in Asia. Median TPC before prophylactic transfusions did not differ significantly between countries (P = 0.08), nor did TPC before therapeutic transfusions (n ​​= 189) differ regionally (P = 0.16) or nationally (P = 0.16). = 0.57) . For ECLS-supported children (n=90), there were no regional (P=0.06) or national (P=0.40) differences for prophylactic transfusions. However, significant differences in TPC before therapeutic transfusions were observed at both the regional (P = 0.02) and national (0.04) levels with the Middle East, particularly Israel, transfusing at the lowest median TPC (IQR) [28 (16 –81) x109cells/L]. For children with an underlying cancer diagnosis (n=233), no differences in TPC for prophylactic transfusions (n=175) were observed at the regional (P=0.19) or national (P=0.20) level. Nor were differences observed in TPC prior to therapeutic transfusions at the regional (0.86) or national level (P=0.33). There was significant variability in the dosage of platelet transfusions both regionally (P<0.001) and nationally (P<0.001). The volume-based median dose (IQR) ranged from 8.4 (5.0–11.2) mL/kg in North America to 12.6 (9.8–16.0) mL/kg in Europe. The vast majority of transfusions were leukoreduced and irradiated, but there is significant variation in storage duration both regionally (P<0.001) and nationally (P<0.001).

Summary/Conclusions:There is regional and national variation in platelet transfusion practices among critically ill children, especially those receiving therapeutic transfusions while supported by ECLS. Given this variation, comparative effectiveness studies may be an appropriate approach to obtain evidence for optimizing platelet transfusion thresholds.

3C-S07-03

PROPHYLACTIC PLATELET TRANSFUSION IN PEDIATRIC PATIENTS WITH CANCER: THE EXPERIENCE OF THE BAMBINO GESU CHILDREN'S HOSPITAL

P Berti, F Lamura, L Costantino, C Damico, A Paoloni, E D'Agostino, L Livesi, I Ferruzzi, M Conte, A Cappelli, M Montanari

Immunohematology and Transfusion Medicine Unit, IRCCS Bambino Gesu' Children's Hospital, Rome, Italy

Bottom:The optimal threshold for prophylactic platelet transfusion (Plts) in pediatric cancer patients remains controversial, and current clinical practice stems from studies in adults and in hospitalized patients. International guidelines (ICMTG, 2015) recommend, for patients of all ages, a prophylactic platelet transfusion when the Plts count is ≤10×1011/L and a platelet dose of 1.1×1011per square meter (m2) of body surface area (BSA) in hospitalized patients and 2.2×1011/sm in the outpatient setting.

Goals:In January 2018, we started a prospective protocol at our Children's Hospital in order to assess the impact on bleeding risk of the current clinical practice of prophylactic platelet transfusion in hospitalized and outpatient oncohematology patients.

Methods:The BSA was calculated from the standardized weight for age. Hospitalized patients received a transfusion dose of 1.1×1011/sm and Outpatients a dose per transfusion of 2.2×1011/sm.

Platelets were transfused when the count was ≤10×1011/L or in the presence of signs of bleeding; pediatric aliquots were obtained from pooled buffy coat-derived platelet concentrates or apheresis platelet concentrates, depending on availability.

Results:From January 2018 to December 2018, a total of 9,839 pediatric aliquots of platelets were transfused: 5,534 (56.2%) were obtained from apheresis platelet concentrates and 4,305 (43.8%) from pooled platelet concentrates derived from apheresis. buffy coat. The majority of pediatric platelet aliquots (7505–76.3%) were transfused to haematological-oncology patients undergoing hematopoietic stem cell transplantation (HSCT) or conventional chemotherapy. Among them, 6,365 aliquots were transfused in the hospital setting: 1,675 (17%) in the hematology unit, 2,772 (28.2%) in the oncology unit, and 1,918 (19.5%) in the HSCT unit.

A total of 1140 (11.5%) aliquots were transfused in the outpatient setting: 840 (8.5%) to patients with hematologic malignancies and 300 (3%) to patients with solid tumors.

Five major bleeding events (WHO grade ≥3) were observed during the study period and all occurred in hospitalized patients. Two patients with solid neoplasia developed a WHO grade 3 haemorrhagic event. Two patients with haematological malignancies and one patient with neuroblastoma (n=3, 1.2%) developed intracranial hemorrhage (WHO grade 4). The platelet count at the time of the event was 22×109/L, 25×109/L y 8×109/L, respectively.

Summary/Conclusions:Our results showed the efficacy, in pediatric haematological oncology patients, of a prophylactic platelet transfusion protocol based on international guidelines: a very low incidence of WHO grade 4 haemorrhage has been observed only in hospitalized patients (1.2% vs. to 1% of the PLADO trial, SJ Slichter, NEJM, 2010), while in ambulatory patients the establishment of the double dose of platelets prevents the occurrence of the major bleeding event (WHO grade ≥3).

3C‐S07‐04

RESULTS OF PATHOGEN-REDUCED RED CELL SUSPENSION TRANSFUSION IN CHILDREN WITH ONCOLOGICAL AND HEMATOLOGICAL DISEASES

To the door, P Trakhtman, N Starostin, L Kadaeva, O Chaykina

Transfusiology, National Research Medical Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia

Bottom:The problem of blood-borne infections is still relevant in transfusion medicine. Pathogen Reduction Technologies (PRT) provide a preventative approach to a wide range of transfusion-borne infectious diseases. To date, PRT is widely used for platelet concentrates and blood plasma; however, the use of these technologies for the treatment of blood products containing red blood cells is under investigation.

Goals:The aim of our study was to assess the safety and efficacy of transfused red blood cell suspensions (RBCS) with reduced pathogens (test group) and to compare these data with gamma-irradiated RBCS (control group).

Methods:Technology based on the combined action of riboflavin and ultraviolet (Mirasol PRT, Terumo BCT, Belgium) was used to reduce pathogens in whole blood. Subsequently, the RBCS of the test group were derived from pathogen-reduced whole blood.

Control RBCS were irradiated in the GammaCell 3000 Elite (Best Theratronics, Canada) at a dose of 25 Gray.

All RBCS were used for transfusion for 14 days from the day of collection.

70 pediatric patients with various oncological and hematological diseases were randomized to 2 groups of 35 members in each group. The test group of patients received transfusions of a pathogen-reduced RBCS; the control group received transfusions of gamma-irradiated red blood cells.

The day after the transfusion, the increase in hemoglobin and hematocrit, the level of potassium and haptoglobin in the patients' serum, and the frequency and severity of transfusion reactions were evaluated. The direct antiglobulin test (DAT) was performed 3-5 days after the transfusion, and the indirect antiglobulin test (IAT) was performed 14-21 days after the transfusion. The interval until the next need for transfusion was also evaluated.

Results:The increase in hemoglobin and hematocrit (P=0.2), as well as the concentration of potassium (P=0.44) and haptoglobin (P=0.25) in the serum of the patients after the transfusion did not differ between the patients. groups. None of the patients in both groups presented hyperkalemia after the transfusion. In each group, two patients had non-hemolytic febrile transfusion reactions of comparable severity (P = 1). All DAT and IAT tests were negative in both groups. The interval between transfusions was not significantly different between the groups (P = 0.39). Only in the test group was a correlation found between the increase in hemoglobin and hematocrit values ​​with the volume of transfusion, with the dose and the adjusted dose of hemoglobin obtained for the transfusion on body weight. And in this group, an inverse correlation was found between the increase in hemoglobin and hematocrit with the level of hemolysis in the SR.

Summary/Conclusions:We found that the clinical efficacy and safety of RBCS of the compared groups did not differ. There was no evidence of immune clearance and allosensitization caused by RBCS with reduction of pathogens. According to our data, the spectrum of efficiency and safety indicators of pathogen-reduced RBCS is no worse than that of gamma-irradiated RBCS, as long as the RBCS are used for 14 days of storage. The correlation found suggests that the efficiency of reduced RBCS in pathogenic transfusions depends more on the characteristics of the RBCS.

3C-S07-05

5-YEAR TEMPORARY TRENDS IN PERIOPERATIVE RED CELL TRANSFUSION IN CHILDREN: NATIONALLY REPRESENTATIVE DATA FROM A LARGE NORTH AMERICAN PROSPECTIVE REGISTRY

A Gupta6, C Josephson3, M Nellis4, oh Karam5, LV Vasovic7, a tobiano8, R Goel1,2

1SIU School of Medicine, Springfield2Johns Hopkins, Baltimore3Pathology, Emory University, Atlanta4Pediatrics, Weill Cornell, New York5Pediatrics, Virgin Commonwealth University, Richmond6Vanderbilt University, Nashville7Weill Cornell School of Medicine, New York8Pathology, Johns Hopkins, Baltimore, United States

Bottom:Patient blood management (PBM) programs are expanding internationally. A recent nationally representative study from the United States found that the pediatric age group was the only age group showing a lack of objective evidence of PBM initiatives (Goel et al, JAMA 2018).

Goals:This study aims to identify trends in perioperative blood utilization in children undergoing elective and non-elective surgeries over a 5-year duration from 2012 to 2016.

Methods:Using 5-year data (2012-2016) from the American College of Surgeons National Surgical Quality Improvement Program (PEDS ACS‐NSQIP) pediatric database, time trends of perioperative red blood cell transfusions in children ( <18 years) undergoing elective/urgent/emergent surgeries were assessed and subgroup analyzes were performed by case type. A trend analysis was performed to assess significance.

Results:A total of 369,176 children (43.2% males and 56.8% females) were analyzed. Of these, 77,521 were infants (<1 year) and 15,858 neonates (<28 days)]. 73.2% of the patients underwent elective surgical procedures, 10.0% urgent and 16.8% emergent, respectively.

Overall, perioperative red blood cell transfusion was documented in 23,835 patients (6.5%). [7,926 (10.2%) infants; 2,487 (15.7%) neonates]. Of these, about 0.7% (n = 2425) children received preoperative transfusions (within 48 hours after surgery). About 5.4 percent (n = 19,968) of the children received red blood cell transfusions intraoperatively or postoperatively (from the start of surgery to 72 hours postoperatively).

Perioperative transfusions steadily decreased per year from 6.4% in 2012 to 5.5% (14% cumulative decrease) in 2016 for children of all ages (OR 0.966, 95% CI 0.957–0.976; p trend < 0.001). The cumulative change in elective procedures was 9.2% versus a 27.2% decrease in urgent/emergent procedures (p trend < 0.001).

Summary/Conclusions:In this large prospective registry study of more than 350,000 children undergoing elective/non-elective surgeries, a statistically significant decrease in the use of perioperative red blood cell transfusions was observed over 5 years from 2012 to 2016, with a more significant decrease in urgent/emergent procedures than in elective procedures.

While these findings need evaluation for non-surgical indications for transfusion, these results may provide the first evidence for the implementation of perioperative blood management strategies in pediatric patients to optimize transfusions in the pediatric population.

Adverse Events: TTIs, Immune Interactions, and Risk

3C‐S08‐01

TTI AND PATIENTS WITH IMMUNODEFICIENCY: SELECTED DERIVATIVES OR CLOSE FOLLOW-UP

HH Hirsch

University of Basel, Basel, Switzerland

Transfusion-transmitted infections (TTIs) are a long-standing and well-recognized concern in medicine, which is addressed at the highest level to ensure the safety of the transfusion procedure for all stakeholders. These include recipient patients, donor volunteers, involved healthcare workers and their respective contact persons. Consequently, current national and international guidelines, including expert societies and the WHO, provide medical, technical and legal frameworks, which are the basis for standard operating procedures. However, there are significant challenges that make ITT a “moving target” and reflect dynamics in three main areas. First, a change in the type and number of recipient patients with a past or current immunomodulatory/immunodeficiency component (eg, HIV/AIDS, TOS, allogeneic HCT, monoclonal antibody therapies, small molecule inhibitors). Second, changing exposure to known agents in donors due to global travel, migration and displacement, as well as climate/environmental change. Third, discovery and diagnosis of old and new agents with their known or assumed impact as TTI. These issues will require careful review of data and studies, and judicious discussion of potential action, such as selection versus strict control to keep TTI rates as low as possible, to provide maximum safety for patients and concerned parties.

3C‐S08‐02

CHARACTERIZATION OF HEPATITIS B VIRUS STRAINS INFECTING BLOOD DONORS WITH HIGH HBSAG LEVELS AND INCONSISTENT DETECTABLE HBV DNA: IMPLICATIONS FOR BLOOD SAFETY POLICY AND SCREENING

D Candotti1, M. Vermeulen2and Kopacz3, M Miletic4, A Saville2P. Grabarczyk3, C. Niederhauser5, L. Boizeau1, S. Laperche1

1DATS CNR RIT, National Institute of Blood Transfusion, Paris, France2The South African National Blood Service, Johannesburg, South Africa3Virology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland4Investigación y Desarrollo, Instituto Croata de Medicina Transfusional, Zagreb, Croacia5Research and development, Inter-regional Blood Transfusion SRC, Bern, Switzerland

Bottom:The implementation of nucleic acid testing (NAT) and the development of sensitive and specific serological assays to detect HBsAg and anti‐HBc antibodies significantly reduced the risk of HBV transfusion transmission. Apparently redundant tests for two direct viral markers prompted debates about maintaining HBsAg screening, particularly in low endemic countries where blood donations are tested for anti‐HBc. However, frequencies of 2 to 20% of confirmed HBsAg-confirmed NAT-positive/NAT-negative donations have been reported depending on the sensitivity limit of the molecular assays used. The nature of this discrepancy between HBsAg and DNA remains largely unknown and it is essential to assess any potential negative impact on blood safety before considering deletion of the HBsAg test.

Goals:The prevalence in blood donors and the molecular mechanisms responsible for a persistent undetectable or barely detectable level of viral replication in the presence of sustained HBsAg production were investigated in a collaborative study involving five laboratories/blood centers in Europe and South Africa. The discrepancy between viral DNA and HBsAg levels suggested the presence of mutations that may negatively affect HBV replication and/or the production of infectious viral particles.

Methods:Samples from donors from France, South Africa, Poland and Croatia were selected for having HBsAg levels ≥100 IU/mL and being ID‐NAT (Procleix‐Ultrio Plus™ [95% LOD: 3 IU/mL]) nonreactive/nonrepeatable reactive (NR/NRR) with undetectable viral load (CV) or <6 IU/mL (n=44) or NAT repeat reactive (RR) with CV <6 IU/mL (n=32). French samples initially tested with NAT NR/NRR with Procleix‐Ultrio (LOD 95%: 11 IU/mL) were retested with Ultrio Plus prior to inclusion in the study. HBV DNA load was quantified (Cobas TaqMan HBV [LOQ: 6IU/ml]). HBV DNA was purified from 5 to 12 ml of plasma after ultracentrifugation. The entire HBV genome, Pre‐S/S, PreCore/Core and BCP regions were amplified and sequenced.

Results:After viral titration, the presence of HBV DNA was confirmed in 79% of all samples with VL undetectable or <6 IU/mL. HBV genotypes were A1 (33.3%), A2 (18.4%), A3 (3.3%), B (3.3%), C (1.7%), D (25%). and E (15%). All samples were anti‐HBc positive and 73% of Ultrio negative samples were Ultrio Plus positive. Unusual 1-2 nt insertions/deletions identified in BCP regulatory elements (TATA boxes, pgInr, epsilon domain) suggest impaired viral replication. Amino acid substitutions (n=16) or deletions (n=4) at positions involved in nucleocapsid formation, particle envelopment, and virion formation were observed in the core protein of 30 samples. The replicative properties of the BCP and core variants are currently evaluated in vitro as a surrogate model for direct infectivity tests. Preliminary results indicate that the variants tested so far have replication capacities similar to those of the control viruses. Analysis of the Pol, S, and HBx proteins is ongoing.

Summary/Conclusions:These data confirmed the presence of extremely low level of circulating DNA-containing viral particles in ID‐NAT non‐reactive or repeat non‐reactive blood donations with concomitant elevated levels of HBsAg and anti‐HBc reactivity. Despite the presence of mutations in the viral genomes that can affect virion production, preliminary data indicate that some of the viruses in plasma retain the ability to replicate in vitro and constitute a potential infectious risk.

3C‐S08‐03

INFECTION BY THE HEPATITIS B VIRUS AFTER VACCINATION IN A BLOOD DONOR: A CASE REPORT

a brass1, M pride1, C tinguously1, P. Gowland1, M. Jutzi1, C. Niederhauser1,2,3

1Interregional Blood Transfusion SRC, Suiza, Berna2Faculty of Biology and Medicine, University of Lausanne, Lausanne3Institute for Infectious Diseases, University of Bern, Bern, Switzerland

Bottom:High sensitivity nucleic acid screening in an individual donation format for hepatitis B virus (HBV ID‐NAT) and detection of hepatitis B surface antigen (HBsAg) are mandatory in Switzerland (Swiss guidelines Transfusion SRC, Switzerland). Since 1998, vaccination against HBV (HB) has been recommended in Switzerland for children and adolescents up to 15 years of age and for adults belonging to known risk groups.

Goals:Note that low anti‐HBs titers several years after HBV vaccination still confer protection and allow the host's immune system to clear HBV DNA without the development of serological markers of disease.

Methods:A retrospective interview with the donors was carried out to complete the information not covered by the questions included in the standard questionnaire for donors. Routine serological screening of HBV donors was performed on a Quadriga system (Diasorin, ex Siemens) with the Enzygnost HBsAg assay (Diasorin, ex Siemens). Further HBV testing was performed on the Abbott Architect i1000 analyzer (HBsAg, HBeAg, anti‐HBc IgG/IgM, anti‐HBc IgM, anti‐HBe and anti‐HBs neutralization). Routine ID‐NAT screening for HIV/HCV/HBV was performed with the Roche cobas MPX test on a Roche cobas 8800 platform. HBV ID‐NAT positive samples were confirmed with a quantitative HBV NAT assay (Abbott).

Results:Testing of implicated donation and pre- and post-donation samples: During screening on December 4, 2018, a 57-year-old male blood donor tested positive for HBV DNA by ID-NAT with a low HBV titer (6 IU/ml) and negative for HBsAg. In a follow-up blood sample taken on December 11, 2018, the HBV NAT result was confirmed positive (<1 IU/mL) and HBsAg returned to negative. Additional serological tests for active or past HBV infection (anti‐HBc IgM/IgG, HBeAg, anti‐HBe) were negative in both samples. The previous 26 donations tested negative for HBV DNA and HBsAg. An additional blood sample, obtained on February 19, 2019, had undetectable levels of HBV DNA, while HBV serology markers, including anti-HBc IgM/IgG, remained negative. The anti-HBs antibody level was 13.86 IU/ml on May 25, 2018, 500 mIU/ml on December 4, 2018, and >1000 IU/ml on December 11, 2018.

Retrospective review of donor interview and medical records: The donor had received HBV vaccine (Engerix B 20 μg/ml) in 2001/2002 according to a standard 3-dose schedule verified in his medical records. He indicated possible exposure to hepatitis B virus from sexual contact in Thailand after the last negative donation in May 2018, more than 6 months before the positive donation. The donor confirmed that he had not had any other potential exposure to HBV in the relevant period.

Summary/Conclusions:In this blood donor previously vaccinated against HBV with an anti‐HBs titer of 13.86 mlU/ml before suspected infection, we detected transient viraemia with no clinical evidence of disease, no HBsAg expression and complete absence of seroconversion. for typical markers of HBV infection. An increase in anti-HBs titer was observed after infection accompanied by complete clearance of HBV DNA. These findings demonstrate the protective effect 17 years after vaccination despite progressive infection and anti‐HBs well below the level considered protective and successful HBV clearance without seroconversion.

3C‐S08‐04

SERUM HEPATITIS B CORE-RELATED ANTIGEN (HBCRAG) ASSAY IN BLOOD DONORS WITH OCCULT HEPATITIS B VIRUS INFECTION

M Spreafico1, B Foglieni1, I Guarnori1, S. Frison1, A Berzuini2, C Bonato3, in Gerosa1, D Prati2

1Department of Transfusion Medicine and Hematology, Lecco Local Health Authority (ASST), Lecco2Department of Transfusion Medicine and Hematology, IRCCS Foundation Cà Granda Ospedale Maggiore Polyclinico, Milan3Department of Laboratory Medicine, Local Health Authority (ASST) of Lecco, Lecco, Italy

Bottom:Hepatitis B core-related antigen (HBcrAg) is a structural antigen of HBV consisting of HBCAg, HBeAg, and the p22cr precore protein. Quantitative measurement of HBcrAg is a sensitive marker of viral replication that reflects cccDNA content and disease persistence. HBcrAg positivity was found to be a significant risk factor for HBV reactivation in patients with HBsAg‐, anti‐HBc+, HBV DNA‐ (occult HBV infection, OBI) receiving immunosuppressive therapy.

Goals:No data are available on HBcrAg status in apparently healthy subjects with OBI. The aim of this study was to analyze this marker in our cohort of OBI blood donors.

Methods:HBcrAg was measured in 69 blood donors confirmed as OBI carriers (HBsAg‐, HBV DNA+). Of these, 59/69 (85.5%) of the donors were anti‐HBc positive and 10 (14.5%) negative. 18 donors had both anti‐HBc and anti‐HBe reactivity. A group of 11 young blood donors vaccinated for HBV infection (HBsAg‐, HBV DNA‐, anti‐HBc‐) and 9 patients with chronic HBV infection (HBsAg+, HBV DNA+) were used as negative and positive control group. , respectively. Serum HBcrAg was measured using a chemiluminescent enzyme immunoassay on the Lumipulse G600 automated analyzer (Fujirebio, Tokyo, Japan). The lower limit of detection (LOD) of the quantitative assay is 2 logU/mL and the lower limit of quantification (LOQ) is >3 logU/mL, due to non-linearity of results between 2 and 3 logU/mL. HBcrAg levels were tested in all three groups and analyzed in comparison to the presence of anti‐HBc and anti‐HBe. Statistical analysis was performed with IBM Statistics SPSS 19.0.0.

Results:All donors in the negative control group had undetectable HBcrAg levels, while all patients in the positive control group had detectable HBcrAg levels (mean value: 3.0 logU/mL, range 2.0 to 4.9). , which confirms that people without previous exposure to HBV would not have detectable levels of HBcrAg. HBcrAg. HBcrAg was detectable in 34/69 OBI donors (49.3%), with a mean value of 2.21 logU/ml (range 2.0-3.20). HBcrAg could only be measured in 2 OBI donors (3.0 and 3.2 logU/ml), being below the LOQ of the test in the majority of OBI (32/34). Considering the presence of anti‐HBc, HBcrAg was detected in 29/59 (49.1%) anti‐HBc+ and in 5/10 (50%) anti‐HBc‐OBI, with no significant difference in their mean levels (2.21 ±0.32 vs. 2.14±0.26, p=0.44). Interestingly, the presence of anti‐HBe (18/62) was independently associated with higher levels of HBcrAg (2.38 ± 0.42 vs 2.14 ± 0.22; P = 0.03).

Summary/Conclusions:The identification of donors with OBI is essential to prevent the risk of transmission by transfusion of HBV. As HBcrAg is associated with cccDNA content and replication, our results suggest that the presence of HBcrAg, even if not quantifiable, could be a useful marker to confirm occult infection status, even in anti‐HBc negative donors. The association between HBcrAg, anti‐HBc and anti‐HBe could also be a useful marker to identify OBI donors at increased risk of HBV reactivation.

3C‐S08‐05

ANALYSIS OF THE IMMUNOLOGICAL CHARACTERISTICS OF T CELLS OF OCCULT HEPATITIS B INFECTION

X-ring1,2, W Zhang2, yup1,2

1Institute of Transfusion, Guangzhou Blood Center2School of Laboratory Medicine and Biotechnology, Southern Medical University, Guangzhou, China

Bottom:Occult hepatitis B infection (OBI) manifests as positive HBV DNA in liver tissue, negative or low HBV DNA in serum, and negative serum hepatitis B surface antigen (HBsAg), which may be accompanied by surface antibodies. Serum hepatitis B test (HBsAb), HBeAb positive. and/or HBcAb. Most OBIs have a strong inhibitory effect on HBV replication and gene expression. However, OBI has not been clearly described in terms of virologic features, host immune response, and epigenetics. In particular, the molecular and cellular immune functions of OBI carriers are unclear.

Goals:To investigate the molecular and cellular immunological function of T lymphocytes, including characteristics of T cell proliferation and IFN-γ secretion capacity of OBI, chronic hepatitis B (HCB) infection, and control of healthy blood donors (HC).

Methods:HBsAg was detected by chemiluminescence in the study population. HBV DNA was detected by nucleic acid test (NAT). Three study population groups were established, including 37 cases in the OBI group, 53 cases in the CHB group, and 23 cases in the HC group. Human peripheral blood mononuclear cells (PBMC) from blood donors were stimulated with a pool of HBV polypeptidesin vitro. T cell proliferation assays (CFSE) were used to detect T cell proliferation, and enzyme-linked immunospot assay (ELISPOT) was used to detect the frequency of T cells secreted by HBV-specific IFN-γ. For the statistical analysis, the statistical analysis software SPSS 20.0 was used. Data measuring the normal distribution were tested using the two-independent-sample t-test; and comparison between multiple groups was analyzed by one-way ANOVA. The Mann‐Whitney U test was used for comparison between non‐normal data sets. P<0.05 was considered statistically significant.

Results:1. Characteristics of T-cell proliferation. CD4 proliferation+T cells were primarily stimulated by a group of specific HBV polypeptides, and the proliferation rates of the OBI group and the CHB group were significantly higher than those of the HC group (3.0%, 3.3% vs. 1, 7%), with a significant difference (3.0% vs. 1.7%, PAG=0.016, 3.3% vs. 1.7%, P<0,001).

2. The frequency of secreted IFN-γ-specific T cells. The response intensity of the OBI group (25 SFC/106PBMC) and CHB group (25 SFC/106PBMCs) was superior to that of the HC group (5 SFC/106PBMC) under HBV pool polypeptide stimulation, and the positive rate of T cell response to HBV pool polypeptide stimulation was highest in the OBI group (64.0%).

Summary/Conclusions:Both OBI and CHB had higher rates of HBV-specific T effector cell proliferation and IFN-γ secretion than the healthy control group. Compared with the CHB group, the OBI group had a higher positive rate of T-cell response, which may be one cause of host immunity resulting in OBI. Further studies on other immune factors are required.

Young Investigators - Excellence in Transfusion

3C-S09-01

DEVELOPING SCENARIOS FOR FUTURE DEMAND FOR BLOOD PRODUCTS IN THE NETHERLANDS: SCENARIO SESSIONS

P Langi Sasongko1, M. van Kraaij2, K van den Hurk1, M. Janssen1

1Donor Drug Research2Donor Affairs, Sanquin, Amsterdam, The Netherlands

Bottom:Western blood transfusion practices are currently changing due to several factors, such as blood management policies, ongoing technological developments, and new therapeutic options. In the Netherlands, as in many high-income countries, this has resulted in a downward trend in red blood cells. Therefore, it is important that blood bank management anticipate the future demand for blood products for decision-making in the medium and long term. To support this decision making, we have used scenario development, which is used in many other sectors (such as finance and transport) and can also be applied to blood transfusion. Based on a prior literature review and semi-structured interviews of international experts, we brought together experts in scenario sessions to assess the opportunities and threats for Sanquin's medium-term (15-20 year) strategy using an online platform and face-to-face discussions. .

Goals:Assess the opportunities, threats and organizational implications of these for the medium-term future of Sanquin, the Dutch national blood bank.

Methods:Twenty-one multidisciplinary blood transfusion experts agreed to participate and were divided into two groups for half-day interactive sessions. Using an iterative process through an online platform, experts brainstormed opportunities and threats for Sanquin, which were categorized into themes. These topics were classified according to importance and certainty, and by consensus, the experts chose two topics with high impact and high uncertainty. For these chosen topics, specific actions were listed for the blood bank to mitigate and/or ameliorate the threat or opportunity. The discussions were extensive at all times.

Results:Regarding the opportunities and threats for Sanquin's medium-term strategy, the experts generated many ideas and categorized them into 10 themes: political context/changing legislation, novel products and alternative applications, donors, international markets, commercialization, digitalization, change perceptions, research, demand and organizational structure. After ranking by importance and certainty, six themes were chosen: changing perceptions, international markets, political context (opportunities), demand (opportunities), research (vulnerabilities), and donors (vulnerabilities). For each of these topics, the experts provided specific actions for organizations to mitigate threats or stimulate opportunities accordingly. These actions included increased transparency and better communication with the (donor) public, lobbying in political spheres, increased activity in educational institutes and large funding organizations, and creation and collaboration on new blood products internationally, to name a few.

Summary/Conclusions:These results show that mapping and evaluating the future of a blood bank using a multidisciplinary group of experts is conducive as an effective means to collect a wide range of opportunities and threats. This provides an opportunity for blood bank management to become proactive in the face of these potential opportunities and threats and possibly develop future strategies for the organization.

3C‐S09‐02

POLYGENIC RISK SCORES BASED ON PLASMA FERRITIN DO NOT PREDICT FATIGUE/LACK OF ENERGY IN WOMEN BLOOD DONORS: RESULTS FROM THE DANISH BLOOD DONOR STUDY

J Dowsett1, M Didriksen1, To Rios1, L Thorner1, E Sorensen1, K Burgdorf1, C. Erikstrup2, O Pedersen3, K. Banasik4, H Any1

1Clinical Immunology, Copenhagen University Hospital, Copenhagen2Clinical Immunology, Aarhus University Hospital, Aarhus3Clinical Immunology, Næstved Hospital, Næstved4NNF Center for Protein Research, University of Copenhagen, Copenhagen, Denmark

Bottom:An analysis from the Danish Blood Donor Study (DBDS) presented at ISBT 2018 showed that female iron-deficient blood donors were more likely to have depressive symptoms than non-iron-deficient female blood donors. Among participants with depressive symptoms, women with low plasma ferritin levels were significantly more likely to report a "feeling of lack of energy and strength" (OR = 2.11; 95% CI: 1.03–4, 31). As blood donors are known to be at increased risk of iron deficiency, it is important to determine whether those genetically predisposed to lower plasma ferritin levels are at increased risk of experiencing the symptom of tiredness/lack of energy.

Goals:To investigate whether there is an association between polygenic risk scores (PRS) based on plasma ferritin levels and the symptom of tiredness/lack of energy in blood donors.

Methods:The DBDS is an ongoing nationwide blood donor cohort, from which genome-wide genotyping data is available for 72,000 participants. Genotyping was performed with the Infinium Global Screening Array (Illumina®) and imputation was achieved based on a Scandinavian reference genome. Ferritin PRS, based on an Icelandic ferritin GWAS (N = 150,000), were calculated for all DBDS participants. 12,903 female donors were available for analysis. Data on depressive symptoms were obtained using the validated Major Depression Inventory (MDI) scale, a self-report mood questionnaire, which assesses the presence of 10 depressive symptoms. A donor was classified as "tired" if she answered "all the time" or "most of the time" to the question "how often does she feel that she lacks energy and strength?" A logistic regression analysis was performed, adjusting for age. To generate the quantile plots, participants were evenly distributed across six quantiles based on their PRS, with quantile 1 containing donors with the lowest PRS (genetically predisposed to lower ferritin levels) and set as the quantile. reference with OR = 1 from the regression analysis adjusted for age (fatigue˜quantile).

Results:The PRS in women ranged from ‐0.42 to 0.50 (mean 0.01). A total of 12,523 female donors were classified as "not tired" and 380 (2.9%) were classified as "tired". No significant differences in ferritin PRS were found between "tired" and "non-tired" female donors (mean tired PRS: 0.00; mean non-tired PRS: 0.01). An age-adjusted logistic regression model found this not to be significant (OR: 0.74, 95% CI: 0.33–1.66), P = 0.47). To visualize the lack of association, a quantile plot was created, separating the female donors into six equal quantiles based on their PRS. No clear trend was observed; donors with the highest PRS (at quantile 6) had an OR = 1.02 (P = 0.93) of being tired compared with those in quantile 1 (OR set to 1).

Summary/Conclusions:No significant association was found between the ferritin PRS of female blood donors and the symptom of tiredness/lack of energy. Further studies are needed to understand the effect of donating blood versus genetic constitution on fatigue among iron-deficient blood donors.

3C‐S09‐03

MOLECULAR EPIDEMIOLOGY OF HIV-1 AND PREVALENCE OF RESISTANCE ASSOCIATED MUTATIONS IN UNTREATED BLOOD DONORS

j zhao1,2,3, L Chang1,2, H Ji1,2,3, L Zhang1,2,3, X Jiang1,2,3, F Guo1,2, L Wang1,2,3

1National Center for Clinical Laboratories, Beijing Hospital, National Center for Gerontology, Beijing, P.R. China2Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, PRC3Graduate School, Peking Union College of Medicine, Chinese Academy of Medical Sciences, Beijing, PRC, Beijing, China

Bottom:Antiretroviral therapy (ART) is essential to control the clinical progression of human immunodeficiency virus (HIV) infections. However, the outcome of ART could be limited by drug resistance-associated mutations (DRMs), including leading to the transmission of drug-resistant HIV to previously untreated patients, such as blood donors, thus it is a great concern for the TAR. The World Health Organization strongly recommends DRM surveillance in HIV-infected groups. Characteristics of genetic diversity and HIV DRMs among blood donors can provide comprehensive data for monitoring viral evolution and optimizing ART, and play an important role in blood safety.

Goals:In China there are limited data on the epidemic of HIV‐1 subtypes and DRM from blood donors. This study aims to investigate the genetic characteristics and DRM of HIV‐1 infected blood donors.

Methods:Between 2016 and 2018, the National Centers for Clinical Laboratories confirmed that 177 blood donations collected from 24 blood centers, covering almost all of China, were HIV-1 positive using the Abbott RealTime HIV-1 assay or the COBAS TaqMan HIV-1 test. 1, version 2.0. Then HIV‐1 Gag (973bp, HXB2: 1074‐2044),politicalGenes (1454bp, HXB2: 2068-3521) (encoding full length protease (PR) and a part of reverse transcriptase (RT)) were sequenced after viral RNA extraction and amplification. HIV-1 subtyping based on the Gag and PR-RT regions was determined by comprehensive analyzes of the Los Alamos HIV BLAST tool, the REGA HIV-1 subtyping tool, phylogenetic trees, and the jpHMM online program. DRM analysis was performed on the Stanford HIV Drug Resistance Database.

Results:Among 177 donations, the Gag and PR-RT regions of 160 samples were successfully sequenced. The HIV-1 genotype distribution was as follows: CRF_07BC=66 (38.8%), CRF_01AE=58 (36.3%), B=9 (5.6%), CRF_08BC=2 (1.3% ), CRF55_01B=4 (2.5%) , CRF59_01B=1 (0.6%), CRF65_cpx=1 (0.6%), CRF67_01B=2 (1.3%), CRF79_0107=1 (0.6% ), CRF85_BC=1 (0.6%), URF_0107=6 (3.8%) and URF =9 (5.6%). Twenty-six of 160 HIV-1 isolates were identified as having DRM. There were 4 (15.4%, 4/26) accessory protease inhibitors (PIs) DRMs, 3 major PIs DRMs, and 20 (76.9%, 20/26) non-nucleoside reverse transcriptase inhibitors (NNRTIs) DRMs. Most DRM blood donors were CRF01_AE and CRF07_BC (61.5%, 16/26). 3 of 4 DRM PI accessories were Q58E. PI's main DRMs included the M46L, M46I and N88S. N88S could result in HLR for atazanavir (ATV) and NFV, LLR for indinavir (IDV) and saquinavir (SQV). V179D/E is the leading NNRTI DRM (70.0%, 14/20). A combination of V179D and K103R between two samples acted synergistically to reduce susceptibility to efavirenz (EFV) and nevirapine (NVP). In addition, two blood donors with a K103N mutation in the reverse transcriptase gene had a high level of resistance to EFV and NVP.

Summary/Conclusions:Overall, the most prevalent subtypes among study blood donors were CRF07_BC (38.8%), CRF01_AE (36.3%). In addition, other rare CRFs and several URF_0107 and URFs were also found in these HIV-1 isolates, suggesting that the HIV epidemic has shifted from high-risk populations to general populations, including blood donors in China. . DRM were observed in 16.3% of donors in China. the study, which can result in resistance to PIs and NNRTIs, especially HIV-1 variants with the N88S mutation in the PR gene and the K103N mutation in the RT gene. In summary, our findings indicate that the increasing diversity of HIV-1 in blood donors and reminds us of the need for timely monitoring of genotypic drug resistance and molecular epidemiological surveillance of HIV-1 among blood donors. .

3C‐S09‐04

BIOTINYLATION OF PLATELETS FOR TRANSFUSION PURPOSES: A NEW METHOD FOR LABELING PLATELETS IN A CLOSED SYSTEM

S Brown1,2, E van de Weerdt2, D. Sijbrands3, R Vlaar1, E. Gouwerok1, B Biemond4, A Vlaar2, R van Bruggen1, D de Korte1,3

1Blood Cell Research, Sanquin Research and Landsteiner Laboratory2Department of Intensive Care, Amsterdam University Medical Centers, AMC location3Product and Process Development, Sanquin4Department of Hematology, Amsterdam University Medical Centers, AMC location, Amsterdam, The Netherlands

Bottom:Platelet labeling is required to measure recovery and survival of transfused plateletslive. A radioactive method is currently used to label platelets. However, its application is limited due to safety concerns and the inability to isolate transfused platelets from circulation. Biotin labeling of platelets is an attractive non-radioactive option; however, there is currently no validated protocol to biotinylate platelets for clinical purposes.

Goals:The aim of this study is to develop a simple, standardized and reproducible method for labeling platelets with biotin as a non-radioactive alternative for tracking transfused platelets.live.

Methods:Six pooled buffy coat-derived platelet concentrates (PCs) stored in 100% plasma were biotinylated on day 1 and day 7 of storage. To distinguish the effect of processing steps from the effects of biotin incubation, "mock" samples were processed. For the biotinylation procedure, 50 ml of PC were washed twice and incubated with 5 mg/L biotin, dissolved in phosphate-buffered saline-PAS-E (1:9), for 30 min. Biotin-labeled platelets were tested for stability after irradiation. Annexin V and CD62P expression were assessed as measures of platelet activation. The applicability of this method to other platelet products was evaluated on three pooled PCs stored in 65% PAS‐E and three apheresis PCs from a single donor.

Results:The method was reproducible performed in a closed system. After biotinylation, 98.4% ± 0.9% of the platelets were labeled. Platelet counts, pH, and "eddy" were within the Dutch blood bank accepted range for standard platelet products. The number of annexin V positive cells was not significantly altered by the biotinylation procedure in both fresh and stored platelets. In contrast, CD62P expression was increased on biotinylated platelets 48.4% IQR (41.7–56.2%) compared to control samples 12.3% IQR (9.5–12.7%) in on day 1 of storage. However, biotinylated platelets were not more activated compared to 50% IQR mock samples (41.7–56.2%). Therefore, only the procedural steps led to increased expression of CD62P and not the biotin tag itself. All samples showed a maximal response to the thrombin receptor activating peptide. For platelets labeled on day 7, a similar pattern was observed. Irradiation of biotin-labeled platelets did not alter the stability of the biotin label or the quality of the cells. Furthermore, this method is also applicable to pooled PCs stored in PAS-E and apheresis PCs, with similar patterns in annexin V and CD62P expression.

Summary/Conclusions:We developed a standardized and reproducible protocol in accordance with the Good Practice Guidelines (GPG) standards for the labeling of platelets with biotin for clinical purposes. The steps of the procedure, which are similar to the steps used for the production of hyperconcentrated platelet products, led to increased expression of CD62P, but did not alter the expression of annexin V. This method can be applied as a non-radioactive alternative to screen and recover transfused plateletslive.

3C‐S09‐05

ISOLATOR A1 REDUCES THE GENOTOXICITY OF A BETA-GLOBIN LENTIVIRAL VECTOR

G Kaltsounis1, P. Papayanni1,2, P Christofi1,2, Yo Valianou1, G. Karponi1, M Yangou2, Anagnostopoulos1M Sadelain3I river4, G. Stamatoyannopoulos5, E Yannaki1,5

1Gene and Cell Therapy Center, Hematology-BMT Unit, George Papanicolaou Hospital2Department of Genetics, Development and Molecular Biology, Faculty of Biology, Aristotle University of Thessaloniki, Thessaloniki, Greece3Cellular Engineering Center4Center for Cellular Therapy and Cellular Engineering, Memorial Sloan‐Kettering Cancer Center, New York5Department of Medicine, University of Washington, Seattle, United States

Bottom:Insertion oncogenesis remains a major limitation for gene therapy (GT). Auto-inactivating lentiviral (SIN-LV) vectors, while safer than retroviral γ vectors, still carry the risk of insertional mutagenesis, especially when, like globin vectors, they incorporate potent enhancers. The use of chromatin isolators (CH) as a means of minimizing vector-mediated genotoxicity through their ability to act as enhancer blockers that prevent activation of endogenous genes by the vector enhancer, has been limited primarily by their large size, affecting titers and suboptimal isolation. . Recently, 27 human elements have been functionally characterized as robust enhancer-blocking isolates, and most of them display enhancer-blocking activity superior to that of the prototypical cHS4 isolate in cell lines and substantially reduce genotoxicity in a mouse model of mediated carcinogenesis. by γ retroviral vector. . Unlike cHS4, these isolators are small in size (119–284 bp vs 1.2 kb) and can be easily accommodated in GT vectors without negatively affecting vector titers.

Goals:Our aim was to test whether A1, one of the newly discovered ICs, could reduce vector-mediated genotoxicity in the challenging context of SIN‐LV, by isolating a globin therapeutic vector.

Methods:We tested the effect of genotoxicity on IL-3-dependent 32D cells, which upon transduction with oncogenic vectors become IL-3-independent, leading to transformation. 32D cells were transduced with SIN-LV: the β-globin-ΤΝS9.3.55-, the isolated β-globin-A1-TNS9.3.55- and the oncogenic vector SFFV-GFP. Transduced cells were expanded in 10% IL-3 and transduction efficiency was determined by vector copy number (VCN). Transduced 32D cells were seeded on methylcellulose with 10% or 0–1% IL-3 to detect IL-3-independent, potentially transformed clones. IL-3 independent clones were further expanded in 10% IL-3 and infused into IL-3 treated, partially myeloablated C3H/HeJ mice. Analysis of white blood cells, blood smears, and bone marrow (BM) cytospins were performed.

Results:The A1 isolator did not negatively affect vector titers (ΤΝS9.3.55, A1‐TNS9.3.55, SFFV‐GFP: 2.8, 1.8, 2.5X10^8IU/ml, respectively). 32D cells were successfully transduced with all vectors (% VCN-positive colonies: 40–100%) and expanded up to 400-fold. The A1 isolator decreased the number of IL-3 independent colonies by 78-93% relative to non-isolate vectors. IL-3-independent colonies transduced with non-isolated vector were greatly expanded in culture with 10% IL-3 over A1-transduced colonies (SFFV, ΤΝS9.3.55, A1-TNS9.3.55: 48, 40, change of 10 times). , respectively). The independence of IL-3 as a transformation event was confirmed in vivo by the development of overt leukemia (hyperleukocytosis, splenomegaly, OM infiltration and extramedullary sites) in transplanted mice with expanded, IL-3-independent colonies.

Summary/Conclusions:Under forced oncogenic conditions, the A1 isolator effectively protected a therapeutic vector from vector-mediated genotoxicity. A1 can serve as a security feature in the globin-SIN-LV construct.

3C‐S09‐06

WEAK D ANTIGEN EXPRESSION IS A COMMON RESULT OF SPLICING DISRUPTION: CHARACTERIZATION OF NOVEL SPLICING SITE VARIANTS AND CORRELATION BETWEEN IN SILICO PREDICTION AND EXTENSIVE FUNCTIONAL STUDIES

iron1,2, C Ka1,2,3, L Vigneron1, Yo Gourlaouen1, I Callebaut4, C Ferec1,2,3, G. Le Gac1,2,3, and Fichou1,2

1UMR1078 Genetics, Functional Genomics and Biotechnology, Inserm, EFS, UBO2GR-Ex Excellence Laboratory3Laboratory of Molecular Genetics and Histocompatibility, University Hospital (CHRU), Brest4Sorbonne University, National Museum of Natural History, UMR CNRS 7590, Institute of Mineralogy, Physics of Materials and Cosmochemistry (IMPMC), Paris, France

Bottom:New rare nucleotide substitutions are frequently identified inright hand drive, the gene encoding the clinically relevant Rh blood group system immunogenic D antigen, resulting in a variant D phenotype. Until now, it has been commonly accepted that amino acid substitutions located in a transmembrane or intracellular domain of the protein RhD induce a weak D phenotype, ie reduced D antigen density on the surface of red blood cells. We recently demonstrated by functional analysis using a "minigene splicing assay" (MSA) that a decrease in D antigen expression may also be due to impaired cell splicing.

Goals:Here we turn our attention to the general disruption of this mechanism and the related phenotypic consequences in novel and previously reported single nucleotide variations inright hand drive. We then sought to functionally characterize by MSA new candidate splice variants inright hand drive. We then extended the project by prospectively studying all single nucleotide variations reported inright hand driveexons, in order to globally assess the correlation betweenin silicoprediction and functional analysis and obtain information on the reliability of bioinformatics tools in line with the available phenotypic and/or clinical data.

Methods:Seventeen novel or uncharacterizedright hand driveMSA selected variations, including missense, synonymous, and intronic substitutions for functional analysis in human cell models. A second set, which includes 46 missense variants reported inright hand driveexons 6 and 7, was further analyzed. Functional data were compared with an algorithm derived from the QUEPASA method and tools available in the Alamut suite. A published 3D protein model was used to visualize the location of nonsense amino acid substitutions and to potentially assess their respective phenotypic consequence.

Results:A new "universal" minigene was successfully validated and used to characterize eleven new splice variants. Those variants include six intronic and four missense substitutions near consensus dinucleotide splice sites, as well as the synonymous variation c.1065C>T associated with a weak D phenotype, creating aagainsplice site. Very interesting, c.1154G>T (Gly385Val; D-negative) completely disrupts normal splicing, while c.1154G>C (Gly385Ala; D weak) and c.1154G>A (Gly385Asp; D-negative) only partially disrupt the mechanism . Further visualization of amino acid changes in a 3D model suggests that Gly385Asp, but not Gly385Ala, drastically alters the structure/folding of the RhD protein. Subsequently, the global analysis of mutations inright hand driveexons 6 and 7 by MSA showed that inclusion of the entire exon sequence in the mature transcript is significantly reduced in 15/46 (32.6%) variants, correlating well with the QUEPASA-like prediction (sensitivity = 0.93, specificity = 0.94). Furthermore, while normal exon inclusion is affected by c.1012C>G (weak D type 70), the associated Leu338Val substitution does not appear to be deleterious to the protein.

Summary/Conclusions:Based on our functional data, this work shows that splice disruption in the presence ofright hand drivevariants is a common and general mechanism that can act independently or synergistically with alteration of protein structure through amino acid substitutions, resulting in a weak D phenotype. It also illustrates the power of combining functional tests andin silicotools for phenotypic/clinical interpretation of rare variants.

Donors and donation: retention of blood donors and the role of side effects

3C‐S10‐01

INCENTIVES FOR BLOOD DONORS: DONOR RETURN RATE BETWEEN COMPENSATED AND NON-COMPENSATED BLOOD DONORS

M Müller‐Steinhardt1,2, C Weidmann3, H Klüter1

1Institute for Transfusion Medicine and Immunology, Mannheim Medical School, University of Heidelberg2Red Cross Blood Service Baden-Württemberg - Hesse, Mannheim3Universidad Hochschule Furtwangen, Furtwangen, Germany

Background/Objectives

Monetary and non-monetary incentives can support blood services in recruiting blood donors, but they have also been criticized for violating ethical principles and threatening blood safety by attracting donors at high risk of infectious diseases. Although incentives for blood donors have been widely discussed in recent decades, empirical research on this topic remains limited. The aim of this study was to describe attitudes towards incentives for blood donors in Europe and to show the return rates of compensated and uncompensated blood donors in southwestern Germany.

Methods:First, we present the results of a secondary analysis of the Eurobarometer, a nationally representative survey across all member states of the European Union. In 2014, participants were asked to rate eight possible incentives for blood donations as acceptable or unacceptable. These incentives were snacks (eg, coffee), physical checks (eg, blood pressure), free laboratory parameters (tests), free medical treatment, complementary items (eg, first aid kits) , travel reimbursements, additional cash reimbursements and release from work.

Second, we performed a retrospective analysis of the donor return patterns of 6,210 compensated and 68,205 uncompensated donors who began donating blood at fixed and mobile donation sites. Compensated donors received EUR 25 as regular reimbursement of their expenses (at a fixed donation site), in accordance with the German transfusion law, or a one-time free entry to an amusement park (at a mobile donation site). . These matched donors were matched with unmatched donors who started at a fixed or mobile donation site. Chi-square statistics were used to assess differences in regular donor status after 24, 36, 48, and 72 months between compensated and uncompensated first-time donors.

Results:Among German Eurobarometer participants, free physicals (51.9%), snacks (50.0%) and free lab parameters (tests) (38.3%) showed the highest acceptance as an incentive for blood donors. blood. Travel reimbursements and free medical treatment were rated as acceptable by 28.6% and 25.3%, respectively. The lowest acceptance was for work release (17.8%), complementary items (13.9%) and additional cash reimbursement (11.8%). Interestingly, the acceptance of potential incentives varies considerably in Europe.

In southwestern Germany, the return of first-time donors differed significantly depending on the type of compensation. Among matched first-time donors, who received EUR 25 as monetary reimbursement, the proportion of regular donors after 48 months (19.9%) was significantly higher than among comparable unmatched donors (9.2%). However, non-monetary compensation (free admission) did not increase donor return rates.

Conclusion:The Eurobarometer survey indicates that in most European countries monetary incentives are only accepted by a small minority. Free snacks, check-ups, laboratory parameters (tests) and free medical treatment were the most popular incentives for blood donors. However, the results from our four non-random donor samples from southwestern Germany suggest that monetary compensation may increase the likelihood that donors will return to fixed donation sites. Therefore, regular monetary reward can help recruit regular donors, especially in urban settings. By the way, non-monetary compensation for a free ticket, however, may not affect the return of donors.

3C‐S10‐02

DEFERRAL AS THE POINT OF NO RETURN: A MIXED METHODS APPROACH TO UNDERSTANDING WLE BLOOD DONOR EXPIRATION AFTER TEMPORARY DEFERRAL

ML Spekman1,2, T van Tilburg2, E. Merz1,2

1Donor Medicine Research, Sanquin2Sociology, VU Amsterdam, Amsterdam, The Netherlands

Bottom:Previous research has shown that whole blood (WB) donors temporarily deferred to site are at increased risk of relapse, however very few studies have focused on differentiating the effects that different reasons for deferral may have (eg ., travel, hemoglobin [Hb]). at the expiration of the donor. In addition, donor experience (i.e., first-time or repeat donor) has also previously been found to affect donor expiration, however, novice donors (1 to 5 prior donations) and reactivated donors (returning after years without donating) may respond differently. Finally, it is currently unclear how and why different reasons for deferral and donor experience interact to influence donor expiration.

Goals:Our goals were to understand 1)asthe reasons for the postponement and the experience of the donor jointly affect the expiration of the donor, and 2)becausedonors may lapse after a temporary deferral.

Methods:A mixed methods approach was used. First, we use the Sanquin donor database for a quantitative analysis of the return behavior of all Dutch World Bank donors between 2013 and 2015 (N=343,564). The first World Bank grant for each donor was identified as the target grant. Lapse was defined as non-return within a two-year follow-up period after target donation. Target donations included 25% new donors, 41% novice donors, 30% experienced donors, and 4% reactivated donors. Reasons for postponement included travel, Hb, short-term medical (<28 days duration), long-term medical (>28 days duration), and miscellaneous. Below, we interviewed 31 temporarily deferred donors to understand the deferral process from their perspective. Semi-structured interviews were used to understand how these donors cognitively and emotionally experienced the on-site deferral. We analyzed the interviews (using the Framework approach, cf. Hillgrove et al., BMC Public Health, 2012) to identify key themes and underlying themes.

Results:Of the planned donations, 11% were deferred, primarily for travel (40%), short-term medical (23%), and Hb (19%). Survival and time-to-event methods showed that different reasons for postponement and levels of donor experience impacted donor return or expiration differently. Importantly, experience and deferral interacted to influence performance (rate). For example, new deferred donors were more likely to lapse than eligible or experienced donors (Os<0.75,whens<0.001). Although delay also affected the return of experienced donors, this effect was less or even absent for certain reasons for delay (eg, travel and Hb-related delays).

Qualitative results showed that almost all donors experienced temporary postponement as disappointing, particularly when it was unexpected (eg, first time postponement). Not all donors (fully) understood the objectives of deferral or how to avoid deferral on site. Donors' beliefs about why the postponement would lead to expiration were related to recurring postponements, (wrongly) interpreting the postponement as permanent, or feeling that all the effort was not worth it.

Summary/Conclusions:Reasons for temporary deferral impact donor forfeiture risks differently at different levels of donor experience. For new donors, all reasons for deferral are related to higher risks of expiration, whereas some reasons for deferral appear not to affect expiration among more experienced donors. Unexpected or recurring postponements may explain why donors expire after the temporary postponement. Blood banks can address disappointment after postponement by explicitly showing that the donor is still valued, for example by using personalized communication or offering an alternative good deed.

3C‐S10‐03

PREDICTION OF HEMOGLOBIN IN BLOOD DONORS USING A LATENT CLASS MIXED EFFECTS TRANSITION MODEL

E-Lesaffre1, K Nasserinejad2,J. van Rosmalen3

1I‐Biostat, KU Leuven, Leuven, Belgium2HOVON Data Center Clinical Trials Center,3Department of Biostatistics, Erasmus MC, Rotterdam, The Netherlands

Bottom:Blood donors experience a temporary reduction in their hemoglobin (Hb) value after donating whole blood. In the Netherlands, the Hb value is measured before each donation and a too low Hb value (cut-off values: 8.4 mmol/l (135 g/l) for men and 7.8 mmol/l (125 g/l) for women) leads to a postponement of the donation, in order to prevent iron deficiency and anemia. The minimum interval between two donations is internationally set at 8 weeks, but over time donors show iron deficiency, so blood donors are temporarily deferred from donating every year. In the US, between 35% and 75% of postponements are due to low Hb levels, especially in women (Editorial, Transfusion, 2012). Due to the recovery process after each donation and the unobserved heterogeneity of donors, advanced statistical methods are needed to model longitudinal data of Hb values ​​from blood donors.

Goals:Estimate the form and duration of the Hb recovery process until the Hb value has returned to its pre-donation level, assess whether it is possible to distinguish between donors with a fast and/or slow recovery of their Hb level, and predict future Hb values.

Methods:The study is based on data from the Donor InSight study, which was a prospective cohort study conducted by Sanquin in the Netherlands from 2007 to 2016. We employed three statistical models for Hb value: (i) mixed-effects models, ( ii) a latent class mixed effects model, and (iii) a latent class mixed effects transition model. In each model, a flexible function was used to model the recovery process after donation. Latent classes identify groups of donors with fast or slow recovery times, and donors whose recovery time increases with the number of donations. The transition effect explains the possible dependence of the state on the observed data. All models were estimated in a Bayesian fashion, using data from a sample of 1000 new incoming donors (500 men and 500 women). Previous information from the clinical literature (Boulton, Vox Sanguinis 2004) on the recovery process three days after blood donation was incorporated into the analysis, as these values ​​were not identified in the observed data.

Results:The results show that the latent class mixed effects transition model fits the data better. We also found that the recovery process shows a concave process (initially fast followed by slower recovery). The estimated recovery time is much longer than the current minimum interval of 58 days between donations. That is, depending on the subgroup to which the donor belongs, males have a recovery time of 100 to 419 days, while the estimated recovery time for females varies between 54 and 503 days. These results suggest that an increase in this interval may be justified.

Summary/Conclusions:The analysis shows the utility of sophisticated statistical models that make use of historical information to model complex processes over time, in this case the trajectory of Hb over time through repeat donations. Furthermore, our results suggest a (much) longer time span between subsequent donations to avoid anemia.

3C‐S10‐04

INTERVENTION STUDY FOR THE PREVENTION OF VASOVAGAL REACTIONS: ANALYSIS OF DONOR RETURN FOR SUBSEQUENT DONATION

JC Wiersum-Osselton1, F Princes2, T Marijt‐van der Kreek3, E van den Brekel4, F. Hermans5

1Donor Affairs Unit, Sanquin Blood Bank, Leiden2donor studies3Donor Affairs Unit, Sanquin Blood Bank, Amsterdam4Donor Affairs Unit, Sanquin Blood Bank, Nijmegen5Donor Affairs Unit, Sanquin Blood Bank, Deventer, The Netherlands

Bottom:Complications from donating blood are known to reduce donor return for future donations. The EPISoDe (Experience Success in Donation) study showed that drinking water shortly before donation had a 23% reducing effect on self-reported vasovagal reactions (VVR) in younger novice whole blood donors (Wiersum‐Osselton, Transfusion, 2019 ).

Goals:In this study we analyze the return for a subsequent donation of the donors participating in the EPISoDe study. This was a predefined secondary outcome of the EPISoDe study.

Methods:The EPISoDe study was conducted in young whole blood donors (<30 years) making their first, second, third, or fourth donation at geographically selected collection centers. Study interventions were: 330 mL water drink, 500 mL water drink, or squeezing a ball (placebo intervention) during the wait after the screening interview and before phlebotomy, and a no-intervention control group. Participating donors were sent an online questionnaire about their experience within a week of their attempted donation.

In the Netherlands, donors are usually invited to donate blood according to the needs of the hospitals; the goal is to invite eligible donors at least once a year. Donors were included in the return analysis if they had received at least one invitation within 400 days of the index donation, and we screened their return for an attempted donation within 421 days. Associations with interventions and donor donation status, gender, and symptoms reported in their index donation were analyzed by calculating percentage return of eligible donors and using binomial logistic regression.

Results:Of the 8,199 EPISoDe participants who had been invited, 6,538 (79.7%) returned within the study period. There was no difference in donor return between the two water groups. The likelihood of return was significantly increased in the water and placebo intervention donors compared with the questionnaire group (OR 1.2, 95% CI 1.06–1.4 and 1.3, 1.12–1 .5, respectively). Return was slightly lower in women (OR 0.88, 0.78–0.99) and lower in first-time donors (OR 0.86, 0.77–0.96) than after 2North Dakota–4hedonation. A staff-reported or self-reported VVR in the index donation reduced donor return (OR 0.47, 95% CI: 0.37–0.60 and OR 0.53, 0.46–0.61, respectively ). Other post-donation symptoms were also associated with a lower percentage of return.

Summary/Conclusions:In this cohort of younger new and novice blood donors, 79.7% returned for a subsequent donation. A VVR (staff-recorded or self-reported) reduced donor return. Donors who received a study intervention, either water or placebo, were more likely to return whether or not they had suffered a VVR. It is conceivable that simply participating in the study could also have increased donor return, even in the questionnaire group; this will be examined in the total donor population of the target group.

3C‐S10‐05

HEALTH STATUS, DONATION PATTERNS, AND IRON DEFICIENCY IN ELDERLY BLOOD DONORS: EVIDENCE FROM A LARGE POPULATION-BASED COHORT AND HEALTH SERVICES USE DATA

S Karki, S Wright, D Irving, T Davison

Research and Development, Australian Red Cross Blood Service, Sydney, Australia

Bottom:The contribution of older blood donors to the blood supply is substantial. In Australia, donors over the age of 50 contributed 41% of all donations made in 2017. However, with aging, the general health status of older donors changes relatively faster, progressively affecting their ability to donate. A thorough understanding of the relationship between the health status of older donors, future donation patterns, and risk of iron deficiency could be of great value in informing the Blood Service to predict future donation numbers and control risk. of iron deficiency. -deficiency.

Goals:To understand the relationship between self-reported health, blood donation patterns, and treatment of identified iron deficiency in elderly blood donors.

Methods:We linked baseline data from the Sax Institute's 45 and Up Study collected between 2006 and 2009 with Blood Service donation records, inpatient records, and Medicare* records. Data linking was performed by the Center for Health Record Linkage. Using these linked data, we examined the relationship between health, donation patterns, and iron deficiency and its management.

Results:22,058 active whole blood donors were followed for 200,403 eligible person-years (mean age at enrollment 56.4 years, 56.3% female, mean follow-up 9.1 person-years). After adjusting for the effect of age, sex, body mass index, education, language other than English spoken at home, country of birth, smoking, physical activity, use regular multivitamin intake, alcohol consumption at enrollment, and total number of whole blood samples. donations in the 2 years prior to enrollment, participants with better self-reported health at enrollment showed significantly higher donation rates. Donors with excellent, very good, good, and fair/poor health status made 1,066 (95% CI 1,056–1,075), 987 (981–993), 900 (891–909), and 710 (690–730) donations for each 1000 person-years, respectively.

Iron deficiency was identified in 8.9% of study donors (n=1964, 95% CI: 8.5–9.3). Sixty percent of people with iron deficiency (n = 1175, 95% CI 57.6–62.0) visited their general practitioner (GP) within 60 days of identifying iron deficiency , and 48.4% (95% CI 45.5–51.3) of people who visited GPs underwent further examination and monitoring of iron status.

After adjusting for several potential confounders, including the total number of donations made during the follow-up period, self-reported excellent health was independently associated with a lower risk of iron deficiency (p for trend = 0.004).

Summary/Conclusions:Information on self-reported health status can be an effective indicator for estimating future donation performance from a panel of older blood donors and the risk of developing iron deficiency. Donors with better self-reported health had a greater number of future whole blood donations and a lower risk of iron deficiency. Donors referred to GPs for iron status monitoring used health services as expected, however there is an opportunity to improve their contact with their GPs.

* Medicare records were provided by the Australian Government Department of Human Services.

Transfusion Practitioner session - Management of anemia - The importance of the Transfusion Practitioner in the multidisciplinary team

3C‐TP01‐01

THE IMPORTANCE OF ANEMIA MANAGEMENT AND IMPACT ON THE HEALTH ENVIRONMENT

a Monday1, 2, 3, Z McQuilten1, 2, E Madera1, 2

1Transfusion Research Unit, Monash University, Melbourne2Department of Hematology, Monash Health, Clayton3Departments of Clinical and Laboratory Hematology, Austin Health, Heidelberg, Australia

Anemia is a major public health problem that affects 25% of the world population according to the World Health Organization. Iron deficiency is responsible for approximately half of all cases globally, with other causes including anemia of chronic disease, other nutritional deficiencies, hemoglobinopathies, renal failure, malignancy, and bone marrow disease. In the elderly, where anemia is even more frequent, the cause is usually multifactorial.

Anemia is associated with increased mortality, decreased cognitive and physical function, depressive symptoms, and fatigue, particularly in older adults. Poor outcomes have also been reported in anemic patients with underlying comorbidities, such as heart and kidney disease, and cancer.

Within a hospital setting, anemia is very common. Preoperative anemia, which affects up to 30% of patients, is associated with poor clinical outcomes, including increased hospital mortality, longer hospital stay, and higher ICU admission rates.

The treatment of anemia requires a proactive and multifaceted approach, usually involving a multidisciplinary team in which the transfusion professional plays a key role. This includes high-risk patient screening and preadmission clinics to identify and treat patients at high risk for perioperative anemia. Implementation of patient blood management (PBM) guideline recommendations has been shown to be effective in preventing and optimally managing anemia within the community and hospital settings. The transfusion physician has key roles in coordinating, monitoring, and auditing PBM programs. Active patient participation and commitment from all members of the multidisciplinary team, including primary care physicians, are also key to enhancing the success of such programs.

3C‐TP01‐02

THE ROLE OF THE TRANSFUSION DOCTOR IN THE EVALUATION AND MANAGEMENT OF ANEMIA: PROCESSES, ADVICE AND RESOURCES TO CREATE CHANGE

Bielby1,R musgo2

1Department of Health and Human Services, Victoria and Australian Red Cross Blood Service, Blood Affairs, West Melbourne, Australia2Department of Laboratory Medicine, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK

Bottom:Patient blood management (PBM) is an evidence-based integrated multidisciplinary approach that aims to improve clinical outcomes through the effective handling and preservation of the patient's own blood, thereby reducing unnecessary exposure to transfusion. PBM has the patient as its central axis with the aim of improving its results and including it in the process.

PBM includes three pillars: 1) optimizing the patient's own blood, 2) minimizing blood loss, and 3) optimizing the patient's physiological tolerance of anemia.

Delayed evaluation/management of anemia contributes to increased healthcare costs and unnecessary blood transfusions, and transfusion has been recognized to be associated with increased morbidity and mortality.

The term Transfusion Professional (TP) includes those known as transfusion nurses, transfusion safety officers, hemovigilance officers, or patient blood management (PBM) coordinators. A key aspect of the role is to drive and influence clinical blood management activities to help align practice with internationally recognized guidelines and standards, including PBM.

Aim:Demonstrate the role of TP in the assessment and management of anemia and discuss strategies, processes, tips, and resources for creating organizational and cultural changes to implement PBM.

Context:The literature highlights the importance of a multidisciplinary team to implement PBM-related changes, and PTs play a critical role within these teams to support "buy-in." PTs are seen as enablers, gathering resources, engaging with stakeholders, providing education, and facilitating change. Often they are the ones conducting audits, collecting data and evaluating the results.

Approaches to implementing PBM must be tailored to individual organizations. The authors will describe different approaches, highlighting where the PT can support or lead activities. One approach to anemia assessment is to perform an audit, examples of available tools will be shown. With this data, the TP together with the PBM team can explore options for corrective action. These could include interventions such as developing a pathway where all or a specific group of patients are assessed or treated at a pre-operative clinic or with their local general practitioner; to more complicated strategies such as the establishment of anemia clinics.

The PT's skills are a valuable asset in analyzing the clinical specialties/patient mix to target for best results, they know the organization and as such are well positioned to help develop a process/concept that suits, and they can provide education and support to promote and incorporate these practices.

Conclusion:Appropriate evaluation and treatment of anemia requires a multidisciplinary approach. The TP plays an active and crucial role in this team. Examples of processes, tips and resources will be shared to support change and embed a PBM culture across the clinical spectrum.

Immunobiology: red blood cell destruction and immune regulation

3D‐S11‐01

INNATE IMMUNITY AND IMMUNE HEMOLYTIC ANEMIA

S Zeerleder

Department of Hematology and Central Laboratory of Hematology, Inselspital Bern, Bern, Switzerland

La anemia hemolítica inmune (HAI) se caracteriza por una mayor descomposición de los glóbulos rojos (GR) debido a alo y/o autoanticuerpos dirigidos a los antígenos de los eritrocitos con o sin activación del complemento. Los signos clínicos y de laboratorio de hemólisis junto con la presencia de una prueba de antiglobulina directa positiva caracterizan la HAI. Los aloanticuerpos formados durante el embarazo y/o después de transfusiones previas pueden causar una reacción transfusional hemolítica aguda o retardada después de la transfusión de un producto de glóbulos rojos incompatible con la especificidad del aloanticuerpo. Los autoanticuerpos contra los glóbulos rojos reducen la supervivencia de los glóbulos rojos endógenos y dificultan la recuperación de los glóbulos rojos del donante después de la transfusión. Las enfermedades linfoproliferativas, las enfermedades autoinmunes, las infecciones o los fármacos a menudo provocan autoanticuerpos contra los glóbulos rojos, pero con frecuencia no se puede identificar una causa obvia.

In addition to antigen specificity, isotype critically determines the biological activity of RBC antibodies in vivo. The isotype defines the affinity for the Fc-gamma receptors of the cells of the reticuloendothelial system as well as the capacity to activate the classical complement pathway, IgM being the most effective. Antibody-mediated activation of complement results in opsonization of red blood cells with C3bc/C3d with subsequent receptor-mediated clearance of complement by phagocytes.extravascularhemolysis). Occasionally, complement activation proceeds through C5 activation to the formation and insertion of the membrane attack complex resulting inintravascularhemolysis

There is increasing evidence that the innate immune system plays an important role in the pathogenesis of AIH. The complement-mediated process of hemolysis results in systemic inflammation, which contributes to the morbidity and mortality of patients with AIH. Activation of complement results in the release of anaphylatoxins, which are strongly vasoactive and mediate chemotaxis, inflammation, and the formation of radical oxygen species. The release of cell-free hemoglobin and cell-free heme after hemolysis induces endothelial cell activation, NO depletion, cytotoxicity, ROS formation, and neutrophil activation. Natural plasma scavengers, such as haptoglobin and hemopexin complex with their target molecules, cell-free hemoglobin and heme, with subsequent clearance of the complexes via CD163- and CD91-mediated phagocytosis. Although they are positive acute-phase proteins due to consumption, plasma scavengers are depleted during chronic hemolysis, thus failing to prevent the adverse biologic effects of circulating cell-free hemoglobin and heme. Inducible heme oxygenase-1 (HO-1) is an effective cellular scavenger by breaking down heme to biliverdin with subsequent formation of bilirubin, CO, and ferrous iron with subsequent oxidation to ferric iron and storage by the ferritin H chain. HO‐1 has an established role in systemic protection against systemic inflammation induced by hemolytic and non-hemolytic diseases. The conference will emphasize the role of innate immunity with a special focus on different cellular and plasma systems involved in the pathogenesis of systemic inflammation in patients suffering from ALF.

3D‐S11‐02

UNDERSTANDING RBC CLEARANCE

C Roussel, P Amireault, P Ndour,Bufet P

Research and teaching, Institut National de la Transfusion Sanguine, Paris, France

Red blood cell clearance is essential in physiology, disease, and transfusion. Removal of RBCs altered by senescence or disease processes is expected to protect the microcirculation from obstruction by sticky or rigid RBCs. It also contributes to the deleterious consequences of anemia and hemolysis in hereditary and acquired diseases of the red blood cells, as well as in conditions associated with autoimmunization or alloimmunization. Antibody-mediated red blood cell clearance has been explored in great detail by immunobiology, but conventional approaches may not be fully operational in explaining delayed hemolytic transfusion reactions. Some important clearance processes are independent of the recognition of molecules or antigens on the surface of red blood cells. Increased erythrocyte rigidity triggers their removal in hereditary spherocytosis, malaria, and possibly also in the setting of autoimmune anemia. Knowledge and unknowns about erythrocyte clearance mechanisms and sites will be presented based on a critical review of old and recent contributions.

3D‐S11‐03

RED CELLS AS MODULATORS OF IMMUNITY

R Rigano, B Buttari, E Profumo

Cardiovascular and Endocrine Metabolic Diseases and Aging, Istituto Superiore di Sanità, Rome, Italy

Existing literature indicates that red blood cells (RBCs), beyond gas transport, play a complex role in human physiology, being involved in many essential functions to maintain ionic, metabolic, and immunological homeostasis. Red blood cells display immunomodulatory activity on adaptive immune cells by promoting T-cell growth and survival and inhibiting activation-induced cell death. The balance between cell death and survival controls T-cell homeostasis, and abnormalities in this balance explain diseases related to T-cell overgrowth or undergrowth. Red blood cells can modulate innate immunity by binding to endogenous molecules such as chemokines and mitochondria-derived DNA, as well as external agents such as pathogens. Red blood cells can also directly modulate innate immune cell activation or tolerance by controlling the maturation of the circulating pro-inflammatory dendritic cell (DC) subset. These cells are potent inducers of primary antigen-specific T cell responses, produce TNF-α when stimulated by LPS, and are the major IL-12p70-producing cells among leukocytes. The proinflammatory capacity of circulating DCs is controlled by red blood cells that can inhibit their maturation and IL-12 production. In diseases characterized by a local Th1 inflammatory response, such as psoriasis vulgaris and rheumatoid arthritis, proinflammatory DCs play a role in inducing and perpetuating inflammation. Taken together, the data from the literature indicate that red blood cells exert important modulatory functions that can result in immune activation or inactivity, depending on environmental conditions. When red blood cells encounter a microenvironment characterized by intense ROS production, the red blood cell's defenses are overwhelmed or unable to counteract the new pro-oxidant state and they become a source of ROS, resulting in the generation of RBCs. senescent signals in red blood cells. The main feature of oxidized red blood cells is the clustering and/or breakdown of Band 3. Other features are complexation of Hb with spectrin, loss of glycophorin A, externalization of phosphatidylserine, and reduction of integrin. "self marker". CD47 associated protein. A similar senescence phenotype has been documented in red blood cells during the storage period. Oxidized, senescent, or stored red blood cells, due to modification of the surface antigen and release of pro-inflammatory molecules, fail to control immune cell homeostasis, contributing to the perpetuation of inflammation and the pathogenesis of associated immune-mediated diseases. to oxidative stress, such as autoimmune diseases and atherosclerosis. Our research group demonstrated that red blood cells from patients with carotid atherosclerosis exhibited a senescent phenotype similar to that acquired by red blood cells from healthy subjects after oxidation in vitro. Oxidized RBCs fail to control lipopolysaccharide-induced T cell apoptosis and monocyte-derived DC maturation, representing dangerous signals for innate and adaptive immunity and contributing to the pathogenesis of atherosclerosis. In conclusion, crosstalk between red blood cells and the immune system represents a mechanism to maintain immune homeostasis. However, under conditions of high oxidative stress, which can occur during a prolonged storage period or in particular diseases, red blood cells can acquire pro-oxidant behavior and lose their functional and homeostatic characteristics. By interfering with the homeostasis of the immune system, red blood cells become a potential tool that can be manipulated to ameliorate or reverse pathological situations characterized by abnormalities in the control of innate and adaptive immunity.

Clinical - Hemoglobinopathies; The last

3D‐S12‐01

TRANSFUSION TREATMENT IN SICKLE CELL DISEASE: WHAT INDICATIONS AND FOR HOW LONG?

K Yazdanbakhsh, H Zhong, Y Liu, F Vinchi, A Mendelson

New York Blood Center, New York, NY, United States

Transfusion therapy remains an important treatment modality for patients with sickle cell disease (SCD). Transfusions are given to reduce the percentage of circulating sickle red blood cells and to decrease blood viscosity and have been shown in clinical trials to reduce the risk of stroke by 90%. However, many indications for transfusion in SCD remain controversial partly because of insufficient randomized clinical trial data and partly because of our limited understanding of the complex pathologic networks that lead to various disease complications in SCD despite of the common single mutation. Similarly, we have an incomplete mechanistic understanding of why chronic transfusion protocols should be continued for those indications supported by clinical data. The benefits of transfusion therapy in SCD must also be weighed against potential transfusion risks, including alloimmunization associated with life-threatening late transfusion reactions, increased iron stores associated with increased oxidative stress, and exposure to infectious agents. . We believe that a deeper understanding of the benefits and harms of transfusions is crucial to optimizing our current transfusion therapy protocols in SCD. This knowledge may provide much-needed guidance, which is currently lacking, for expanding or limiting existing indications for chronic transfusions in SCD.

3D‐S12‐02

TREATMENT OF THALASSEMIA

and Aydinok

Department of Pediatric Hematology, Ege University, Faculty of Medicine, Bornova/Izmir, Turkey

Thalassemia is a devastating blood disease with a significant global burden. Every year 60,000 children are born with thalassemia major. Lifelong RBCC transfusions and iron chelation remain the standard of care treatment in thalassemia. Transfusion therapy still accounts for significant iron overload-related morbidity and mortality despite chelation therapy being associated with poor adherence, safety concerns, and mixed efficacy. There is an increased risk of transfusion-transmitted infections (TTIs) for patients with thalassemia whose exposure to transfusions is sustained for life. Although the risk of transmission of traditional viruses is extremely rare in the modern era, emerging infectious diseases continue to be recognized as potential threats to transfusion safety. The inadequacy of blood safety points to the need for an additional layer of safety for the blood supply in the developing world. Pathogen reduction technologies for RBCC may imply a proactive and more widespread approach against new and re-emerging pathogens in the developed world and may be an ultimate safeguard for transfusion safety in developing countries. Red cell alloimmunization may become a major challenge in the management of thalassemia. Prevention is the key to reducing the burden of alloimmunization. Although the recommendation is to transfuse thalassemic patients with blood compatible with C/c,E/e,Kell, it is not universally practiced. Extended molecular typing of red blood cells may be an appropriate adjunctive test in addition to serologic typing before embarking on transfusion therapy. If a complete red blood cell antigen profile has not yet been performed in an alloimmunized patient, genotyping is the only option for accurate detection of red blood cell antigens that can guide antibody identification. Allogeneic stem cell transplantation (A‐SCT) is the only curative treatment available in children with HLA-matched siblings that is available for approximately 20% of patients. In the absence of MSD, MUD transplantation with high match criteria still has limited experience. SCTs of umbilical cord blood and related haploidentical donors with mismatches are considered experimental. A‐SCT carries a considerable risk of SAE and mortality, which increase with the age of the recipient and the severity of the disease. DFS is 88% in pediatrics and 65% in adults. Gene therapy for the correction of α-globin chain imbalance overcomes donor availability issues and immunologic complications associated with TA-SCT. Multicenter clinical studies of gene addition therapy using an autoinactivating lentiviral vector are currently underway. Recently, gene editing by disrupting or correcting genes emerged as a potential alternative to gene addition therapy in beta thalassemia. A new era of novel therapies in the management of thalassemia is developing. Several targets have been identified that may ameliorate alpha/beta chain imbalance, ineffective erythropoiesis, or iron dysregulation, and several of these now have agents in preclinical and clinical development. Hydroxyurea may ameliorate globin chain imbalance and be beneficial in reducing or omitting the need for transfusions in a selected group of patients. Ruxolitinib has shown a limited effect on pre-transfusion hemoglobin and reduction of transfusion requirements, but allowed a consistent decrease in spleen volume that may serve to avoid splenectomy in beta-thalassemia. Luspatercept can restore normal erythroid differentiation and ameliorate anemia, and hepcidin mimetics or TMPRSS6 inhibitors can modulate ineffective erythropoiesis through iron restriction and ameliorate anemia and organ iron load.

3D‐S12‐03

BLOOD SAFETY PROTECTION FOR THALASSEMIA PATIENTS

Police C1, A Eleftheriou2, C Richardson3, E Zervou4, M Angastiniotis2, P Englezos2

1Hellenic Center for Hemovigilance Coordination, Hellenic Center for Disease Control and Prevention, Athens, Greece2International Thalassemia Federation, Nicosia, Cyprus3pantheion university,4Hellenic Center for Disease Control and Prevention, Athens, Greece

Bottom:Thalassemia major (particularly β-type) and sickle cell disease (SCD) are the most common clinically important hemoglobinopathies and represent major sources of morbidity. The recommended therapy is regular transfusion of safe, good-quality blood and control of related complications. The Thalassemia International Federation (TIF) guidelines, in effect since 1987, include strategies for precautionary measures and the use of scientific progress in the detection, inactivation, and elimination of transfusion-transmissible pathogens. Antigen matching strategies to avoid alloimmunization against red cell antigens and other measures, including hemovigilance, are key components of safe blood, along with laboratory quality assurance and voluntary blood donation programs and unpaid.

Goals:We present the contribution of TIF and the Greek experience to ensure the safety and availability of blood for patients with thalassemia by applying internationally accepted standards and recommendations.

Methods:TIF, a patient-driven, not-for-profit organization with 204 national thalassemia associations in 62 countries, promotes national control programs for prevention and management that contribute to achieving a definitive cure. The main working methods are the provision of education, expert support, networking, communications and projects to support improvements in the quality of health, social and other care.

In Greece, technical standards are applied for the selection and analysis of blood donors in accordance with Directive 2004/33/EC, as well as hemovigilance programs and traceability procedures to record adverse reactions and events associated with the transfusion of red blood cells ( Directive 2005/61/EC) . The pre-transfusion and transfusion measures recommended by the Council of Europe are applied. In particular, measures are practiced for the transfusion of "the right blood at the right time for the right patient", leukodepletion, washing of red blood cells and accurate crossmatching and detection of antigens and antibodies for an extended compatibility policy. Fresh red blood cells (up to 15 days old) are used. Molecular tests for ABO and Rh D are performed in cases with blood group mismatches.

Hemovigilance in Greece covers 95% of the total blood supply. Data on TTI in 3067 patients with thalassemia and SCD‐thalassemia in 2010-2017 are analyzed.

Results:The prevalence of TTI in thalassemia syndromes was: HBV 1.8% (occult type 1.3%), HCV 54%, HIV 0.3%, HTLV 0.8%, WNV 0.5% and HEV 3%. . The most frequent adverse reactions in 2015-17 were allergic (incidence 1:854), non-hemolytic febrile reactions 1:2,631, “Other” 1:5,883, alloimmunization 1:6,667, TACO 1:100,013, TAD 1: 50 006, TT-HEV 1:100,013. Hyperhemolysis was diagnosed in two patients with SCD, delayed hemolytic transfusion reaction in one patient with thalassemia intermedia.

Trends in 2010-2017 show a reduced incidence of alloimmunization against red blood cells. Allergic and pyrexian AR rates remained stable. No major cases of ABO incompatibility were reported and no fatal transfusion reactions were recorded.

Summary/Conclusions:The safety of blood in transfusions has improved significantly in high- and upper-middle-income countries, but unfortunately not in low- and low-income countries. The scarcity of blood and the lack of strict protective measures for patients with thalassemia is the reality of many developing countries.

TIF pays particular attention to supporting and promoting initiatives that promote the safety and adequacy of blood, a key component of the lifelong treatment of patients with transfusion-dependent thalassemia.

3D-S12-04

HEPCIDIN GENE POLYMORPHISMS AND IRON OVERLOAD IN PATIENTS WITH β-THALASSEMIA MAJOR REFRACTORY TO IRON CHELATION THERAPY

P Zarghamian, A Azarkeivan, A Khazaeli, S Majid

Research Center for Blood Transfusion, Higher Institute for Research and Education in Transfusion Medicine, Tehran, Iran

Bottom:β-thalassemia is the most common group of hereditary hemoglobinopathy diseases. People affected with thalassemia major are dependent on regular blood transfusions, which leads to iron overload. Hepcidin is a peptide and an important regulator of iron homeostasis. The expression of this hormone is influenced by polymorphisms within the hepcidin gene, HAMP.

Goals:This study aimed to analyze the association of three polymorphisms in the HAMP promoter, rs10421768, rs117345431, and rs142126068, with iron overload in patients with β-thalassemia major unresponsive to iron chelation therapy.

Materials and methods

A total of 102 samples were collected from patients with β thalassemia major. Genomic DNA was extracted and sequenced for SNPs rs10421768, rs117345431, and rs142126068. Statistical analysis was performed in IBM*SPSS* STATISTIC 23 using the independent t-test and Fisher's test.

Results:Our analysis revealed a statistically significant difference between cardiac iron concentration level and the c.‐582A>G variant (P = 0.02). For rs117345431, statistical analysis bordered on a significant relationship between the minor allele and serum ferritin (P = 0.058). All samples were homozygous for the T allele of rs142126068.

Summary/Conclusions:Different factors affect iron overload in thalassemia. Our findings and others emphasize the role of the hepcidin polymorphism as a key component in iron homeostasis.

Adverse events: update on retroviruses in transfusion medicine

3D‐S13‐01

ENDING AIDS IN AFRICA - VISION OR ILLUSION?

ND Labhardt1,2

1Infectious Diseases and Hospital Epidemiology, University Hospital Basel2Medicine, Swiss Institute of Tropical and Public Health, Basel, Switzerland

Ten to twenty years ago, the countries of South-East Africa faced the peak of the devastating HIV/AIDS epidemic that caused a drop of up to 20 years in overall life expectancy. With the burden of HIV/AIDS falling primarily on the economically active population of young and middle-aged adults, the epidemic threatened social and economic stability in the hardest-hit nations. Today, despite the fact that AIDS remains one of the leading causes of death in Southeast Africa, the epidemic has become an example of the public health benefits that can be achieved through programmatic approaches based on in evidence supported by globally aligned policies and financing strategies.

Drawing on his work from Lesotho, where one in four adults is infected with HIV, Niklaus Labhardt will take auditors through the history of HIV programs in South-East Africa and show how innovative, pragmatic, and on the evidence brought the region to a stage where the goal of ending the AIDS epidemic by 2030 could be within reach.

3D‐S13‐02

EVOLUTION OF THE BLOOD DONOR DEFERRAL POLICY FOR MEN WHO HAVE SEX WITH MEN IN FRANCE: IMPACT ON THE RISK OF HIV TRANSMISSION THROUGH TRANSFUSION

J. Pillonel1, Plate C1, C Wild1, B Danic2, C Martinaud3, F Exit4, I Santa Maria5, B. Coignard1, S Bruto6, P. Tiberghien6, S. Laperche7, Lote F1

1Department of Infectious Diseases, Public Health France, Saint-Maurice2French blood establishment, Rennes3Army Blood Transfusion Center, Clamart4National HIV Reference Center, Regional University Hospital, Tours5National Agency for Medicines Safety6French blood establishment, Saint-Denis7National Reference Center for Transfusion Infectious Risks, INTS, Paris, France

Bottom:In France, the deferral for men who have sex with men (MSM) was reduced from permanent to 12 months in July 2016. As this change has not affected the residual risk (RR) of undetected HIV among blood donations, the Ministry of Health is considering greater access to donating blood for MSM. Two scenarios have been studied: S1. deferral of MSM during the 4 months prior to the donation; S2. postponement of MSM who have had more than one sexual partner in the 4 months prior to the donation, like all other blood donors in France.

Goals:To assess the impact of these two scenarios on the estimated HIV RR over the period July 2016 to December 2017, which is the baseline RR with the current 12-month deferral for MSM.

Methods:Baseline HIV RR was calculated using the classical Incidence-Window-Period method, where HIV incidence was derived from a detuned assay (EIA-RI) detecting recent infections (≤180 days) since all blood donations positive for antibodies to HIV‐1 are tested with this test. The evaluation of the impact of both scenarios on the baseline HIV RR was based on (i) data obtained from surveys among MSM in the general population and from blood donors (compliance survey), to estimate the number of additional MSM who would donate blood in each case. and in (ii) estimating the incidence of HIV among these additional donors. This incidence was estimated: for S1, from MSM blood donors with the current deferral policy (12 months) and for S2, from monogamous MSM from the general population.

Results:From July 2016 to December 2017, 8/28 (29%) of HIV-1 positive blood donors tested with the EIA-RI were identified as newly infected, allowing the baseline HIV RR to be estimated at 0 .16 in 1 million donations [95% CI: 0.04–0.34], or 1 in 6,380,000 donations. For S1, the number of additional MSM donors was estimated to be 733 and the number of additional HIV-positive donations to be 0.09, resulting in an HIV RR of 0.16 in 1 million donations [95% CI: 0.04–0.35] or 1 in 6,300,000 donations. For S2, the number of additional MSM donors was estimated to be 3,103 and the number of additional HIV-positive donations to be 4.92, resulting in an HIV RR of 0.23 in 1 million donations [95% CI: 0.05–0.56] or 1 in 4,300,000 donations. The sensitivity analysis shows that if both the number of MSM and the incidence of HIV were multiplied by 1.5, the risk would be 1 in 6,225,000 donations for S1 and 1 in 3,000,000 for S2.

Summary/Conclusions:For both scenarios, the RR of HIV is still very low. For S1 (4-month lag), the risk is identical to the baseline RR and is highly robust to variations in model parameters. For S2 (no more than one sexual partner, 4 months), the risk is 1.5 times higher than the point estimate of the reference RR and the sensitivity analysis shows that this estimate is less robust than for S1, since the risk could be 2 times greater than the baseline RR. For both scenarios, there was a modest increase in donation from eligible MSM.

3D‐S13‐03

RISK FACTORS FOR RECENTLY ACQUIRED HIV INFECTION IN BLOOD DONORS IN SOUTH AFRICA

K van den Berg1,2, M. Vermeulen3, G. Jacobs3, R. Swanevelder4, J Hemingway‐Foday5, Dcreel5, U Jentsch6, E. Murphy7,8, B Custer7,9, for the NHLBI REDS-III Program in South Africa.

1Department of Translational Research, South African National Blood Service, Port Elizabeth2Department of Clinical Hematology, University of Cape Town, Cape Town3Operations Test Department4Business Intelligence Department, South African National Blood Service, Roodepoort, South Africa5RTI International, Research Triangle Park, United States6Specialized Laboratory Services, South African National Blood Service, Roodepoort, South Africa7Department of Laboratory Medicine, UCSF, San Francisco, United States8Scientific and Research Programs, Vitalant Research Institute, San Francisco, South Africa9Scientific and Research Programs, Vitalant Research Institute, San Francisco, United States

Bottom:Recruiting safe blood donors from the world's largest HIV-positive population is a major challenge for South African blood transfusion services. South African donor deferral criteria and deferral periods for activities perceived to be high risk have evolved over time, but current risk factors for infection have not been formally assessed. Furthermore, most studies have reported risk factors for prevalent HIV infection, while risk behaviors for incident infection are more informative, as donations with these infections could occur during window periods of the screening assays available.

Goals:To identify demographic and behavioral risk factors associated with incident HIV infection among blood donors in South Africa.

Methods:A case-control study was performed with incident HIV-infected blood donors compared with infectious marker-negative controls. HIV incident cases and controls seronegative for HIV, hepatitis B and C viruses, and syphilis were collected from a pool of donors covering 8 of the 9 provinces of South Africa. Controls were matched in frequency in a 3:1 ratio to cases by race, age, and geography. Incident HIV infections were positive for HIV RNA by individual donation nucleic acid amplification tests (ID‐NAT; Procleix, Grifols) but negative for antibodies (Ab) (PRISM, Abbott), as were those RNA+/ Ab+ with newly acquired HIV based on Limiting Antigen Avidity Assay (LAg) results with normalized OD values ​​of <1.5. Eligible cases and controls completed a confidential audio computer-assisted structured interview (ACASI) on motivations for donating blood and behavioral factors, including behaviors in the 6 months prior to donation. Frequencies and measures of statistical association for risk behaviors comparing cases and controls are reported after adjusting for multiple comparisons.

Results:From November 2014 to January 2018, we enrolled 323 incident HIV cases and 877 controls; 202 (62.5%) cases and 544 (62%) controls were ≤29 years of age. There were significantly more female cases 230 (71.2%) than female controls 439 (50.1%) (P<0.0001). Significant HIV risk factors (all P < 0.0001) reported within 6 months prior to donation included: having a male primary sexual partner; reporting increasing numbers of male sexual partners for both women and men; frequency of vaginal sex; frequency of vaginal sex without condoms; use of methods to clean, dry, or squeeze the anus before sex; and have visited a traditional healer for medical care. Lack of medical care (private health insurance) and reports of injuries or accidents with blood loss were also associated with an incident of HIV infection.

Summary/Conclusions:Our study has identified a set of novel putative risk factors for incident HIV infection among South African blood donors, while confirming a number of previously known risky sexual behaviours. Not having private health insurance and being injured may be markers of socioeconomic background that place people at higher risk rather than behaviors that directly increase the risk of HIV transmission. The detection of risk behaviors by ACASI in donors who passed pre-donation questionnaires and interviews suggests that ACASI has the potential to improve the identification of risk behaviors.

3D‐S13‐04

SETS OF HIV-1 AND RISK FACTORS IN BLOOD DONORS FOUND POSITIVE FOR HIV IN FRANCE

Cappy1,2, Un Chaillon3, an exact4, J Pillonel5, M Chaix6,7, P. Tiberghien8, L Meyer9, F Exit10,11, S. Laperche1,2

1Department of Transmissible Agents in the Blood2CNR Transfusional Infectious Risks, INTS, Paris, France3Division of Infectious Diseases, UCSD, La Jolla CA, United States4INSERM CESP U1018, University of Paris Sud, Le Kremlin-Bicêtre5Department of Infectious Diseases, Public Health France6Department of Virology - HIV CNR, Saint-Louis Hospital - APHP7INSERM U944, University of Paris Diderot, Paris8UMR 1098 INSERM, University of Franche-Comté, EFS, Besançon9Public Health Service, Hospital Bicêtre ‐ APHP, Le Kremlin‐Bicêtre10Virology Laboratory associated with CNR HIV, CHRU de Tours11INSERM U1259, University of Tours, Tours, France

Bottom:In France, between 2000 and 2016, among male blood donors (mBDs) found to be HIV-1 positive at blood donation screening, 31% did not reveal any risk factors for HIV infection during post-donation interviews. donation, while 38% reported having had sex with men (MSM), and 24% and 7% reported heterosexual sex (HTS) and other risk factors, respectively.

Goals:In order to gain new insights into risk factors for HIV-1 infection in mBDs, we performed an analysis of the HIV-1 genetic network, including HIV-1 positive mBDs and patients included in the French ANRS CO6 PRIMO cohort of primary HIV infection (PC).

Methods:284 mBD, who donated blood between 2000 and 2016, and 1340 CP, included between 1998 and 2014, were studied. Epidemiological data were collected by the French Blood Service (EFS) following blood donation or post-donation interviews to mBD, and after inclusion for CP. Viral strains were sequenced and genotyped inpoliticalgene, and a recent infection assay was performed to date the infection in mBD (recent: <6 months). A partial transmission network based on the Tamura-Nei 93 nucleotide distance (threshold for HIV-1 s/t B = 1.5%; for non-B s/t = 0.8%) was calculated and selective mixing was evaluated. for mBD epidemiological data, including risk factors for HIV infection (MSM, SHT, other and unknown). The self-reported data was then compared with the assortment-enhanced data.

Results:HIV-1 strains of 81 mBD and 126 PC were linked into 54 clusters that included at least one mBD. PRIMO groups only were excluded from the analysis. Compared with mBDs who did not pool, those found to be network-associated were younger (30 vs 36 years; P < 0.01) and more likely to have a recent infection (48% vs 34% ;P = 0.03). Selective mixed indices showed that matched individuals were more likely to live in the same area (P<0.001) and to have the same risk factor for HIV infection (P<0.001) compared to a random distribution. Imputation of the MSM risk factor to MSM-matched non-MSM individuals changed the distribution of risk factors as follows: MSM: 38% vs. 49%, HTS: 24% vs. 21%, Other: 7% vs. to 6% and unknown: 31 against 24%.

Summary/Conclusions:After validating the range of risk factors between matched individuals and imputing the MSM risk factor to individuals self-reported as non-MSM (including those with no identified risk factor), up to 18% (31/176) of MSM could be reclassified like MSM. This is the worst case, as the network analysis does not exclude the possibility of one or more people between two matched individuals (missing link). Taken together, these results could help to reassess the residual HIV risk associated with MSM mBDs, especially in the context of evolving blood donor deferral criteria.

3D‐S13‐05

FROM UNIVERSAL TO SELECTIVE HTLV SCREENING IN THE UNITED KINGDOM

k davison1, H. Harvala2, C Reynolds3, S. Brailsford3

1NHSBT/PHE Epidemiology Unit, Public Health England2Microbiology Services,3NHSBT/PHE Epidemiology Unit, NHS Blood and Transplant, London, UK

Bottom:Although most people remain asymptomatic, HTLV infection can cause adult T-cell leukemia/lymphoma (ATLL) and HTLV-1-associated myelopathy (HAM). The serious nature of these diseases, evidence of transmission through blood without leukodepletion, and concern about a high prevalence among donors from endemic areas led UK blood services to introduce universal blood donation screening in 2002. Infected donors were invited to participate in the National HTLV Registry cohort study to assess disease progression. An expert working group reviewed these data, along with evidence from the previously untested donation review and cost-effectiveness analysis, in 2013 and 2015.

Goals:To describe the epidemiology of HTLV among UK blood donors and evidence of disease progression from long-term follow-up of asymptomatic donors.

Methods:UK blood donations screened and infected donors identified are reported to a national surveillance scheme. These donors are contacted, their results are explained and information is collected about their clinical history and possible sources of infection. When appropriate, HTLV-infected donors receive consent for registration, and participants complete an initial questionnaire about their health, are marked on registries for cancer or death, and are followed up approximately every 2 to 3 years.

Results:In the UK between 2002 and 2017, 254 HTLV-infected donors were identified. The prevalence among new donors remained around 5/100,000 donations. Prevalence among repeat donors peaked in 2002 (2.7/100,000 donations), and most had not been previously tested. From 2004 to 2016, a prevalence of 0.07 per 100,000 donations (average of one positive/year) was recorded. In 2017, the prevalence among new donors increased to 9.9/100,000 donations (17 positives), with an increase in the figures associated with Asian ethnicity and coinciding with an increase in collections from BAME groups.

Overall, the majority were female (182/254, 72%), UK-born (125/254; 49%), and HTLV‐1 infected (228/254; 90%). The mean age was 43 years. Almost all of the positive donations were from previously untested donors (240/254), with seroconversion within one year of the previous donation confirmed for only 5 of the 14 previously tested donors. Infections were generally associated with endemic countries (including the Caribbean region, West Africa, Iran, India, and Japan), acquired through breastfeeding or from a heterosexual partner originating from these countries. Interestingly, three were thought to have been infected by self-flagellation. A total of 114 asymptomatic HTLV-positive blood donors have already been recruited to the National HTLV Registry, and during more than 800 person-years of follow-up, none had developed ATLL or HAM.

Summary/Conclusions:During 16 years of testing, few seroconverters were identified, suggesting that there is very little ongoing transmission among UK blood donors. The lack of disease among the study cohort was also reassuring, although it is probably too early to detect associated symptoms of slow-onset disease. Recruitment for this unique dataset continues, also outside of the blood donation setting. As a result of these surveillance data, retrospective evidence, and cost-effective analysis, in 2017 the NHSBT stopped testing donations from previously screened donors unless the donation was used to manufacture a non-leukodepleted component.

Management and organization: improvement of the organization and practice of transfusions

3D‐S14‐01

MANAGING THE BLOOD SUPPLY IN A COUNTRY WITH LONG DISTANCES

M Syrjälä

Blood Service, Finnish Red Cross, Helsinki, Finland

Finland is located in Northern Europe between the 60°y 70°latitude N. The length of the country is 1150 km and the width is 550 km. By area it is the fifth largest country in the EU. The country's population is 5.5 million, resulting in the lowest population density in the EU (15.8 inhabitants/km3). The entire country is inhabited, although most of the population is concentrated in the south. Finland's climate is mainly influenced by its latitude, but the warm waters of the Gulf Stream and North Atlantic Drift Current also play a role. Due to Finland's northern location, winter is the longest season. The southern parts of the country are covered in snow for about three to four months of the year, and the northern regions for about seven months. Long distances, low population density, and extreme weather present logistical challenges. It is estimated that these logistics costs can reach 10-20% of GDP in Finland.

The Finnish Red Cross Blood Service (FRC BS) has been the national provider of blood services in Finland since 1948. FRC BS annually collects around 200,000 units of whole blood, of which 50% is collected in 10 fixed sites and 50% in mobile sessions around the country. The core activities (donor recruitment, medical support, production, testing, supply chain management, digital services and administration) are located in Helsinki.

Transfusion management is highly dependent on logistical arrangements from blood donation sites to central facilities and from central inventory to hospitals.

Logistics is outsourced to three main partners, all of whom have their roots in public transport and logistics services nationwide. Posti Ltd is a state-owned company with its roots in the national post office and telecommunications. Today, it is the leading postal and logistics company with the widest network coverage in Finland. Units of blood collected at different fixed sites and mobile sessions are transported overnight by Posti Ltd to the central FRC BS facility at 8am the day after blood donation. Posti Ltd is also used for regular deliveries of blood products to hospitals. The other major partner is Matkahuolto Ltd, which was founded in the 1930s to maintain bus stations and act as a common marketing company for bus and coach services in Finland. It maintains a nationwide package delivery system based on the network of scheduled bus routes. Matkahuolto LTD is used to transport donor test samples from the donation sites to the central laboratory. Using this arrangement, it is possible to obtain most donor samples for the lab around midnight, which significantly speeds up the completion of lab results. The third logistics partner is JetPak Finland Ltd, which operates airfreight for the national airline Finnair.

Blood transfusion services can be centrally managed in a large, sparsely populated country in a way that is high-quality, safe, and cost-effective. However, the supply chain must be carefully planned.

3D‐S14‐02

EDUCATING THE MASSES: THE USE OF E-learning IN TRANSFUSION MEDICINE

peterson, T Clark, T Verrall, L English, S Ogley

Education and Training Centre, BloodSafe eLearning Australia, North Adelaide, Australia

Bottom:E-learning is a divisive issue. It is often criticized as an inferior form of education, while at the same time being promoted as a means of delivering education to large numbers of people in a consistent and cost-effective manner.

BloodSafe eLearning Australia (BEA) is a government-funded blood transfusion education program that began in 2007 and offers courses on clinical transfusion practice and patient blood management (PBM), including:

  • Transfusion Clinical Practice (4 courses)

  • PBM: General (7 cursos)

  • PBM: Medical (6 courses)

  • PBM: Intensive and Surgical Care (4 courses)

  • PBM: Obstetrics and Maternity (3 courses)

  • PBM: Neonates and Pediatrics (7 courses)

Goals:Determine the engagement, outcomes and learning impact of BloodSafe eLearning Australia courses.

Methods:A retrospective analysis of user records, course completion records, course evaluation data, and red blood cell use in Australia to determine learner demographics and the impact on knowledge acquisition and application to clinical practice.

Results:In the period from July 1, 2007 to January 31, 2019:

  • 489,600 people registered as students

  • 1,072,299 courses were completed

  • These students came from 182 countries, 11,141 (2.3%) of them outside Australia.

The analysis by profession shows that:

  • 82.4% are nurses and/or midwives

  • 11.2% are doctors

  • 6.4% are laboratory technicians, anesthetists or others.

Analysis of user evaluation data (n=2885) from April 1, 2015 to January 31, 2018 shows that these courses have a positive impact, as 88.7% of respondents claimed to have gained additional knowledge, 65.2% were able to make changes in clinical practice and 88.2% reporting that these changes will improve patient safety and outcomes. Analysis of international participants shows greater benefits: 93.5% gain knowledge, 76.4% can change their clinical practice, and 91.9% believe this will improve patient outcomes.

Analysis of red blood cell use in Australia shows that since 2012 there has been a 21.1% reduction in red blood cell emission. This has been achieved through a number of PBM activities including guideline development, research and audits, education, waste reduction strategies and promotional campaigns. BloodSafe eLearning Australia courses on PBM were launched in 2012 and are a part of this PBM activity, notably these courses have the widest scope, being taken by a large proportion of doctors, nurses and midwives in Australia They are not directly related to the blood sector.

Stakeholder feedback shows that the program provides credible and consistent education that is cost-effective, reduces duplication, is "best practice" e-learning, is easily accessible, and allows institutions to focus on developing practical learning skills. transfusion.

Summary/Conclusions:This analysis shows that e-learning is a well-accepted and well-used form of education for healthcare workers to learn about clinical transfusion practice and patient blood management, and for students to gain knowledge that can change their practice. clinic and improve patient outcomes. It is also likely that these courses have contributed to a better use of a scarce and freely donated resource.

This approach is global in scope and availability, and is a cost-effective model for improving transfusion practice in the developing world by providing education to millions of healthcare workers.

3D‐S14‐03

PLATELET PROSPECTIVE AUDIT: ANALYSIS OF STUDENT COMPLIANCE WITH THE GUIDELINES

S Vossoughi, J Schwartz

Pathology, Columbia University, New York, United States

Bottom:Apheresis platelets are a high-cost, limited-supply component product. In addition, there is a potential for serious transfusion reactions associated with this product, such as transfusion-related lung injury (TRALI) and sepsis due to bacterial contamination. Therefore, many centers closely monitor compliance with transfusion guidelines. This quality control analysis describes our experience with prospective platelet auditing performed by physicians in pathology residency training.

Goals:This study aims to assess the ability of trainee physicians to conduct prospective audits and compare policy compliance for different levels of experience.

Methods:This is a quality control analysis of a prospective platelet audit program over a 12-month period (January 2018 to December 2018). The blood bank called the doctor on call each time an order was placed for a patient with a platelet count of > 50,000/μL, ≥ 2 doses of platelets with no intermediate count, or an unknown platelet count. Audit records created by trainee physicians in their first postgraduate year (PGY1) were compared with subsequent years (PGY>1). The information collected included the total number of doses requiring approval, the number of approved products, the year of training of the approving physician, and the indication for transfusion. Cost analyzes assumed $500 for one dose of platelets. Descriptive statistics and comparative analysis using Pearson's Chi‐Square were used, considering a difference of P < 0.05 statistically significant.

Results:There were 1,446 platelet doses requiring approval with 670 (46%) targeting the PGY1 group and 776 (54%) targeting the PGY>1 group. A total of 847 (59%) doses were ordered that complied with the hospital's transfusion policy and 599 (41%) that did not comply with the hospital's policy. Of the 847 correctly ordered doses, the PGY1 group refused the release of 7, forcing the clinical team to insist on the release without approval, and there were no such cases in the PGY>1 group. When sought by the blood bank, PGY1 physicians approved the release of non-compliant product for 191/670 (29%) doses, while PGY>1 physicians approved off-label products for 79/776 (10%). %) of the doses (P<0.01). Products not indicated by hospital policy were not released by PGY1 physicians for 113/670 (17%) doses and 216/776 (28%) doses by PGY>1 physicians (P<0.01). Doses ordered that were not in compliance with hospital policy had an estimated cost of $299,500. Of this cost, there was a calculated savings of $164,500 of unreleased products due to prospective audits. There was an additional potential savings of $135,000 for products not listed but released ($95,500 from the PGY1 group and $39,500 from the PGY>1 group).

Summary/Conclusions:Despite the higher number of requests being sent to the highest ranking PGY>1 group, there were a disproportionately higher number of non-compliant platelet orders issued by the PGY1 group, as well as several times withholding needed products. Potential mitigation strategies for this could include a higher level of oversight for PGY1 physicians, and potential monetary savings could warrant hiring a dedicated patient blood management team or quality control manager to monitor compliance and provide feedback to clinicians.

3D‐S14‐04

WHAT CAN WE LEARN FROM HOW ADVERSE EVENTS ARE DETECTED?

Fleslandia, C Steinsvag, A Espinosa

Norwegian Directorate of Health, Oslo, Norway

Bottom:The primary goal of reporting systems, like haemovigilance systems, should be learning and improvement and identifying risk areas, not simply counting errors. To understand and learn from adverse events, the description of how, where and why they occur, and how they are detected is important. To support our understanding, we use a default classification that is required for reporting to the EU, supplemented by the classification suggested by the IHN, WHO, and ourselves. In 2015 we started asking blood establishments what steps they would take to prevent the event from recurring and added a simple classification to say how the adverse event was detected.

Goals:This study aims to analyze how different types of adverse events reported to the hemovigilance system were detected, whether current quality management systems used in Norwegian blood establishments had effective barriers, and whether new barriers should be considered.

Methods:Adverse events reported to the Norwegian hemovigilance system in 2017 and 2018 were analyzed focusing on how the adverse event had been detected. In all cases, the classification had been made by the adverse event reporter and they were confirmed, or reclassified if necessary, by the hemovigilance team before analysis. For the analysis based on the classification, PowerBI (Microsoft) was used.

Results:A total of 188 adverse events were reported in Norwegian blood establishments. All had been classified according to how the adverse event had been detected. Twenty (10.6%) adverse events were detected due to alarms or warnings from IT systems or equipment. Routine checks by blood establishment staff detected 39 (20.7%) events, and formal internal or external reviews detected one event. Seven (3.7%) events were detected because the donor became ill shortly after the donation, but the disease was not caused by the donation. Sixty-four percent of the events were detected in a way that did not fit our current classification and were therefore classified as "Other."

Twelve of 16 incorrect blood in the tube were detected by an IT system alarm or routine check, as were six of 22 events involving blood orders, two of seven test errors, six of 17 events where wrong blood had been transfused, and eight of 64 events related to donor selection.

In 80 reports human error was mentioned as the cause of the event and 27 of these were detected by alarms or routine controls.

Summary/Conclusions:Detection of adverse events through alarms or routine checks is most effective when the blood facility has historical data to check, such as incorrect blood in the tube or a patient requiring irradiated blood components. When historical data does not exist or when quality management systems do not require routine checks, events are often detected by chance. More analysis is needed to see if and where quality management systems need to be improved. The wide variety of adverse events can make it difficult to select which area to prioritize for improvement work.

3D‐S14‐05

HEMOGLOBIN MEASUREMENT: HOW TO ASSESS THE COMPETENCE OF NURSES AND THE ACCURACY OF THE METHOD AT THE POINT OF CARE (POC)

J Castrén, P Korkalainen, M Arvas, A Valkeajärvi, S Bäckman

Finnish Red Cross Blood Service, Helsinki, Finland

Bottom:Measurement of finger prick hemoglobin is an important work step in the eligibility assessment of blood donors. Too low hemoglobin is the most common reason for donor postponement at the Finnish Red Cross Blood Service (FRCBS). 3.5% of donation attempts were rejected due to low Hb in 2018. An adequate and correct technique in donor Hb measurement could significantly affect the rate of Hb deferral.

Goals:The aim of this study was to ensure the competence of nurses to measure finger prick hemoglobin. The aim was also to collect a representative data set of Hb measurements to assess the accuracy of the method currently in use for donor Hb measurements.

Methods:Each nurse participating in the practical skill test (n=168) documented donor Hb POC measurements from five donors eligible for donation. A total of 845 Hb POC measurements were analyzed in this study. In addition, venous blood samples were taken from the blood bag sample bag and analyzed in the laboratory using a cell counter to assess the accuracy of the POC method.

Results:Hb measurements from the finger prick were on average 1.2 g/L (0.9%) higher than those from the venous blood samples. The range of the difference was ‐21 ‐ +22 g/L. These results were used to add novel information to determine the measurement uncertainty of Hb measurement in FRCBS. In 1.4% (12/845) of the donors in this study, venous hemoglobin measurements were below the donor eligibility cut-off point. In these measurements, the difference between the fingerstick and the venous hemoglobin measurement was a maximum of +9 g/L.

92% of finger prick hemoglobin results were in the range of ±10 g/L compared to venous hemoglobin results. 63% of finger prick results were within ±5 g/L (device precision) compared to venous hemoglobin results.

In 13 cases, the difference between fingerstick and venous measurements was outside 2 standard deviations of the mean, that is, 2.5% from the bottom (n=9) or top (n=4) of the distribution . There were systematic errors in the results of some nurses towards too low or too high Hb results on the finger prick measurement and some nurses had random errors in both directions.

The lot of cuvettes, donor age, gender, or timing of sampling were not found to have an impact on the difference between fingerstick and venipuncture Hb measurements in this study.

Summary/Conclusions:The results of the POC measurements in comparison with the cell counter were in agreement with the published data and with the manufacturers' information about the device.

The practical skill test is a viable way to develop proficiency and operations in measuring finger prick hemoglobin. It offers the opportunity to give nurses personal feedback on their personal performance in using the current Hb measurement technique. It also provided data on the accuracy of the POC method in the daily donor selection process.

Donors and Donation - Blood Donation; Iron loss, anemia and beyond

3D‐S15‐01

BLOOD DONATION AND IRON LOSS, WHAT ARE THE IMPLICATIONS?

MG van Kraaij1, M Swegers2, M. Janssen2, K van den Hurk2

1Transfusion Medicine and Donor Affairs Units2Donor Medicine Research, Sanquin Blood Supply, Amsterdam, The Netherlands

Bottom:Whole blood donation has been frequently linked to iron deficiency. A blood donor loses by donation about 8% (men) to 81% (menstruating women) of iron stores. To replace the iron lost from donating blood in a 56-day donation interval, a donor needs to absorb 4.5 mg of iron per day. This amount exceeds the maximum reported amount of absorbed iron of 3 to 4 mg/day, eventually leading to iron deficiency, with consequences such as donor postponement and possibly iron deficiency-related symptoms (decreased physical stamina , fatigue, pica, restless legs syndrome and cognitive functions).

Since Hb levels do not reflect the true iron status of donors, ferritin measurement is a better way to detect low iron stores in whole blood donors. Studies from the USA and Denmark showed that with the introduction of ferritin measurement with extended donation intervals or iron supplementation in case of low iron stores, deferral rates for low Hb decreased in both male and female donors.

Goals:To learn more about the iron status of whole blood donors during their donor career, how this affects donor health, and what measures can prevent low iron stores in donors.

Methods:In the Netherlands, Sanquin Blood Bank is currently implementing a policy with ferritin-guided donation intervals. Briefly, ferritin levels are measured in all new and repeat donors every 5th donation or in case of Hb below the deferral threshold. Donation intervals are extended if ferritin levels are < 15 μg/l, or ≥ 15 and ≤ 30 μg/l (for 12 and 6 months, respectively). We anticipate that routine ferritin measurement will ultimately result in a lower prevalence of iron deficiency, fewer Hb deferrals, and better donor retention. This will be further evaluated in a "FIND'EM" wedge cluster randomized trial, which may also identify subgroups of donors prone to developing (symptoms of) iron deficiency. Furthermore, the implementation of ferritin screening may lead to lower donor availability. For this purpose, we model the impact of implementing our ferritin deferral policy on donor availability over time, which provides insight into the expected size of the impact of the ferritin deferral policy and the time and speed at which this impact is expected to occur. occur. This allows the blood bank to timely plan actions to counter potential donor shortages and ensure an adequate blood supply. Lastly, iron supplementation can be an alternative measure to postponing the donation. Since the used and recommended dose of iron supplementation varies widely among blood services, Sanquin plans to initiate a new study in whole blood donors to obtain evidence on the dose and frequency of iron supplementation and its effect on iron levels. of ferritin and hemoglobin and the health of the donors.

Results:The studies mentioned above are ongoing and results are expected from 2020.

Summary/Conclusions:Iron deficiency is a common side effect of donating whole blood. To prevent iron deficiency and its consequences, such as donation postponement and health problems, more evidence-based information on iron management of whole blood donors is being generated.

3D‐S15‐02

SUPERDONORS: GENETIC RISK PROFILE AND RISK OF POSTPONEMENT OF LOW HEMOGLOBIN

AS Rigas1, C. Erikstrup2, O Pedersen3, K Rostgaard4, G. Edgren5, L thørner1, E Sorensen1, K. Banasik6, K Burgdorf1, H. Hjalgrim4, H Any1

1clinical immunology, university hospital of copenhagen, university hospital of copenhagen, copenhagen2clinical immunology, Åarhus University Hospital, Åarhus3clinical immunology, Næstved Hospital, Næstved4Epidemiological Research, Statens Serum Institute, Copenhagen, Denmark5clinical epidemiology unit, Karolinska Institutet, Stockholm, Sweden6NNF Center for Protein Research, University of Copenhagen, Copenhagen, Denmark

Bottom:There is no reliable method to stratify new blood donors into those who can maintain sufficient hemoglobin (Hb) levels and those who will be deferred due to low Hb (<7.8mmol/l [<12.57g/dl] for women and <8.4mmol/l [<13.54 g/dl] for men). Polygenic risk scores (PRS) have shown great promise in predicting the risk of complex diseases. PRS could also be useful for the identification of donors genetically predisposed to low Hb levels and, therefore, to a higher risk of deferral.

Goals:The aim of the study was to assess the association between PRS (modeled to predict Hb level as a quantitative trait) and risk of deferral as a binary outcome.

Methods:The Danish Blood Donor Study (DBDS) is an ongoing national cohort of blood donors since 2010 with more than 110,000 participants. Extensive genotyping has been performed on approximately 72,000 DBDS participants using the Infinium Global Screening Array (Illumina®) and extended by using imputations based on the pan-Scandinavian reference genome. Based on Hb and genetic data from more than 150,000 Icelandic individuals (an independent discovery cohort), we constructed 9 different weighted PRS for DBDS individuals. Information on whole blood donations from donors after inclusion in the DBDS through the end of 2017 was obtained from a nationwide donation database, SCANDAT. The best Hb predictor among the nine PRS was chosen and used in all subsequent analyses. We performed a mixed-effects multilevel linear regression analysis with Hb as the outcome and PRS as the factored explanatory variable with cutoffs at 5, 10, 25, 40, 60, 75, 90, and 95.hepercentiles, respectively. In addition, the models had two-level clustering on donor identification and donation site and an identification-specific random intercept; and further adjusted by: sex (binary), age (continuous), year of donation (factored) and time since last donation (continuous). Finally, the risk of postponement was assessed in random-effects logit models with similar covariates and clustering structure.

Results:The mean number of donations per donor after DBDS inclusion was 6.9 donations. Overall, we observed a statistically significant positive association between PRS(Hb) and current Hb levels. Compared to donors in the 40-60th percentile PRS group, donors below the 5thhepercentile had lowest (‐0.23 Hb mmol/L (95% CI: ‐0.25, ‐0.21)) and donors above 95hehighest percentile (+0.19 Hb mmol/L (95% CI: 0.18, 0.21) Hb levels. In random-effects logit models, we observed a marked increase in the risk of deferral with decreasing PRS percentile strata. Using the 40–60 percentile PRS stratum as a reference, donors below 5hepercentile and donors above 95hethe percentile had odds ratios for postponement of OR=2.58 (95% CI: 2.27, 2.93) and OR=0.46 (95% CI: 0.39, 0.54), respectively.

Summary/Conclusions:We found a statistically significant positive association between PRS(Hb) and Hb levels and a markedly increased risk of deferral with decreasing PRS(Hb). From a scientific point of view, it is not surprising that an Hb genetic score from one independent cohort is associated with Hb in another cohort. However, from a practical perspective, PRS can be the first step in a donation approach tailored to donors and their risk of deferral.

3D‐S15‐03

MODELING OF OPTIMAL INTERVALS BETWEEN DONATIONS WITH PERSONALIZED RISK ASSESSMENT FOR ADVERSE IRON OUTCOMES

Russell1,2, D Scheinker1,3,4, B Custer2,5

1Management Sciences and Engineering, Stanford University, Stanford2Vitalant Research Institute, San Francisco3Lucile Packard Children's Hospital4School of Medicine, Stanford University, Stanford5Laboratory Medicine, University of California San Francisco, San Francisco, United States

Bottom:Individually calibrated intervals between donations for repeat blood donors have the potential to minimize the risk of iron-related adverse outcomes (eg, hemoglobin deferral or collection of a donation from a donor with iron stores). low or absent) without unduly affecting the donated blood supply. Machine learning has shown promise for personalized clinical risk assessment.

Goals:Our goal is to use machine learning to develop personalized, donor-specific intervals between donations that minimize the risk of adverse outcomes while maintaining or improving the adequacy of the donated blood supply.

Methods:Using a publicly available dataset from the REDS-II Donor Iron Status Evaluation (RISE) study (Cable, Transfusion, 2012), we defined donor profiles with physiological measures including hemoglobin, ferritin, and soluble transferrin receptor along with responses to questionnaires. on diet and reproductive health indicators. and demographics. We used these profiles (58 characteristics, 3162 donations from 1025 repeat donors) and time to next donation attempt to predict iron-related outcomes of the next donation attempt. Possible outcomes were no adverse outcome, hemoglobin deferral, low iron donation (ferritin <20 ng/ml for women and <30 ng/ml for men) or no iron donation (ferritin <12 ng/ml for men). and women). We trained multiple machine learning models on 2543 of the donations and selected the model with the best performance (lowest cross-entropy loss in cross-validation). We evaluated the best performance of the model on a pool test set of 620 donations, which were not used to train or select the model. We then used our model to generate risk estimates for these 620 test donors based on days since their last donation, which ranged from 56 days to 250 days. To show individual variation, we generated graphical representations of individual donor risk over time.

Results:Ferritin, log ferritin, body iron, and time since last donation were most useful in predicting iron-related adverse outcomes at the next donation attempt. The estimated risk of adverse outcome at the next donation attempt varied considerably between donors. As expected, the risk of adverse outcomes 250 days after the last donation was less than the risk 56 days after the last donation for most donors (hemoglobin carryover risk decreased for 84% of donors; the risk of donation with low iron content decreased for 61%, and the risk of no iron donation decreased by 94%).

Summary/Conclusions:The risk of iron-related adverse outcomes as a function of time since last donation varies considerably between donors. Machine learning models trained on relevant donor profiles can effectively estimate how an individual's risk will change over time. Individual risk estimates could allow blood centers to protect high-risk repeat donors while continuing to allow more frequent collections from low-risk donors. Further studies are needed to ensure that this approach works well for donor classes that are not well represented in the RISE data set, to assess the prediction of risk outside of the physiological measures collected in the RISE study, and to determine the feasibility of assign an optimal interval. donation interval to a first-time donor using this approach.

3D‐S15‐04

A COMPOSITE MEASURE OF HEME IRON CONSUMPTION PREDICTS INCIDENT IRON DEPLETION IN REPEATED BLOOD DONORS

BR Spencer1, Zorro M2, L Sabio2, right wire3

1Scientific Affairs, American Red Cross, Dedham, MA2Epidemiology, Boston University School of Public Health, Boston, MA3Scientific Affairs, American Red Cross, Farmington, CT, USA

Bottom:Iron depletion is common among repeat blood donors, who contribute a large proportion of the blood supply in many countries. Exogenous iron from multivitamins with iron supplementation or iron alone helps prevent donation-induced iron depletion, but whether dietary iron protects against iron depletion in repeat donors has not been rigorously evaluated. Available data from the REDS‐II RISE study in the USA (Cable, Transfusion, 2011) and the Danish Blood Donor Study (Rigas, Transfusion, 2014) suggest a minor impact of dietary iron intake on iron status. iron in blood donors in multivariable regression models. Both studies, however, looked at foods individually, such as beef or fish, rather than together, so precision was limited.

Goals:To assess whether a composite measure of dietary heme iron intake, weighted for frequency and iron content, was associated with incident iron depletion among repeat blood donors.

Methods:A new analysis of the RISE cohort was performed to test the hypothesis that reported levels of animal protein consumption were associated with a lower risk of incident iron depletion among repeat blood donors. The six blood centers that participated in RISE recruited frequent and first-time donors for 15-24 month follow-up of donation frequency and iron status. A short checklist of 8 food categories was administered at baseline to assess the frequency of consumption of various categories of animal proteins that are rich in heme iron, the most easily absorbed biochemical form of iron. An iron composite score (ICS) weighted by frequency and heme iron content was derived and subjects were grouped into ICS tertiles (thirds). Iron status was assessed at study enrollment and completion and at approximately one-third of donation visits in between. Modified Poisson regression with generalized estimating equations was used to generate hazard ratios controlling for frequency of donation and other covariates.

Results:Of 2,425 enrolled donors, 1,406 were iron-replete at baseline and completed the food checklist. The mean value of the ICS for each tercile (from lowest to highest) was 7.2, 13.1 and 22.0 mg of weekly heme iron. These values ​​equate to approximately 3, 6, and 9 servings of beef per week, or alternatively double the servings of chicken or pork. In 2,236 follow-up visits with iron results analyzed, almost 33% of donor visits were associated with intermediate iron depletion (serum ferritin <26 ng/mL) and 8.5% with complete depletion of iron stores. of iron, which represents a serum ferritin <12 ng/ml. After controlling for demographic factors and frequency of donation, the lowest tercile of ICS was associated with a more than two-fold increased risk of complete iron depletion during all follow-up visits (RR 2.40, 95% CI: 1.51, 3.81, compared to the highest). tertile).

Summary/Conclusions:In this longitudinal assessment of dietary iron and iron status, blood donors with low heme iron intake were at elevated risk of developing advanced iron depletion. These results indicate that blood centers should continue to recommend iron-rich diets for repeat blood donors.

3D‐S15‐05

DIETARY INTAKE OF HEME IRON IS ASSOCIATED WITH FERRITIN AND HB LEVELS IN DUTCH BLOOD DONORS: RESULTS FROM DONOR INSIGHT

T Timmer1, R deGroot1, J. Rijnhart2, J. Lakerveld2, J Uso3, C Peral4, M Bart4, F Princes1, S. Zalpuri1, W de Kort5,K van den Hurk1

1Donor Drug Research, Sanquin Research2Epidemiology and Biostatistics, Amsterdam UMC3Amsterdam School of Communication Research (ASCoR), University of Amsterdam, Amsterdam4Division of Nutrition and Human Health, Wageningen University and Research, Wageningen5Public Health, Amsterdam UMC, Amsterdam, The Netherlands

Bottom:Blood donors lose approximately 250 mg of iron with each blood donation. As a result, frequent blood donors are at risk of iron deficiency and low hemoglobin (Hb) levels, which can affect their health and eligibility to donate. Lifestyle behaviours, such as dietary iron intake and physical activity, can influence iron stores and therefore Hb levels. Gaining insight into associations between lifestyle behaviors and Hb levels is valuable to blood supply organizations as lifestyle behaviors may be considered to prevent Hb deferrals. Examining the mediating role of ferritin, a measure that reflects iron stores, in these associations will help gain insight into whether iron stores might be the limiting or enabling factor linking lifestyle behaviors to recovery. Hb after donation.

Goals:To investigate associations between lifestyle behaviors (haem and non-haem iron dietary intake and physical activity) and Hb levels, and whether ferritin mediates these associations.

Methods:Donor InSight‐III (DIS‐III) is a Dutch cohort study of blood and plasma donors and included 2552 donors. Participants who were pregnant, had hemochromatosis, used iron supplements/medications, had a hysterectomy or bilateral oophorectomy (n = 292) were excluded. Hb levels were measured in EDTA whole blood samples using a hematology analyzer (XT-2000, Sysmex, Japan) and ferritin was measured in plasma from lithium heparin tubes (Architect Ci8200, Abbott Laboratories, USA). .). Dietary intake of heme and non-heme iron (grams/day) using a food frequency questionnaire adapted to measure iron intake. Moderate to vigorous physical activity (MVPA, minutes/day) was assessed using the International Physical Activity Questionnaire (IPAQ)-short form.

Results:In total, 2260 participants (1186 women) were included. Donors with higher intakes of heme iron had significantly higher Hb levels (regression coefficient (β) [95% confidence interval (95% CI)] in men and women respectively: 0.147 (0.069 to 0.225) and 0.094 (0.013 to 0.175) mmol/L), regardless of age, smoking, menstruation, number of donations in the previous two years, donation interval, sedentary behavior, other lifestyle variable (ie i.e. (non-)heme iron intake or MVPA) and baseline Hb level. Non-heme iron intake was negatively associated with Hb levels (‐0.015 (‐0.026 to ‐0.004) and ‐0.018 (‐0.032 to ‐0.005) mmol/L for men and women respectively). Ferritin-mediated associations between dietary iron intake and Hb levels (indirect effect in men and women respectively: 0.073 (0.046 to 0.107) and 0.065 (0.031 to 0.100) μg/L for heme and ‐0.003 (‐0.008 to 0.000) and ‐0.007 (‐0.013 to -0.002) for non-heme). More MVPA was negatively associated with Hb levels only in men (‐0.004 [‐0.008 to ‐0.001]), which was not mediated by ferritin.

Summary/Conclusions:In conclusion, higher heme and non-heme iron intake is associated with higher Hb levels in donors via higher ferritin levels, indicating that donors with high heme iron intake may be better able to maintain iron stores to recover Hb levels after blood donation. More MVPA was associated with lower Hb levels, although effect sizes were small, independent of ferritin. Taking a donor's lifestyle behaviors into account may be helpful in preventing low Hb levels in blood donors.

Immunobiology: news in blood cell autoimmunity

4A‐S16‐01

DETECTION OF PLATELET AUTOANTIBODIES TO IDENTIFY PTI STATE OF THE ART

M de Haas1,2,3,L Porcelain1

1Diagnostic immunohematology, Sanquin, Amsterdam2CCTR, Sanquin3IHB, LUMC, Leiden, The Netherlands

Immune thrombocytopenia (ITP) is still diagnosed by exclusion of other causes of thrombocytopenia. Sensitive and specific detection of antiplatelet autoantibodies can support clinical diagnosis and prevent misdiagnosis of ITP. For example, the direct immobilization assay of monoclonal antibodies to platelet antigens (MAIPA), performed withlivepatient's sensitized platelets, offers detection of platelet glycoprotein-specific autoantibodies with high precision. One drawback is that low platelet counts require a large blood sample to have enough of the patient's platelets available for analysis. Circulating antiplatelet autoantibodies are more difficult to detect with MAIPA; and may require more sensitive detection platforms, such as those using surface plasmon resonance.

In general, the presence of anti‐GPIIb/IIIa, anti‐GPIb/IX and anti‐GPV platelet autoantibodies is investigated. All of these antibody specificities have been found in patients with ITP. In ITP, platelet autoantibody-mediated destruction via the spleen has been proposed; but other mechanisms leading to low platelet counts in ITP may also play a role. Inhibition of megakaryocytopoiesis by autoantibodies or by T cells has been suggested. In mice, GPIb-directed antibodies induce loss of platelet sugar epitopes, thereby inducing destruction of medicated platelets by hepatocytes. Platelet autoantibodies can cause complement activation, which may contribute to platelet autoantibody-mediated destruction. Interestingly, we recently found that the lack of detectable platelet autoantibodies correlates with the lack of response to rituximab (CD20 MoAb) treatment in ITP patients. In children with newly diagnosed and often transient ITP, antiplatelet autoantibodies of the IgG class are often not found, but the IgM class are present for a short time.

In conclusion, testing for the characteristics of platelet autoantibodies and their pathological effect may be helpful in establishing the diagnosis of ITP and choosing the best individualized therapy for ITP patients.

4A‐S16‐02

TREATMENT WITH THROMBOPOIETIN RECEPTOR AGONISTS (TPO‐RA) RAISES PLATELET COUNT AND INDUCE IMMUNOMODULATION IN IMMUNE THROMBOCYTOPENIA (ITP)

JW Semple1, R Islam2, And mota2, J Rebetz1R. Kapoor1

1Lund University, Lund, Sweden2St. Michael's Hospital, Toronto, Canada

Bottom:ITP is an autoimmune bleeding disorder in which autoantibodies and/or autoreactive T cells are directed to destroy platelets and megakaryocytes in the spleen and bone marrow. Various therapeutic options, e.g. corticosteroids, intravenous immunoglobulins (IVIG), rituximab, and splenectomy are available to patients, but inadequate efficacy, side effects, and/or cost may make them undesirable. Over the past 10 years, TPO‐RA, p. Romiplostim and Eltrombopag have made a substantial contribution to the treatment of ITP patients refractory to first-line therapies. Of interest, approximately 30% of patients who are tapered from TPO-RA show a sustained response (eg, a higher and more stable platelet count than before treatment). The mechanism by which TPO-RA induces these sustained responses is unknown.

Goals:To analyze the efficacy and immunomodulatory properties of a murine TPO-RA (AMP4, Amgen) in a well-established murine model of ITP demonstrating antibody- and T-cell-mediated thrombocytopenia (Chow L et al., Blood 2010).

Methods:Platelet glycoprotein (GP) IIIa (CD61) knockout (KO) mice were immunized with CD61+platelets and ITP was initiated by transferring their splenocytes to mice with severe combined immunodeficiency (SCID). SCID mice were treated weekly with placebo or TPO‐RA and platelet counts and serum antiplatelet antibodies were measured weekly.

Results:In an initial dose escalation pilot study, naïve SCID mice treated with a single subcutaneous bolus of different concentrations of murine TPO‐RA (1, 10, and 20 ug/kg) had significantly higher platelet counts than 72 h after the infusion. Furthermore, compared to untreated mice, bone marrow histology revealed a significantly higher number of megakaryocytes. Maximal increases in platelet count were observed with the highest dose of TPO‐RA and this dose was chosen to treat SCID mice suffering from ITP. When SCID mice were treated with weekly injections of TPO-RA, platelet counts began to increase after 2 weeks and fully recovered to control levels after 3 weeks after splenocyte transfer. Of interest, compared to untreated ITP mice, serum IgG antiplatelet antibody production in TPO-treated mice was significantly reduced starting two weeks after splenocyte infusion.

Summary/Conclusions:These results suggest that murine TPO-RA is not only an effective therapy for murine ITP, but also induces immunomodulation indicative of immunosuppression. Therefore, this model can elucidate the mechanism by which TPO‐RA induces immunosuppression in ITP patients.

4A‐S16‐03

AUTOANTIBODY-mediated changes in the pattern of platelet glycans: potential impact on platelet function and lifespan in immune thrombocytopenia

j broke1, the sailors1, R. Jouni1, F. Rigoni1,T Bakchoul1,2

1Transfusion Medicine, Tübingen Medical School2Center for Transfusion Medicine Clinic ZKT GmbH, Tübingen, Germany

Bottom:Desialization, the loss of sialic acid content in platelet glycoproteins (GPs) (PLTs), was recently identified as a contribution to immune thrombocytopenia (ITP). However, the potential impact of autoantibodies (AAbs) on megakaryocyte sialylation remains unclear.

Goals:To investigate the effect of ITP AAbs on PLT and megakaryocyte (MK) sialylation and the subsequent impact on PLT survival.

Methods:AAbs from well-characterized ITP patients induced by GP modifications were analyzed by a lectin-binding assay. After incubation of MK or PLT with ITP or control sera, glycan changes were analyzed by flow cytometry (FC). To investigate the impact of desialylation on the lifetime of PLTs, the NOD/SCID mouse model was used.

Results:In this study, 112 ITP sera were investigated. 35 sera (31%) induced a significant increase in RCA signal on the PLT surface compared to control sera from healthy donors (mean RCA increase (RCA‐FI): 3.23, range: 1.76– 13.61, P = 0.0001). In addition, 23 sera (21%) caused increased ECL binding to test PLTs (ECL‐FI: 2.31, range: 1.54–5.7, P=0.0001). Injection of desialylating AAbs resulted in accelerated clearance of human PLTs from the circulation of NOD/SCID mice, which was significantly reduced by a specific neuraminidase inhibitor that prevents desialylation on the PLT surface (survival of human PLTs after 5 h: 29%, range 22–40% vs. 48%, range 41–53%, P=0.014, respectively). Most interestingly, a subset of ITP sera induced desialylation on the surface of MKs. In particular, 8 of 13 (62%) induced a significant increase in RCA signal at the MK surface (mean RCA‐IF: 2.19, range: 1.15–3.66, P = 0.01); and 10 of 13 (77%) sera with PLT desialylated AAbs increased ECL binding (ECL‐FI mean: 1.29, range: 1.01–1.7, P = 0.005).

Summary/Conclusions:Our findings suggest that ITP AAbs of different specificities can induce desialylation in PLTs and MKs, which appears to result in impaired function and contribute to PLT destruction in vivo.

4A‐S16‐04

AUTOIMMUNE HEMOLYTIC ANEMIA: SEROLOGICAL CHARACTERISTICS AND TRANSFUSION CHALLENGES

M Raos1, D. Pulanic2,3, M. Lukic1, M. Vinkovic1, P Kilic3, G Tomac1, I Vidovic1, BG Cepulic1

1Clinical Department of Transfusion Medicine and Transplant Biology2Department of Internal Medicine, Division of Hematology, Clinical Hospital Center Zagreb3Zagreb University Faculty of Medicine, Zagreb, Croatia

Bottom:Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease characterized by hemolysis associated with the presence of immunoglobulins (IgG, IgM, or IgA) and/or components of the complement system in red blood cells (RBCs), which is usually demonstrated by a positive result. direct antiglobulin test (DAT). Depending on the presence of an underlying disorder, AIHA can be further subdivided into primary and secondary and, based on the temperature at which autoantibodies optimally bind to red blood cells, into warm antibody AIHA (wAIHA), mixed AIHA (which includes both IgG warm and cold IgM antibodies), cold agglutinin disease (CAD), paroxysmal cold hemoglobinuria (PCH), and AIHA DAT negative. A frequent finding in immunohematology is the presence of autoantibodies on red blood cells without clinical symptoms of hemolysis that may develop later.

Goals:The aim of this study was to analyze serological findings and transfusion support in patients with AIHA and also to analyze DAT-positive patients without clinical symptoms.

Methods:We included data from all AIHA and DAT-positive adult patients without clinical symptoms diagnosed and/or treated at University Hospital Center (UHC) Zagreb, Croatia in the period between 2014 and 2018. The diagnosis of AIHA was defined by anemia with features of hemolysis (elevated bilirubin and/or elevated lactate dehydrogenase and/or low haptoglobin level) and a positive DAT.

Results:Data from 64 patients (52% women) who met the inclusion criteria were analyzed. The mean age at the time of the AIHA was 63 years (range 22-89 years). The mean Hg level at diagnosis was 68.60 g/L. DAT results were mostly positive with IgG+C3d (59%) or IgG (31%). Most of the patients had warm AIHA (70%). Other types of AIHA diagnosed were mixed AIHA (15%), CAD (11%), PCH (1.5%), and AIHA DAT negative (1.5%). In 6 cases alloantibodies with autoantibodies were detected in the patient's plasma. Patients were treated with corticosteroids as first-line therapy and some with intravenous immunoglobulins (IvIG). In severe or refractory patients, rituximab and/or splenectomy were applied. A total of 80% of the patients received a transfusion with a mean hemoglobin level of 67.88 g/l. During this period we detected 136 DAT positive patients without clinical symptoms.

Summary/Conclusions:Most of the patients in our study were diagnosed with AIHA of the warm type, followed by AIHA of the mixed type and CAD. On the other hand, AIHA negative PCH and DAT were very rare, which is in agreement with the relevant literature. Most of the patients were transfused despite the therapy used, which is undesirable in patients with AIHA and should be better controlled, especially in moderate cases of anemia, where this is rarely necessary. A significant number of patients who were DAT positive without clinical symptoms may subsequently develop AIHA and should be closely monitored.

4A‐S16‐05

AUTOIMMUNE HEMOLYTIC ANEMIA: A SURVEY OF DIAGNOSTIC AND MANAGEMENT PRACTICE IN ENGLAND

Horan1,a charlton1, Bullock2, E. Massey3, S. Allard4, A hill5, Stanworth6, Hill Q5

1NHS Haematology, Blood and Transplantation, Newcastle upon Tyne2Red blood cell immunohematology3NHS Hematology, Blood and Transplantation, Bristol4Hematology, NHS Blood and Transplant, London5Hematología, The Leeds Teaching Hospitals NHS Trust, Leeds6Hematology, NHS Blood and Transplant, Oxford, UK

Bottom:Autoimmune hemolytic anemia (AIHA) is decompensated acquired hemolysis caused by the host's immune system acting against its own red blood cell antigens. AIHA is a rare disorder and although the British Society of Hematology (BSH) diagnosis and treatment guidelines were published in February 2017, there is little evidence for clinical practice in the UK.

Goals:To investigate the approach to the diagnosis, investigation and management of patients with AIHA at English NHS Trusts.

Methods:A survey of diagnostic and management practices was designed, tested and disseminated to clinical transfusion leaders across all Acute English NHS Trusts from November 2017 to March 2018. It was completed by a consultant haematologist treating AIHA patients, but a response that represented a departmental consensus was encouraged. .

Results:Responses represented 42% (58/137) of English acute trusts. The median number of adults with AIHA diagnosed annually was 4 to 6. In the previous 5 years, 31% (18/58) recalled at least one patient who had died due to AIHA. Although 7% (4/57) underwent bone marrow biopsy in all patients, 93% required additional characteristics, mainly: neoplasia, age over 60 years or being refractory to treatment. /58) would not organize confirmatory tests, either because they considered them unnecessary (29/34) or because clinicians were unsure how to access the tests (5/34). In determining the AIHA subtype, 29% (17/58) indicated that there were no circumstances in which they would perform cold antibody tests (antibody titer and/or temperature range), 12 considered this unnecessary and 5 were unsure How to access the tests.

In 4 clinical scenarios of patients with AIHA and DAT-positive C3d ± IgG ± cold-associated symptoms, up to 87% (47/54) of respondents would not test for cold antibodies. For first-line treatment of primary warm AIHA, the mean duration of prednisolone 1 mg/kg administered before judging the patient refractory and reducing the dose was 3.5 weeks (SD 1.70, range 1-19 weeks). . The second-line treatment of choice was rituximab for 82% (45/55) of the respondents and splenectomy for 5%. Intravenous immunoglobulin and splenectomy were the most cited salvage therapies. For primary cold hemagglutinin disease (CHAD), first-line treatment was based on rituximab for 88% (49/56), but single-agent steroid for 9%.

We also explore the potential for future audits and investigations. 64% (37/58) of the respondents were able to identify patients with AIHA who previously required transfusion. 96% (55/57) of respondents would consider endorsing a registry of AIHA patients requiring transfusion. The key questions that respondents thought a registry should address were: morbidity and mortality, response to treatment, and differences in diagnosis and treatment of AIHA subtypes. There was uncertainty about access to cold and drug-induced antibody testing and clinicians do not always perform the BSH-recommended cold antibody tests for C3d DAT-positive AIHAs. Initial treatment of primary warm AIHA and CHAD was broadly consistent with BSH guidelines, although 44% (25/57) would continue prednisolone at 1 mg/kg beyond the recommended 21 days before beginning a taper, with a increased risk of toxicity.

Summary/Conclusions:The findings support the need for a variety of research initiatives, including the creation of an AIHA registry.

Clinician - Patient blood management

4A-S17-01

AN UPDATE ON PATIENT BLOOD MANAGEMENT

A Pavenski

Laboratory Medicine, St. Michael's Hospital, Toronto, Canada

Preoperative anemia is common and is associated with adverse outcomes in the perioperative period. Preoperative anemia also increases the risk of allogeneic blood transfusions, which can lead to increased perioperative mortality, longer length of hospital stay, and infections. The diagnosis and treatment of anemia is one of the principles of patient blood management (PBM), along with the reduction of unnecessary transfusions and diagnostic phlebotomies, as well as the use of hemostatic agents to reduce bleeding, among many others. Effective PBM is multidisciplinary, multimodal, timely, individualized, and patient-centered. Early referral to PBM and multimodal PBM interventions are associated with greater improvement in preoperative hemoglobin. PBM has been shown to reduce transfusions and cost, while system-wide multimodal programs may also be associated with improved mortality. Using examples from our research and local practice, I will discuss three aspects of PBM. Iron and erythropoiesis-stimulating agents (ESAs) are effective, safe, and widely used in the treatment of preoperative anemia. Previous studies have questioned whether ESA leads to an increased risk of thrombosis, however recent systematic reviews do not support these concerns. Another PBM approach is to reduce bleeding during surgery through the use of hemostatic agents such as tranexamic acid (TXA). TXA reduces transfusion requirements in hip and knee arthroplasty, and is safe, widely available, and relatively inexpensive. TXA is effective in both anemic and non-anemic patients, making it an attractive universal PBM strategy. Finally, there are evidence-based recommendations and guidelines on PBM, including the most recent international guidelines developed by the International PBM Consensus Conference. However, the translation of knowledge into PBM has been a problem and a number of barriers to its implementation have been identified. These include a perceived or actual lack of expertise, time, and resources, as well as a lack of physician and patient commitment. One way to approach patient engagement is education through character-driven animation and we are currently testing this approach.

4A-S17-02

LOW VS. HIGH HEMOGLOBIN TRIGGER FOR TRANSFUSION IN VASCULAR SURGERY (TV): A RANDOMIZED CLINICAL FEASIBILITY TRIAL (THE TV TRIAL)

a soft1, H. Nielsen2, J. Wetterslev3, O Pedersen4, D. Hellemann5, Store P3, K Marcussen5, B Ramsing6, A Mortensen5, J Jacobsen3, S Shahidi7

1Anestesia y Cuidados Intensivos, Hospital Slagelse, Slagelse2Sanos Clinic, Herlev3Copenhagen Test Unit, Rigshospitalet, Copenhagen4Clinical Immunology, Naestved Hospital, Naestved5Anesthesia and Intensive Care6Anesthesia and Intensive Care7Cirugía General y Vascular, Hospital Slagelse, Slagelse, Dinamarca

Bottom:Current guidelines recommend limiting red blood cell transfusion during surgery, but the feasibility and safety of such a strategy remain unclear, as most evidence is based on stable postoperative patients.

Goals:The effects of a protocol aimed at restricting red blood cell transfusion during elective vascular surgery were evaluated.

Methods:Fifty-eight patients scheduled for lower extremity bypass or open abdominal aortic aneurysm surgery were randomized to a low trigger (hemoglobin <8.0 g/dL, 5 mmol/L)contra. high trigger (hemoglobin <9.7 g/dL, 6 mmol/L) for red blood cell transfusion during hospitalization. The intraoperative change in brain and muscle tissue oxygenation was assessed using near-infrared spectroscopy. We used a national registry to collect data on death and major cardiovascular events, including (1) serious adverse transfusion reaction, (2) acute myocardial infarction, (3) stroke, (4) recent-onset renal replacement therapy, ( 5) vascular reoperation, and (6) amputation of the lower limb.

Results:The primary outcome, mean hemoglobin within 15 days after surgery, was significantly lower in the low activation group: 9.46 g/dL.contra. 10.33 g/dl in the high activation group (mean difference 0.87 g/dl; P = 0.022, longitudinal analysis) as were the units of red blood cells transfused (median [interquartile range (IQR)] 1 [ 0–2]contra. 3 [2–6]; p=0.0015). While brain desaturation load increased in the low activation group (median [IQR] 421min*% [42–888]contra. 127 [11-331], P = 0.0036), muscle oxygenation was similar. The low-trigger associated with a higher rate of death or major cardiovascular events: 19/29contra. 8/29 (hazard ratio 3.18; P=0.006) and fewer 90-day out-of-hospital lives (median [IQR] 76 [67–82]contra. 82 [76-84] days, p = 0.049).

Summary/Conclusions:A perioperative protocol restricting red blood cell transfusion successfully separated hemoglobin levels, units of red blood cells transfused, and intraoperative oxygenation of brain tissue. The exploratory results suggested potential harm with low triggering and warrant further trials in vascular surgery before such a strategy is universally adopted.

4A-S17-03

REDUCTION OF RED CELL USE THROUGH AN HB-ACTIVATED SINGLE UNIT TRANSFUSION POLICY IN A POPULATION OF HOSPITALIZED HEMATO-ONCOLOGY PATIENTS: A SINGLE-CENTER RETROSPECTIVE ANALYSIS

Lil's H1, J Omen1, C Eijsink2, N Happy Lives1, M. Hoeks1, D Evers1

1Hematology2Laboratory medicine, Radboudumc diagnostic laboratory, transfusion medicine section, Radboudumc, Nijmegen, The Netherlands

Bottom:Controlled non-hemato-oncology studies have consistently shown that a single-unit red cell (RBC) transfusion policy, as well as a strict hemoglobin (Hb) red cell transfusion threshold, is safe and reduces the use of blood products. However, it is not clear whether these conclusions also apply to the hemato-oncology patient population.

Goals:To quantify the reduction in red cell blood product utilization by introducing a restrictive single-unit Hb-activated red cell transfusion policy among the inpatient hemato-oncology population.

Methods:Under the liberal transfusion protocol, applied until November 1, 2017, standard double-unit red blood cell transfusion was indicated with an Hb threshold ≤ 8.1 g/dL and/or anemia-related symptoms. After this date, the restrictive transfusion protocol involving a lowering of the threshold to 7.3 g/dl and transfusion of a single unit was introduced. For patients with an ASA score of II-III and IV, an Hb threshold of ≤ 8.1 g/dL and ≤ 9.7 g/dL, respectively, was applied.

We evaluated the use of red blood cell blood products over a 6-month period beginning December 1, 2016 (liberal protocol) and December 1, 2017 (restrictive protocol) in all hemato-oncology patients admitted for chemotherapy, including transplantation. of hematopoietic stem cells (HSCT) with an expected duration of neutropenia of ≥7 days.

Analysis of categorical and continuous data was performed using the chi-square and Mann-Whitney tests, respectively.

Results:During both observation periods, 137 patients were admitted who received a total of 164 cycles of therapy, including 56 cycles of acute myeloid leukemia (AML) induction and 69 autologous HSCT.

The distribution of indications for admission, median age, length of hospitalization, and duration of neutropenia did not differ between the two periods.

During the restrictive period, 303/402 (75.4%) of the transfusions met the assigned Hb threshold. The percentage of single-unit transfusion episodes increased from 29/112 (29.0%) to 81/111 (73.0%) with the introduction of the restrictive protocol.

Overall, red cell blood product utilization per admission was not reduced by the restrictive protocol (cumulative number of red cell units transfused 4.0 [interquartile range (IQR) 2.0–8.0] during the liberal vs. to 2.5 (IQR 0.0–9.0) during the restrictive period (P =0.36)). However, red cell blood product utilization per neutropenic day demonstrated a trend toward reduction: 0.25 (IQR 0.11–0.33) versus 0.15 (IQR 0.00–0.32) units per day during the liberal versus restrictive period, respectively (P = 0.06). This reduction was primarily attributed to autologous HSCTs during which red cell blood product utilization decreased from 2.0 (IQR 0.0–2.0) to 0.0 (IQR 0.0–1.5) units ( P=0.06), which corresponds to a reduction from 0.13 (IQR 0.00–0.21) to 0.0 (IQR 0.0–0.13) (P=0.01) units per neutropenic day. Furthermore, 14/38 (36.8%) patients during the liberal period versus 21/31 (67.7%) during the restrictive period did not require red blood cell transfusion during admission. Consequently, strict Hb thresholds compared to single unit transfusions appear to have a stronger impact on red blood cell product utilization.

Summary/Conclusions:A single-unit Hb-triggered transfusion policy results in a sharp reduction in the use of red cell blood products in the setting of autologous HSCT. No reduction in utilization was observed among other populations of hospitalized blood-oncology patients receiving intensive chemotherapy. Further improvement in protocol compliance rates could potentially increase the benefit of this blood-saving strategy.

4A-S17-04

ASSESSING THE HB CONTENT OF PACKAGED RED GERBLES (PRBC): IS IT TIME TO LABEL EACH UNIT WITH THE HB CONTENT?

R Jain1, N. Marwaha2, Sachdev2

1Transfusion Medicine, Aiims, New Delhi2Transfusion Medicine, Pgimer, Chandigarh, India

Bottom:In today's era of evidence-based medicine and individualized patient care, red blood cell transfusion continues to be administered on the basis of conventional wisdom and the notion of average benefit per unit. Existing blood transfusion practice based on "number of units transfused" ignores the fact that total Hb varies markedly between individual units of red blood cells.

Goals:The present study aimed to estimate the Hb content in the unit of red blood cell concentrate prepared by three different protocols of 350 ml and 450 ml of whole blood in three types of blood donors: replacement blood donor (RD), first time voluntary donor (FTVD) and regular. volunteer blood donor (RTVD).

Methods:A total of 900 potential blood donors were included in this study. 300 whole blood samples were taken from each of the three groups of donors (RD, FTVD and RTVD). Within each group, 100 extractions were made in Double 350ml, Triple 450ml and Quadruple 450ml blood bags respectively. A pre-donation venous sample was drawn from the specimen collection bag for analysis on a hematology analyzer as a reference method for donor Hb concentration. The Hb content of the units of packed red blood cells was estimated after the collection of a representative sample of the unit of blood. The unit volume of PRBC was estimated by the formula of the weight of blood in PRBC divided by the specific gravity. The Hb content in the unit was estimated by the formula: Hb content in the unit = Hb value of the PRBC unit (g/dl) × volume of the PRBC unit (dl).

Results:In this study, the Hb concentration (g/dl) was comparable between the three types of blood donors, except that RTVD had lower Hb values ​​compared to RD (P = 0.007). The hemoglobin concentration of the PRBCs ranged from 14.2 to 29.6 g/dl; the mean Hb was 21.02±2.90g/dl. The net Hb content of the PRBC pocket was lower in PRBC prepared from RD compared to FTVD (P = 0.0001) and RTVD (P = 0.008). The Hb content of the PRBC units prepared from the 450 ml harvest ranged from 35.19 to 87.36 g and from the 350 ml harvest ranged from 30.77 to 65.78 g. We observed a wide range of net Hb content in PRBC units and the correlation coefficient showed the strongest association of PRBC unit net Hb content with total PRBC volume (r= 0.730, P = 0.0001). Larger volume red blood cells have more Hb content. The volume of the PRBC bags in the study ranged from 155 ml to 370 ml (including the 350 and 450 ml collections).

Summary/Conclusions:The present study shows that the labeling of the Hb content of the PRBC unit helps better inventory management for patients. Hb content can help in decision making for unit release for pediatric/underweight versus adult/heavier weight patients. Adoption of an RBC transfusion dose-optimizing policy could have the potential to significantly improve RBC utilization and decrease patient exposure to allogeneic blood. This would further aid evidence-based transfusion clinical practices.

4A-S17-05

EVALUATION OF CLINICAL PRACTICES OF RED CELL TRANSFUSION IN A TERTIARY CARE ONCOLOGY CENTER

NV More, P Desai, S Rajadhyaksha, A Navkudkar, N Deshpande

Transfusion Medicine, Tata Memorial Centre, Homi Bhabha National Institute, Bombay, India

Bottom:Red blood cell (RBC) transfusion is an important medical therapy that benefits the patient in a broad spectrum of clinical settings. Critical Intensive Care Unit patients in particular, as well as medical and hemato-oncology patients, are among the largest group of RBC users. Periodic review of the use of blood components is essential to assess the pattern of blood use in any hospital or health care facility. Our institute is a 639-bed tertiary care cancer center with approximately 18,000 to 20,000 red blood cell transfusions per year. These transfusions are required at various stages of a patient's treatment, including chemotherapy, radiation therapy, surgical and palliative care, and the institute sets guidelines for physicians to follow.

Goals:Study the clinical practices of red blood cell transfusions based on indications and evaluate the adequacy of the practices of use of red blood cells in the institute.

Methods:This was a prospective observational study, initiated after the approval of the Institutional Ethics Committee. A total of 4413 RBC transfusion events in adult patients over a four-month period were included and analyzed according to institutional guidelines for appropriateness. Details of transfusion events in the form of pre-transfusion hemoglobin, transfusion indication, type of request, number of units requested and issued, time of issue, site of transfusion and adverse reactions, etc., were obtained from the records. of the Department of Transfusion Medicine. The general statistical analysis was descriptive using the SPSS software. The chi-square test was applied in cross tables to see the relationship between different variables and it was considered significant if the p value was <0.05.

Results:A total of 4413 red blood cell transfusion events for 2012 patients were analyzed. There were 1877 (43%) events in 628 medical oncology patients and 2536 (57%) in 1384 surgical oncology patients. The maximum transfusions were received by patients in the age group 41 to 60 years (47%). 83% of transfusion events were appropriate according to institutional guidelines. All transfusions administered in the operating room were found to be appropriate with a p value < 0.05. Inadequacy was greater than 53% (396/735) and significant in the daycare setting (P < 0.05). Anemia was the most common indication for red blood cell transfusion observed in 90% of events (3971/4413). 62% of red blood cell transfusions were performed as planned and 38% as urgent transfusions. The most common adverse transfusion event observed was an allergic reaction in 0.3% of all transfusion reactions.

Summary/Conclusions:The clinical practice of red blood cell transfusions in our hospital was found to be largely appropriate and rational with adherence to institutional guidelines. Blood use audits should be carried out regularly by transfusion services and the results should be discussed with the physician to ensure judicious use of the scarce resource. The concept of Transfusion Safety Officer (TSO) can be introduced for better coordination between clinicians and blood transfusion services to improve practices.

Adverse events: current relevance of viral, parasitic and bacterial infections in transfusion medicine

4A-S18-01

APPROACHES TO CONTROL INFECTIONS IN VARIOUS CONTEXTS

CM Nuebling

Instituto Paul Ehrlich, Langen, Germany

On a global scale, blood services are very diverse in aspects such as organizational structure, regulatory background, donor populations, donation rates or epidemiology of pathogens. The World Health Organization (WHO) recognizes blood and blood products as essential medicines and provides guidance to member states on various aspects, such as blood regulation, best practices in blood collection and transfusion, or parameters detection. More recently, a WHO guideline on the residual risk of transfusion-associated infections was established that may facilitate decision-making on the most appropriate screening algorithms. Emphasizes the need for a regional evaluation of screening trials and regulatory control of blood-associated IVDs.

4A‐S18‐02

BABESIA SCREENING IN US BLOOD DONORS

J Sunga1, K Chug1, S. Bakkour2, J Cruz3, Y Erickson4, J Gottschall5, M. Janzen6, B Sahais7, T. Strauss8, J Tebo9,Pate L10

1Molecular Systems Roche, Pleasanton2Vitalant Research Institute, San Francisco3Versiti Indiana, Indianapolis4Mississippi Valley Regional Blood Center, Davenport5Versiti Wisconsin, Milwaukee6Innovative Blood Resources, St. paul7Delmarva Blood Bank, Newark8Community Blood Center, Appleton9Central Pennsylvania Alliance Laboratory, York10Medical and Scientific Affairs, Roche Molecular Systems, Pleasanton, USA

Bottom:Babesia, a protozoan parasite that infects red blood cells, is a leading infectious cause of mortality in US transfusion recipients.BabesiaIt is usually transmitted through the bite of an infected tick, but it can be transmitted by transfusion (TT) or passed from mother to child during pregnancy. Babesiosis is a worldwide disease; the ticks they carryBabesiahave a worldwide distribution. Babesiosis has been reported throughout Europe and in Canada, Korea, India, and Japan. Prospective testing of blood donations in endemic areas of the US revealed that 0.38% of donors tested positive forBabesiaDNA or antibodies (Moritz, NEJM, 2016)

Goals:Report the results of the ongoing Babesia clinical trial

‐ Explain the importance of Babesia as a TT infection

Methods:Incobas®Babesia for use in thecobas®6800/8800 Systems, is a qualitative polymerase chain reaction nucleic acid amplification test, developed to detect in samples from whole blood (WB) donors the 4BabesiaSpecies that cause human disease:B. microti, B. duncani, B. divergens,yb. hunters. Testing began in October 2017 under a US FDA-approved investigational new drug application. WB was harvested in a proprietary medium that lysed red blood cells and stabilizedBabesiaRNA and DNA. Donations were collected in states with high, low, and noneBabesiaendemic and analyzed as individual blood donor (IDT) samples. Reactive index donations were retested in simulated minigroups of 6 (MP6), plus 3 IDT replicates withcobas®Babesia. The reactive index donations were also tested with 2 alternate validated Babesia NATs and forB. microtiIgM and IgG antibodies. Donors with reactive results were invited to participate in a follow-up study to assess for additional evidence of infection.

Results:To date, 256,802 valid donations have been screened withcobas®Babesia, and 15 (0.006%) were reactive. 13 of 15 (87%) initially reactive donations were confirmed positive forBabesiawith positive NAT or alternative serology result. 1 of 13 (8%) confirmed positive donations were collected in a state with lowBabesiaendemic (Pennsylvania), and 1 (8%) was collected in a state whereBabesianot considered endemic (Iowa). 11 of 13 (85%) confirmed positive donations were collected from states with high endemicity. 8 of 13 (62%) confirmedBabesia‐positive donations were detected in late fall or winter. The 13 (100%) confirmedBabesia‐positive donations were reactive in MP6. Serology results are available for 12 of 13 confirmed positive donations: In the index, 6 of 12 confirmed donationsBabesia‐positive donations were only IgG positive, while none were only IgM positive; 3 were positive for both IgG and IgM. 3 of those confirmedBabesiapositive donations were negative for IgG and IgM antibodies.cobas®Babesia showed an overall specificity of 99.999% (256,787/256,789; exact 95% CI: 99.997%>100%).

Summary/Conclusions:Hecobas®The Babesia test successfully identified 13Babesia-positive donations, including 3 confirmed positive donations without IgM or IgG reactivity. 2 donations were collected in states considered low or non-endemic toBabesia. 8 confirmed positive donations were collected outside of the summerBabesiaseason, when most clinical cases occur. screened withcobas®Babesia continues in various laboratories.cobas®Babesia is not licensed by the FDA or commercially available.

4A-S18-03

PREVALENCE OF BABESIA MICROTI IN CANADIAN BLOOD DONORS

S O'Brien1, S. Stramer2, Proctor M.2, L Tonetti2, Vbres3, lines J3, F Bernier4, G Delage4, T Gaziano5, and Gregory4, J Labrie4, M Bigham5, G. Hawes5, V Scalia5, M. Fearon5, S draws6

1Epidemiology and Surveillance, Canadian Blood Services, Ottawa, Canada2Cruz Roja Americana, Gaithersburg3Grifols Diagnostic Solutions Inc, San Diego, United States4Hema-Quebec, Saint-Laurent5Canadian Blood Service, Ottawa, Canada6Medical Microbiology, Canadian Blood Services, Ottawa, Canada

Bottom:Babesiosis in humans is caused by the erythrocyte protozoan parasite,babesia microtiwhich is transmitted by tick bites, but is also transmitted by transfusions. Although it is frequently asymptomatic or presents with flu-like symptoms in a normal host, if the infection is immunocompromised it can lead to serious complications and death.B. microtiit is endemic to the Northeastern/Upper Midwestern United States, where partial testing of donations has been implemented. In Canada, a 2013 study of ˜14,000 donors did not identify anyB. microtisamples with positive antibodies, which suggests a low risk at that time, but the risk should be monitored.

Goals:To assess the prevalence ofB. microti‐positive donations in potentially at-risk areas in Canada.

Methods:Between July and November 2018, 50,752 blood samples were selected from donors at sites near the US border. The wading pools were tested forB. microtinucleic acid by transcription mediated amplification (TMA) using Procleix®Babesiaessay on the panther®system with individual tests in reactive pools. Reactive donations were also tested byB. microti‐specific: American Red Cross (ARC) IgG immunofluorescence assay [IFA] and IMUGEN IFA/PCR. A subset of 14,758 TMA-negative samples were tested, primarily from the province of Manitoba and eastward into Nova Scotia.B. microtiantibody using the ARC IFA and if positive, the IMUGEN IFA/PCR. Donor age, gender, donation status, residential location, and collection site location were recorded. Donors who tested positive/reactive were informed, deferred and questioned about risk factors (possible tick exposure and travel within Canada, US and elsewhere, history of symptoms) and a follow-up sample was requested for testing complementary (TMA, ARC IFA) . Reactive donations have been removed from inventory.

Results:The 50,752 donor samples were commensurate with collections in the targeted geographic regions. Age group, gender, and donation status were also similar to the donor base in the collection areas. A sample from Winnipeg, Manitoba was reactive to TMA and positive for antibodies on supplemental tests. The donor had no recollection of symptoms or spending time in wooded areas. She visited the city of Fargo, North Dakota, United States. The subset of 14,758 samples tested for antibodies was also proportional to the collections in the target areas. Four antibody-positive samples were identified from mid-September through October 1, all in southwestern Ontario near Lake Erie. None were reactive with TMA. Three were interviewed and none recalled any symptoms, probable tick exposure, or relevant travel within Canada or the US.

Summary/Conclusions:this is the biggestB. microtiPrevalence study in Canada. The results indicate a very low prevalence with only 1 MAT-confirmed positive donation out of 50,752 tested. The donor was from the only region of Canada where an indigenous human case was reported and active tick surveillance was identified.B. microtipositive tick populations. The seropositive donations in southwestern Ontario may suggest a low prevalence in that region, but the interpretation is less certain due to the lack of corroborating follow-up results or case histories. Given the proximity to the US border, forgotten trips to the US should not be ruled out.

4A‐S18‐04

SEROEPIDEMIOLOGY OF TOXOPLASMA GONDII IN BLOOD DONORS IN PORTUGAL

F Teixeira Rodrigues1, Sousa2, Cepillo M2, J Condenço3, Pires4, J. Dubey5, L Cardoso1,6, in Lopes1,6

1Animal and Veterinary Research Center (CECAV), University of Trás-os-Montes and Alto Douro (UTAD), Vila Real2Lisbon Blood and Transplantation Center, Portuguese Institute of Blood and Transplantation (IPST), Lisbon3Porto Blood and Transplant Center, IPST, Porto4Coimbra Blood and Transplant Center, IPST, Coimbra, Portugal5Animal Parasitic Disease Laboratory, Beltsville Agricultural Research Center, Agricultural Research Service, United States Department of Agriculture, Beltsville, MD, United States6Department of Veterinary Sciences, UTAD, Vila Real, Portugal

Bottom:The protozoan parasiteToxoplasma gondiiit is prevalent in animals and humans worldwide. Wild and domestic cats are the definitive hosts and homeothermic animals act as intermediaries. After primary infection, the parasite persists for life within dormant tissue cysts. Transmission is by ingestion of raw or undercooked meat infected with cysts, by ingestion of food or water contaminated with oocysts, or through the placenta. However, it can also be acquired through blood transfusion and organ transplantation. Toxoplasmosis can be a serious illness in immunosuppressed people and newborns whose mothers have acquired a primary infection during pregnancy.

Goals:There is no information on the specific epidemiology ofT. gondiiinfection in blood donors in Portugal. Therefore, we sought to determine the seroprevalence ofT. gondiiand associated risk factors in the population of blood donors in Portugal.

Methods:Between September 2015 and July 2017, 520 blood donors who attended the Portuguese Institute of Blood and Transplantation blood banks located in Porto, Coimbra and Lisbon, and also in regional blood collection meetings, were invited to participate in the study. Written informed consent was obtained and a questionnaire on sociodemographic and behavioral variables was answered. Sera were tested for IgG antibodies againstT. gondiiby a commercial modified agglutination test (MAT) kit (Toxo-Screen DA®bioMérieux, Lyon, France).

Results:Of the 520 blood donors (mean age 38.55±11.14; range 18-65 years), 38.1% were positive for antibodies againstT. gondii. When asked about toxoplasmosis, almost half of the blood donors had no knowledge of the disease. The Center of Portugal had the highest seroprevalence (55.1%), followed by the North (37.2%) and the South (25.3%). Blood donors living in rural areas had a significantly higher seroprevalence (P=0.001) than those living in urban areas. Seroprevalence increased with age, with the highest seroprevalence (60.2%) being found in the 46-55 age group (multiple logistic regression [MLR]: OR=7.68; CI: 4.08–14, 46; P<0.001), and decreased with education. level (P<0.001). Participation in soil-related activities (gardening or agriculture) was significantly related toT. gondiiseropositivity (P=0.02). Regarding water consumption, untreated sources were confirmed as a risk factor (although it included mineral and tap water) (MLR: OR=2.72; CI: 1.27-5.86; P=0.001). Other behavioral and feeding characteristics, including cats in the home, eating raw or undercooked meat, processed pork products, or not washing raw fruits and vegetables before eating, were not associated withT. gondiiinfection.

Summary/Conclusions:The risk ofT. gondiitransmission through blood transfusions is low, and serologic testing for antibodies, excluding blood donors, appears not to be feasible. Immunocompromised persons, organ transplant patients, and pregnant women should receiveT. gondiiBlood components with negative antibodies for transfusions. This study explored the epidemiology ofT. gondiiin Portugal thus providing useful information on seroprevalence and potential risk factors forT. gondiitransmission. Public health and medical authorities could promote information about toxoplasmosis and its prevention among blood donors, and also among the general population, when addressing policies and designing detection programs to monitor and control infections and diseases in Portugal.

4A-S18-05

WHO IS EXCLUDED FROM SYPHILIS TESTS?

Reynolds1, C. Pearson2, K Davison2, S. Brailsford1

1NHSBT/PHE Unit of Epidemiology, NHS Blood and Transplantation2NHSBT/PHE Epidemiology Unit, Public Health England, London, UK

Bottom:Screening for treponemal antibodies to detect syphilis in blood donors has been performed in England since the 1940s. Transfusion transmissions of syphilis have not been reported in England since records began, partly due to the sensitivity of the organism to storage cold. Since we have specific tests for other sexually transmitted infections, such as HIV and hepatitis B virus (HBV), the usefulness of syphilis screening is often questioned. However, it may be a useful indicator for higher-risk behaviors, particularly after the reduction in deferrals for higher-risk sexual behaviors from 12 to 3 months in November 2017 and in a context of rising infectious syphilis in the general population.

Goals:Here we describe the epidemiology of recently acquired syphilis in blood donors in England compared with HIV and acute HBV infection between 2009 and 2018.

Methods:Results of monthly donation tests are obtained from screening centers and the NHS Blood and Transplant (NHSBT) reference laboratory. Demographics, potential sources of infection, and donor selection compliance in confirmed positive donors are collected pro forma in the post-test discussion with the NHSBT clinical team. Recent syphilis is classified as IgM positive and/or recent history including a negative donation within 12 months for regular donors.

Results:Between 2009 and 2018 there were 153 recent cases of syphilis, 121 HIV infections, and 32 acute HBV infections identified by donation screening. Recent syphilis rates per 100,000 donations increased from 0.66 to 1.64, while HIV decreased from 1.04 to 0.19 with fewer than 5 positive donations in 2018. Acute HBV rates increased slightly from 0.28 to 0.38 in 2018. Men outnumbered women with 71.9%, 63.6%, and 59.4% of recent syphilis, HIV, and acute HBV cases respectively. Nearly a quarter of recent syphilis and HIV cases have been seen in donors younger than 25 years. Of the male donors with recent syphilis, 58.2% reported sex between men and women (SBMW), 19.1% sex between men (SBM), and 22.7% reported no risk. This was in contrast to HIV, where 45.5% of male donors reported SBM, only 2.6% reported no risk. Overall, 19, 32, and 3 men with recent syphilis, HIV, or acute HBV, respectively, were not in compliance with the SBM deferral in effect at the time of donation. In 2018, 26 donors with recent syphilis between the ages of 23 and 65 (median 36 years) were excluded from the donor pool, including 3 who did not comply with the SBM deferral. There were fewer than 5 HIV cases identified in 2018, all 40+, all compliant, reporting SBMW. Of the 6 acute HBV cases in 2018, 5 were men, all but one in the 45+ age group.

Summary/Conclusions:Over the 10-year period, the demographics of recent syphilis cases appeared similar to that of HIV, with the highest rates in young men, although the lowest proportions reported SBM. After the switch to a 3-month lag, HIV case detection continued at a low level, while syphilis screening continued to exclude higher numbers spanning all age groups potentially at risk for other sexually transmitted infections. , including non-compliant donors.

Donors and donation: tools for personalized donor care

4A-S19-01

CURRENT OPINION ON DONOR HEALTH – PERSONALIZED CARE FOR THE DONOR

C Erikstrup1, O Pedersen2, H Any3

1Department of Clinical Immunology, Aarhus University Hospital, Aarhus2Department of Clinical Immunology, Naestved Hospital, Naestved3Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark

Bottom:Globally, an estimated 113 million blood donations are made annually. In the blood service we are obliged to monitor the health of donors and ensure that blood donation is safe. In recent years, large-scale blood donor cohort studies in several countries have increased our knowledge of the effects of blood donation on health. Health problems relate to both immediate side effects such as fainting and potential long-term health problems associated with repeated blood or plasma donation. Studies have provided us with data that can now help us introduce evidence-based individualized donor care, a parallel to personalized medicine.

Individualized care of the donor in the management of iron depletion

Studies have shown that a large percentage of our frequent whole blood donors, especially young women, are iron deficient. Iron depletion is a strong predictor of postponement due to low hemoglobin levels, but has also been associated with e.g. restless legs syndrome and low birth weight in offspring of frequent donors. The risk of iron deficiency can be mitigated by ferritin-guided prolongation of intervals between donations or by iron supplementation. Longer intervals between donations can challenge our inventories. Iron supplementation, on the other hand, can have gastrointestinal side effects and other effects have also been proposed, e.g. the masking of the malignant disease and the increase in the availability of iron with the consequent risk of infection. In a large study we found that iron supplementation is not associated with an increased risk of infection. What is the optimal balance between iron supplementation and lengthening the intervals between donations?

A growing number of blood services have implemented various types of iron control regimens generating more results. Furthermore, genetic studies on p. the UK, USA, Netherlands and Denmark can help us find donors at high risk of iron depletion or low hemoglobin. We can use all this data in a Big Data approach in the search for an individualized risk assessment model.

Other risks for blood donors

The presentation will also cover other risks associated with donating. New studies identify predictors of fainting after blood donation and also new interventions to prevent fainting. The global demand for plasma-derived medicines has multiplied several times in the last 10 years. Plasma donors bleed themselves up to 104 times a year in the US Very little is known about the health effects of frequent plasma donation. We know that immunoglobulin levels decrease with frequent donation, but how does this affect health?

Summary/Conclusions:The precautionary principle mitigates risk through early pre-test intervention. We tolerate almost no risk of transfusion-borne infectious diseases. However, the health of blood donors has not been similarly protected. We owe it to our whole blood and plasma donors to investigate the effects of donating blood on health and to ensure its safety. While early attempts may not be perfect, we now have the tools to build models for individualized donor care.

4A-S19-02

PILOT OF THE TOOL FOR CLASSIFICATION OF THE SEVERITY OF ADVERSE EVENTS OF THE DONOR IN A LARGE BLOOD COLLECTION CENTER

M Townsend, M. Bravo, H. Kamel

Medical Affairs, National Office, Vitalant, Scottsdale, USA

Bottom:In 2014, the ISBT, AABB, IHN, and EBA jointly issued the Standard for the Surveillance of Complications Related to Blood Donation that classified Adverse Donor Events (AEDs) into 6 categories (16 subcategories) defined by specific criteria. Severity and imputability were briefly described but were optional. Subsequent validation of these categories demonstrated consistency in the categorization of the reactions, but a wide variation in the assignment of severity. In 2018, with international input, the AABB Donor Biosurveillance Committee developed a Severity Rating Tool (SGT) using a recognized medical adverse event grading system with neutral grades replacing grades subjective terms (mild, moderate, severe).

Goals:A large US blood collection facility (BCE) applied the draft SGT to evaluate its use in real-world AED cases.

Methods:A retrospective analysis of all allogeneic and needle apheresis donations was performed between 1/1/2017 and 9/30/2018. The severity classification was assigned according to the criteria defined by the SGT. A review of the DAE database was performed and each event was assigned a grade based on the type of outpatient medical care (OMC) and specific key search terms. Search terms for WTO includedEmergency Room, Emergency Medical Response, Urgent Care, Health Professional,yhospital admission. Additional specific key search terms includeddental injury, fracture, concussion, laceration, surgery,yhospitalization. Since activities of daily living (ADL) duration and limitations were not captured in our AED database, cases in our AED claims database were reviewed. Case files of events classified as Grade 2 or higher were individually evaluated by a physician to determine the accuracy of the rating.

Results:In 1,511,758 needle collections, 31,320 AEDs were classified according to severity. The majority (16,143, 51.5%) were vasovagal reactions (VVRs), followed by 8,570 apheresis-related events (27.4%), 6,572 needle-related (21.0%), and 35 allergic events (0 ,1 %). The majority of AEDs were Grade 1 and represented 98.6% of all AEDs, followed by Grade 2 (1.2%) and Grade 3 (0.1%). There were 2 AEDs of grade 4 and none of grade 5.

Among the VVRs, 98.1%, 1.6%, 0.2%, and 0.01% were Grade 1, 2, 3, and 4, respectively. Grade 3 VVRs included 14 concussions, 11 fractures, 1 dental injury, and 2 pre-fainting events and 8 fainting requiring hospitalization for the study. Two grade 4 VVRs involved falls resulting in intracranial hemorrhage requiring immediate medical intervention. For allergic and apheresis AEDs, there were only 6 and 5 Grade 2 reactions, respectively, and no Grade 3 or 4 events. Needle-related AEDs included 98.3% Grade 1, 1.6% Grade 2, 0 .1% Grade 3 and no Grade 4 events. Of the six Grade 3 needle-related EADs, 4 were nerve irritations lasting longer than 6 months and 2 were DVTs requiring hospitalization.

Summary/Conclusions:The SGT provided a consistent assignment of severity for most AEDs, based on External Medical Care search terms and specific key. Assignment of severity based on impact on activities of daily living or duration of injury/condition requires follow-up over time, making such assignments more difficult; Modifying our DAE tracking database and claims database to capture ADL and Duration should improve severity assignment for such cases.

4A-S19-03

COMPLICATIONS OF BLOOD DONATION: ELEVEN YEARS OF INTERNATIONAL DATA

JC Wiersum1, P Constantino2, C Richardson3, P Renaudier4, N Go to5, E. Grouzi6, L Kevin7

1TRIP and Sanquin, Leiden, The Netherlands2Hellenic Center for Disease Control3Panteion University, Athens, Greece4Hospital Pierre Zobda‐Quitman, Fort de France, Martinica5Japanese Red Cross, Tokyo, Japan6Oncological Hospital “St Savvas”, Athens, Greece7Vitalant, San Antonio, United States

Bottom:The International Hemovigilance Network (IHN) has collected aggregated data on complications of whole blood and apheresis donations from member national hemovigilance systems (HVS) since 2006.

Goals:We analyzed data collected between 2006 and 2016 to learn from the data and consider future improvements in data collection.

Methods:National HVS entered annual data on donor complications into the password-protected online database "ISTARE" (International Surveillance of Adverse Reactions and Transfusion Events). Beginning in 2008, the donor complications spreadsheet allowed separate data entry for whole blood donation (WBD) and apheresis, but also provided an option to enter data for all donation types. The annual figures for whole blood and apheresis donations were also collected. International harmonized standard definitions were implemented in 2015. Reactions were captured by level of severity (mild, moderate, severe) but without distinction between donor gender or first-time versus repeat donation. The extracted data were used to calculate national and aggregate donor complication rates (generally per 1000 donations).

Results:Twenty-four HVS provided figures for donations and donor complications for one or more years (median years per country 7, IQR 2–8). The total number of country-years (CY) was 138, covering 155 million donations. The global rate of complications was 6.3/1000 donations and the national median rate was 3.2 complications/1000 donations (IQR 1.1-10.1).

Rates were generally consistent within an HVS from year to year, but showed considerable variation between HVS; this was also the case for reactions classified as severe. Not all countries differentiated between mild and moderate reactions and some reported all reactions under a single level of severity.

Vasovagal reactions were the most frequently reported complication: overall 4.6/1000 donations, national median rate 3.1/1000 donations (IQR 0.6–7.7). Apheresis-related and rare complication types such as generalized allergic reaction (0.10 per 100,000, 40 CY) and major blood vessel injury (category available as of 2015; overall 0.12 per 100,000, 6 CY ) were only occasionally reported.

Eighteen of the HVS provided separate data for complications of whole blood and apheresis donations in one or more years (total 89 CY, 101.6 million WBD and 26.3 million apheresis, total 128 million donations). For these HVS, the mean rate of vasovagal reactions was 3.4/1000 WBD (IQR 1.0–9.1) and 1.5/1000 apheresis procedures (1.0–4.2). Reported hematoma rates were higher for apheresis than WBD: median per HVS was 0.39/1000 WBD (IQR 0.31–1.2) vs. 4.2/1000 apheresis (0.69 –5,6); rates of arm pain and/or nerve injury (not separated in 2006–2013) also tended to be higher: median 0.09/1000 with WBD, IQR 0.03–0.34, vs 0.39 /1000 with apheresis, 0.05–0.57.

Summary/Conclusions:International reporting allows HVS to study blood donation complication rates, to distinguish between WBD and apheresis complication rates and to capture information on very rare events. Variability in reporting and assessment of severity between countries impairs the feasibility of comparisons between HVS. Work is needed to improve harmonization of classification of donation complications and assessment of severity for data comparison and research.

4A‐S19‐04

IMPLEMENTATION OF FERRITIN TESTING IN STOCKHOLM: FIRST REPORT

MK Kvist, F Boström, E Watz, J Berg Thorsson, B Aspevall Diedrich

Clin Immunology and Transfusion Medicine, Karolinska University Hospital, Stockholm, Sweden

Bottom:To prevent iron-related Hb wasting, screening with ferritin testing was implemented in Stockholm County (approximately 52,000 registered blood donors) during a two-year rollout. Iron supplementation is offered to blood donors, but has not prevented Hb deferrals that result in 8,000 check-ups per year. The ferritin test is supposed to increase iron compliance.

Goals:Implementation of ferritin tests for the monitoring of iron levels for the entire population of blood donors with specific attention to new donors, women returning after pregnancy, donors with low Hb and at the return visit after low Hb . Annual analysis of plasma and platelet donors.

Methods:Ferritin tests were implemented, after a staff education program, for applicant donors, low Hb donors, women after pregnancy, apheresis donors, followed by an evaluation of registered blood donors by donation site. After the initial evaluation, donors will be evaluated every 4he(women) or 8he(men), and with annual testing of young adult blood donors under 25 years of age. Six nurses were trained to process the ferritin and blood count results. Donors with aberrant ferritin were contacted by letter.

Results:The establishment of cut-off levels and algorithms for ferritin testing and iron therapy was evidence-based, but had practical limitations, such as the number of tests and results that could be processed per week, limitations in LISS setup, demand of blood contrary to the preferred cuts, Compliance with iron supplementation. For applicant donors, Hb testing shows that 20% of female applicants and 9% of male applicants are unable to register due to low Hb levels (125 and 135 mg/L respectively). Adding ferritin testing, a preferred cut-off level of 30 μg/mL (male reference level), would result in an additional loss of 24% female and 1.3% male applicant donors. As this would threaten the demand for blood, the limit was set at 15 μg/mL for women, above the female reference of 10 μg/mL, with an acceptable loss of 6% of requesting female donors. For registered blood donors, extra 4000 mg low ferritin iron tablets (10–29 μg/mL) were offered. This was sometimes combined with prolonged intervals, and often repeated before ferritin reset above 30 μg/mL. Donors with ferritin below 10 μg/mL (0.6% of applicant donors, 0.8% of registered donors) or above 600 μg/mL (0.5% of applicant donors, 0.1% from registered donors) were deferred and recommended to see their doctor. For Hb deferral, the interval was extended from 3 to 5 months, regardless of ferritin levels. This, along with iron supplementation, resulted in a 50 to 70% increase in approved Hb upon return. The team of nurses who process ferritin and blood count results (1½ full-time nurses on weekdays) reacted to approximately 40 donor results daily, representing 20% ​​of test results.

Summary/Conclusions:Many women seeking donations have suboptimal ferritin levels even though they meet the Hb requirements for donation. Iron treatment was added to retain donors with low ferritin levels, as only long intervals can compromise blood supply. For the implementation of ferritin testing, it is necessary to have a well-functioning and agile organization to create and apply algorithms for testing, interval extension, and iron treatment.

4A-S19-05

FERRITIN SCREENING IN THE NETHERLANDS: FIRST RESULTS OF A NATIONWIDE DONOR DEFERRAL POLICY

M. Janssen,M Vinkenoog

Donor Medicine Research, Sanquin, Amsterdam, The Netherlands

Bottom:Since November 2017, a new donor screening regimen has been introduced in the Netherlands, where serum ferritin levels in whole blood donors are regularly measured to further monitor potential iron deficiency in donors. Donor deferral thresholds are set at 30 and 15 ng/ml, and six and twelve months respectively if ferritin levels are below these values. Since the information available on ferritin recovery in whole blood donors is limited, the policy is introduced in parts so that adaptations to implementation can be considered based on intermediate results and the impact of the measure on the welfare of the donor.

Goals:To assess the effect of donor deferral on donor ferritin levels.

Methods:Ferritin levels are measured in new donors and at every fifth donation in repeat donors. Donors with ferritin levels below the indicated thresholds are deferred and ferritin retested upon return for donation after six or twelve months. The policy allows estimation of long-term trends in post-donation ferritin levels in repeat donors. Since ferritin levels are measured in all new donors, a reference distribution of ferritin levels in healthy individuals is also obtained.

Results:Among repeat donors, 46% (44% of 16,433 male donors and 48% of 13,525 female donors) have ferritin levels below 30 ng/mL and are deferring their next donation. Furthermore, the distributions of ferritin levels in repeat male and female donors are similar, each having an average ferritin level of 43 ng/mL. In contrast, we found that only 27% of new female donors (n=13,283) and 1.7% of new male donors (n=6,334) had ferritin levels below 30 ng/mL. The average ferritin level in the new donors was 148 ng/mL for men and 60 ng/mL for women. Comparing ferritin levels in new and repeat donors, a reduction in average ferritin levels was observed between 1.5 and 2.0 in female donors and between 3.2 and 4.4 in male donors. Both proportions increased with the age of the donor. As of the end of December 2018, 2,884 donors with low ferritin levels returned to donate after a deferral of six or twelve months. Repeated measurements of ferritin show that, on average, ferritin levels in female donors increased by 13 ng/mL per year, while average ferritin levels in male donors increased by 34 ng/mL per year.

Summary/Conclusions:In line with previous findings in the literature, our results show that repeat donations substantially reduce ferritin levels in repeat donors. These range from 1.5 to 2.0 in female donors and from 3.2 to 4.4 in male donors, who generally have higher ferritin levels. The deferral of donors with low ferritin levels appears to be effective in increasing donor ferritin levels; however, further follow-up monitoring in repeat donors is warranted to see if the proposed regimen allows for sufficient donor recovery over time.

Plenary Session - Big Data

PL‐02‐01

CURRENT OPINION ON DONOR HEALTH – PERSONALIZED CARE FOR THE DONOR

WH Ouwehand1,2,3

1Department of Hematology, University of Cambridge2Welcome Sanger Institute3NHS Blood and Transplant, Cambridge, Reino Unido*En nombre de NIHR BioResource, 100,000 Genomes Project y Blood transfusion Genomics Consortium

There are ˜7000 different rare diseases and the genes for half of them have been identified. Approximately 3.5 million UK citizens experience premature ill health due to a rare disease. Generally, a conclusive diagnosis is not reached and, on average, the diagnostic odyssey lasts 2.2 years. The main objectives of the 100,000 Genomes Project are to reduce the delay in diagnosis by incorporating whole genome sequencing (WGS) to accredited standards in the care pathway for patients with undiagnosed rare diseases. The project started in 2013 and WGS analyzed DNA samples from 100,000 NHS patients and their close relatives. Here we review the results of the NIHR BioResource pilot study for the 100,000 Genomes Project comprising phenotype and genotype data from 13,037 individuals recruited from 83 hospitals using approved eligibility criteria for 15 rare disease domains.

We determined population structure, including ethnicity and relatedness estimation, high-level phenotypes collected using Human Phenotype Ontology (HPO) terms, and quality control and summary metrics for samples and variants. The sequence resource contains more than 165 million unique variants across 10,258 genetically independent samples, with 47% of variants not previously observed in other large-scale publicly available genomic datasets. We summarize curation of gene lists and relevant findings across 2000 diagnostic-grade unique genes for all 15 domains. More than 1,000 reports assigning pathogenic or probably pathogenic causative variants have been issued with diagnostic yields ranging between domains from 0.5% to 55%, while the proportion of new causative variants ranged from 25% to 73%. We show the power of the Bayesian association test, BeviMed, in recapitulating decades of clinical genetic discoveries and by identifying more than 30 new disease-causing genes and novel variants in the non-coding space of the genome.

We show how typing data for all red blood cell antigens, HPA and HLA can be extracted from WGS data. We extracted data from the 100,000 Genomes Project and similar sequence resources to revert the content of the UK Biobank Axiom array probe. We genotyped 7,588 donors from England and the Netherlands with this new matrix and observed a concordance of 99.92% when comparing 92,387 blood center-determined antigen typing results with those determined by genotype. For the 48 RBC and HPA antigens that were available for 7,473 donors, array typing provided a 3.6-fold increase in typing results per donor (13.2 vs. 47.9) and 38 donors were identified. rare. Using the genotyping data, we identified 2.6 times more matches among this donor cohort when blood demand was modeled using reference data from 3146 English patients with more than three RBC alloantibodies.

In conclusion, the 100,000 Genomes Project has demonstrated the feasibility of using WGS in a universal health care system to provide diagnosis to patients with rare diseases. Based on these results, the NHS has commissioned the analysis of a further 500,000 DNA samples from patients with cancer and rare diseases. With WGS DNA analysis and arrays becoming part of routine clinical care, blood services must develop competencies to extract transfusion and transplantation-relevant information from clinical-grade genotyping data.

PL‐02‐02

FROM MOLECULAR GENETICS TO GENOMICS

F Yamamoto1,2

1Immunohematology and Glycobiology, Josep Carreras Leukemia Research Institute (IJC)2Cancer Medicine Prediction and Personalization Program (PMPPC), Germans Trias i Pujol Health Sciences Research Institute (IGTP), Badalona, ​​Spain

Next Generation Sequencing (NGS) enables the sequencing of thousands of genes, exomes, and even entire genomes using single experiments at a reasonable cost. There have also been advances in cytometry: the use of antibodies with different fluorescence labels allows simultaneous monitoring of the expression of dozens of antigens. However, immunological methods cannot detect all the variants discovered by NGS. Genome sequencing reveals not only the exome but also transcriptional/translational regulatory elements, such as promoters and enhancers. RNA sequencing determines which genes and spliced ​​transcripts are expressed. It is surprising to realize how much this new technology has contributed to a better understanding of various biological phenomena.

Since the initial cloning of human blood group A transferase cDNAs in the early 1990s, we have been studying theTHEYgenes, glycosyltransferases A and B, and oligosaccharide A and B antigens. Several scientific disciplines have been applied to their study, including genetics, immunohematology, biochemistry, enzymology, and glycobiology. We have made several important scientific contributions. We demonstrate the central dogma of ABO: the A and B alleles in theTHEYthe genetic locus encodes transferases A and B, which synthesize A and B antigens, respectively. We elucidate the allelic basis of the ABO system. We found 4 amino acid substitutions between transferases A and B and inactivating mutations in the O alleles. We were the first to achieve ABO genotyping, discriminating AA and AO genotypes, as well as BB and BO, which was impossible due to the immunological approach. .

We have taken a simple experimental strategy: preparation of eukaryotic expression constructs of A/B transferases and their derivatives, transfection of DNA into human HeLa cells or their sublines, and immunological detection of A/B antigen and/or biochemical examination of enzymatic activity. . . We use this to show that codons 266 and 268 are crucial in determining the GalNAc/galactose sugar specificities of A/B transferases. We also identified mutations in several subgroup alleles that restricted substrate use and decreased transferase activity. We also show thatcisThe AB and B(A) alleles that specify the expression of the A and B antigens by individual alleles encode A-B transferase chimeras. Since then, other scientists have characterized more than 250 ABO alleles. Recent sequencing of the human genome has identified many more variations of single nucleotide polymorphisms. Genome sequences of many species are also available. Taking advantage of these sequences and associated information, we have expanded our investigation to include evolutionarily related α1,3-Gal(NAc) transferases and their genes, and have extended it from the genetic to the genomic level.

In this talk, I would like to present the following. 1: Our clarification of the molecular genetic basis of the ABO blood group system (as requested by the organizer); 2: Identification of new ABO alleles by others; 3: More SNP data from genomic sequences and potential problems for ABO genotyping; 4: Findings obtained from the analysis of ABO genes from other species; bacteria, vertebrates, primates; 5: α1,3-Gal(NAc) transferases and their genes and crosstalk between A transferase and Forssman's glycolipid synthase (FS); and 6: the potential causes of ABO polymorphism generation and species variations of theGBGT1gene specifying the FORS polymorphism.

PL‐02‐03

METHODOLOGICAL CONSIDERATIONS FOR BIG DATA APPROACHES TO RESEARCH IN TRANSFUSION MEDICINE

N Roubiniano1,2,3, S. Kleinman4, E. Murphy2,3, S. Glynn5, G. Edgren6

1Kaiser Permanente Research Division, Oakland2Vitalant Research Institute3Laboratory Medicine, University of California, San Francisco, United States4University of British Columbia, Vancouver, Canada5National Heart, Lung, and Blood Institute, Bethesda, United States6Karolinska Institute, Stockholm, Sweden

In recent years, there has been a concerted effort to improve our understanding of the quality and efficacy of transfused blood components. The increasing use of large data sets created from electronic health records allows for investigation of potential benefits or adverse outcomes associated with transfusion therapy. Together with data collected on blood donors and components, these data sets allow for an assessment of the effect of donor factors and blood components on transfusion recipient outcomes. Large data sets linked between donor and recipient provide the power to study exposures relevant to the efficacy and safety of transfusions, many of which could not otherwise be studied for sample size or practical reasons. Analysis of these large blood bank transfusion medicine data sets allows characterization of study populations and provides an evidence base for future clinical studies. The knowledge generated from linked analysis has the potential to change the way donors are selected and how components are processed, stored and allocated. However, unrecognized confounding and biased statistical methods remain limitations in the study of transfusion exposures and patient outcomes. Results from observational studies of blood donor demographics, storage age, and transfusion practice have been conflicting. This review will summarize the statistical and methodological challenges in analyzing outcomes related to the blood donor, component and recipient of transfusion.

Immunobiology: new blood group alleles

4C‐S20‐01

A GREAT REMOVAL SPREADXGYGYG2CONSTITUTES A GENETIC BASE OF THE XGNULL PHENOTYPE, UNDERLYING ANTI-XgaPRODUCTION

And read1, J History1, Team V Karamatic2, G. Halverson3, N. Thornton2, Molson1

1Department of Laboratory Medicine, Lund University, Lund, Sweden2International Reference Laboratory for Blood Groups, NHS Blood and Transplant, Bristol, UK3LifeSouth Community Blood Centers, Atlanta, Georgia, USA

Bottom:The XG blood group system comprises the Xg homologous antigensaand CD99. HeCD99The gene resides within the pseudoautosomal 1 region on the short arms of the sex chromosomes and therefore mimics autosomal inheritance.XG, on the other hand, is X-linked and straddles the pseudoautosomal boundary; a truncated pseudogene composed of only the first 3 exons remains on the Y chromosome, and males therefore carry a single complete copy ofXG. This phenomenon is manifested as asymmetric frequencies of the Xg(a+) phenotype between the sexes: approximately 11% of women and 34% of men are Xg(a−). Furthermore, while Xgaimmunization is rare, the vast majority of all anti‐XgaThe reported makers are men. We recently reported that the rs311103C variant disrupts a GATA motif betweenXGyCD99. This suppresses erythroid Xgaexpression and causes the common red blood cell phenotype Xg(a–). However, rare people who produce anti‐Xgacannot be explained by this finding. We hypothesize that a structural defect in theXGcoding region causes the true underlying anti-Xg Xgnull phenotypeaproduction.

Goals:We set out to determine a genetic explanation for anti‐Xgaproduction.

Methods:Genomic DNA (gDNA) was extracted from two whole blood samples and cell-free DNA (cfDNA) from 13 archived plasma samples from donors producing anti-Xg antibodies.a; one cfDNA sample came from a female donor and the rest from men. Polymerase chain reaction (PCR) experiments, Sanger sequencing, and database searches were performed to identify and confirm the deletion. Aliquots of gDNA from four males reported to have a similar deletion were also analyzed in the 1000 Genomes Project.

Results:In a gDNA sample, exon-specific PCR identified a deletion involving part ofXGand the downstream geneGYG2. Database searches indicated that the most likely deletion was the rare genomic structural variant esv2662319 reported in the 1000 Genomes Project. Further analysis with one short (714 bp) and one long (3555 bp) PCR amplicon at the suspected breakpoint determined that this deletion was approximately 114 kb and corresponded well to esv2662319. This finding was confirmed in the second gDNA sample. Given the rarity of anti-Xgaproducers, we decided to test the same deletion on cfDNA extracted from old archived plasma samples. Of the 13 cfDNA samples, poor quality in four prevented amplification of even control reactions and one was contaminated with bacterial DNA. In the remaining nine samples, eight could be amplified for the deletion-specific short 714 bp amplicon, while one was negative for the deletion. Sanger sequencing of the amplicons revealed a heterogeneous repetitive DNA element, LTR6B, suggesting a previously reported recombination event. This deletion was not detected in the 1000 Genomes Project samples, reiterating the previously identified deficiency in data interpretation and deletion reporting.

Summary/Conclusions:A large suppression that interrupts theXGyGYG2genes explains the Xgnull phenotype underlying the majority (10 of 11) of anti-Xgamanufacturers One sample remained unexplained, indicating further heterogeneity to explore. Our data help explain why anti‐Xgaproduction is rare and has been reported primarily in men.

4C‐S20‐02

GYPB*S WITH TWO MUFFLER CHANGES THAT ARE COMMONLY INHERITED INDEPENDENTLY

JE Aeschlimann1, S Vegeta1, C Lomas-Francis1, C Westhoff1, G Designation2

1Immunohematology and Genomics, NYBC, Long Island City2Blood Research Institute, Versiti, Milwaukee, United States

Bottom:S and s antigens encoded byGYPBdiffer by one nucleotide (nt), c.143C>T, p.Thr48Met. Two different genetic backgrounds are associated with silencing of the S antigen and a U+ antigenwphenotype. These include the nt c.230C>T (p.Thr77Met) change that causes partial exon skipping and designatesGYBP*03N.01(GYPB*NY)and c.270+5G>T, an intron change that causes complete skipping of exon 5, designatedGYPB*03N.03 (GYPB*P2).

Goals:Samples from three individuals, an African American patient with sickle cell disease (P1) who had received a previous transfusion, a blood donor of unknown ethnicity (P2), and an African American patient (P3) (Lapadat R. 2014 AABB abstract) were investigated for of serological and molecular discrepancies. results when determining the S and s phenotype.

Methods:Standard methods for RBC typing with licensed S and s reagents were used and RBCs from donor P2 were also tested with monoclonal and polyclonal anti‐S and anti‐s. DNA was isolated from WBC and HEA PreciseType performed on P1 and P2. P1 was also tested byGYPB*S/sAS-PCR, exon 5 PCR-RFLP for c.270+5G>T and AS-PCR for c.230C>T. P3 was tested forGYPB*S/sand c.230 C>T and c.270+5G>T changes by a real-time PCR fluorogenic 5' nuclease TaqMan chemistry. For all,GYPBexons 1–6 were amplified and Sanger sequenced and aligned to consensus using Clustal X.

Results:Red blood cells from all three probands typed S– and strongly s+ while DNA tests indicated c.143T/C (GYPB*S/s). Essay for the two commonsGYPB*Sthe silencing alleles, c.230C>T and c.270+5G>T, indicated that all three samples had both silencing mutations previously reported to be independently associated with an S−U+wphenotype. HEA PreciseType was unable to interpret this new allele combination and indicatedGYPB*sas PV (possible variant). Samples were confirmed to be heterozygous for c.143C/T, c.230C/T, and c.270+5G/T by exon-specific sequencing and AS-PCR, PCR-RFLP, and real-time PCR. By long-range sequencing ofGYPB,the three were heterozygotes c.59T/G and c.60A/G (p.20Leu/Trp), c.67A/T (p.23Thr/Ser), c.71A/G and c.72G/T (p.20Leu/Trp). 24Glu/Gly), c.143C/T (s/S), c.208G/T (p.70Val/Leu), c.230C/T (p.77Thr/Met) and c.270+5G/T . All samples were also c.251G/G (p.84Ser) and heterozygous for several previously recognized silent changes in exon 2, c.87T/C, c.96T/C and c.102A/G.

Summary/Conclusions:We report a silenced novelGYPB*Sallele that can confuseGYPBgenotyping interpretation. The allele was found in three probands associated with an S−s+ phenotype. In these samples, two changes previously reported to be independently inherited and both associated with silencing of the S antigen are transmitted on the same allele. DNA-based evidence could not rule out that c.230T or c.270+5T are separate and thatGYPB*swas also silenced. Solid s+ RBC typing indicates that both changes are activatedGYPB*S. Gene sequencing confirms that the c.270+5T change is in aGYPB*03N.02 [GYP*Ed(NY)]background. c.230C>T (rs79492560) and c.270+5G>T (rs139511876) have a frequency of 0.0053 respectively 0.032 in the African population (ExAC). Although we identified 3 samples, the frequency of this new allele is unknown.

4C‐S20‐03

A LUTHERAN-RELATED ANTIBODY DETECTED IN A PATIENT WITH A HOMOZYGOUS MISSENSE BCAM MUTATION INDICATING A NEW SYSTEM ANTIGEN

Jose L.1, Team V Karamatic2, and Shinar1, Oh Zelig3, V Yahalom1,4, J Benjamin2, P Walser5, N. Thornton2,I eat1

1Immunohematology, Magen David Adom, Ramat‐Gan, Israel2International Reference Laboratory for Blood Groups, NHS Blood and Transplant, Bristol, UK3Blood Bank, Hadassah Medical Center, Jerusalem4Institute of Apheresis and Blood Services, Rabin Medical Center, Petah Tikva, Israel5Clinical Biotechnology Centre, NHS Blood and Transplant, Bristol, UK

Bottom:The Lutheran blood group system currently consists of 25 antigens. These antigens have low immunogenicity and can cause mild to moderate transfusion reactions and hemolytic disease of the fetus and newborn. Activation of the Lu/BCAM glycoprotein in red blood cells (RBCs) and its interaction with laminin 5α are thought to play a role in vessel occlusion in sickle cell disease and other hematologic disorders. The two glycoprotein isoforms Lu‐glycoprotein and BCAM are encoded by theBCAMgene consisting of 15 exons located on chromosome 19q13.2. Several rare Lutheran phenotypes have been previously reported in Israel, including LU:-6.9 observed among Iranian Jews, LU:-20 in a patient with thalassemia, and a case of LU:-21. In this report, a pregnant Arab patient previously transfused with β-thalassemia intermedia was investigated because she had an antibody against an unknown high-frequency antigen (HFA), potentially related to the Lutheran system.

Goals:Characterize a new Lutheran antigen through serological and molecular investigation of a patient with a Lutheran-related antibody.

Methods:Initially, the red blood cell phenotype and the presence of a Lutheran-related antibody in the patient's serum were detected by standard serological techniques, using enzyme-treated and chemically modified cells and rare cells and sera from the NBGRL collection. Additional serological investigations were performed using the standard IAT technique (LISS tube and Bio-Rad gel). Plasma inhibition studies were performed using soluble recombinant Lu (srLu) protein. Eluates were prepared using the acid elution method (Gamma Elu‐kit II). Genomic DNA was isolated from whole blood and all exons of theBCAMThe gene was amplified by PCR and directly sequenced by Sanger sequencing. The impact of the identified mutation on the structure of the Lutheran glycoprotein was studied using molecular dynamics calculations.

Results:The patient's plasma reacted with all cells tested except three examples of In(Lu) cells and cells treated with 2-aminoethylisothiouronium bromide, trypsin and α-chymotrypsin. Inhibition studies with the srLu protein showed complete inhibition of the antibody, confirming that the antibody is directed towards an epitope on the Lu glycoprotein. In addition, inhibited plasma tests revealed the presence of underlying anti-E and anti-Fy.a. An eluate was prepared to isolate the Lu-related antibody from the patient and this eluate was found to be incompatible with examples of LU:-5, LU:-6, LU:-8, LU:-13, LU:-21, LU : -22 and LU: -23 cells, while In(Lu) were compatible. Results of serological typing of the patient's cells for Lu system HFAs could not be conclusively determined because the patient had recently received a transfusion. However, the results suggested (through the lack of mixed field reactivity) that the patient's cells were LU:‐1,2,8,12,13,‐19,21.BCAMsequence analysis confirmed that the patient wasLU*02,LU*18and revealed a new homozygous c.1351A>C mutation in exon 11, encoding p.Lys451Gln in the Lutheran glycoprotein.

Summary/Conclusions:A new homozygous c.1351A>C (p.Lys451Gln) mutation in exon 11 ofBCAMit was identified in a patient with an antibody against a Lutheran HFA. The serological and genetic evidence presented here indicates the discovery of a new Lutheran blood group system antigen, which we propose to name LURA.

4C‐S20‐04

A NEW HIGH-FREQUENCY ANTIGEN IN THE LUTHERAN BLOOD GROUP SYSTEM (LUNU)

V Karamatic Crew1, B Mayer2, L Baglow1,s heart2, T Bartolmas2, P Walser3, N. Thornton1

1International Reference Laboratory for Blood Groups, NHS Blood and Transplant, Bristol, UK2Instituto de Medicina Transfusional, Charité‐Universitätsmedizin Berlin, miembro corporativo de Freie Universität Berlin, Humboldt‐Universität zu Berlin y Berlin Institute of Health, Berlin, Germany3Clinical Biotechnology Centre, NHS Blood and Transplant, Bristol, UK

Bottom:Lutheran glycoprotein and basal cell adhesion molecule antigen B-CAM are two isoforms of a type I membrane glycoprotein that reside on the surface of red blood cells. Both isoforms are adhesion molecules with the primary function of binding to laminin, and both carry antigens of the Lutheran blood group (LU) system. The system currently comprises 25 antigens, all encoded by mutations in the single alternatively spliced ​​gene.BCAMlocated on chromosome 19. ISBT currently lists 20 high incidence antigens in the system.

Goals:We present a case study of an individual with an unidentified alloantibody against a high incidence antigen present in his plasma. Samples from the patient and her family were investigated. We provide here serological and molecular evidence for a new high-incidence antigen of the Lutheran blood group system.

Methods:Serological investigations were performed using the standard IAT technique (LISS tube and Bio-Rad gel). Plasma inhibition studies were completed with soluble recombinant Lu (srLu) protein. Genomic DNA was isolated from whole blood of the patient and her relatives; all the exons of theBCAMgene were amplified by PCR and analyzed by direct Sanger sequencing. The impact of the identified mutation on the structure of the Lutheran glycoprotein was studied using molecular dynamics calculations.

Results:The presence of a Lu-related antibody in the patient's plasma, which reacts moderately strongly, was confirmed by LISS IAT with untreated and papain-treated cells. Cells from the patient's mother, father, and two brothers were all incompatible with her plasma, although weaker than the cells in the panel, reflecting the dose. Only In(Lu) cells were compatible with the patient's plasma. The antibody was successfully inhibited with the srLu protein, confirming that the epitope recognized by the antibody resides on the Lutheran glycoprotein. The patient cells were found to be LU:‐1, 2, 3, 5, 6, 8, 13, 20, 21.BCAMsequencing revealed a new homozygous c.121G>A mutation in exon 2, encoding p.Val41Met in the Lu glycoprotein. The c.121G>A change appears to be an extremely rare mutation, listed in the gnomAD database with a frequency of 3.98 × 10‐6and no known homozygous examples. The homology model of the new Lutheran glycoprotein was subjected to all-atom molecular dynamics calculations to analyze possible conformational changes.

Summary/Conclusions:We present serological and genetic evidence for a new antigen from the Lutheran system, which we propose to name LUNU. Evidence will be submitted to the ISBT Red Cell Immunogenetics and Blood Group Terminology Working Group for consideration for assignment of antigen status. The absence of this high-incidence antigen arises from a rare single amino acid change p.Val41Met in the Lutheran glycoprotein and it was hypothesized that the presence of anti-LUNU in the plasma of the patients occurred in response to a previous pregnancy.

4C‐S20‐05

CHARACTERIZATION OF A NEW ANTIGEN OF HIGH PREVALENCE IN THE JMH BLOOD GROUP SYSTEM

C Vrignaud1,2,3, S Ramelet1, a herb1Ranieri1, M. Khalloufi4, G. Laiguillon1, J Babenet1, S Azouzi1,2,3,peyrard1,2,3

1National Reference Center for Blood Groups, National Institute of Blood Transfusion2UMR_S1134 Inserm Paris Diderot University3GR-Ex Excellence Laboratory, Paris,4Avicenne site, French blood establishment Ile de France, Bobigny, France

Bottom:The JMH blood group system includes six highly prevalent antigens carried by semaphorin 7A (Sema7A/CD108), a GPI-linked glycoprotein.SEMA7Ait consists of 14 exons and encodes a 666 amino acid preproprotein, proteolytically cleaved to generate a 604 amino acid mature protein. JMH:‐1 is found mainly in elderly people and is considered an acquired phenotype, whereas JMH:‐2 to JMH:‐6 originate from homozygous missense mutations inSEMA7. JMH antibodies are considered clinically insignificant, the majority being IgG4, but they can mask alloantibodies of clinical relevance.

Goals:Here we describe a novel antigen with high prevalence in the JMH blood group system.

Methods:Blood samples were submitted for investigation of a panagglutination. Antibody identification (IAT gel test, polyspecific and IgG, Bio-Rad) was performed on papain-treated (Diagast) and trypsin-treated (Sigma) native red blood cells. Genomic DNA was extracted from peripheral blood cells by an automated method, amplified bySEMA7Aexon-specific and sequenced primers.

Results:The proband was a 32-year-old patient of Moroccan origin, group A, D+C+E‐c+e+, K‐, with no history of transfusions. She was hospitalized at 27 weeks gestation for a ruined ovum that required manual vacuum aspiration, with significant risk of bleeding. A first laboratory performed a detection of RBC antibodies. The antibody reacted 1+ by IAT in all wild-type reactive RBCs, with negative autocontrols, but did not react in cells treated with papain and trypsin. An anti‐Ge2 was initially suspected, due to the pattern of reactivity and ethnicity. New blood samples were sent to our national immunohematology reference laboratory. The antibody showed the same profile. Anti‐Ge2 and anti‐Ch1 could be ruled out. Serum was nonreactive with two JMH:-1 samples and positive with two JMH:-3 samples. The patient was found to be JMH1 positive. In addition, a soluble recombinant JMH protein (JMH Imusyn/Inno‐train) completely abolished the panagglutinating antibody reactivity. The antibody was an IgG4. Overall, these results were consistent with a probable variant of JMH and prompted us to performSEMA7Asequencing Three nucleotide changes were found, in the homozygous state: a rare non-synonymous change in exon 7, c.709G>A (p.Asp237Asn, rs140707085, MAF<0.01, SIFT score=1); a common synonymous change in exon 12, c.1545A>G (p.Gln515Gln, rs741761, MAF=0.5); a rare non-synonymous change in exon 14, c.1865G>A (p.Arg622His, rs140128092, MAF<0.01, SIFT score=0.36). Asp surface accessibility analysis237y Arg622using the 3D structure of Sema7A (RCSB PDB-3NVQhttps://www.rcsb.org/estructura/3nvq) showed that only Arg622it was predicted to be an exposed epitope. Interestingly, all other reported JMH variant phenotypes correspond to an arginine substitution. Of note, we retrospectively found another individual of Algerian descent (pregnant woman) with a panagglutinating IgG4 antibody showing a similar pattern of reactivity and with the same three changes inSEMA7A. Unfortunately, we were unable to perform a cross-compatibility test with the proband (no material left and failed contact).

Summary/Conclusions:Serological and molecular studies allowed us to provide evidence of a new highly prevalent antigen in the JMH blood group system, most likely encoded by the p.Arg622His substitution in Sema7A. We propose to provisionally assign the name JMH7 to this antigen. Interestingly, our two unrelated JMH:‐7 individuals were of North African descent.

4C‐S20‐06

β1,3GalNAc-T1 DEPENDENT EXTENSION OF GROUP B ANTIGEN FROM HUMAN BLOOD RESULTS IN A NEW ABO-RELATED GLYCOLIPID STRUCTURE IN RBCs

J Ricci Hagman1,2, a baron3, J Westman4, J History1,2, Jin C3, a cabin1,2, S. Teneberg3, ML Olsson1,2

1Department of Laboratory Medicine, Lund University2Department of Clinical Immunology and Transfusion Medicine, University Laboratories, Skåne Region, Lund3Department of Medical Biochemistry and Cell Biology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden4Sanford Burnham Prebys Medical Discovery Institute, Center for Nanomedicine, University of California Santa Barbara, Santa Barbara, CA, United States

Bottom:The ABO system was discovered almost 120 years ago and the underlying structures were later elucidated as carbohydrates carried by glycoproteins and glycolipids. The terminal trisaccharides GalNAcα3(Fucα2)Gal and Galα3(Fucα2)Gal constitute the clinically important epitopes A and B, respectively. closureet al. (PNAS, 1985) showed that the A antigen could span a repetitive glycolipid A epitope, GalNAcα3(Fucα2)Galβ3GalNAcα3(Fucα2)Galβ4GlcNAc‐R. However, extended forms of the B antigen have not been described. We found two situations related to unexplained serological reactivity. First, enzymatic conversion to treatment of group O red blood cells (RBCs) from group B (B-ECO) with α3-specific GH110 family exogalactosidase (Bzyme) removes B antigens detected by hemagglutination and flow cytometry with all monoclonal anti-B analysed. . Despite this, it has been reported that 40% of group O plasmas are cross-matched positive with B‐ECO red blood cells. Second, the plasmas of individuals AB and B in the globoside-deficient group PkThe phenotype contains anti-P and anti-PX2 but reacts more strongly with Bpp-RBC than with App/Opp-RBC. Based on these findings, we hypothesized the presence of a Bzyme-resistant B-related glycolipid.

Goals:Identify the molecular basis of the enigmatic serological observations described above.

Methods:Plasma and eluates from an A1B individual with the P1kphenotype were investigated by hemagglutination and flow cytometry, as were the eluates of B P1kand O plasma. Red blood cell membrane glycolipids were extracted from two lots of pooled expired units of group B red blood cells (frozen 500-liter reference slide and freshly harvested 24-unit confirmation slide). Native or enzyme-treated glycolipid fractions were analyzed by liquid chromatography electrospray ionization mass spectrometry (LC‐ESI/MS) and thin layer chromatography (TLC) plate immunostaining. Antigen expression in the H+B- human erythroleukemia (HEL) cell line was analyzed by flow cytometry after overexpression of selected glycosyltransferases.

Results:Anti-P-depleted eluates made from A1B P1kplasma contained anti-PX2 and antibodies of unknown specificity that reacted more strongly with native or papain-treated Bpp-RBCs compared to App/Opp-RBCs. Anti-PX2 was removed by adsorption on Opp-RBC, but reactivity (herein referred to as anti-ExtB) remained against B/Bpp/B-ECO RBCs. LC-ESI/MS of the glycolipid fractions of the group B units revealed an unknown heptasaccharide HexNAc-Hex-(Fuc-)Hex-4HexNAc-Hex-4Hex. About β‐norte-Acetylhexosaminidase treatment of this candidate structure produced a group B type 2 hexasaccharide, demonstrating that the terminal HexNAc of the heptasaccharide HexNAc-Galα3(Fucα2)Galβ4GlcNAcβ3Galβ4Glc was β-linked. Immunostaining of TLC fractions with specific GalNAcW. floribundalectin gave distinct binding as did anti‐ExtB. Bzyme converted B-hexasaccharide to H-pentasaccharide while the candidate heptasaccharide persisted. Cotransfection of HEL cells with wild typeTHEY(GTB)yB3GALNT1induced expression of GalNAcβ3Galα3(Fucα2)Galβ4GlcNAcβ3Galβ4Glc, as demonstrated by anti-ExtB staining of HEL cells. Cotransfections involving mutatedGTB(c.261delG) oB3GALTN1(c.202C>T) reactivity completely ablated.

Summary/Conclusions:We demonstrate for the first time the presence of extended blood group B glycolipids with a β3-terminal attached GalNAc and propose that this previously undescribed structure be named ExtB. Plasma from tested globoside-deficient AB or B individuals contains anti-ExtB, as do many group O plasmas. We identified the elongating glycosyltransferase B as P synthase (β1,3GalNAc‐T1). Consequently, ExtB meets all blood group criteria and is hereby proposed as an emerging antigen of the GLOB system. Our findings may explain Bzyme-resistant cross-reactions, which have hampered attempts to produce universal ABO red blood cells for transfusions.

Clinical - What about platelet function?

4C-S21-01

An update on antiplatelet agents

cox

Royal College of Surgeons of Ireland, Dublin, Ireland

Since the discovery of the antiplatelet effects of aspirin, platelets have been an important therapeutic target for pharmaceutical companies and also a very profitable target. However, the effectiveness of aspirin has also been a challenge, as it is an inexpensive drug and any new agent must show a clear benefit over aspirin. In addition, the risk of bleeding from antiplatelet agents, especially brain bleeds, has also presented challenges. In the 1990s, orally active GPIIb/IIIa antagonists were considered the "super aspirin," but clinical trials showed increased mortality and ultimately this class of drugs was relegated to intravenous use only. in high-risk patients. GPIb/IX/V antagonists were also a promising drug target, but no agent reached the market. The real breakthrough was the discovery of the P2Y12 antagonist clopidogrel which, together with aspirin, proved highly effective in preventing thrombotic events and as a result became the world's best-selling drug at the time. With clopidogrel now off-patent, the combination of aspirin and clopidogrel poses a formidable challenge for any new agent, both in terms of efficacy and pharmacoeconomics. So is there a future for new antiplatelet agents? With increasing awareness of the role of platelets in inflammation and understanding of how platelet immune activation differs from classical platelet hemostatic activation, it is now possible to develop new antiplatelet agents that target inflammation without compromise hemostasis. This is where we must look for the next generation of antiplatelet agents.

4C‐S21‐02

MEASUREMENTS OF PLATELET FUNCTION IN TRANSFUSION MEDICINE

P fontana

University Hospitals of Geneva, Geneva, Switzerland

Platelet function defects, whether congenital or acquired, are associated with an increased risk of bleeding, particularly in a perioperative setting. Therefore, the use of platelet function assays is tempting to tailor transfusion and limit platelet transfusion to those bleeding patients with impaired platelet function, as assessed by those assays.

However, current guidelines provide only weak recommendations supporting the routine use of these assays. In fact, there are numerous platelet function assays on the market that differ in their method of assessing platelet function, and the agreement between their results is moderate at best. Threshold values ​​beyond which the bleeding risk associated with the procedure becomes concerning are not standardized. Furthermore, observational studies addressing the predictive value of platelet function tests in perioperative or spontaneous bleeding are not consistent. Finally, management trials with randomized patients evaluating the benefit of platelet function tests are scarce. However, more recent data have identified select situations in which platelet function tests may be useful.

I will review the different platelet function trials as well as selected clinical studies addressing the impact of platelet function tests in improving bleeding and transfusion related outcomes. The last recommendation will also be addressed.

4C‐S21‐03

PLATELET COMPATIBILITY AND DETECTION OF PLATELET ANTIBODIES: A STEP TO RESOLVE THE DILEMMA IN THE MANAGEMENT OF PLATELET REFRACTORITY IN ONCOLOGICAL PATIENTS

it's tomorrow, A. Kacker, N. Simon

Transfusion Medicine and Immunohematology, Sri Balaji Action Medical Institute, New Delhi, India

Bottom:Platelet refractoriness complicates the provision of platelet transfusions in the management of thrombocytopenia in cancer patients. Platelet refractoriness poses a challenge due to alloimmunization to HLA and human platelet antigens and is associated with adverse clinical outcomes.

Goals:A prospective study was carried out to analyze the result of platelet compatibility with the increase in platelet count after transfusion and to determine the presence of antiplatelet antibodies as a causal factor in platelet-refractory cancer patients.

Methods:Eighty cancer patients with thrombocytopenia at a tertiary care center; Both solid organ and hematologic malignancies requiring platelet transfusion were included. Leukoreduced, ABO-compatible random donor platelets with less than 72 hours of storage were transfused. Simultaneously, a platelet crossmatch was performed with the pre-transfusion sample. Blood samples were collected 1 hour after the completion of the transfusion for post-transfusion platelet count and calculation of the corrected count increment. In the case of platelet refractoriness and the presence of platelet incompatibility, the platelet antibody detection test was performed using the SPRCA technique. The Mann-Whitney test was used for Quantitative variables and Fisher's exact test for Qualitative variables. A p value <0.05 was considered statistically significant.

Results:The study population was from 18 to 85 years with a maximum number of cases (31.3%) in the age group of 60 to 70 years with the same number of cases of both sexes. 64 cases (80%) cases showed platelet crossmatch, while 16 cases (20%); 9 male and 7 female patients were incompatible with platelet crossmatch. Among the crossmatches for incompatible platelets, 14 (87.5%) cases showed the presence of platelet alloantibodies (17.5%) and all but one case showed platelet refractoriness. Of the 64 cases cross-matched for compatible platelets, 38 cases (59.37%) showed platelet refractoriness, which is statistically significant than the cases showing adequate ICC. None of these cases showed platelet alloantibodies. Platelet yield in compatible platelet crossmatches was higher than in patients with incompatible platelet crossmatches (p-value<0.001). Previous pregnancy history in female patients (61% of cases) and transfusions (54% of cases) played a vital role in platelet determination. refractoriness and development of platelet alloantibodies. Solid organ malignancies showed more refractoriness (67.4%) than hematological neoplasms (63.15%). Patients treated with chemotherapy (78.8%) had a high risk of platelet refractoriness. Leukocytosis had a statistically significant correlation with platelet refractoriness. Age and gender did not affect the increase in platelets. The Body Surface Area had a negative correlation with the increase in platelets.

Summary/Conclusions:For the management of platelet refractoriness in medical cancer patients, platelet crossmatching; Similar to RBC cross-matching, the use of the SPRCA method is an effective and useful tool and rapid first-line approach to select matched platelets from the local inventory compared to HLA-matched platelets in the treatment of thrombocytopenic cancer patients. . Platelet crossmatch in conjunction with antiplatelet antibody testing is an important, less time-consuming, and cost-effective component than molecular testing in the management of cancer patients. Blood services must be aware of measures to prevent alloimmunization and correct identification. of refractoriness to provide adequate transfusion support for cancer patients.

4C-S21-04

EVALUATION OF THE CORRELATION OF THE RESULTS OF CROSS-MATCHING OF PLATELETS USING THE SOLID PHASE RED CELL ADHESION ASSAY (SPRCA) WITH INCREASED POST-TRANSFUSION PLATELET COUNT IN ADULT HEMATO-ONCOLOGY PATIENTS

PB Sontakke, P Desai, A Navkudkar, S Rajadhyaksha

Transfusion Medicine, Tata Memorial Centre, Mumbai, India

Bottom:Platelet transfusions are an important aspect of supportive transfusion therapy for patients with hematologic malignancies and hypoproliferative thrombocytopenia. A less than expected increase in platelet count occurs in about 20% to 70% of patients with thrombocytopenia who receive multiple transfusions. HLA-compatible platelet transfusion is the best strategy to overcome this clinical condition caused by alloimmune mechanisms. The disadvantage of HLA-matched platelet transfusion is that it is logistically challenging. An alternative approach is to transfuse cross-matched platelets in these patients, which is convenient and feasible. In this study, we attempted to assess the correlation of the SPRCA platelet crossmatch result with post-transfusion platelet count increase among adult hemato-oncology patients in the form of a one-hour corrected count increment (CCI).

Goals:To evaluate the result of platelet crossmatch by SPRCA and find its correlation with the increase in platelet count after transfusion among adult hemato-oncology patients.

Methods:This was an institutional ethics committee-approved pilot study that included 50 adult patients with hematologic malignancies with a history of two or more platelet transfusions and no non-immune causes for an inadequate response to platelet transfusion after obtaining prior informed consent. They were transfused with one unit of ABO identical single donor platelets from which platelet samples were preserved. The ICC was calculated and documented from ten minutes to one hour after the transfusion. ICC>7500 was considered an adequate response for each patient. The SPRCA crossmatch was performed using preserved platelet samples from donor units with the respective patient's serum. Statistical analysis of the correlation between platelet crossmatch results and ICC was performed using appropriate statistical tools.

Results:Of 50 crossmatches, 78% (39/50) of the samples showed compatible results and 22% (11/50) showed incompatible results. Among 39 compatible results, 87.2% (34/39) showed adequate CHF and 12.8% (5/39) inadequate CHF. Among 11 inconsistent results, 18.2% (2/11) had an adequate ICC and 81.8% (9/11) had an inadequate ICC. The difference between the response to platelet transfusion in terms of ICC for compatible and incompatible crossmatches was found to be statistically significant (P<0.05). Other variables such as gender, age, body surface area, number of previous transfusions, and underlying clinical status of the patient were not found to have any effect on crossmatch compatibility (P>0.05).

Summary/Conclusions:In the present study, most of the patients who showed an adequate CCI had compatible crossmatches. To select the compatible unit from the available inventory, SPRCA is a rapid, effective, and feasible method in an oncology setting that requires multiple platelet transfusions to patients with hematologic malignancies. Therefore, transfusion of cross-matched platelets from the available inventory for patients with haematological malignancies receiving multiple transfusions may be a better option than transfusion of randomly selected platelets.

Adverse events: serious adverse events other than TTID

4C‐S22‐01

UPDATE ON TRALI/TACO AND TAD (PRE-AABB MEETING)

a vlaar

Intensive Care Medicine, Amsterdam UMC, Amsterdam, The Netherlands

Pulmonary complication after blood transfusion is the leading cause of transfusion-related morbidity and mortality, with a reported incidence of between 0.05 and 15% of all transfused patients. The most important transfusion-related pulmonary complications are transfusion-associated circulatory overload (TACO), transfusion-related acute lung injury (TRALI), and transfusion-associated dyspnea (TAD). In this presentation, recent changes in international definitions will be presented and discussed. In addition, knowledge about the different underlying pathophysiological mechanisms will be highlighted. Prevention strategies for TRALI have only been successfully designed and implemented in recent decades. No evidence-based treatment strategy is currently available for any of these life-threatening syndromes. Knowledge of the pathogenesis of pulmonary complications after transfusion should pave the way for future prevention and treatment studies.

4C‐S22‐02

IRON OVERLOAD DUE TO TRANSFUSION AND IMPACT ON TRANSPLANT OUTCOMES

and angels1, F Pilo2

1Hematology and Oncology, IRCCS San Martino Polyclinic Hospital, Genoa2Internal Medicine and Oncology, Businco Cancer Center, Cagliari, Italy

The question of the impact of iron overload/toxicity on the outcome of hematopoietic stem transplantation (HCT) has been first addressed in the field of transfusion-dependent thalassemia. Today the concept has been extended to other diseases characterized by periods of variable duration of transfusion dependence such as Myelodysplastic Syndrome (MDS) and myeloproliferative diseases. Patients who require regular blood transfusions certainly develop an iron overload that leads to tissue and organ damage.

Iron loading before transplantation significantly affects outcome and long life after transplantation.

Iron overload is well known to be detrimental to organs such as the liver, heart, and endocrine glands, and it has been postulated that it might also increase the risk of infections and severe graft-versus-host disease soon after HCT.

Recent preclinical data have shown how the increased production of reactive oxygen species (ROS) resulting from an iron overload condition could affect the cloning, proliferation, and maturation capacity of stem cells. Furthermore, cells in the microenvironment could be affected through this mechanism. For this reason, iron overload is becoming an important issue also in the early engraftment period after transplantation.

High baseline ferritin levels before HCT have been shown to negatively influence clinical outcome, but today, ferritin is considered a stable, nonbiologically active form of iron, while free iron is formed as unbound iron. to transferrin (NTBI) and labile plasma iron (LPI). ) are considered the main trigger of cell damage, the most representative of dynamic tissue damage. The scientific community is moving iron disease from a "bulky" disease, such as classic thalassemia (based on quantitative iron parameters such as ferritin, red blood cell transfusion number, MRI) to a "toxic" disease (based on factors active and dynamic biologics). markers such as NTBI/LPI).

At this time, in all published studies on the HCT setting, only the correlation between direct or indirect estimates of iron overload (mainly serum ferritin) and outcome parameters have been explored, while duration of exposure to toxic iron species has not been taken into account. .

The first study to explore the role of LPI in relation to outcome was published by Wermke and colleagues in malignant tumors. They investigated the predictive value of stored (MRI-derived liver iron content) and non-transferrin-bound iron, defined as increased labile plasma iron (eLPI), on post-transplant outcomes in patients with acute myeloid leukemia or MDS. Their ALLIVE prospective observational study showed that patients who had elevated eLPI at baseline also had a significantly higher incidence of day 100 nonrelapse mortality (33%) compared with those who had normal eLPI at baseline. of the study (7%) (p = 0.00034).

Reinterpretation of transplant predictors in light of current advances in understanding iron homeostasis further supports the concept that the key to successful transplantation is regular, lifelong chelation therapy to consistently suppress constant tissue reactive iron species and prevent tissue damage in the years prior to HCT.

4C‐S22‐03

IMPACT OF BLOOD DONOR GENDER ON RECIPIENT OUTCOMES

R Middelburg1,2

1Transfusion Clinical Research Center, Sanquin Research2Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands

In transfusion medicine, the role of donor gender was long considered to be limited to the increased risk of TRALI seen after transfusions from female donors. This risk has been shown to be limited to female donors with a history of pregnancy and to plasma-rich products (ie, red blood cell products, which typically contain <50 mL of plasma, are excluded).

Until, in 2011, we discovered that transfusions of unequal-sex red blood cells were associated with increased recipient mortality. Since then, several other studies have confirmed these findings, but some studies also found no association. All of these studies were based on analyzes of routinely collected healthcare data, which were not primarily intended to be used for research. As a result, the analyzes are complex and often difficult to properly assess based on published descriptions. Therefore, the discussion about the possible reasons for these discordant findings has largely focused on the methodological approaches of the different studies. Other possible explanations include differences in patient or donor populations, production methods, or storage time of blood products. The different potential explanations are expected to be associated with different underlying biological mechanisms. Thus, further delineating which donor, patient, and product characteristics modify the observed association could provide more insight into the underlying mechanism.

In 2017 we observed that only transfusions from female donors with previous pregnancies were associated with higher mortality and only in male recipients under 50 years of age. This leads us to postulate that pregnancy-induced long-term changes in the female immune system are transferred during red blood cell transfusion, with negative consequences for young male recipients. The low amount of plasma present in the red blood cell products further leads us to assume that a cellular component is involved, such as passenger leukocytes. It has been shown that microchimerism of passenger leukocytes can persist for decades after transfusion, even of leukocyte-depleted blood products, suggesting that long-term immune modulation might play a role.

It was hypothesized that transient leukocytes would die during storage of the blood products and therefore the negative effect of pregnant female donors on the survival of young male RBC recipients would be attenuated with increased storage time. . However, our data seems to indicate otherwise. The risk of death increased more than threefold for young male recipients ofviejo(>24 days of storage) RBCs from ever-pregnant donors, compared with young male recipients offresco(<10 day storage) RBCs from ever-pregnant donors (3-year cumulative incidence of death 15.4% versus 4.8%). The negative control group (ie, young men recipients of red blood cells from male donors) showed a much weaker association of mortality with storage time (ie, 7.2% vs. 4.7%).

These findings seem to falsify our hypothesis that mortality could be caused by passenger leukocytes, establishing long-term immunomodulatory effects.

Another potential mechanism that has been suggested could be the presence of cell-free DNA in transfused blood products. This cell-free DNA increases during storage. However, more research is needed to establish whether cell-free DNA can also be linked to previously pregnant blood donors, and by what mechanism it might negatively affect young men who receive transfusions.

Management and organization: challenges in resource-constrained environments

4C‐S23‐01

CHALLENGES OF THERAPY WITH BLOOD COMPONENTS IN SUB-SAHARA AFRICA

JO Mulenga

Zambia National Blood Transfusion Service, Lusaka, Zambia

The World Health Organization (WHO) defines blood components as blood components that are prepared by physical means at controlled speed, time, and temperature.

The four components of blood are: red blood cell concentrates (Rcc), fresh frozen plasma (FFP) platelets, and cryoprecipitate. The value of blood component therapy includes: provision of optimal use of the products, patients receiving the proper portion of blood for the condition being treated or controlled.

According to the WHO AFRO regional status report on blood component production on the African continent, blood component preparation Red blood cell concentrates were being prepared in 32 countries in 2006 compared to 29 countries in 2004, while 25 Countries reported being able to prepare platelet concentrates in 2006 compared to 29 in 2004. The same number of countries reported preparing fresh frozen plasma in both 2004 and 2006, while the number of countries preparing cryoprecipitate dropped dramatically from 29 in 2004 to 15 in 2006

STRAIGHT

  • Lack of a centrally coordinated blood system:

  • Inadequate and/or deficient blood component production equipment

  • Lack of adequate budget for equipment maintenance.

  • Lack of sufficient funds for operations.

  • Lack of apheresis equipment

  • Lack of gamma irradiated products

  • They lack leukodepleted products.

  • Lack of ability to detect rare antibodies

  • First Time Unpaid Volunteer Blood Donor Unit

  • Surrogate Family Donor Unit

  • Lack of capacity to recruit the next generation of donors using ICT solutions.

  • Increased cost of reaching blood donors, as most collections take place on long outreach trips

  • Lack of evidence-based donor selection criteria;

  • Lack of capacity to investigate the long-term effects of donations.

  • High incidence of ITT in donors and general populations.

  • Lack of specialized continuing education for physicians on the appropriate use of blood and blood components

  • Absence of Hospital Transfusion Committees.

4C‐S23‐02

CHALLENGES OF CLINICAL TRIALS IN RESOURCE LIMITED SETTINGS: PERSPECTIVES FROM UGANDA

A tent

Institute of Infectious Diseases, Makerere University, Kampala, Uganda

Clinical trials (CT), the gems of clinical research for generating solid evidence in medicine and public health, are expensive and complicated undertakings. In a resource-constrained setting such as sub-Saharan Africa (SSA), where health systems are suboptimal and research capacity is limited, performing CT can be a daunting challenge.

The challenges of performing TC in RL can be categorized based on the occurrence of bottlenecks in relation to the regulatory and ethical approval process:

prior approval

Protocol Development: In order to develop a context-specific protocol that subsequently undergoes a regulatory and ethical approval process, researchers must review and ensure that the protocol is pragmatic and feasible with respect to implementation. This results in a repetitive protocol reality check process that is very time consuming.

Site Selection: In light of the limited research infrastructure, RLS investigators and their developed world partners spend considerable time reviewing and selecting suitable sites to participate in the anticipated protocol for TCs. Suitable sites are often very few and with competing ongoing studies.

Approval:Institutional Review Board (IRB) Approval: The IRB approval process can be quite long (6-9 months) with considerable unpredictability in the periods between initial and subsequent IRB reviews.

(Video) Interactive Session at the ISBT Congress in Basel

National Regulatory Approval: The requirements of national regulators are unusually myriad with limited flexibility to accommodate specific TCs.

Post approval

Key post-approval challenges for TC implementation at RLS are achieving adequate participant enrollment and maintaining high retention rates. Specifically, for participant enrollment, the challenge may be unforeseen CT competition targeting the same group of participants or community perspectives that may discourage participants from getting CT tested. Retention can also be challenging, particularly when participants view enrollment as an opportunity to access healthcare services and therefore may have no incentive to remain in a study after initial study visits. .

In conclusion, CTS are complex tasks wherever they are carried out, but doubly challenging in RLS such as sub-Saharan Africa. Bottlenecks at the pre-approval, approval, and post-approval stages are considerable. However, it is rewarding to perform CTU at RLS as the data generated there is highly valued by national regulators and can speed up the medical product registration process.

4C‐S23‐03

Towards an Appropriate Pathogen Reduction Technology for Whole Blood in Resource Limited Settings

s amar1, R. Schwabe1and Grzesiczek1, M Lanteri2, N Mufti2, J. Pitman2, Tayou Tagny3,4

1Transfusion service, Transfusion CRS Suisse, Bern, Switzerland2Cerus Corporation, Concord, California, United States3Hematology and Blood Transfusion Service, Yaoundé University Teaching Hospital4Faculty of Medicine and Biomedical Sciences, University of Yaounde I, Yaounde, Cameroon

Bottom:Interest in a suitable and effective whole blood (WB) pathogen reduction technology (PRT) is growing, especially in sub-Saharan Africa, where the residual risk of transfusion-transmitted infections (TTIs) remains unacceptably high and WB still is frequently used. Cerus Corporation, manufacturer of the INTERCEPT™ Blood System, and Swiss Transfusion SRC are collaborating on a clinical development program to adapt the INTERCEPT PRT using amustaline (S-303) and glutathione (GSH) for red blood cells (RBCs) into a PRT appropriate for WB. in resource limited settings in Africa. Amustaline/GSH treatment has been shown to inactivate a broad spectrum of transfusion-transmissible pathogens in red blood cells. Studies with amustaline/GSH in WB have shown efficacy against duck hepatitis B virus (>5.3 log reduction) andPlasmodium falciparum(>7.5 log reduction), with future studies planned. A WB PRT system with amustaline/GSH also has the potential benefit of minimal electrical requirements.

Goals:Describe the clinical and safety objectives for a Phase 1 clinical trial using the amustaline/GSH PRT system for WB in Africa, and describe the research and development efforts to adapt the INTERCEPT PRT system for red blood cells into a robust WB system and appropriate for environments with high TTI loads and limited resources.

Methods:The protocol for a Phase 1 clinical trial using amustalin/GSH-treated pathogen-reduced WB in an African country is presented, as well as current research and development activities related to the development of a PRT system for WB.

Results:In the planned Phase 1 clinical trial in Africa, 20 clinically stable patients with anemia requiring WB transfusion will be randomized into two study arms at a large medical center in a sub-Saharan African country. Enrolled patients will receive one unit of amustalin/GSH-treated non-leukocyte depleted WB, or one unit of untreated WB or control RBCs. The primary safety endpoint will be the incidence of high attributable transfusion reactions (Swissmedic ≥Grade 2) within the first 24 hours of transfusion. Data will also be collected on all adverse events and transfusion reactions (all grades) and the development of treatment-emergent antibodies against pathogen-reduced WB or autoantibodies within 59 (±3) days of study transfusion. Clinical efficacy will be characterized by the increase in hemoglobin 24 hours after the transfusion adjusted to the hemoglobin dose and body weight.

Summary/Conclusions:A PRT system for WB based on the INTERCEPT PRT for red blood cells is under development and is in advanced development in Europe and the United States. INTERCEPT-treated red blood cells have met efficacy and safety endpoints in Phase 3 clinical trials. The amustaline/GSH PRT system used to treat INTERCEPT red blood cells has demonstrated effective inactivation against a broad spectrum of agents that can cause TTI. A Phase 1 clinical trial using a tailored PRT system for WB in Africa is the first step in a clinical development program that includes additional pathogen inactivation efficacy studies and improvements to the WB PRT implementation process. Together, these developments and evaluations represent progress towards a realistic and appropriate PRT for WB in Africa and other resource-constrained settings.

Donors and donation - Collection of blood components - Effects on donors and recipients

4C‐S24‐01

FIRST-TIME PLASMA DONOR RECOVERY: FINDINGS FROM AN INTERVENTION STUDY

R Thorpe1,t davison1, B lots2, L Nguyen1

1Clinical Services and Research, Australian Red Cross Blood Service, Melbourne2School of Psychology, University of Queensland, Brisbane, Australia

Bottom:In Australia, the demand for plasma-derived products has increased dramatically and there is a need to increase plasma collections. First-time donor retention, including the rate at which first-time donors return, is a pressing issue. A rapid return is optimal as it increases the total plasma yield and is associated with long-term retention. However, evidence of effective interventions to encourage first-time donors, particularly those who donate plasma, to return and establish a more frequent donation routine is lacking.

Working from the framework of Schultz (2014), this intervention study drew on insights from interviews with first-time plasmapheresis donors. Participants identified barriers such as time and lack of knowledge about plasmapheresis. Enablers included being able to help more people and donating more frequently than allowed with whole blood. Participants generally favored donating every 4 weeks.

Goals:The aim of this study was to test the effectiveness of three intervention conditions compared to procedure as usual (BAU) on the proportion of donors returning to donate plasma and the number of plasma donations. We report data 2 months after donation.

Methods:Donors were randomly assigned to one of four study conditions. In Conditions 1 and 2, donors received an email one day after their initial donation. In the first condition, donors received the thank you email from BAU. Donors in the second condition received an alternate email with content derived from the interview study. Donors in the remaining conditions received the BAU email (Condition 3) or revised email (Condition 4) along with a phone call. The phone call was scripted to provide additional information about plasma, including how often plasma can be donated, a suggestion to donate every 4 weeks, and a notice to resend appointments.

Results:The final sample (N=6788) consisted of 3859 women (57%) and 2929 men (43%) from 18 to 70 years old (mean=32). After two months, 37.2% of the donors returned to donate plasma at least once. After controlling for sex, age, and blood group, donors in each of the intervention conditions were more likely to return to donate plasma than donors in the BAU condition. The largest effect was found among donors randomized to Condition 4 (reviewed email + phone call), OR=1.305, CI=1.128–1.510, and BAU. Donors assigned to the two telephone conditions (Condition 3 and 4) donated plasma more frequently than BAU.

Summary/Conclusions:This study tested the effectiveness of interventions designed to encourage first-time plasma donors to return to donate plasma and establish a donation routine. Early indicators suggest that evidence-based phone call and email elements are more effective than BAU in getting donors to return to donate plasma, with the revised email combined with a phone call having the greatest positive effect. in plasma production in the short term.

4C‐S24‐02

DOUBLE ERYTHROCYTE APHERESIS VERSUS CONVENTIONAL WHOLE BLOOD PHLEBOTOMY AS THE TREATMENT OF IRON DEPRESSION IN HEALTHY CARRIERS OF HFE MUTATIONS WITH HYPERFERRITHINEMIA

the children1,2, G Leitner3, and Plattner1, V. Pehlic1, a holbro1,2, N Worel3, a busero1,2

1Swiss Red Cross Blood Donation Center Basel2Hematology Division, University Hospital, Basel, Switzerland3Clinic for Blood Group Serology and Transfusion Medicine, University of Medicine, Vienna, Austria

Bottom:Healthy individuals with hereditary hemochromatosis (HH defined as hyperferritinemia and homozygous p.C282Y mutation), but also carriers of otherHFEmutations (p.C282Y/p.H63D or H63D homozygous) with elevated serum ferritin (SF) are accepted as blood donors, if local regulations allow and eligibility is met. Generally, blood components are released for transfusion at normal SF levels (<200 ng/mL in women, <300 ng/mL in men).

Goals:Randomized, prospective, two-center study comparing the efficacy and tolerability of double red blood cell apheresis (2RBCaph) and whole blood phlebotomy (WBph) for iron depletion in asymptomatic subjects with HH or hyperferritinemia and othersHFEmutations in the context of routine blood donation.

Methods:Eligibility criteria included age ≥ 18 to 60 years, total blood volume ≥ 5 L, BMI < 35 kg/m2, Hb≥140g/L, high FS levels and no target organ damage due to iron overload. 2RBCaph (360mL RBC) were scheduled every 14 days and WBph (450mL) every 7 days until SF was <100ng/mL. A complete blood count and SF were measured at baseline, at each visit, and at follow-up 8 weeks after study completion. Adverse events were systematically recorded. The treatment effect was tested by Poisson regression, with gender,HFEmutation, BMI, and baseline SF as covariates.

Results:30 subjects (5 women; mean age 47 years) were randomized to WBph (n=16; 1 woman) or 2RBCaph (n=14; 4 women).HFEThe mutations were p.C282/p.C282Y in 17 subjects, p.C282Y/p.H63D in 9, and p.H63D/p.H63D in 4. At baseline, mean Hb was 149 g/L (SD 7,8) and the median SF was 504 ng/mL (IQR 406-620 ng/mL). 222 procedures were completed (WBph n=146, 2RBCaph n=76); 9 were interrupted (local hematoma, insufficient flow); 35 (16 WBph, 19 2RBCaph) were postponed due to low Hb and 15 for non-medical reasons. There were two dropouts in the WBph arm due to depression and poor compliance, respectively. Anemia (Hb<130 g/L in men, <120 g/L in women) occurred after 15 visits in 8 WBph subjects and after 5 visits in 3 2RBCaph subjects. Fatigue was reported after 37 phlebotomies and 31 apheresis. Only 5 participants (17%) completed the study per protocol. A total of 136 blood components (94 packed red blood cells and 42 units of plasma) were obtained for transfusion. Overall, a median of 7.5 WBph (IQR 6.2–9.8) was needed to achieve SF<100ng/mL, which corresponds to 1.8 times 2RBCaph (median 4.0, IQR 3.0– 5.8) (P=0.0001). Analyzing carriers p.C282/p.C282Y and p.C282Y/p.H63D separately, the WBph to 2RBCaph ratio was 1.6 and 1.8, respectively. treatment arm andHFEmutation were the covariates with a significant effect on the primary endpoint (P = 0.0001 and 0.007, respectively).

Summary/Conclusions:2RBCaph is more efficient than WBph for iron depletion in healthy subjects with HH or otherHFEmutations and moderate hyperferritinemia. Intensive treatment schedules, generally recommended for HH, are difficult to adhere to due to Hb falloff and compliance. A less intensive treatment in asymptomatic people with HH and their inclusion in the blood donation would avoid negative effects on quality of life and would benefit blood collection centers in the long term.

4C‐S24‐03

LONG-TERM EVOLUTION OF HEMOGLOBIN AND FERRITIN VALUES IN HIGH-FREQUENCY BLOOD DONORS WHOLE BLOOD OR DOUBLE ERYTHROCYTE APHERESIS

To Pehlica1, Volk T2, a holbro1,3, the Jirout1, B Drexler1,3, a busero1,3, L. Infanti1,3

1Blood donation center Basel Switzerland, Basel2Faculty of Health Professions, Zurich University of Applied Sciences, Winterthur3Hematology Division, University Hospital Basel, Basel, Switzerland

Bottom:Serum ferritin (SF) measurements in whole blood (WB) donors demonstrated that female gender and intensity of donation are major risk factors for iron deficiency. With WB donation, approximately 200 mL of red blood cells (RBCs) and 200–240 mg of iron are lost. Double-unit RBC (2RBC) collections of 360 mL (approx. 40 mL less than the number of RBCs from two WB donations) lead to a loss of about 400 mg of iron. In Switzerland, the maximum donation frequency allowed for male donors is once every 6 months for the 2 RBC donation and once every 3 months for the WB donation.

Goals:To describe and compare the course of hemoglobin (Hb) and SF in male WB and 2RBC donor subjects at our institution.

Methods:We included 294 WB and 151 2RBC donors (n=445) who donated at the maximum donation frequency allowed over 48 months between 2008 and 2013, yielding 4704 WB and 1208 2RBC donations. We excluded subjects with hyperferritinemia and knownHFEmutations Hb cutoffs were 135 g/L for WB and 140 g/L for 2 RBC donation. With 2RBC apheresis 360 ml of RBC were collected. SF was measured in a predonation serum sample; Hb was determined from samples obtained by digital puncture. Donors did not receive iron replacement. We use generalized estimating equation models for the Hb and SF trajectories.

Results:The mean age of the first blood donation was 53 (WB) and 48 years (2RBC), respectively.

In the first donation, the mean Hb was 153 g/l (SD 13) in WB and 159 g/l (SD 8) in donors of 2 RBCs; the mean SF was 44 (SD 52) and 73 μg/L (SD 56), respectively. On average, Hb and SF were higher in 2GR donors (5.1 g/L and 26 μg/L, respectively; P < 0.001). There were 137 subjects with SF<30μg/L in WB and 19 in the 2RBC group, and 85 with SF<50μg/L (but >30μg/L) and 40, respectively.

In 2GR donors, between the first and the last donation, the mean Hb decreased from 159 g/l to 157 g/l (p < 0.05) and the mean SF from 73 μg/l to 66 μg/l (ns). . In WB donors, mean Hb was reduced from 153 g/l to 152 g/l (p < 0.05) and SF from 44 μg/l to 35 μg/l (p < 0.001). Similar results were found when adjusting for age and season.

Hb values ​​fell from baseline to 11hedonation for WB donors and until 4hedonation for 2RBC donors with an upward trend thereafter. In both groups, no Hb value was observed below the blood donation limits or anemia.

SF reached a nadir at 4hedonation in WB and 2RBC donors (37 μg/L and 60 μg/L) and subsequently increased in 2RBC donors. In WB donors, SF followed a parabolic trend that peaked in the 10hedonation, and then rejected until the last donation.

Summary/Conclusions:The maximum allowed blood donation frequency for WB and 2RBC male donors in Switzerland not only protects against the development of anemia, but also for the postponement of blood donors due to low Hb. This was observed even in subjects with low SF at baseline.

4C‐S24‐04

IMPACT OF HYDROXYETILL STARCH AND MODIFIED FLUID GELATIN ON GRANULOCYTE PHENOTYPE AND FUNCTION

No Doubles1,2, Un Bredthauer2, M Mohrez1, in Hahnel1, Graph B2, M Gruber2, N. Ahrens1

1Institute of Clinical Chemistry and Laboratory Medicine, Transfusion Medicine2Department of Anesthesiology, Regensburg University Hospital, Regensburg, Germany

Bottom:Transfusion of packed granulocytes is a potentially lifesaving option for patients without functional neutrophils. However, recent studies have not been able to demonstrate the anticipated clinical effectiveness of this procedure. Granulocyte concentrates are manufactured using sedimentation agents to separate granulocytes from red blood cells and improve granulocyte collection efficiency. High molecular weight hydroxyethyl starch (HES) is most often used for this. However, the authorities recently restricted the use of HES due to its unfavorable risk-benefit profile. Modified Fluid Gelatin (MFG) is an alternative settling agent already in use. Since the granulocyte product contains these substances, any impact of the settling agent on granulocyte function may affect the clinical efficacy of granulocyte transfusion.

Goals:We tested the hypothesis that MFG is not inferior to HES in terms of granulocyte functionality and viability.

Methods:Granulocytes from ten healthy donors were isolated, aliquoted and incubated in parallel for 2 hours with 0% (control), 7.5%, 15% or 30% MFG (Gelafundin 4%, B. Braun Melsungen AG) or HES (Hespan 6 %/ 450/0.7, B. Braun Medical Inc.), respectively, and subsequently granulocyte migration, chemotaxis, reactive oxygen species (ROS) production, neutrophil extracellular trap formation (NETosis), expression of CD11b, CD62L and CD66b antigens, and viability. in vitro.

Testing was performed using live cell imaging of cells embedded in a collagen I matrix for parallel testing for migration, ROS production, and NETosis. In addition, flow cytometric analysis (FACS) was used to measure surface marker expression, viability, and respiratory burst.

Results:Granulocyte migration was decreased in a dose-dependent manner in response to HES and MFG. Relative to controls, all three HES concentrations reduced migration distances (P<0.001 respectively), while only the highest concentrations (15% and 30%) of MFG showed lower relative migration distances (P<0.001). respectively). Track straightness was reduced by both settling agents by 15% and 30% to the same extent (P<0.001 respectively).

HES resulted in lower CD11b expression (P = 0.028) and higher CD62L expression (P = 0.007) compared to controls, while the differences for CD66b did not reach statistical significance. MFG did not affect the expression of any surface antigens investigated that mediated endothelial adhesion and transmigration compared to controls.

No significant differences were observed in the timing of ROS or NETosis production, or in neutrophil viability or respiratory burst.

Summary/Conclusions:These results indicate that MFG is not inferior to HES in terms of phenotype and in vitro granulocyte function when used at equal concentrations, and that potential impairment of granulocyte function may occur with HES.

4C‐S24‐05

PLATE PHERESIS DONATIONS AND DONOR RISK OF SUSTAINED THROMBOPENIA

Guay1, M Barnoux2

1Medical director2Manager of Muestreo, Center EFS Pays de la Loire, Saint Jean de la Ruelle, France

Bottom:Platelet donation leads to a well-known transient decrease in donor platelets. The question of long-term effects raised with the development of regular giving by some donors to meet increasing demand. A seminal work (Lazarus, Transfusion, 2001) affirms that there is a sustained thrombocytopenia in frequent platelet donors, correlated with the total number of donations.

Goals:French regulations authorize up to 12 platelet donations by apheresis per year, with a minimum interval of 4 weeks between them. We tried to assess the risk of sustained thrombocytopenia in these conditions.

Methods:We retrieved all platelet donations that occurred between 01/01/2014 and 08/31/2018 from the French civilian blood donor pool and then selected a donor cohort with at least 24 donations during that period. To minimize measurement errors, the platelet counts analyzed were averages of three consecutive donations, that is, 8 measurements for each donor.

Results:The cohort includes 2,186 donors (384 women and 1,802 men). The mean platelet count fluctuates between 276.4 and 278.6 platelets/mL. The analysis of variance does not show any statistically significant difference (F=0.462), even taking into account the gender or age of the donor. There is also no difference if we consider the total duration of the 24 donations. Donors with the lowest early counts show a significant increase in subsequent measurements and donors with the highest counts show a downward trend, exhibiting classical regression towards the mean.

Summary/Conclusions:The French regulation of platelet pheresis does not appear to have a risk of sustained thrombocytopenia in the donor. This conclusion is in agreement with data from recent literature.

Immunobiology ‐ Platelet alloimmunity

4D-S25-01

HLA IN BLOOD TRANSFUSION

Z Grubic

Tissue Typing Center, Zagreb University Hospital Center, Zagreb, Croatia

The primary biological function of the human leukocyte antigen (HLA) system is the regulation of the immune response to foreign antigens. Because of this role, HLA genes and molecules play an important role in transplantation, the etiology of many autoimmune, non-autoimmune, and infectious diseases, but also in transfusion medicine.

There is an increasing probability of HLA-mismatched blood, tissue, or organ products due to the extremely high polymorphism of HLA genes, with more than 20,000 alleles described to date, and their differing frequency distributions in various world populations.

The HLA system, originally discovered as a result of a transfusion reaction in the 1950s, can cause deleterious immune reactions in transfusion therapy. HLA antibodies present in the patient are responsible for some of these reactions, while in other cases HLA antibodies or HLA reactive cells present in the transfused product are responsible for immunoreactivity. HLA antibodies form as a result of exposure to foreign HLA antigens during pregnancy, transplantation, and blood transfusions and can cause platelet immune refractoriness, febrile transfusion reaction, transfusion-related acute lung injury, and graft-versus-disease. transfusion-associated host. To avoid or reduce the development of these transfusion-related events, HLA antibody-negative or matched products should be used.

Almost all existing methods currently used for molecular typing of HLA polymorphisms are based on the polymerase chain reaction, but with different levels of resolution (low resolution: two digits or high resolution: four digits). In addition to providing more accurate detection of polymorphisms at classical HLA loci (eg, HLA-A, -B, -C, -DRB1, -DQB1), molecular methods can also determine polymorphisms at HLA loci than previously they could not be typed by serology. (eg, HLA-DRB3, -DRB4, -DRB5, -DQA1, -DPA1). Until recently, the most widely used method for the detection of HLA antibodies was the complement-dependent cytotoxicity (CDC) technique, but it is increasingly being replaced by a more sensitive solid-phase-based method (Luminex technology). In conclusion, an accurate and precise determination of both the HLA gene polymorphism and the presence of HLA antibodies is essential for the safe and efficient administration of transfusion products.

4D‐S25‐02

DETECTION OF GLYCOSYLATION OF ANTI-HPA 1A ANTIBODIES BASED ON SURFACE PLASMON RESONANCE, AN ASSAY FOR PREDICTING DISEASE SEVERITY IN ALOIMMUNE CYTOPENIAS

The Shittner1, R Temming1, D Schimdt1, El Bentlage1, R. Visser1, S. Lissenberg‐Thunnissen1, J Mok2, W van Esch2, M. Sonneveld1, E de Graaf1, M. de Haas3,4, M Wuhrer5, Evan der Schoot1, G. Vidarsson1

1Department of Experimental Immunohematology2Sanquin reagents3Department of Immunohematological Diagnostics, Sanquin Research and Landsteiner Laboratory, Amsterdam4Clinical Transfusion Research Center, Sanquin Research and Department of Immunohematology and Blood Transfusion, Leiden University Medical Center5Center for Proteomics and Metabolomics, Leiden University Medical Center, Leiden, The Netherlands

Bottom:Serious fetal/neonatal disease develops in only a minority of pregnancies complicated by anti‐HPA1a antibodies. The difficulty in predicting which mothers should be treated with IVIG makes it difficult to implement FNAIT screening. We found that fucosylation and galactosylation of the Fc core are highly variable in anti-HPA1a IgG, and that these glycan characteristics strongly affect FcγRIIIa receptor binding. The level of Fc core fucosylation of anti‐HPA 1a alloantibodies was found to correlate with platelet count and newborn outcome, suggesting that specific antibody fucosylation could serve as a biomarker in FNAIT screening. However, at present, the glycosylation pattern of Fc can only be determined by complicated methods involving purification of antigen-specific IgG and analysis of trinsically released IgG-derived glycopeptides by liquid chromatography and mass spectrometry (MS) techniques. ) in tandem. These methods, while powerful, are not yet suitable for high-throughput clinical detection.

Goals:Our aim was to provide a simplified method to quantify the biological activity of anti‐HPA‐1a antibodies and possibly other alloantibodies against blood cells.

Methods:Here we explore whether cell surface plasmon resonance (SPR) imaging can replace MS, resulting in less complicated handling of patient sera and donor antigen-bearing cells. The strength of platelet binding to FcγR on the SPR sensor was monitored under flow. The SPR sensor was equipped with WT FcγRIIIa (sensitive to Fc glycosylation status) and FcγRIIIa‐N162A mutant (insensitive to Fc glycosylation status). In addition, the biosensor was primed with anti‐platelet CD61 (C17) and anti‐IgG to calibrate the number of platelets injected, as well as to quantify IgG opsonization. The quality of anti-HPA 1a glycosylation was monitored as the ratio of opsonized platelet binding to the WT and the N162A-FcγRIIIa mutant. Platelets opsonized with recombinant glycoengineered antiplatelet antibodies with different levels of Fc fucosylation were used as standards. For validation, 166 plasma samples with anti-HPA1a antibodies, already analyzed by mass spectrometry and with known clinical results, were analyzed (Sonneveld, BJH, 2016).

Results:We found that the relationship between binding to WT FcγRIIIa and to the N162A-FcγRIIIa mutant correlated with the level of fucosylation of HPA1a antibodies, measured by mass spectrometry (r=−0.524; p<0.0001). Overall, a predictive value for disease severity similar to what we previously reported for this retrospective cohort was obtained. In addition, quantitative information on antibody concentration can also be extracted using the FcγRIIIa-N162A receptor as on-chip sensor, whereas anti-IgG provided specific signals, presumably because it also recognized cytophilic platelet-FcγRIIa-bound antibodies.

Summary/Conclusions:In conclusion, the combined use of WT and mutant FcγRIIIa in a label-free SPR assay provides both quantitative and qualitative information on platelet-bound anti‐HPA 1a antibodies, avoiding the need for specific antibody purification and laborious spectrometric analysis of masses. This approach might be generally applicable to determine the biological activity of cell-bound antibodies not only for anti‐HPA1a in FNAIT, but also for anti‐RhD alloantibodies in HDFN or antiplatelet antibodies in ITP.

4D‐S25‐03

RESULTS OF THE HPA-1A SCREENING PROGRAM FOR THE IDENTIFICATION OF PREGNANT WOMEN AT RISK OF FETAL/NEONATAL ALOIMMUNE THROMBOCYTOPENIA (FNAIT)

M Uhrynowska1, K Guz1y Orzinska1, A Gierszon1, S Purchla-Szepioła1, M. Debska2, P. Lopacz1y Hill3,K whey1, H rudder4, A Husebekk5, R. Debski6,E Brojer1

1Department of Immunohematology and Transfusion Medicine, Institute of Hematology and Transfusion Medicine22nd Department of Obstetrics and Gynecology, Postgraduate Education Medical Center3Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland4Institute of Medical Biology; University of Tromsø The Arctic University of Norway5Institute of Medical Biology, University of Tromsø Arctic University of Norway, Department of Obstetrics and Gynaecology, University Hospital of Northern Norway, Tromso, Norway62nd Department of Obstetrics and Gynecology, Postgraduate Education Medical Center, Warsaw, Poland

Bottom:Immunization against the HPA‐1a alloantigen of human platelets is the most common cause of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT) in otherwise healthy term infants. HPA-1a antigen detection in pregnant women is an important tool for the identification of pregnant women at risk of having a fetus/newborn with FNAIT. Any targeted intervention depends on effective detection methods, as well as sensitive and specific methods for the detection of anti‐HPA‐1a. Within the framework of the Polish-Norwegian project (PREVFNAIT), we have carried out a detection program for HPA-1a in Poland.

Goals:Our objective was to assess the frequency of detection of anti‐HPA‐1a antibodies and the clinical outcome of the newborns identified through the study. The women who entered the program due to the FNAIT in the previous child or in the current newborn are not analyzed in this study.

Methods:HPA-1a detection of 24,244 pregnant women at 8-40 weeks of gestation was performed by FACS phenotyping or RQ-PCR genotyping at IHTM in Warsaw. HPA‐1a negative/HPA‐1B/1Bthe women were examined forHLADRB3*01:01and for anti‐HPA‐1a antibodies by MAIPA (follow-up at weeks 17–20, 28, 32, 38–40 and 6 weeks after delivery). If anti‐HPA‐1a antibodies were detected, quantitative MAIPA was performed. All HPA‐1a negative women were contacted for information about the newborn. If the neonate had thrombocytopenia and MAIPA did not detect anti‐HPA‐1a, retrospective specimens were tested retrospectively using the PAKLx test (Immucor).

Results:A total of 554 HPA-1a negative women (2.3%) were identified. MAIPA detected anti‐HPA‐1a antibodies in 44 women (two preadolescents). In addition, PAKLx subsequently detected anti‐HPA‐1a antibodies in an additional 3 women who delivered with severe thrombocytopenia or ICH. The total number of immunized mothers was 47 (8.5%). They gave birth to 49 babies; 35 were children. Three women were treated by IVIg: two for 4 and 8 injections since 33hey 26heg w respectively. The concentration of anti‐HPA‐1a in the 1calleone was 0.4; 0.1; 5.88UI/ml in 17, 28, 32 gw respectively and in the 2North Dakota<0.05 IU/ml in all samples examined. The treatment decision was based on the low PLT count ˜50G/L in the fetus at cordocentesis. Her newborns (one of the delivered tweens) were healthy. The 3rdthe treated woman entered the program at 35 gw (anti‐HPA‐1a concentration was high, 22.64 IU/ml). She got an IVIG injection. Her baby was born with mild thrombocytopenia without ICH. Severe FNAIT occurred in 5/49 infants: in 3 with anti‐HPA‐1a detected only on PAKLx and in 2 with antibody concentration on MAIPA ‐1calle: 6.86/12.91/23.36 al 28/32/38hegw respectively; 2North Dakota: 8.85/17.58 a 32/38heg w respectively. ICH was observed in all of them; PLT count was <50x109in four, 56×109/ in one.

Summary/Conclusions:1/ Severe thrombocytopenia due to anti‐HPA‐1a alloimmunization in our prospective study occurred in 2/10,000 pregnancies 2/ PAKLx could improve detection of anti‐HPA in the screening program and should be considered as an additional diagnostic test, if a MAIPA result is obtained it is negative 3/ The frequency of HPA-1a alloimmunization is higher in pregnancies with male than female fetuses.

4D‐S25‐04

PLATELET ALLOIMMUNIZATION AND CLINICAL MANIFESTATIONS IN THE MATERNAL-FETAL CONTEXT

C Martageix1, F Bianchi1, C Casale1, C Chenet1, N Ferré1, N Francelle1, J Quesne1, T Granchon‐Riolzir1, L Gilles1, and moms1, But Jall1,Peterman1,2

1Platelet Immunology, INTS, F‐75015 Paris2Cordeliers Research Center, INSERM, USPC, Paris Descartes University, Paris Diderot University, F‐75006 Paris, France

Bottom:Fetomaternal platelet alloimmunization (FMPAI) is characterized mainly by fetal and/or neonatal thrombocytopenia (FNAIT), sometimes revealed by intracranial hemorrhage (ICH) or even fetal deathin the womb(FDDI). The experience of PNIL Milwaukee (USA) reported in 2014 that the diagnosis of alloimmunization was made only in 33% of cases of neonatal thrombocytopenia with clinical symptoms highly suggestive of alloimmune aetiology.

Goals:The objective of this two-year study was i) to determine the frequency of platelet incompatibilities in FNAIT, ICH and FDIU and ii) to assess the frequency of detectable platelet alloantibodies (aloAb) and their specificity in cases of incompatibility.

Methods:Platelet genotyping was performed with the HPA Beadchip Genotyping kit (BioArray Solutions, Immucor, Warren, NJ). Serological investigation was carried out using 3 different methods: complete MAIPA kit (apDia bvba, Turnhout, Belgium), Pack LxTM assay (Immucor GTI Diagnostics, Waukesha, WI), and in-house MAIPA. All 2017 and 2018 data was collected using the laboratory information management system.

Results:544 patient files were analyzed. No incompatibility was demonstrated in the HPA-1 to ‐9, ‐11 and ‐15 systems in 19.3% (n=105). HPA-1 and/or 3 and/or 5 incompatibilities were found in 271 cases (49.8%), HPA-2 and/or 15 in 87 cases (16%). Platelet alloimmunization was globally confirmed in only 10.6% of cases. A total of 58 platelet alloAbs were identified regardless of clinical manifestations: 24 anti‐HPA‐1a (41.4%), 20 anti‐HPA‐5b (34.5%), 8 anti‐CD109 (13.8%), 2 anti ‐HPA‐5a and anti‐HPA-15b (3.4% respectively) and 1 anti-HPA-1b and anti-CD36 (1.7% respectively). Forty alloAbs were found in the context of neonatal thrombocytopenia, 6 in ICH and 10 in FDIU, and 1 in a pregnancy follow-up. Even if no anti‐HPA‐3 alloAb could be identified, mismatch in this system was highly associated with FNAIT, ICH, and FDIU (n = 55, n = 32, and n = 17 in 114 cases).

Summary/Conclusions:This study strongly confirmed the known immunogenicity of some HPA systems and highlighted the overall severity of HPA-3 and HPA-5 incompatibilities. Definitive diagnosis of FMPAI is difficult to make due to current technical difficulties in detecting antibodies against the HPA-3 and HPA-15 systems. However, our results suggest that special attention should be paid to the management of pregnancies with these incompatibilities due to the frequency of serious fetal/neonatal adverse events.

4D‐S25‐05

RAPID, LOW-COST MATERNAL HPA-1A ELISA FOR HIGH-THROUGH DETECTION OF WOMEN AT RISK OF FNAIT

D Winkelhorst1,2,L Porcelain3, E. Muizelaar3, G major3, E. Huiskes1,E van der Schoot1

1Immunohematology, Sanquin, Amsterdam2Obstetricia, LUMC, Leiden3Immunohematology, Sanquin, Amsterdam, The Netherlands

Bottom:Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a life-threatening disease caused by the formation of maternal alloantibodies against fetal human platelet antigens (HPA), of which anti‐HPA‐1a accounts for the rapid majority of cases. Population screening for FNAIT has been a topic of debate for decades. Both logistically and financially, the main challenge of such screening is the typing of pregnant women to recognize the 2% HPA‐1a negative women. At present, HPA-1a typing is mainly performed by genotyping. For cost-effective implementation of anti‐HPA‐1a screening, a low-cost, rapid, high-throughput phenotyping assay is needed.

Goals:The objective was to develop a low-cost, rapid, high-throughput phenotyping assay to identify HPA-1a-negative pregnant women.

Methods:An automated sandwich ELISA was developed to perform HPA-1a phenotyping using a murine monoclonal anti-GPIIIa as the coating antibody and horseradish peroxidase-conjugated recombinant anti-HPA-1a IgG1 as the detection antibody. To ensure the applicability of the high throughput tests in a potential screening setting, 20 µL of the top plasma from tubes of EDTA anticoagulated blood stored 3 to 6 days old was used, without first shaking or spinning. In two phases, samples from pregnant women were analyzed and compared to a gold standard allelic discrimination polymerase chain reaction assay. In the first phase, samples from unselected consecutive pregnant women were analysed. The second phase was part of a prospective pregnancy screening study and confirmatory genotyping was restricted to samples with an arbitrary set of OD<0.500 in the HPA-1a ELISA.

Results:The developed ELISA was optimized to not require additional manipulation (swirl or twist) of the stored tubes. During phase I, 506 consecutive samples were analyzed. In phase II, the HPA-1a ELISA was performed on another 62,171 consecutive samples, with confirmatory Q-PCR in 1,825. In the two phases combined, samples from a total of 1585 HPA-1a negative and 823 HPA-1a positive pregnant women were genotyped. The assay achieved 100% sensitivity with an OD cutoff between 0.075 and 0.200, leading to a specificity of 99.6%.

Summary/Conclusions:A rapid, low-cost, and reliable assay for HPA-1a phenotyping has been developed that can be used in a population-based screening setting to select samples to be tested for the presence of anti-HPA1a antibodies. Because plasma from unmixed or spun tubes of three to six day old samples can be used, this assay is applicable to settings with suboptimal conditions.

Adverse events: evaluation of new screening platforms/trials

4D-S26-01

EVALUATION OF AN AUTOMATED CMV DETECTION ASSAY AT IBTS: A CHALLENGING PROCESS FOR BLOOD DETECTION LABORATORIES

D Coyne, D Butler, P Williams, N O'Flaherty

Virology, Irish Blood Transfusion Service, Dublin, Ireland

Bottom:Cytomegalovirus (CMV) seroprevalence in Ireland is lower than that reported in many other European countries. A study of 1047 pregnant women conducted in 2002 found that 30.4% of Irish women were CMV seropositive compared to 56% in Western Europe, 92% in Eastern Europe and 97% in Africa. An internal study conducted by the Irish Blood Transfusion Service (IBTS) in 2010 indicated that the CMV seropositivity rate in Irish blood donors was 21.97%. Therefore, a significant proportion of the Irish donor and recipient population is susceptible to primary CMV. This is of particular concern for patients in certain risk groups, such as very-low-birth-weight CMV-seronegative neonates, CMV-seronegative patients undergoing transplantation, and other CMV-seronegative immunocompromised patients. This results in a demand for the supply of CMV seronegative blood components. In 2018, the IBTS evaluated the Abbott Alinity CMV IgG assay as a replacement for the CMV Mastazyme EIA (Total AB EIA).

Goals:To assess the performance of the Abbott Alinity CMV IgG Screening Assay in comparison to the CMV Mastazyme EIA (Total AB EIA).

Methods:Diagnostic sensitivity was determined by testing 48 confirmed positive CMV IgG donors from an external laboratory. Sensitivity was assessed using three seroconversion panels (n=54). Analytical sensitivity was calculated using linear regression analysis of the first WHO international standard for anti-CMV IgG. Diagnostic specificity was determined by testing 6127 donors. Further evaluation of discordant results was carried out using the Architect anti‐CMV IgG and IgM and VIDAS anti‐CMV IgG and IgM assays.

Results:The diagnostic sensitivity of the Alinity anti‐CMV IgG assay was determined to be 100%. Seroconversion sensitivity reported 42 of 54 reactive samples. The analytical sensitivity of the Alinity s CMV IgG assay was determined to be 1.12 IU/mL. The validation reported 65 discordant results from 6127 donor samples tested with the Alinity CMV IgG assay and the current Mastazyme total assay. There were 60 discordant results (Alinity s anti‐CMV IgG positive/Mastazyme total negative). Additional testing of these samples classified 27 discordant results as positive, 12 as negative, and 21 as indeterminate. 5 discordant results were observed (Alinity s anti‐CMV IgG negative/Mastazyme total positive). Additional tests classified these samples as negative. Overall, the diagnostic specificity was determined to be 99.80%.

Summary/Conclusions:Both seroconversion and analytical sensitivities are comparable between the Alinity CMV IgG Assay, the CMV Mastazyme Total AB Assay, the Architect CMV IgG Assay, and the Vidas IgG Assay. Slight variations can be attributed to individual trial cut-off definitions, which can vary widely between CMV trials. It should be noted that the determination of diagnostic specificity (99.80%) does not include indeterminate discordant results. Further testing will be done to try to characterize all discordant samples in collaboration with Abbott. This evaluation did not identify any donors with confirmed CMV IgM antibodies isolated from a pool of 6127 donors. Based on this evaluation, the Abbott Alinity CMV IgG assay is a suitable replacement for Mastazyme's total AB assay for blood donor screening.

4D‐S26‐02

DRY PLASMA SPOT TESTING: THE ANSWER TO MAKE BLOOD TRANSFUSION TESTING SAFER IN AFRICA?

Pistorius

Virology, Western Cape Blood Service, Cape Town, South Africa

Bottom:Africa has a unique set of challenges with regard to safe blood transfusion. Two of the main contributing factors are: 1) The most common disease states in sub-Saharan Africa (SSA) require large amounts of blood as life-saving interventions, e.g. malaria, 2) the greatest burden of transfusion-transmissible infectious diseases (Tapko, Toure, & Sambo, 2014) is found in SSA. This has often led to the binary donor base that exists in SSA, consisting of voluntary unpaid blood donors (VNBD) and family or replacement donors (FRD), as blood establishments are unable to meet demand when They depend solely on VNBD.

Unpaid voluntary donors are the safest blood donors as they have no incentives (other than altruistic motives) and are not under social pressure to donate, both of which may induce people who know or suspect they are infected with a blood-borne agent to donate blood.

Nucleic acid testing (NAT) along with serological testing is the gold standard for testing, however the vast distances and high temperatures of Africa make transporting traditional plasma samples a logistical challenge. Many publications have been published evaluating the stability, suitability, and ease of use of dried blood spots (DBS) for NAT. In general, the results have been shown to be comparable to traditional plasma samples. DBS is being used successfully in early childhood diagnosis (EID) programs for HIV using PCR testing, especially in Africa.

Goals:

  1. Demonstrate that DBS and/or Dried Plasma (DPS) tests are suitable for screening blood donors and can make NAT tests more widely available in Africa

  2. To determine the diagnostic sensitivity and specificity of DPS and DBS sample tests, compared to plasma sample tests.

Methods:900 negative samples from new donors and 100 confirmed positive samples from donors, as defined by routine blood safety testing performed at the Western Cape Blood Service, were tested using a dried blood spot kit. After completion of routine testing, one DBS sample and one DPS sample were prepared for each blood donor and tested with the Ultrio Elite assay on the Panther analyzer.

Results:Invalid rate: 5 DBS invalid 0.56%

Specificity (n=900)
DBS: 100%
DPS: 100%
Sensitivity
Human immunodeficiency virus (HIV)
ECP (n=30): 96,67 %
SPD (n=40): 97,50%
Hepatitis B (VHB)
ECP (n=33): 57,58 %
SPD (n=50): 58,00%
Hepatitis C (VHC)
DBS (n=2): 100%
SPD (n=10): 100 %
Overall Accuracy: 98%

Open in a separate window

Summary/Conclusions:DBS/DPS can be used as a sample for blood donor screening as the invalid rate was 0.56% and was only found in DBS samples. Logistically, DBS/DPS is very suitable for resource-poor countries, as the samples are:

  • Easy to obtain (finger samples can be used).

  • Transport is simplified as samples are not filtered or hemolyzed due to high temperatures.

  • Samples can be stored at room temperature.

DBS/DPS demonstrated acceptable specificity. The Ultrio Elite performed well with respect to HIV and HCV sensitivity. Sensitivity for HBV was not as high, but this could be due to very low and erratic viral loads.

4D‐S26‐03

EXPERIENCE WITH ALINITY S ASSAYS AFTER 5 MONTHS OF ROUTINE USE IN LARGE VOLUME SCREENING OF BLOOD DONATIONS

Un Van Weert1, M Koot2, E. Bakker1

1Sanquin National Screening Laboratory2Sanquin Diagnostics Virology and MAT Services, Sanquin Bloodsupply, Amsterdam, The Netherlands

Bottom:Sanquin Blood Supply is responsible for blood transfusion services in the Netherlands. At the Sanquin National Screening Laboratory (NSS) more than 750,000 blood and plasma donations are analyzed annually, an average of 3,000 samples per day. For more than 10 years, serologic tests for infection have been performed with PRISM (Abbott Diagnostics), but since mid-July 2018, serologic tests for HBsAg, HIV Ag/Ab, Anti-HCV, and Anti-HBc are performed with the Abbott's Alinity system. .

Goals:To compare the number of initially and repeatedly reactive results from whole blood and plasma donation samples and the rate of non-specific results leading to donation and donor deferral for the PRISM and Alinity assays using data from 6 months before and 5 months after the Alinity implementation. s systems in NSS.

Methods:Initial and repeat reactive rate of assays performed by PRISM (HBsAg, HIV O Plus, HCV) or Alinity s (HBsAg, HIV Ag/Ab Combo, Anti‐HCV) for January to June 2018 (PRISM) and August 2018 were calculated. as of December 2018 (Alinity s). Due to the lack of a true confirmatory method for Anti‐HBc, we only compared the rate of repeat reactive results for PRISM HBc and Alinity s Anti‐HBc.

Results:The rate of repeat reactive results for the PRISM (P) and Alinity s (A) assays were as follows: 1) HBsAg P 0.01% (42/390,736) versus A 0.03% (87/322,394); 2) HIV P 0.07% (262/390,735) versus A 0.06% (201/322,470); 3) Anti‐HCV P 0.11% (427/390,737) versus A 0.03% (109/322,476). The rate of anti‐HBc reactive samples was not significantly different between PRISM (0.39%) and Alinity s (0.42%). During the study period, the rate of initially reactive samples for the three main detection assays (HBsAg, HIV, HCV) was also comparable between the Alinity s (0.39%) and PRISM (0.34%) assays, mainly attributable to a fairly high number of initially reactive Alinity HIV Ag/Ab results. This was due to teething problems with the blood collection tubes that were resolved. As a result, in December, the rate of initially reactive samples decreased to 0.16%, which was significantly lower than for all three PRISM assays (0.33%).

Summary/Conclusions:The introduction of Alinity assays led to a 0.17% decrease in mean repeat reactive results (HBsAg, HIV, HCV) compared to PRISM, primarily due to a lower false reagent rate of the Alinity s Anti assay -HCV. . This will be further investigated for first time and multiple donors. With the implementation of Alinity s at Sanquin we seek to improve not only operational efficiency but also further minimize unwarranted donor disapproval. These early data show that the low initial and repeat reactive rates of Alinity assays have a positive impact on unnecessary donation and donor deferrals.

4D‐S26‐04

EVALUATION OF THE USABILITY OF THE NEWLY LAUNCHED ALINITY S AND THE SPECIFICITY OF HIV COMBO, ANTI‐HCV, HBSAG AND SYPHILIS IN A BLOOD DONOR SCREENING SETTING

C tinguously, M Hotz, C Niederhauser

Infection marker, interregional blood donation SRK AG, Bern, Switzerland

Bottom:In blood banks, testing all blood donations for infectious disease markers plays an important role in maintaining the safety of blood transfusions. Mandatory serological tests in Switzerland are performed for anti-HCV, HIV Ag/Ab, HBsAg and syphilis. Highly specific and sensitive tests with corresponding automation are essential for this purpose.

Goals:A comparative study was carried out to assess the usability of the newly launched Alinity s System (Abbott) and the specificity of the infectious disease parameters HBsAg, Anti‐HCV, HIV Combo and Syphilis (Abbott) with the ELISA methods currently used in the Quadriga BeFree System (all DiaSorin, formerly Siemens Healthcare Diagnostics).

Methods:The study was carried out at the Interregional Blood Transfusion Service in Bern, Switzerland. The specificity of the parameters was studied in 2,748 blood donor sera from first-time and repeat donors. Samples were first tested on the Quadriga Be Free System with the Enzygnost HBsAg 6.0, Enzygnost Anti‐HCV 4.0 and Enzygnost HIV Integral 4 assays and on the PK7300 with the newbio‐pk TPHA assay (Newmarket Biomedical). All samples were retested on the same day with HBsAg, Anti‐HCV, HIV Combo and Syphilis on Alinity s. The initial reactive samples were replicated in duplicate. Screening tests for repeatedly reactive samples were performed using alternative screening tests and neutralization (for HBsAg) on ​​an Abbott Architect i1000 system and immunoblots (HIV-, HCV-, syphilis-INNO-LIA, Fujirebio). For all samples, the results of our routine individual donation nucleic acid tests (HCV, HIV, HBV, Roche cobas 8800 system) were available.

Results:Based on test results from 2,748 blood donations, the observed specificities of the Alinity s (A) and Enzygnost (E) assays are comparable: % Specificity/95% Confidence Interval: HBsAg 99.96/99.80 – 100.00 (A), 99.67/99.38 – 99.85 (E), HCV 100.00 / 99.87 – 100.00 (A), 100.00 / 99.87 – 100 (E ), HIV 99.89 / 99.68 – 99.98 (A), 99.89 / 99.68 – 99.98 (E), Syphilis 99.89 / 99.68 – 99.98 (A) and 100.00 / 99.87 – 100.00 for TPHA. Baseline reactant rates (IRR%) were also comparable, %RI: HBsAg 0.15 (A), 0.44 (E), HCV 0.00 (A), 0.00 (E), HIV 0.18 (A), 0.11 (E), Syphilis 0.11 (A), 0.00 (TPHA).

Summary/Conclusions:The Alinity system was easy for operators to use after very short introductory training and provides good operational efficiencies such as high throughput even when selective sample testing is required. The observed specificity of the Abbott Alinity s versus Siemens Enzygnost assays is comparable in a blood donor screening setting. Unfortunately, we were unable to statistically analyze the specificity data due to the insufficient number of donor samples tested in parallel. It is worth noting that around 90% of the samples included in the study were from repeat donors who had previously been tested with the Enzygnost assays but were "first time donors" for the Alinity assays. The four assays of both systems exhibit very good specificity and are very suitable and practical for routine screening of blood donors.

4D‐S26‐05

ELECSYS CLINICAL PERFORMANCE EVALUATION®INFECTIOUS DISEASE PARAMETERS ON THE COBAS E 801 ANALYZER FOR ROUTINE SCREENING OF FIRST-TIME BLOOD DONORS

C Maugard1, J. Relave1, M Ahne2, M. Klinkicht2, C Fabra3,F Langen2

1French blood establishment, Occitanie, Montpellier, France2Roche Diagnostics GmbH, Penzberg, Germany3French blood establishment, Provence Alpes-Côte d'Azur, Marseille, France

Bottom:Effective screening for transfusion-transmissible infections is essential to ensure safe blood transfusions. The World Health Organization recommends mandatory serological testing of blood donations for human immunodeficiency virus (HIV), hepatitis B (HBV)/C (HCV), and syphilis. Due to the increasing demand for clinical laboratories, there is a need for reliable and accurate automated blood screening tests. The fully automatedcobas andThe 801 analyzer can be used with Elecsys®infectious disease parameters for examining blood samples from donors.

Goals:To compare the performance of Elecsys®parameters of infectious diseases in thecobas and801 (Roche Diagnostics) with other commercially available assays for the routine screening of blood donors for the first time.

Methods:We provide results from the Etablissement Français du Sang (Montpellier), a blood bank that participated in a large multicenter study of thecobas and801 analyzer. The following infectious disease marker assays were compared: HIV, Elecsys®HIV Duo versus PRISM HIV O Plus; VHC, Elecsys®Anti‐HCV II versus PRISM HCV; HBV Surface Antigen (HBsAg), Elecsys®HBsAg II versus PRISM HBsAg; Antibodies against HBV core antigen (anti‐HBc), Elecsys®Anti‐HBc II versus PRISM HBcore; sífilis, Elecsys®Syphilis versus newbio pk TPHA assay. Specificity was tested using fresh residual serum samples from unscreened first-time blood donors and calculated according to the assay package inserts and site-specific breakpoints. Samples were tested with comparator assays and then retested the same day with Elecsys.®Assays Initially reactive samples were replicated in duplicate; Confirmatory tests were performed on repeatedly reactive samples. Confirmatory tests: HIV, Nucleic Acid Test (NAT), ARCHITECT HIV Ag/Ab, and INNO‐LIA®HIV I/II scoring assays; HCV, NAT, ARCHITECT HCV and INNO‑LIA®HCV scoring assays; HBsAg, NAT, ARCHITECT HBsAg, and Elecsys®/PRISM HBsAg Confirmatory assays; anti‐HBc, NAT, HBsAg, Anti‐HBs and ARCHITECT Anti‐HBc assays; syphilis, ARCHITECT Syphilis TP and INNO‐LIA®Syphilis scoring assays. Sensitivity was tested using 30 preselected, anonymized, positive citrate-phosphate-dextrose plasma samples (Plasmatec Laboratory Products) and compared to archived data for comparison assays. Sensitivity was calculated according to the final NAT result.

Results:Across all infectious disease markers, specificity to detect repeatedly reactive samples using Elecsys®vs. comparison trials was similar (99.81–100.00% vs. 99.79–99.98%; n≥5195). In specificity analyses, there were 14 inconsistent results for HIV tests, 27 for HCV, two for HBsAg, eight for anti‐HBc, and five for syphilis. Elecsys Sensitivity®The HIV Duo trial (83.33%; 95% CI 65.28–94.36) was larger than the PRISM HIV O Plus trial (76.67%; 95% CI 57.72–90.07), but the difference was not statistically significant. Elecsys Sensitivities®and comparison trials were the same for HCV (85.19%; 95% CI 67.33–95.97), HBsAg (70.00%; 95% CI 50.60–85.27), anti‐HBc (100.00%; 95% CI 85.75–100.00) and syphilis (100.00%; 95% CI 88.43–100.00); three HCV and six anti‐HBc samples were classified as negative/indeterminate and were excluded from the analyses. In sensitivity analyses, there were two inconsistent results for the HIV test, three for HCV, and five for anti‐HBc.

Summary/Conclusions:Elecsys®parameters of infectious diseases in thecobas andThe 801 analyzer demonstrates high specificity/sensitivity for the detection of blood donor samples for the first time, with clinical performance similar to other commercially available assays.

4D‐S26‐06

SIDE-BY-SIDE COMPARISON OF THE SPECIFICITY OF THE ALINITY S AND COBAS E801 SEROLOGICAL ASSAYS IN SERUM AND PLASMA SAMPLES

Wagner1, B Gindl1, R Ilk2, rollo R1, Mach M3, G. Driesel4, C Schmitt4, D Jahn4, B Baumann‐Baretti4

1plasma analysis2Statistics and Six Sigma3BioLife Europe Quality Assurance, Takeda, Vienna, Austria4Haema AG, Berlin, Germany

Bottom:Individual plasma and serum samples from whole blood or plasmapheresis donors are tested for the absence of infectious agents by serological assays prior to their use for transfusion or production of blood-derived therapeutics. The Plasma Analysis Department (PA), Takeda (Austria) and Haema AG, Grifols (Germany), both laboratories with high throughput and a high level of automation, were looking for alternatives to replace their current serological test systems (Abbott PRISM Next ).

Goals:To allow a direct comparison of the two final candidate analyzers Alinity s (Abbott) and cobas e801 (Roche Diagnostics GmbH), an evaluation was carried out in parallel by PA and Haema with the support of Abbott and Roche (instrument and reagent supply). The objective was to compare the specificities of the assays, as well as the handling and performance of the instruments. The result should be used to better understand potential specificity differences and practical handling aspects (performance, etc.) of a next generation serology analyzer.

Methods:The two candidate instruments were installed in the PA. From March to June 2018, nearly 10,000 aliquots from routine prescreened repeat donors, provided by Haema, were processed on both study instruments in parallel. Plasma samples were analyzed for HBs antigen (Ag), HCV antibody (Ab), HIV Ag/Ab and partly syphilis Ab. Serum samples were further analyzed on HBc Ab. Samples with repeat reactive results ("RR", two reactive results from three tests) not confirmed by confirmatory tests were counted as false reactives. The necessary sample size was calculated based on a unilateral comparison of proportions with the objective of detecting possible differences in specificity (a=10%) in the size specified by the manufacturer's instructions. Two different batches were tested for the three main trials.

Results:From 7,389 plasma samples and 2,242 serum samples, RRs were found in 41 test results representing 37 individual donations on one or both instruments. Two positive samples (1xHBsAg, 1xHCV) were confirmed, another two were indeterminate. The sample containing low-level HCV antibodies was PCR negative and only detected by the Roche system.

The percentage of false reactive results for the five assays in the two systems was (Alinity s/e801): HBs Ag: 0.04/0.03% in a total of 9590/9589 samples tested; HCV Ab: 0.01/0.09% in 9620/9585, P<10%; HIV Ag/Ab: 0.03/0.09% in 9362/9329, P<10%; Ab syphilis: 0.1/0.07% in 2971/2987; HBC: 0/0% in 1531/1549. No significant differences were found between the specificities calculated in our study and the manufacturers' data.

A potential influence of sample matrix and kit lots was evaluated. A trend towards more false reactive results in serum versus plasma was found for almost all assays. No clear statistical differences were observed between batches.

Summary/Conclusions:The study results are consistent with the manufacturers' specificity data, demonstrating that the Alinity HCV Ab and HIV Ag/Ab assay exhibits slightly higher specificity in a population of plasma and serum samples from PRISM-prescreened repeat donors. A possible influence on test specificity by the sample matrix was detected but needs further investigation.

Cellular therapies: looking for more

4D-S27-01

SPECIFIC CELL THERAPIES FOR TUMOR

H Laubli

No abstract available.

4D-S27-02

CELL THERAPIES IN THE ERA OF CRISPR‐CAS

Cathomen

Institute for Transfusion Medicine and Gene Therapy, Medical Center - University of Freiburg, Freiburg, Germany

The possibility of editing complex genomes in a specific way has not only revolutionized basic research, but also biotechnological and therapeutic applications. With the rapid development of genome editing tools, particularly zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and the CRISPR-Cas system, a wide range of therapeutic options. at unprecedented speed. Therapeutic genome editing in hematopoietic cells enables new interventions in the blood and the immune system, including novel approaches to treat immune disorders, infectious diseases, and cancer. We have developed GMP-compliant protocols for manufacturing gene-edited CD34+ hematopoietic stem and precursor cells (HSPCs), as well as chimeric antigen receptor (CAR) T cells, with the ultimate goal of providing novel cell therapies for patients suffering from primary immunodeficiencies, chronic immunodeficiencies . human immunodeficiency virus type 1 (HIV‐1) infection and some tumor entities. Despite great success in improving their specificity, engineered nucleases can induce genotoxic side effects by introducing mutations or chromosomal aberrations. We have established new genome-wide assays that enable us to detect chromosomal aberrations induced not only by off-target activity but also by on-target activity, such as microaberrations and translocations, with unmatched sensitivity. Altogether, our developed protocols allow us to achieve genome editing in hematopoietic cells with high efficiency and to assess the genotoxic risk associated with the expression of CRISPR-Cas and TALEN nucleases in clinically relevant human cells, thus forming the basis for the planned phase I . I clinical studies.

4D-S27-03

T-CELL CELL THERAPIES

MC workers

Hematopoiesis, Sanquin Research, Amsterdam, The Netherlands

Adoptive T-cell therapy (ACT) has proven to be a potent means of treating solid tumors and blood-borne tumors. Adoptive cell therapies include T cells genetically engineered with tumor-specific T cell receptors (TCRs) or with chimeric antigen receptors (CARs). Additionally, tumor infiltrating cells (TILs) can be isolated from tumor lesions, which are then expanded and reprogrammed in vitro prior to transfusion into the patient.

The antitumor efficacy of ACT products depends on several parameters, including the ability of CD8+T cells to produce cytokines, chemokines, and granzymes, a feature that is critical for effective antitumor responses. Here I will discuss our efforts to develop and improve ACT products for future clinical use. I will present the preclinical work on the development of TIL therapy for non-small cell lung cancers. Furthermore, I will show that human CD8+T cells can be divided into different subsets, and only one of those subsets is highly cytotoxic. This finding may help improve the quality of genetically engineered T cell products, such as TCR and CAR T cell products.

Donors and Donation: Approaches for Safe Donors

4D-S28-01

TOWARDS UNREMUNERATED VOLUNTARY BLOOD DONATION IN THE BALTIC STATES: A COMMON STARTING POINT DOES NOT GUARANTEE THE SAME RESULTS

R Kullaste1, E Vilutyt≐2and pole3

1North Estonian Medical Center Blood Center, Tallinn, Estonia2National Blood Center, Vilnius, Lithuania3State Center for Blood Donors, Riga, Latvia

Bottom:The Baltic States: Estonia, Latvia and Lithuania have a lot in common. We are located next to each other, we share the Baltic Sea as a gate to the West and, most importantly, a common history. We were members of the USSR and suffered 50 years of Soviet occupation. We held hands in a 600 km long human "chain" across the three states to express our support for each other, and later even joined the European Union on the same day, June 1.calle, 2004.

The three differ somewhat in size, population, and more so in the languages ​​spoken in each, but that doesn't explain why the path to voluntary unpaid giving varies so much.

Aim:The aim is to describe the path towards voluntary and unpaid blood donation in the Baltic States after regaining independence from the Soviet Union.

Methods:Information was collected from published and unpublished memoirs, annual reports, and written interviews with Latvian and Lithuanian colleagues.

Results:In Soviet times, all orders came from Moscow, and quality control was carried out from the Latvian capital, Riga. Donors were mostly paid and given an extra day of vacation. The big factories were the best places to collect blood, and people lined up to donate. In 1991, the Soviet Union fell apart and the Baltic States suddenly gained the freedom and responsibility to decide.

In Estonia, the first edition of the “Guidelines for the preparation, use and quality assurance of blood components” was taken as a guide in 1992. Much advice came from Finnish colleagues. In 1997 it was decided to move towards voluntary non-remunerated donations. The process took 6 years. The early years were financially difficult for the reborn state, as money was worth less than food. Instead of cash, donors received rapeseed oil, sugar and pasta, for example. As the situation improved, the food items were replaced with small token gifts that have sentimental value. It has been that way for over 15 years.

In Lithuania, the process started later, the first program to develop a framework for voluntary unpaid donations was carried out in 2006-2015. The result was that 51% of the donations remained unpaid. The second program started in 2016 is still ongoing, with the goal of reaching 100% of non-remunerated donations by 2020. By the end of 2018, they had reached 99.2%. At first, the main obstacle was a private blood center that created unfair market conditions.

In Latvia, there is still monetary compensation for blood donations, but the younger generation has been encouraged to donate blood for free and some results can already be seen.

Summary/Conclusions:A common starting point does not guarantee the same results, at least not at the same time.

Examining the circumstances that led to the different results could benefit countries that have not yet begun to move towards non-remunerated donations, as well as those considering the opposite.

4D‐S28‐02

DEMOGRAPHIC AND HEMATOLOGICAL PARAMETERS IN FIRST BLOOD DONORS

K Magnussen1,with Zykova1,2

1Center for Blood and Medical Biochemistry, Innlandet Hospital Trust, Lillehammer2Institute of Clinical Medicine, UiT-The Arctic University of Norway, Tromso, Norway

Bottom:Little information is available on demographic and hematological parameters in first-time donors.

Goals:Describe the distribution of age, sex, haematological parameters, and ferritin in first-time donors.

Methods:Between 01.10.13 and 31.01.17, 16,803 first-time donors had routine blood samples drawn at the Blood Center in the Capital Region, Denmark. Complete blood count (FBC) was measured with a Sysmex XE‐2100D. Ferritin was measured on an Ortho Vitros 3600 or 5600, in the sample that was also used to test for viral markers. The missing values ​​for FBC were 4.7% and for ferritin 1.3%.

Results:Age(years): 23.9% <20 (Group 1; 64.2% women), 50.9% 20-29 (Group 2; 57.9% women); 13.6% 30-39 (Group 3; 50.9% women), 8.3% 40-49 (Group 4; 54.5% women) and 3.3% 50-61 (Group 5; 55.4 % women).

Hemoglobin(Hb) was, as expected, significantly different between women and men (mean ± SEM: 13.8 ± 0.01 vs. 15.5 ± 0.01 g/dl; P < 0.000). The percentage of women with low Hb<12.5g/dl was 7.1%, 4.9%, 5.2%, 6.7% and 4.2%, the percentage of men with Hb<13.5g/ dl was 0.5%, 0.6%, 0.7%, 1.7% and 1.2% for age groups 1-5 respectively.

Ferritinvalues ​​were higher in men than in women (median; 25he-75he%>tile: 51;31–79 vs 157;106–231μg/l; P<0.000) and in older age groups compared to younger age groups (median; range in age groups 1–5 in women: 40;3–702, 52;6–619, 60;6–480, 60 ;8–725, 98; 10–604 and in men: 99;8–661, 161;18–1080, 206;15–1090, 220;26–1430, 221;33–981 respectively). The percentage of women with ferritin≤15μg/l was 8.6%, 3.8%, 3.7%, 6.7% and 2.0%, while the percentage of men with ferritin≤15μg/l was 0. .2%, 0.0%, 0.1%, 0.0% and 0.0% for age groups 1-5 respectively.

White blood cell counts(WBC) were slightly higher in women compared to men (mean ± SEM: 7.2 ± 0.02 vs. 6.6 ± 0.03; P < 0.000). Percentage of women with WBC>12x109/L were 1.8%, 1.3%, 1.7%, 1.4% and 0.3%, while the percentage of men with WBC>12x109/L were 1.4%, 0.9%, 0.5%, 1.2%, and 0.9% for the age groups 1 to 5 years, respectively. None had WBC <2x109/l

platelet counts(PLT) were higher in women than in men (mean±SEM: 257±0.6 vs 222±0.6; P<0.000). Percentage of women with PLT<150x109/L were 1.0%, 1.5%, 2.2%, 2.4% and 1.0%, while the percentage of men with PLT<150x109/L were 2.6%, 3.6%, 2.7%, 2.4%, and 1.6% for the age groups 1 to 5 years, respectively. Among the low PLT counts, most were caused by EDTA-dependent pseudothrombocytopenia. Extreme deviations from normality rarely occurred and were referred to GPs for further investigation.

Summary/Conclusions:First-time donors are young with 75% under 30 years of age and the female/male ratio was 58/42. Of the 16,583 first-time donors with available ferritin data, 14% had low ferritin levels (≤30 μg/L). Typical first-time male donors did not have low Hb or low ferritin, with even significantly lower ferritin in younger donors. In female donors for the first time, the prevalence of low Hb (6%<12.5g/dl) and low iron stores (23%≤30μg/l) is high. In all, while all first-time donors are highly appreciated, campaigns could target the male population to balance the gender imbalance. Blood Centers should be aware of the higher prevalence of low iron stores in younger donors.

4D‐S28‐04

POST-DONATION INFORMATION MANAGEMENT ‐ CONTRIBUTION TO THE SAFETY OF TRANSFUSION TREATMENT

T-Vuk, J Ljubičić, J Gulan Harcet, T Očić, I Jukić

Croatian Institute of Transfusion Medicine, Zagreb, Croatia

Bottom:The objective of evaluating the suitability of potential blood donors is the protection of their health and the safety of the transfused patients. The screening process is not always effective in obtaining all relevant information from blood donors in a timely manner. For various reasons, some risks are not detected or disclosed in a future donation. Therefore, the registration and management of post-donation information (PDI) are of great importance to improve transfusion safety, donor counseling and education, as well as the general improvement of the selection process.

Goals:The aim of the study was to present the results of IDP management at the Croatian Institute of Transfusion Medicine (CITM) and the effect of educational activities on its trends.

Methods:We have analyzed the reports of PDI registered in a period of two years (2017-2018), according to the types of information obtained, the age and sex of the blood donors, the total number of their previous donations to the PDI and the time of reception of information. The effect of an informative brochure on POI launched in November 2017 was evaluated by comparing the results in two years of study.

Results:A total of 491 IDPs were registered: 266 in 2017 (1/396 donations) and 225 in 2018 (1/452 donations) with the following distribution: non-sexual risk such as tattooing and piercing (17.5%), surgical procedures (17 .1%), travel history (16.1%), infections/contact (15.3%), other medical reasons (13.4%), endoscopy/invasive diagnostic procedures (12.2%), malignancy (4 3%), autoimmune diseases (3.7%) and sexual risks (0.4%). The majority (76.4%) were late POIs, revealed in the future donation(s): 58.7% in the first following donation, 28.9% in the second and 12.3% after of more than 2 subsequent donations. The mean age of blood donors associated with PDI was 40±12 years (median 39 years), while the mean age of all donors in 2017/2018 was 38 years (median 37 years). Of all the POIs, 81.1% were related to male donors (84% in the total group of CITM donors). Using the Chi-square test, there were no significant differences between female and male donors in the total frequency of PDI and in their distribution into early and late PDI (P > 0.05). The median number of all previous donations to the PDI was 6 for female donors and 19 for male donors. The implementation of the educational booklet for blood donors resulted in a 15.4% reduction in PDI in 2018 compared to 2017 (P>0.05). The effect is more pronounced (P<0.05) when comparing the second and first semesters of 2018 (‐25.6%). A reduction is observed in all types of PID except for infections/contact (because they are mostly early PID) and malignant diseases. The proportion of early PDI increased from 21.1% in 2017 to 26.7% in 2018, which may suggest a greater awareness of blood donors about the importance of informing the blood bank about changes in their health status. .

Summary/Conclusions:Our study points to the importance of systematic registration and management of PDI, including educating blood donors on the need to provide all relevant data related to their health and the safety of donated blood in a timely manner. We are planning further improvements by providing information on this topic on banners and displays at donation sites.

4D‐S28‐05

THE DEXTOR PROJECT: TRANSFUSION DATA EXCHANGE, OPEN RESOURCE

BI Whitaker1, Earth K2, P Ashford3, K Chada1, R Silvestre4, Logia L5, J. Wiersum6, Un Ryder7, P Distler8

1Office of Biostatistics and Epidemiology/CBER, US Food and Drug Administration, Silver Spring, MD2Clinical Services, Vitalant, Tempe, AZ, United States3ICCBBA, Minster on Sea, United Kingdom4United States Blood Centers, Washington, DC, United States5Scottish National Blood Transfusion Service, Edinburgh, Scotland, UK6TRAVEL, Leiden, Netherlands7University of Tennessee Health Sciences Center, Memphis, TN8ICCBBA, Redlands, CA, United States

Bottom:Currently, the transfer of data between organizations and/or computer systems is very limited and, when it does exist, it is usually proprietary. In the absence of a standardized reference format, individual organizations and vendors trying to integrate disparate databases must develop unique solutions. Aggregating information from multiple sources is complex and expensive, constituting a major barrier to effective data analysis to improve practice and inform policy.

Goals:Standardize definitions and facilitate integration of key data elements used in blood donation and transfusion. We report here on an initial effort to map internationally harmonized critical steps in the blood collection/donation process to test the approach.

Methods:Through a collaborative process of serial conference calls and correspondence, an informal multinational consortium of experts in the transfusion industry is attempting to create a vocabulary with definitions precise enough to be used by automated systems and that can be the basis for from a blood collection/ Transfusion Medicine Common Data Model (CDM), following the steps below:

  • Define the scope of activity to address and segment into key processes.

  • Identify the set of data elements in each segment that are common to all systems.

  • Review and consider existing standards and definitions for each data element.

  • Develop draft definitions for each data element.

  • Release the draft into the public domain for critical review and refinement with the long-term goal of gaining widespread support.

Results:A standardized approach to blood donation was mapped through the identification of common pathways and mappable core data elements. Denominator data associated with donor characteristics and blood draw were selected as the first segment to be addressed. A dictionary (or vocabulary) of common terms has been created and will be submitted for international comment.

Summary/Conclusions:Developing an international consensus on core elements and their definitions throughout the transfusion chain is critical to data integration and automation efforts. The expected benefits of this effort include that it allows the establishment of algorithms to automate reporting and therefore reduce staff work time; reduces the time and resources required to integrate new databases; allows systems to continue to use existing concepts and definitions internally while providing data output in a standardized format; supports the ability to analyze, interpret, and present information consistently, regardless of the data source; establishes data definitions against which new systems can be developed; helps improve comparability of results by providing a common data model for researchers and policy makers; improves confidence in the integrity of the data and the reliability of the information derived as a basis for making rational decisions; and reduces the effort and cost of data collection, thus improving opportunities for more efficient/complex data analysis.

Standardization of the transfusion medicine dataset is the first step in achieving the automation of data transfer and analysis needed globally to drive patient safety, research innovation, and best business practices. Additional steps should address the precise methods of data exchange, the identification of entities responsible for maintenance and further development, and the involvement of IT system developers.

Immunobiology: red blood cell alloimmunity

5A-S29-01

RECEPTOR FACTORS INFLUENCING RED CELL ALLOIMMUNIZATION

J hendrickson

Laboratory Medicine, Yale University, New Haven, United States

Red blood cell (RBC) alloantibodies develop in a subset of individuals after exposure to foreign red blood cells through transfusions, pregnancy, or other activities; these antibodies can cause difficulty in locating compatible red blood cells, acute or delayed hemolytic transfusion reactions, or hemolytic disease of the newborn. Alloimmunization is underestimated due in part to antibody evanescence, the random nature of post-transfusion antibody screening, fragmented medical care, and lack of widespread antibody registries. The factors that influence who will develop detectable alloantibodies are not well understood. Transfusion burden is a risk factor for alloimmunization, although many people who receive many transfusions never form alloantibodies despite exposure to many units of red blood cells (and many non-self ABO blood group antigens). People with sickle cell disease (SCD) and myelodysplastic syndrome (MDS) are more likely to form RBC alloantibodies than most other patient populations. People with rheumatology and other forms of autoimmunity, although not chronically transfused, are also at higher than average risk of forming alloantibodies against red blood cells. Inflammation, in a broad sense, is a common thread among these diagnoses associated with high prevalence rates of red blood cell alloimmunization. Reductionist mouse models support that some types of inflammation (including viral-like stimuli) around the time of red blood cell exposure are associated with an increased likelihood of alloantibody formation. Strategies other than transfusion avoidance or extended antigen matching beyond ABO/Rh would be beneficial in preventing the formation of new red cell alloantibodies, especially in patients at highest risk.

5A-S29-02

FREQUENCY OF RED CELL ALLOIMMUNIZATION IN PATIENTS WITH SICKLE CELL DISEASE IN OMAN

H Al Balushi, W Oudeh

Hematology and Blood Transfusion, Royal Hospital, Muscat, Oman

Bottom:The unique genetic makeup of the Omani population makes them rich in the genetic blood disorder. 45% of Oman's populations carry the −α/−α gene, 44% −α/αα and 11% of the population are αα/αα. About 10% of Omani citizens carry the HbS gene and 2-3% carry the β‐thalassemia gene. Recent statistics show that there are around 400 patients with thalassemia major and 3000 with SCD in Oman. The other red blood cell abnormality that is common in Oman is G6PD deficiency found in 28% of men and 12% of women. Omanis are known to have the highest frequency of α-thalassemia and G6PD reported so far in any race. Although blood transfusion is one of the supportive treatments of SCD, it can cause some serious complications for patients. Alloimmunization of red blood cells is one of the consequences of blood transfusion. Alloimmunization of red blood cells can cause hemolytic transfusion reactions and may trigger hyperhemolysis, in which the transfused and the patient's own red blood cells are destroyed. Alloantibodies can cause a delay in the transfusion process, can be expensive and time consuming. A high number of patients developing alloantibodies may indicate a large difference in the patient and donor population. It may also indicate the lack of a generalized and controlled sickle cell patient management policy. In Oman, the decision to transfuse the patient with SCD is left to the physicians caring for the patient.

Goals:This study aims to highlight the increasing number of alloimmunized sickle cell patients. At the Royal Hospital we receive 40 new cases of sickle cell patients with alloantibodies each year. Recognition of these cases may help to assess the current practice of transfusing patients with SCD, or help to define the difference between the donor and patient population.

Methods:418 patients were recruited at the Royal Hospital for this study. Blood samples with EDTA were taken for the antibody detection test and in the positive cases the antibody was identified, all the tests were carried out by the capture technique using the Immucor Neo machine.

Results:Of the 418 SCD patients, 49% of the patients were male and 51% female, the mean age was 17 years, in the range 1 to 72 years. 38% of the SCD cases were positive for alloantibodies, 72% were women and 28% were men, the age range was 6 to 68 years. 78% of the positives were SCD, 19% S trait and 3% S/bthal. Most patients developed one antibody, however, cases of multiple antibodies were also detected. Fifty-one percent of the patients had a single alloantibody, 30% of them with two antibodies, 10% with three antibodies, 7% with four antibodies, and 2% with five antibodies. Most of the cases were IgG against Rh anti-E antigens being the majority 23%, followed by anti-D 13%, anti-K 17%, anti-C 14%, anti-c 8%, anti-Jka5%, anti-Jkb5%, anti‐Fya5%, anti-e 3%, anti-S 3%, anti-s 1%, anti-Kpa0.7%, anti‐Fyb0.3% and IgM being 2%.

Summary/Conclusions:The red blood cell alloimmunization rate is high in Oman, most of the affected patients are women. Interestingly, patients with sickle cell trait also received transfusions, and 19% of them developed alloantibodies. The practice of transfusing units of Rh and Kell compatible blood was implemented four years ago and a high percentage of alloimmunization is still achieved.

5A-S29-03

ANTIBODIES TO BALLOONS IN PATIENTS WITH SICKLE CELL DISEASE WHO RECEIVED MULTIPLE TRANSFUSION IN GHANA; PREVALENCE, SPECIFICITIES AND RISK FACTORS

LA Boateng1,2,3, H Schonewille2, P. Lighthart2, un javadi2, and Dei-Adomako4, A Osei-Akoto5, yo bates1, C van der Schoot2

1International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK2Experimental Immunohematology, Sanquin, Amsterdam, The Netherlands3Medical Laboratory Technology, Kwame Nkrumah University of Science and Technology4Hematology, Ghana Institute of Clinical Genetics (Adult Sickle Cell Clinic)5Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana

Bottom:In Ghana, routine pretransfusion investigations for patients with sickle cell disease (SCD) involve only ABO-D typing and immediate spin crossmatch, without detection of red cell irregular antibodies.

Goals:To determine the prevalence and specificities and risk factors of RBC alloantibodies in multitransfused patients with SCD

Methods:In 2018, a cross-sectional study was conducted in multitransfused patients with SCD, from two tertiary hospitals in Ghana. Participant data on demographics, transfusions, and medical history were recorded. Antibody detection and identification tests were performed in Sanquin, The Netherlands, with standard serology using LISS as enhancer and with papain-treated ("enzyme only") red blood cell cell panel. Characterization ofright hand drivegenes was performed using the multiplex ligase amplification assay. Logistic regression was used to determine the association of patient characteristics, i.e., sex, age at enrollment (continuous), age at first transfusion (classified as ≤1, 2-5, 6-9 and ≥10), previous pregnancy, number of units transfused (2, 3-5 and 6-10 and >10) and years after the last transfusion (<1, 1-2, 2-5, >5 years) with presence of alloantibodies

Results:226 patients were included (100 men and 126 women, median age 17 years, range 1.7-66). The median number of transfusions was 3 (range 2-40). The median number of years after the last transfusion was 2 (range 2 weeks to 55.5 years). In 56 patients, anti‐RBC antibodies were detected. In 14 of them, the antibodies were weakly reactive only with enzyme-treated cells or pan-reactive, possibly some of them represent autoantibodies or antibodies against high-frequency antigens. In seven patients anti-Le only enzymaticademonstrated, probably natural antibodies. Thus, in at least 34 patients (15.0%) alloimmunization was proven or suspected; in 11 patients the alloantibodies were "only enzymes". In addition, the 36 alloantibodies of known specificity (8 anti-D, 2 anti-D+C, 16 anti-E, 1 anti-C, 3 anti-e, 1 Anti-K, 1 anti-s, 1 anti-Lea, 1 anti‐Goa), three antibodies reactive only with Fy(a‐b‐) cells and two antibodies of specificity not yet identified were detected. Anti-D was found in six D‐patients (3 had been pregnant) (along with anti‐C in two patients). In three out of four D+ patients with anti‐D, oneright hand drivethe gene variant was demonstrated (2 DAU alleles and 1 DIII type 4 or DIVa-2).

Logistic regression revealed that none of the risk factors analyzed was associated with the presence of antibodies in the 34 patients.

Fifty-eight patients had experienced an adverse reaction during or shortly after the transfusion (12 patients had dark urine). Adverse reactions were associated with the number of units received (OR 1.71 (95% CI, 1.25-2.33; P=0.001), but not with the presence of antibodies (P>0.7).

Summary/Conclusions:Alloimmunization could be demonstrated in at least 15% of multitransfused patients with SCD, mainly (80%) directed against Rh antigens. The unique enzyme reactivity, together with the absence of antibodies in 7 of 12 patients with probable haemolytic reaction and the known disappearance of antibodies especially non-Rh suggest a possible low titer and disappearance of some clinically relevant antibodies.

Given the high immunization rate coupled with the high frequency of adverse transfusion reactions, pretransfusion screening for antibodies against red blood cells should be considered for patients with SCD.

5A-S29-04

STRONG ANTI-D IMMUNIZATION INDUCED BY PREGNANCY IN THE PHENOTYPE OF WITH ALLELE RHD*01EL.04

M Pisacka1, J Kralova1, V Hanzikova2, P caliente3, A Hori4, E Pazourkova4, S. Schneider5, S. Scholz5

1Immunohematology Reference Laboratory, Institute of Hematology and Blood Transfusion2Department of Transfusions, Hospital General Universitario3Center for Fetal Medicine, Charles University and University General Hospital4Institute of Biology and Medical Genetics, General University Hospital, Prague 2, Czech Republic5Inno-train Diagnostics GmbH, Kronberg, Alemania

Bottom:The Rh blood group system and mainly the D antigen is one of the most immunogenic, diverse and clinically important protein-based blood groups. Anti-D antibody can induce hemolytic transfusion reactions and hemolytic disease of the fetus and newborn. Anti-D prophylaxis becomes ineffective if anti-D immunization has occurred. Approximately 1% of the D+ population carriesright hand drivealleles associated with reduced expression of the D antigen. Qualitative variants, in which some epitopes are missing and can produce anti-D antibodies, are generally referred to as partial D. In contrast, D weak is commonly defined as a quantitative variant that has all D epitopes and should not produce anti‐D. Del is a very weak form of the D antigen and cannot be detected by routine serologic testing. Because some of the Del individuals have already developed an anti‐D antibody while others have not, this group contains both qualitative and quantitative changes.

Goals:The investigation began when discrepant results were found in the typing of the D antigen in a pregnant woman/3rdpregnancy 1callechildbirth, 2 abortions in 1callequarter/. Routine serologic techniques detected D negativity and the presence of allo‐anti‐D antibodies at clinically significant titers. Non-invasive testing of fetal D status from maternal peripheral blood was indicated, but this was not applicable due to the presence of theright hand drivegene in the woman's DNA sample isolated from a buccal swab. Our goal was to investigate the discrepancy and determine the underlying cause.right hand drivegenotype.

Methods:Blood samples, peripheral blood DNA and buccal smears of the pregnant woman were investigated. Routine blood grouping and antibody testing was performed by column agglutination. Two anti-D sera (ID-DiaClon anti-D IgG (ESD1 cell line) from BioRad and Anti-D duo IgM+IgG, clone: ​​TH28+MS26 from Immucor) were used for the adsorption/elution test for the identification of the Initial Front phenotyperight hand drivegenotyping was performed by RT‐PCR (exons 5,7,10) with DNA from buccal swabs; further resolution was performed using PCR‐SSP (FluoGene; Inno‐train Diagnostik GmbH); Sequencing was performed by Sanger analysis (Inno‐train Diagnostik GmbH).

Results:The genotype was identified asRHD positiveby CE-certified PCR-SSP kits (FluoGene). Sanger sequencing ofright hand drivefrom exon 1 to 9 revealed the presence of a nucleotide deletion at position c.147delA, which is specific for the alleleRHD*01EL.04. This nucleotide change results in the amino acid change p.Val50Leufs*5 causing the Del phenotype. The presence of the D antigen was checked by adsorption/elution technique. The anti‐D titer increased during pregnancy to the 2000 level two weeks before delivery. The newborn was born by S.C. No signs of hemolytic disease. The newborn's blood group revealed blood group A, D negative, DAT negative, the test for Del was not performed.

Summary/Conclusions:The case reported here shows that women withRHD*01EL.04allele are capable of developing strong anti-D immunization, so this type of Del phenotype belongs to the "Partial Del subgroup". variant presenceright hand driveA gene in the mother that disables prenatal fetal genotyping from maternal blood by current methods requires a more attentive approach to the care of such pregnancies. Compatible with MH CZ-DRO UHKT 00023736 and RVO-VFN 64165.

5A-S29-05

ANTI-RBA IS A VERY COMMON RED CELL ANTIBODY IN GERMANY

EA Scharberg1, S. Rothenberger1, A Stürtzel1, N Gillhuber1, S. Seyboth1, my judge1, lane G2, P Bugert2

1Institute for Transfusion Medicine and Immunohematology, DRK-BSD Ba-Wü-He, Baden-Baden2Institute for Transfusion Medicine and Immunology, University of Heidelberg, Mannheim Medical School, Mannheim, Germany

Bottom:Rba(DI6) is a low prevalence antigen of Diego's blood group system. It has been found in few families only. The clinical importance of anti‐Rbais unknown so far. HeSLC4A1*c.1643C>T(p. Pro548Leu; ISBT allele name: DI*02.06) the allele is the molecular basis of Rbaantigen. In the gnomAD database, this genetic variant was found in only one of the 125,742 sequenced genomes (allelic frequency: 0.000004).

Goals:To test the frequency of the allele in our population and obtain an Rbapositive donor we perform a molecular screening toDI6in 1,700 blood donors. After our antibody screening test accidentally contained an Rbapositive test cell, we found that anti-Rbait is a very common antibody specificity. The frequency of the antibody in patients and blood donors was checked.

Methods:For the molecular screening of blood donors we developed a PCR-SSP method. Antibody detection testing in 3,652 patients and 964 blood donors was performed in the gel technique (BioRad AHG ID-Cards) using a 3-cell detection panel (DRK-BSD SRC) including an Rbapositive test cell. Positive reactions with Rbapositive cells were confirmed by an additional Rbapositive test cell from different source. Additional antibodies were excluded or identified by the same method using an antibody identification panel (DRK‐BSD IRC).

Results:Molecular screening of the DI*02.06 allele in 1,700 blood donors did not reveal any positive individuals. Within the first 2 weeks of using our antibody detection test that inadvertently contained the Rbapositive cell test 84 patients with anti‐RbaThey were found. It was 2.3% of 3,652 patients tested in 21 laboratories in different parts of Germany. Some laboratories stopped using Rbapositive batch to avoid costly and time-consuming identification and conformation tests. In 18 of 964 randomly tested blood donors (1.9%) anti‐anti‐Rbawas also present.

Summary/Conclusions:Despite the very low frequency of the DI*02.06 allele, anti‐Rbait is an unexpected antibody very common in patients and blood donors in Germany. Obviously, it occurs naturally and is even more prevalent than anti-Wr.aand anti‐Vw that we found in previous studies in around 1% of patients and donors.

Clinical - Hemovigilance

5A-S30-01

THE IMPORTANCE AND APPROACH TO IMPLEMENTING A HEMOSURVEILLANCE SYSTEM

year

National Blood Center, Ministry of Health and Sports, Yangon, Myanmar

Hemovigilance, which detects every event of not only patient reactions and donor complications, but also incidents and near misses definitely improves the quality of blood transfusion services, especially in those situations where it is not possible to implement all standards at the same time.

The health system in Myanmar is still at the stage of requiring priority for clinical professions and has limited resources for support functions. Support services, including the transfusion service, are not yet a focus of prioritization in the health care system. Blood transfusion service has been practiced in Myanmar since 1935. The true essence of blood transfusion service is hidden behind laboratory practice and transfusion is considered as part of laboratory research. Hospital laboratories are responsible for analyzing blood donated by replacement donors. These types of transfusion services under the laboratory umbrella are still practiced in Myanmar, except for the National Blood Center (NBC), which was established in 2003 in accordance with the Blood and Blood Products Act. This Law was formulated in a manner consistent with the WHO blood safety strategies. In 2002, the global survey based on WHO data sent out questionnaires to assess the safety status of the blood transfusion service. NBC noted that there was no data that could support corrective actions for the safety. From then on, active retrospective review of existing data and entry of records, prospective detection of process errors and any hospital blood bank events were recorded and acted upon locally. In 2003, the review of the pattern of screening between voluntary and replacement donations raised the alarm about the importance of education and the systematic recruitment of voluntary donors in a situation of high prevalence of viral carrier rates in the general population. The introduction of the donor deferral system, verification of previous donation and test history were the result of this active analysis. The results of the international EQAS in 2003 further motivated us to change the testing methods of HBs Ag. By reviewing the history of the Japanese transfusion service, systematic recruitment of voluntary donors, changing testing strategies, and planning were gradually introduced. of blood transfusion services so that they are well organized at the national level. In 2018, NBC supported 140,560 units of blood components to meet the demand for 14 HBBs from 99% voluntary donations using systematic planning based on system data. The TTI test is now used Minipool of 6 NAT for new donors and Eclia for repeat donors. The government covers the cost of each unit of blood. In 2017, the National Committee for Blood and Blood Products was established. The steering committee is working hard to gain the cooperation of all services to prevent these undesirable events before establishing national policies, standards and guidelines for sustainable service quality.

In conclusion, by using the essence of hemovigilance as a tool, the quality of the transfusion service can be improved step by step to fill the gap despite the limited resources. The system started at the local level, spreads to the regional level by gaining significant agreement on hemovigilance results, and finally nears approval at the national level.

5A-S30-02

LEARNING FROM TRANSFUSION "NEVER EVENTS": REVIEW OF UNINTENDED OR INCOMPATIBLE TRANSFUSION AS REPORTED ABOUT SERIOUS TRANSFUSION RISKS 2010-2017

s narayan1, J Addison1, poles D2, H Mistry3, S Carter‐Graham1, one watt4

1Clinical‐ Hemovigilance2research analyst3Laboratory Incident Specialist, Serious Transfusion Hazards4Human Factors Expert at SHOT Working Expert Group, Independent, Manchester, UK

Bottom:Erroneous transfusion of ABO-incompatible (ABOi) blood almost always reflects a preventable failure in transfusion protocols and standard operating procedures and can have disastrous consequences, with significant morbidity and mortality. These incidents should be systematically investigated to identify system vulnerabilities to mitigate risks and improve patient safety. Since 2016, SHOT reporters have been asked to rate (0-10) the extent to which the cause of incidents can be attributed to key factors: personal, environmental, organizational, and governmental/regulatory, helping to recognize the key factors identified during the investigation of these. incidents

Goals:Understand why unintentional transfusion of ABOi blood components continues to occur despite standard procedures and available national guidance.

Methods:A retrospective analysis of unintentional transfusion of ABOi blood components reported to SHOT between 2010 and 2017 (inclusive) was performed to identify common themes and recognize areas for improvement. Information provided through the SHOT Human Factors Investigation Tool (HFIT) between 2016 and 2017 was reviewed to understand more about why the errors occurred.

Results:67 unintentional ABOi transfusions were reported between 2010 and 2017; the majority (56/67, 83.6%) were red cell transfusions, but ABOi plasma (9/67) and platelet (2/67) transfusions were also observed. Most errors occurred in the clinical area (45/67, 67%) and could have been detected at the point of administration. In 21 (31%) cases, the error could not have been detected at the point of administration with a primary laboratory error in 10/21 (48%) incidents.

Reviewing the HFIT data for cases in 2016-2017 (13 ABOi cases), the total staff guilt score was 100, compared to a total score of 99 for the other three organizational and system factors. This disparity is most obvious in the 4 ABOi red cell cases, all of which scored the maximum out of 10 for staff culpability, ie 40/40 compared to 8/120 as the combined total score given to the other factors. In previous years (2010 to 2015), HF scores were not available; however, the emphasis on personnel-related culpability is demonstrated in 37 cases that included a local case review outcome and 14 (37.8%) mentioned personnel-related disciplinary or retraining procedures. The risk of hemolysis and serious damage is more likely with ABOi red blood cells than with other components with 2/56 (4%) causing death, 14/56 (25%) major morbidity, and 40/56 (71%) none or minor adverse reaction. Of these cases, one resulted in a manslaughter conviction and at least two staff dismissals.

Summary/Conclusions:Transfusion events never continue to occur, and it is apparent that investigations of such incidents focus primarily on staff failure and do not consistently identify system-wide changes that need to be incorporated to address prevailing issues. National recommendations and a safety alert to “use a bedside checklist” were issued immediately before the administration between 2015 and 2018 to support the prevention of such errors, but the events never persist. The current approach is ineffective because it often leads to apportioning blame, rather than understanding the multidimensional and often complicated factors that contribute to failure. This must be replaced by a holistic approach that addresses local job pressures and embraces advances in automated technology such as e-prescribing and barcode scanning.

5A-S30-03

REDUCED WHOLE BLOOD HEMOSURVEILLANCE IN PATHOGENS FROM MIRASOL IN GHANA

Un Owusu-Ofori1, L Asamoah-Akuoko2, M. Acquah2, S Wilkinson3, J Ansa2,B Brown3,S Owusu-Ofori1

1University Hospital Komfo Anokye, Kumasi2Hospital Docente Korle Bu, Accra, Ghana3Terumo BCT, Lakewood, United States

Bottom:Data collection and monitoring are critical elements of a hemovigilance (HV) system. Terumo BCT, Inc. (TBCT) and AABB Consulting Services collaborated with the Ghana National Blood Service to optimize HV data collection. The Japan International Cooperation Agency funded this project.

Goals:The objectives of the project were to improve transfusion practice by establishing a system to monitor and evaluate the safety of blood transfusions in two hospitals, Korle Bu Teaching Hospital (KBTH) in Accra and Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana. An assessment of transfusion-related acute adverse reactions (TRARs) was performed between whole blood (WB) transfusions treated with the Mirasol Pathogen Reduction Technology (PRT) system versus conventional WB transfusions.

Methods:HV trainings were conducted in May 2017. HV training based on ISBT standards included: 1) quality systems, 2) TRAR, 3) HV forms and reports, and 4) database development. Routine use data was collected prospectively. Data collection focused on assessing the acute ARR of WB transfusions. In December 2018, data was analyzed to assess the safety of Mirasol-treated WB in routine use in radiotherapy, obstetrics and gynecology, oncology, pediatrics, hematology, gynecology and maternity emergency rooms.

Results:As of December 2018, 2,181 transfusion records were collected; 1019 transfusions of WB treated with Mirasol and 1162 transfusions of conventional WB. Overall, there was 4.02% TRAR in Mirasol-treated WB recipients and 5.59% in conventional WB recipients. In Mirasol-treated WB recipients, there were n=7 (0.69%) allergic reactions (ARs), n=17 (1.67%) febrile nonhemolytic transfusion reactions (FNHTRs), n=3 (0.29 %) transfusion cases ‐ acquired circulatory overload (TACO), transfusion-related acute lung injury (TRALI) and n = 14 (1.37%) unclassified transfusion reactions. Of the confirmed TRARs, n=27 were possibly related to treatment, n=2 TRARs were probable, and n=2 were definitely related to treatment; n=37 ARRT were grade 1, n=4 grade 2, and none were grade 4. In conventional WB recipients, there were n=13 (1.12%) RA, n=32 (2.75%) FNHTR , n=1 (0.09%) TACO, n=0 TRALI, and n=16 (1.38%) unclassified transfusion reactions. Of the confirmed TRARs, n=55 were possibly related to treatment, n=1 TRARs were probable, and n=8 were definitely related to treatment; n=54 TRARs were Grade 1, n=1 Grade 2, and n=1 Grade 4. There were 21 Mirasol-treated WB transfusions in pregnant women and 2 TRARs (9.5%), both Grade 1 and probably related. . There were 80 transfusions of Mirasol-treated WB and 84 transfusions of conventional WB in patients <18 years of age, resulting in n=7 (8.33%) TRAR in recipients of Mirasol-treated WB and n=10 (11, 90%) in conventional WB receivers.

Summary/Conclusions:Timely reporting of TRAR data and expansion of HV infrastructure has helped improve the HV system in Ghana. Of 2181 transfusions of WB commonly used in Ghana, there were 4.02% TRAR in Mirasol-treated WB recipients and 5.59% in conventional WB recipients. In addition, Mirasol-treated WB was safely transfused into pregnant women and pediatric patients.

5A-S30-04

USE OF IRRADIATED BLOOD PRODUCTS IN PATIENTS AT RISK OF TRANSFUSION ASSOCIATED GRAFT VERSUS HOST DISEASE

H Yuen, Rushford K , Dunstan T , Michael C , Tey A , Yeoh K , Wood E

Hematología, Monash Health, Melbourne, Australia

Bottom:Transfusion-associated graft-versus-host disease (TA‐GVHD) is rare and usually fatal. It can be prevented by providing irradiated blood products to patients at risk, such as those receiving nucleoside analogues, alemtuzumab, bendamustine, or those with Hodgkin lymphoma (HL). The duration of risk is uncertain, so ensuring that these people correctly receive irradiated blood components for life, as currently recommended by the ANZSBT and BSH guidelines, is challenging. In Australia, platelets are routinely irradiated, but red blood cells (RBCs) are not.

Goals:To determine whether patients receiving fludarabine, cladribine, bendamustine, alemtuzumab, or dacarbazine (for HL) correctly received irradiated red blood cells. Secondary outcomes included TA-GVHD rates after unintentional exposure to non-irradiated components, factors influencing correct issuance of irradiated red blood cells such as transfusion treatment plans, and provision of adequate clinical information on blood requests.

Methods:We conducted a retrospective audit to identify patients receiving therapies indicating risk of TA‐GvHD using pharmacy dispensing records from January 2008 to October 2018 at Monash Health, a multi-campus teaching hospital in Melbourne, Australia. Diagnosis, dates of treatment, group and hold (G&H) requests, red blood cell transfusions, and follow-up information were obtained from medical and laboratory records.

Results:We identified 310 patients who received fludarabine (n=52, 17%), bendamustine (n=29, 9%), cladribine (n=17.5%), dacarbazine for HL (n=164, 53%), and alemtuzumab (n = 48.15%). The median age of the patients was 46 years (range 8-92) and 171 (55%) were men. The median follow-up was 30 months (range 0 to 132). Post-challenge, 42 patients (14%) received transfusions and 33% correctly received irradiated red blood cells. The remaining 28, all from hematology/oncology, received a total of 192 unirradiated red blood cells. In 8 patients, this was corrected by subsequent transfusions. There were no cases of AT‐GVHD at the median follow-up of 14.5 months (range 0 to 75) from the first red blood cell transfusion.

After drug administration, 99 patients requested G&H after a median of 3 months (range 0-129). Only 23% of requests had sufficient clinical information to request irradiation, such as HL or medication details, and only 20% requested irradiated components.

Preventive strategies have now been employed. Transfusion management plans for hematology patients were implemented in March 2017. For audited patients, these were written from 38 days before to 104 days after drug exposure. Two were written after an inadvertent transfusion of non-irradiated red blood cells.

Patients identified in this audit will be issued a laboratory alert and, prospectively, pharmacy dispensing records will be sent to the blood bank to identify at-risk patients. Our hospital is transitioning to electronic medical records (EMR). An alert will be generated in EMR when ordering transfusions if there has been exposure to these medications. However, clinical awareness and documentation remain vital. Additional measures include patient education, alert cards, and ongoing collaboration with medical staff to encourage transfusion planning.

Summary/Conclusions:Recognition of patients at risk for TA‐GvHD remains low, even among hematology units. We are making progress to ensure a lifetime supply of irradiated blood components in patients exposed to nucleoside analogues or alemtuzumab, as well as in patients with HL. The implementation of an EMR and additional strategies in this domain is important to prevent TA‐GvHD.

5A-S30-05

REPORTING OF TRANSFUSION-RELATED ADVERSE EVENTS AND DOCUMENTATION COMPLIANCE AMONG HEALTHCARE PROFESSIONALS IN DEVELOPING COUNTRIES WITH THE OBJECTIVE OF IMPROVING PRACTICES

N anwar1, N Fatima2, H. Mujtaba2, T Shamsi1

1Hematology2Research and Development, National Institute for Blood Diseases and Marrow Transplantation Karachi Pakistan, Karachi, Pakistan

Bottom:Blood transfusion is considered an essential element in the management of patients worldwide. It can be risky and transfusion-related adverse reactions can occur with the least adherence to transfusion policies. Standard guidelines regarding screening for infectious disease in the blood, genuine need for transfusion, and ABO compatibility are drastically followed and monitored. However, assessment of the patient during the transfusion, especially at the patient's bedside and after the transfusion, is equally important as well.

Goals:We are a newly established hospital and we are working to achieve the best possible management of patients. In this sense, in order to minimize transfusion errors and highlight if any fault is practiced during the transfusion, we conducted this study to observe the rate of compliance with the documentation of the transfusion form by health personnel and also to observe compliance with the course of action taken in the event of the appearance of transfusion reactions.

Methods:This was an observational study conducted at NIBD and BMT, PECHS campus from February 2018 to February 2019. Ethical approval was obtained prior to the study. The transfusion form was completed for each transfusion. The form provided information on the documentation of the name of the recipient of the blood product, employee identity number, date and time of receipt of the blood product, name of the patient, medical record number in the units, on the patient's wristband, and on the registration form. transfusion. ABO compatibility on the unit and on the form, wristband medical record number, name and employee ID number of two healthcare personnel who started the transfusion, start and end time of the transfusion. Time, temperature, blood pressure, pulse, and staff initials at the time of the order, at baseline, after 15 minutes, and at the end of the transfusion were also included. The transfusion reaction form was also filled out by health personnel. Data was analyzed using SPSS version 23.0.

Results:A total of 500 transfusion forms were analyzed. Overall, the compliance rate was 18%. Of 500, 115 (23%) forms were available in the source notes and of 115, 88 (76%) were partially and completely completed. Greater compliance was observed in the initial months of the hospital setting than in the subsequent months (P value = 0.000). The highest non-compliance was observed in the documentation of the initials of the doctors on duty on the transfusion form at the end of the transfusion (3%) and the highest compliance was observed in the documentation of the name by the nursing staff of care doctor at the beginning of the transfusion (89%). A total of 02 (0.4%) RBC and platelet adverse events were reported. The median time to onset of symptoms was 2 hours and 30 minutes for red blood cells and for platelets it was 1 hour and 13 minutes. The transfusion was stopped instantly as symptoms appeared without delay and steps were taken to resolve the reactions. The time of onset of symptoms and the time of starting medication were documented and free of errors. All blood bags were returned to the blood bank and discarded after 6 hours per hospital policy.

Summary/Conclusions:The study was carried out to highlight the few practices that health personnel are implementing in the context of documentation and notification of transfusion reactions in our hospital. Strict actions must be taken for adherence to compliance by health personnel to avoid morbidity and mortality. We believe that it will also be useful to provide reference information in the process of preparing a national guideline and protocol on blood transfusion procedures.

Adverse events: new indications for pathogen reduction methods

5A-S31-01

IMPACT OF PATHOGEN INACTIVATION ON PLATELET SURVIVAL AND ALLOIMMUNIZATION

how to buser, in Holbro, L. Infanti

Regional Blood Transfusion Service, Swiss Red Cross, Basel, Basel, Switzerland

To make the blood supply safer, Pathogen Inactivation (PI) technologies have been developed. They rely on photochemical treatments (amotosalen/UVA or riboflavin/UV) or UV‐C light to reduce potential pathogens in blood components. However, this security gain could be offset by the "off-target" effects of these technologies.

In virtually all platelet transfusion clinical trials, post-transfusion increases with PI platelet (PLT) components have been shown to be minor compared with conventional components, indicating different biologic behavior such as survival/ purification of treated and untreated PLT. Published studies have also suggested shorter survival of platelets in vivo in animal studies.

Furthermore, data for alloimmunization and refractoriness rates after PI platelet transfusion show conflicting results. Animal studies suggest a reduction in alloimmunization rates when PLT PI is transfused (leukoreduced) compared to conventional PLT.

In the clinical setting, published data, including very recent reports, have shown different HLA class I and II alloimmunization rates with the two currently available photochemical-based PI technologies.

While the PI components of PLT surely benefit patients with respect to pathogen safety, the impact of possible off-target effects possibly impairing the efficacy of PI PLT transfusions needs further investigation.

5A-S31-02

EFFICIENT INACTIVATION OF BRUCELLA CLINICAL ISOLATES IN HUMAN PLATELET CONCENTRATES IN 100% PLASMA WITH AMOTOSALEN AND TREATMENT WITH UV LIGHT A

F Alseraye1, Oh Alsaweed1, F. Albloui1, H. Alghethber2, a hazazi3, F. Aldakheel4

1Pathology and Laboratory Medicine2Internal Medicine, Hematology, Security Forces Hospital, Riyadh3Department of Pathology and Laboratory Medicine, Security Forces Hospital, Riyadh4Clinical Laboratory Sciences, King Saud University, Riyadh, Saudi Arabia

Bottom:Brucellosis is an endemic disease and remains a major health problem in Saudi Arabia. The Saudi Arabian Ministry of Health listed brucellosis as a notifiable disease due to its endemicity. In the last ten years, the incidence has decreased significantly to approximately 15 cases per 100,000, but it is still higher than in developed countries. Human-to-human transmission is extremely rare, including through breastfeeding, transplacental, sexual, and blood transfusions. Five cases of brucellosis due to blood transfusion have been reported in the literature. Transmission of Brucella through blood transfusions is likely unreported due to the long incubation time of 2 to 4 weeks (range, 5 days to 5 months), vague clinical presentation, and lack of hemovigilance systems. in endemic areas.

Goals:Evaluation of the efficacy of the Amotosalen/UVA technology to inactivate clinical isolates of Brucella in 100% concentrated human platelets in plasma. Considering a minimum infectious dose of 10-100CFU, sterilization is needed to prevent infection.

Methods:100% plasma whole blood derived provisional platelet units (IPUs) were produced with an automated Reveos system (Terumo BCT). Six IPUs were pooled and inoculated with approx. 12,000 CFU of a clinical isolate of Brucella per group. Baseline samples were taken from the pool pre-inoculation and tested for bacterial growth, red blood cell count, white blood cell count, pH, platelet count, eddy, and HIV/HBV/HCV serology. and NAT. The pool was incubated at 20-24 °C with continuous shaking for 24-30 h, followed by division into a therapeutic test unit and a small volume control unit. The test unit was treated with the INTERCEPT Blood System Large Volume Processing Set for Platelets (Cerus Corporation), while the control unit was not treated. Both units were stored until day 7 at 20-24°C with continuous agitation, taking samples for blood culture using an automated BacT/ALERT system (Biomerieux) before inactivation and on day 7 of storage. Negative blood cultures were incubated for 21 days.

Results:All the pools were negative for bacterial growth, did not show the presence of aggregates and had an RBC count≤01.x10.6/mL. Six different clinical isolates of Brucella were characterized by 16s rRNA sequencing and used for independent inactivation experiments. The average incubation time after inoculation was 26:47 h (25:30-27:00 h). Taking that into consideration, the pre-inactivation of the bacterial load was calculated based on a doubling time of 2.5 to 3.5 hours and an initial titer of approx. 30CFU/mL to be approx. 5760-46080CFU/mL. Test units had an average volume of 289 mL (281-300 mL) and a total platelet dose of 3.3x1011(2.9‐4.0x1011). After inactivation, all test units (day 1 and day 7) were negative for 21 days of blood culture, while control units were positive after a mean culture time of 20:17 h (19:25 to 9:24 p.m.) on day 1 and 7:21 a.m. (4:26-8:38 a.m.) on day 7.

Summary/Conclusions:All six Brucella isolates were efficiently inactivated in 100% plasma human platelet concentrates, pointing toward better prevention of transfusion-transmitted Brucella infections.

5A-S31-03

THERAPEUTIC RESPONSE TO MOTOSALEN/GRAPE-TREATED PLATELETS WITH UP TO 7 DAYS OF STORAGE DURING 5 YEARS OF ROUTINE PRACTICE

the children1, a holbro1, J Passweg2, D Tappe3, irish j4, JLin3, L. Corash3, Benjamin R.3, a busero1

1Basel Regional Blood Transfusion Service, Swiss Red Cross, Division of Hematology, University Hospital2Division of Hematology, University Hospital, Basel, Switzerland3Cerus Corporation, Concord, CA, United States,4Cerus BV, Amersfoort, The Netherlands

Bottom:The Swiss Red Cross blood transfusion service, Basel, introduced the universal use of pathogen-inactivated apheresis (80-90%) amotosalen/UVA (INTERCEPT™ Blood System for Platelets) and derived whole blood mixture, layer leukocyte (10-20% platelet components (PC) in 65% platelet additive solution (PAS) (Intersol) and 35% plasma in 2011. PC were routinely stored for up to 7 days.

Goals:The study evaluated the impact of PC storage age on the therapeutic efficacy of amotosalen/UVA-treated PC under routine use conditions for hematopoietic stem cell transplantation (HSCT) and non-Hematology/Oncology (Heme/Onc) patients. HSCT treated at the University Hospital Basel. .

Methods:Amotosalen/UVA-treated PCs stored for up to 7 days were transfused for all indications with routine collection of platelet counts prior to transfusion and 1 to 4 hours post-transfusion. Platelet component and recipient characteristics of all platelet transfusions were prospectively captured and retrospectively analyzed by day of storage. The platelets were transfused in order of entry, without taking into account the age of the PC. The risk of hemostasis failure was assessed by the need for an additional CP or RBC transfusion on the day or the day after an index CP transfusion.

Results:Between January 10, 2011 and May 17, 2016, 22,579 INTERCEPT PCs were transfused to 2,809 general hospital patients. The platelet dose was 3.0±0.4×1011with a storage age of 4.2 ± 1.4 days. About 18.3% were > 5 days of age at the time of transfusion. Heme/onc and HSCT patients used 77.5% PC and comprised 982 (35.0%) of the transfused population, 441 (15.7%) heme/onc, 411 (14.6%) allogeneic (alloHSCT ) and 130 (4.6%) autologous (autoHSCT). ) HSCT patients, with corrected mean count (ICC) increments of 8.7 × 103, 8,0×103y 7.2×103, respectively. Mean ICC decreased linearly between day ≤2 and day 7 PC (9.0 × 103, 9,1×103y 8,5×103en≤2días; 6.7×103, 5,8×103y 4,9×103at 7 days, respectively), although the number of PCs transfused on day 7 to patients with autoHSCT was small (n = 71). The proportion of transfusions followed by additional PC on the same or next day was 47.8%, 73.4%, and 50.4% for day ≤2 PC vs. 46.4%, 73.6%, and 66 .2% for day 7 CP in Heme/Onc, alloHSCT, and autoHSCT patients, respectively. Same-day or next-day use of RBCs as transfused index PC was 49.7%, 53.2%, and 44.8% for day ≤2 PC vs. 49.6%, 48.0% and 49.3% for day 7 PC, respectively. The median time to next CP transfusion was ≤1.0 days for day ≤2 CP and 1.0 days for older CPs in all three groups. The incidence of all transfusion reactions, febrile nonhemolytic transfusion reactions, and allergic reactions was comparable for CP ≤5 or >5 days of age in all groups.

Summary/Conclusions:Transfusion of pathogen-inactivated CP older than 5 days to hematology/oncology, allogeneic, and autologous HSCT patients is safe and efficacious and did not affect hemostasis as assessed by the need for additional CP or RBC transfusions on the day or day after a transfusion index PC.

5A-S31-04

NIPAH VIRUS IS EFFICIENTLY INACTIVATED IN PLATELETE CONCENTRATES BY UVC LIGHT USING THERAFLEX UV PLATELET TECHNOLOGY

the gravemann1, M. Eickmann2,W Handke1, F Tolksdorf3, A stranger1

1Research and Development, Red Cross Blood Service NSTOB, Springe2Institute of Virology, University of Marburg, Marburg,3Macopharma, Langen, Germany

Bottom:Nipah virus (NiV) is a paramyxovirus (genus Henipavirus) that emerged in the late 1990s in Malaysia and has since been identified as the cause of sporadic outbreaks of severe febrile illness in Bangladesh and India. NiV infection is frequently associated with severe respiratory or neurological illness in infected humans with transmission to humans through inhalation, contact, or consumption of NiV-contaminated food. The Nipah virus (NiV) belongs to the list of pathogens identified by the WHO with the potential for a global pandemic.

Goals:This study aimed to investigate the efficacy of the THERAFLEX UV-Platelets system to inactivate NiV in platelet concentrates (PC). The THERAFLEX UV‐Platelets (Macopharma) system uses UVC light without the need for any additional photoactive compound.

Methods:Plasma-reduced PCs from 4 BC (35% plasma in SSP+ additive solution) were spiked with virus suspension (10% v/v). PCs (n = 2,375 mL) were then irradiated with UVC in the Macotronic UV machine (Macopharma) and samples were taken after aggregation (load and hold sample) and after illumination with different light doses ( 0.05, 0.1, 0.15 and 0.2 (standard. ) J/cm2)). Titer of NiV (Malaysia) was determined as tissue culture infective dose (TCID50) by endpoint titration in microtiter plate assays on Vero 76 cells (ATCC®CRL‐1587™).

Results:The results of the infectivity assay demonstrated that UVC radiation inactivated NiV in a dose-dependent manner. After adding a NiV titer of 6.2 (#1 bag) and 6.5 (#2 bag), log10 TCID50/mL was received in the PCs. At a UVC dose of 0.10J/cm2and higher NiV was inactivated up to the detection limit of the system (1.9 log10 TCID50/mL), resulting in log10 reduction factors of ≥4.3 (bag #1) and ≥4.6 ( bag #2).

Summary/Conclusions:Our results demonstrate that the THERAFLEX UV‐Platelets procedure is an effective technology to inactivate NiV in contaminated PC.

5A-S31-05

USE OF PLATELET PATHOGEN REDUCTION TO IMPROVE STOCK MANAGEMENT IN A NATIONAL BLOOD SERVICE

n arnason1,2, Landro R.1, G. Swansdottir1, B. Harderson1, yo Hjalmarsdottir1, T. Jonsson1, S. Gudmundsson1, OE Sigurjonsson1,2,3, A Halldorsdottir1,3

1The blood bank, Landspitali‐The National University Hospital of Iceland2Faculty of Science and Engineering, Reykjavik University3Faculty of Medicine, University of Iceland, Reykjavik, Iceland

Bottom:The Reykjavik Blood Bank (BB) is a nationwide blood transfusion service in Iceland serving a population of 350,000. Due to Iceland's unique geographic location, managing our blood stocks is both a challenge and a matter of public safety. To stabilize the supply of platelet concentrates (PCs) and reduce the risk of bacterial contamination, Pathogen Reduction (PR) of all PCs was implemented in 2012. The INTERCEPT Blood System™ (IBS) allowed platelet storage to be extended from 5 to 7 days. Prior to 2012, PC stocks fluctuated greatly, resulting in periods of PC shortages and disposal of obsolete units. The implementation of IBS with 7-day storage was expected to reduce fluctuations, have a positive impact on waste, and reduce incidences of PC shortages.

Goals:To compare the use of PC in Iceland in two periods, before and after the implementation of the SII in 2012, including the age of units transfused and the number of units transfused per year and per patient.

Methods:Data on platelet ordering was extracted from the ProSang blood bank information system. The number of PC requested per year, the number of PC transfused per patient, the age of the PC (in days) at the time of the transfusion, and the platelet content of the PC were compared in two periods of five years, before (2007- 2011) and after (2013-2017) the implementation of public relations

Results:There was a change in the seniority of the PC at the time of the request when the periods before and after the implementation of the SII were compared, since the average seniority of the PC at the time of the request before the SII was 2.0±0, 24 days (range 0-5 days) compared to 4.16±0.23 days (range 0-7 days) after SII implementation (P = 1.93 × 10‐8). The number of PC per year in our center did not change after implementing the SII, since the number of platelet concentrates requested annually before PR was 1682±383 (range 1035-2087 units) compared to 1923±59 ( range 1763-2090) after PR (P=0.19). In addition, the mean number of PC per patient did not change, since the mean use of PC per patient and year before PR was 5.42 ± 0.35 units/patient (range 4.93-5.83 units/ patient) versus 5.86±0.38 (range 5.39‐6.17 units/patient) after RP (p=0.07). PC buffy coat platelet content was significantly lower after RP implementation (274±37.7×10e11 vs. 364±20.6×10e11 platelets/unit, P<0.001), while platelet content PC apheresis did not change (305±9.9 vs. .300, ±16.1, P=0.57).

Summary/Conclusions:The reduction in pathogens resulted in the transfusion of older PCs on average, but without altering the number of PCs requested or the use of PCs per patient. Pathogen reduction has improved PC stock management without an increase in platelet demand, despite lower PC buffy coat platelet content after PR implementation.

Donors and donation - Donor adherence - are we doing the right thing?

5A-S32-01

KEEP THE BLOOD FLOWING

L Eberhart

Donor Management, Austrian Red Cross, Wien, Austria

The transfusion procedure is the last step in a multi-process supply chain. The task of matching supply with demand requires donor managers to consider average weekly or monthly consumption rates, but also to have an idea of ​​variability in order distribution and potential attribute (blood group) requirements. . Since hospitals and blood banks are generally not deeply interrelated and often only ex post data are available, forecasting methods must be implemented. A thorough analysis of the order pattern is required to establish weekly target inventories and security levels to close the information gap. A collection plan should identify potential bottlenecks that can be prevented by planning shipments between shipments, changing message urgency, and creating pools of reserve donors.

Constant analysis of fundraising and mobilization KPIs enables donor managers to implement the continuous wave planning approach and continually adapt to changing requirements, unexpected events, and overall systemic variability. Variability occurs on the demand side, as order quantities and their attributes, such as blood group distribution, are subject to change. However, the supply is also subject to significant variation, as donor response rates, attrition, deferrals, and overall donor availability are not constant. Unfavorable combinations of variable factors often lead to bottlenecks if only long-term average values ​​find their way into the planning process.

5A‐S32‐02

THE BEHAVIOR CHARACTERISTICS OF THE FIRST BLOOD DONORS IN TURKEY: AN EXTENSIVE ANALYSIS OF THE MODEL OF THE THEORY OF PLANNED BEHAVIOR

NN Sozmen, Ulukanligil M , Caglak S , Coplen S

General Directorate of Blood Services, Turkish Red Crescent, Ankara, Turkey

Bottom:A total of 7,338,696 donors had donated blood in Turkey between 2009 and 2017, with the frequency of donation decreasing proportionally (Ulger, 2019, Vox Sanguinis ISBT Series). The percentage of donors who donated blood only once is 51.8%, while those who donated sixteen and twenty-four times are 0.14% and 0.005% over 8 years. These results indicate that first-time donors make up a large part of the TRCS donor pool. An understanding of donor behavior and the factors that motivate them to donate blood again after the first donation is necessary to improve donor retention.

Goals:In this study, we focus on donor retention by examining a number of factors that may contribute to first-time donor intentions to donate blood again by using structural equation modeling to present the relationships between extended theory of planned behavior (TPB) in the literature. and additional factors.

Methods:Data were collected using the face-to-face interview method immediately after donation. 1,478 first-time donors attended the study at 18 regional blood centers in 29 cities in Turkey.

The survey included items according to the standard TPB predictors of attitude, self-efficacy, and intention. Self-identity, anticipated regret, donation anxiety, paraphernalia anxiety, personal moral norm, descriptive norm, satisfaction, and motivation were also assessed for first-time donors.

The relationship between predictors and intention was confirmed with correlation analysis. The distribution of predictors analyzed by multiple linear regression. Various goodness-of-fit indices were calculated and examined for each model tested (IBM, AMOS SPSS).

Results:The predictors were significantly correlated with intention. The basic TPB model was compared with the proposed model derived from the results of the France model (France, Transfusion, 2007) and subsequently with the Masser model (Masser, Transfusion, 2009) (Cmin/Df: 354.94, 40.505 and 29,785, respectively). The results of the goodness of fit tests for the proposed model provided a better fit to the data than these models (Cmin/Df=14). In addition, this result indicated that the fit between the proposed model and the data could be improved with additional modifications with the inclusion of pathways between motivation and attitude, self-identity, and intention. In addition, the inclusion of the paths between anxiety and donation intention and between self-efficacy and attitude, contrary to recent analyzes that suggest opposite paths.

The evaluation of the goodness of fit tests showed a good result for the revised model with a value of Cmin/Df=3.55, close to the perfect fit. The revised model revealed that attitude was the strongest positive direct predictor of intention, followed by personal moral norm, self-identity, motivation, and anticipated regret (path coefficients: 0.47, 0.28, 0, 19, 0.17 and 0.5, respectively). Donation anxiety was the direct negative predictor of intention (‐0.05). Satisfaction was the strongest positive surrogate predictor of intention via attitude, followed by self-efficacy (0.90 and 0.08). Paraphernalia anxiety was the negative surrogate predictor of intention (‐0.03). The descriptive norm did not show any significance. Our model accounted for 75.3% of the variance in intention.

Summary/Conclusions:These findings suggest several potential avenues to improve donor retention. The results obtained with this study provide important data from the point of view of donor retention, which should be implemented in the future strategies of the Turkish Red Crescent.

5A‐S32‐03

TOWARDS MORE UNIFORM DONOR ELIGIBILITY CRITERIA: OVERVIEW OF THE FIRST RESULTS OF TRANSPOSE

Mori, E Merz, K van den Hurk, S van Walraven, M van Kraaij

Sanquin, Amsterdam, Netherlands

Bottom:TRANSPOSE-TRANSfusion and Transplantation: Donor Selection and Protection, is a European consortium project, including partners from 16 countries, that reviews donor selection and protection policies for substances of human origin (SoHO). One of the main problems in the current donor selection system. , which TRANSPOSE seeks to address, is that for many, if not most criteria, it is not evidence-based. Therefore, the TRANSPOSE consortium tries to re-evaluate the selection criteria, revised them where necessary and provided evidence-based recommendations where possible. TRANSPOSE also adds to the current European Directorate for the Quality of Medicines and Healthcare (EDQM) Guidelines by emphasizing donor safety.

Goals:The aim is to compare existing donor eligibility criteria across Europe and compile a list of risks to consider, with evidence-based or consensus deferral criteria to provide more uniform donor selection criteria.

Methods:There are three horizontal work packages (WPs); WP1 Coordination, WP2 Dissemination and WP3 Evaluation of the project, and four technicians with specific deliverables and milestones that will occur periodically:

  • WP4 Inventory of Donor Selection and Protection Practices;

  • WP5 Development of Risk-Based Guidelines for Donor Selection and Protection;

  • WP6 Development of a Donor Standard Health Questionnaire (DHQ);

  • WP7 Training Course/Workshop on the Use of the Guiding Principles, Guidelines and the DHQ.

The TRANSPOSE project was launched in September 2017 and will be completed in Spring 2020. WP4 completed its work in October, WP5 will complete its work in June 2019, and WP6 and WP7 started recently.

Results:Using the deliverables created by WP4, we have created a detailed inventory of current practices in donor selection and protection, including an overview of the similarities and differences between European countries and between SoHO types. There is agreement among experts that existing guidelines are often based on the precautionary principle rather than risk assessment. Consequently, in developing the WP5 Donor Selection and Protection Guidelines, we now make an effort to also emphasize donor safety, in a more evidence-based manner through the use of risk-based assessments. This will result in a standardized DHQ with a common trunk and more detailed questions per SoHO.

Summary/Conclusions:The impact of the TRANSPOSE results will be threefold. Firstly, the results are expected to help revise the EU Directives related to donor selection and protection. Second, the set of guiding principles and Donor Selection and Protection Guidelines will make it easier for EU member states to take the next step in implementing donor selection and protection policies in a coherent and clear manner to the benefit of both both donors and recipients of SoHO. Third, a standard Donor Health Questionnaire with carefully guided local/regional/national adjustments will be made available by SoHO which can be widely used and consequently will enable comparisons of the prevalence of certain risks and risk behaviors across Europe.

5A‐S32‐04

CURRENT PRACTICES IN THE SELECTION AND PROTECTION OF DONORS IN EUROPEAN COUNTRIES AND SUGGESTIONS FOR IMPROVEMENT: THE CASE OF BLOOD AND PLASMA

E Merz1, G. Mori1, K van den Hurk1, S Van Walraven2, M. Van Kraaij2

1donor studies2Donor Affairs, Sanquin Blood Supply, Amsterdam, The Netherlands

Bottom:TRANSPOSE – TRANSFUSION and TRANSPLANT PROTECTION AND SELECTION OF DONORSis a European consortium project, including partners from 16 countries, that reviews donor selection and protection policies for blood, plasma, tissue, assisted reproductive technology (ART) and stem cells (together SoHO). Donor Selection Criteria (DSC) in Europe are based on EU directives and guidelines and additional country-specific criteria. The literature shows that particular criteria are outdated or not risk-based, often leading to unnecessary deferral of donors or underestimation of risks to donors.

Goals:To 1) provide a comprehensive inventory of current systems for the selection and protection of donors and donations, 2) critically review them, and 3) recommend a comprehensive Donor Health Questionnaire (DHQ) that includes allnecessarycriteria currently used by different EU member states (EU-MS).

Methods:In-depth semi-structured interviews with key blood collection stakeholders were conducted to identify major themes for improvement in the current DSC. These formed the basis for a survey sent to practitioners at collecting institutions across SoHO to obtain feedback on current systems from as many EU-MS organizations as possible. Questionnaires were sent to a total of 163 experts (40 blood, 40 plasma, 27 tissue, 47 stem cells, 9 ART) and 39 (24%) completed questionnaires were received. Where information was lacking, additional experts were asked to make DSC recommendations.

Results:For blood and plasma donation, four main areas of concern were identified in DSC: risk-based selection, adaptability, flexibility, and consistency. Stakeholders agreed that DSCs are often out of date and lack evidence, leading to unnecessary deferral of donors and underestimation of risks to donors. They suggested basing the DSC on group risk assessment (risk-based selection) and further research to achieve standardized risk perceptions and evidence-based deferrals, either for recipient or donor safety. The criteria could be made more detailed to adapt to specific groups to defer fewer donors (adaptability). Furthermore, implementation of the criteria was considered easy, but abolishing the criteria when they are no longer considered a risk seems almost impossible (flexibility). In addition, deferral periods are perceived as too long, seen both as negative, that is, endangering the donor's intention to return, and positive, that is, without risk to security (consistency). Changing the legislation to a guide was an often mentioned suggestion to improve the DSC. Comments specific to plasma donations revealed that many whole blood topics are not applicable to plasma-only donors, e.g. parasitic infections such as malaria (no postponement needed); travel history (no deferral needed) and recent bacterial and viral infections (deferral periods currently too long). A clear need for more research on issues related to plasma collection was identified.

Summary/Conclusions:DSCs are perceived by most stakeholders to be redundant in a considerable number of respects. In addition to achieving the goal of savings and sufficient SoHO for patients, many regulations could be improved to decrease deferrals and lower donor risks. TRANSPOSE will join the review, improvement and harmonization of these standards and criteria. In addition, TRANSPOSE will provide suggestions for improving directives and guidelines and a DHQ, focusing both on protecting the health of donors and on the safety of donations, but also removing deferral criteria that are no longer relevant, and will offer a future research agenda to make DSC more evidence. -based.

5A‐S32‐05

LARGE DIFFERENCES IN THE REPORTING OF ADVERSE REACTIONS IN BLOOD AND PLASMA DONATIONS WITHIN THE EUROPEAN UNION – RESULTS OF THE TRANSPOSE PROJECT

C Mikkelsen1, J Castrén2, C Eguizábal3, J Fernandez Sojo4, S. Fontana5, M Hansen6, K van den Hurk7, M. van Kraaij8, R. Kullaste9, To Navarro Martinez‐Cantullera10, G. Mori11, F Urbano3, M Vesga3, E Veropalumbo12, S. Zahra13, H Any1

1Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark2Finnish Red Cross Blood Service, Helsinki, Finland3Basque Center for Transfusion of Blood and Human Tissues, Galdakao4Blood and Tissue Bank of Catalonia, Barcelona, ​​Spain5Interregional Blood Transfusion SRC, Berna, Suiza6Blood Center Copenhagen, Copenhague, Dinamarca7Sanquin Research8Sanquin Blood Bank, Department of Transfusion Medicine and Donor Affairs, Amsterdam, The Netherlands9North Estonian Medical Center Blood Center, Tallinn, Estonia10Catalan Transplant Organization (OCATT), Barcelona, ​​Spain11Sanquin, Amsterdam, Netherlands12Italian National Blood Center (NBC), Rome, Italy13Scottish National Blood Transfusion Service, Edinburgh, UK

Bottom:TRANSPOSE -TRANSfusion and transplantation: Protection and selection of donors, is a project co-financed by the European Commission with the participation of 24 stakeholders from private and non-profit blood collection organizations, as well as researchers and officials. The project aims to create new evidence-based donor selection criteria, as well as guiding principles for risk assessment of threats to the safety of all substances of human origin (SoHO), except solid organs. As part of this, an inventory of the current risks associated with donation was carried out, including an investigation of the type and number of reported adverse events.

Goals:Here we aim to present an overview of adverse events reported in whole blood and plasma donation in Europe and to compare this with the anticipated risks rated by TRANSPOSE stakeholders.

Methods:National or local data on adverse reactions from the years 2014 to 2017, both serious and mild, were collected in whole blood and plasma donors from relevant stakeholders (18 and 19 respectively). Stakeholders were also asked to rate the most important anticipated donor risks based on severity, level of evidence, and prevalence. We then compare the relevant stakeholder-assessed risk categories with the categories in the data provided, as well as the heterogeneity of the category numbers.

Results:Thirteen stakeholders provided data on adverse events during whole blood donation in a given year, including a total of thirty-three different categories of adverse events, ranging from a single unspecified reaction to seventeen different categories, with an average of nine. categories by stakeholder. The most used categories were hematoma (included by 77%), arterial puncture (77%) and nerve damage (54%). Vasovagal reactions were also frequently included (75%); however, this was being performed variably as unspecified vasovagal reactions and acute and/or delayed vasovagal reactions. Only one actor reported iron deficiency.

For plasma donation, seven stakeholders provided data on adverse events. A total of twenty-seven different categories were reported, ranging from one to seventeen per stakeholder, with an average of nine. The most frequently reported adverse events were hematoma (86%), citrate reactions (86%), and arm pain and nerve damage (both 57%, respectively).

Anticipated risks in donating blood were rated by nine stakeholders who rated iron deficiency, vasovagal reactions, and bruising as the greatest risks for donors. For plasmapheresis, six stakeholders rated vasovagal reactions, bruising, and citrate reactions as higher risk.

Summary/Conclusions:As shown, the categories used to describe blood donation adverse events vary greatly in Europe, with some countries only being able to provide the total number of adverse events without further specification. In addition, there is a gap between the elevated donor-perceived risks and the adverse reaction categories reported in surveillance of whole blood donors, as reports of iron deficiency are virtually absent despite the risk being considered. more important.

Our findings show the need for international collaboration to create a standardized international donor surveillance system, to collect more information on donor risks to protect donor health.

Plenary session: a glimpse into the future

PL‐03‐01

INVISIBLE ORGANS

R Blasczyk

Institute for Transfusion Medicine, Hannover Medical School, Hannover, Germany

Modern transplant medicine has progressed significantly in recent decades due to a better immunological understanding of rejection and advances in immunosuppression. However, the serious side effects of long-term, usually lifelong, immunosuppression and the scarcity of donor organs remain the main constraints on transplantation. The idea behind all research to improve transplant outcome has always been modification of the recipient's immune system to ideally induce a specific tolerance towards the donor graft. In fact, immunological blindness of the recipient to the donor graft is achieved by a general reduction in the competence of the immune system and represents a significant burden for transplant patients. The idea of ​​invisible organs is a completely different approach to solving the problem: instead of inducing immunological blindness of the recipient's immune system, an immunological invisibility of the donor organ is created. This is accomplished by genetically engineering the transplant to eliminate the immunogenicity of the organ defined by the major histocompatibility complex (MHC) gene products and minor histocompatibility antigens. In addition to manipulating the expression of MHC genes necessary for immune recognition, immune cloaking strategies are used to evade immune rejection. These approaches take advantage of the creation of an immunosuppressive environment and the expression of immunosuppressive molecules through immunomodulatory transgenes. MHC engineering and immunocloaking in a whole organ is achieved during ex vivo perfusion by lentiviral transduction of gene expression modifiers and transgenes to induce permanent immunological invisibility of the organ. Importantly, MHC engineering also prevents the presentation of minor histocompatibility antigens, which typically cannot be matched between donor and recipient, but which trigger potent immune responses and graft rejection. Eliminating the targets of cellular and humoral rejection, as well as creating a specific immune environment for the allograft through immune cloaking, camouflages the organ and equips it with a powerful set of defense weapons. Immunoengineering of transplants achieved during the unavoidable ex vivo period of the allograft after explantation without the need to accept off-target effects allows the recipient's immune system to be kept fully functional and capable of fighting infection and cancer. In vivo preclinical studies from rodents to minipigs could demonstrate a clear survival advantage of ex vivo engineered transplants. This approach has the potential to remove the burden of organ rejection and immunosuppression, thereby sustainably increasing transplant survival, organ availability, and quality of life.

PL‐03‐02

GENE EDITING IN SICKLE CELL DISEASE

D Bauer

Pediatric Hematology, Boston Children's Hospital, Boston, United States

Gene editing for sickle cell disease

Reexpression of fetal γ-globin genes (HBG1/2) could be a universal strategy to ameliorate severe β-globin disorders, sickle cell disease (SCD) and β-thalassemia by inducing fetal hemoglobin (HbF, α2γ2). we have previously identifiedBCL11AErythroid enhancer sequences, marked by common HbF-associated genetic variants, which are required for HbF repression in adult-stage erythroid cells but dispensable in non-erythroid cells. We have recently optimized the conditions for target-selection-free CRISPR-Cas9 editing in human HSCs as a near-complete reaction with no detectable genotoxicity or deleterious impact on stem cell function. We demonstrate that Cas9:sgRNA ribonucleoprotein (RNP)-mediated cleavage in the core sequences of +58BCL11AThe erythroid enhancer results in highly penetrating disruption of the GATA1-binding motif, reduced expression of BCL11A, and induction of fetal γ-globin. Graft-edited HSC SCD erythroid progeny express therapeutic levels of HbF and resist sickle cell formation, whereas those from patients with β-thalassemia show a restored globin chain balance. Furthermore, we found that HSCs preferentially undergo non-homologous repair compared to microhomology-mediated final junctional repair. based on NHEJBCL11AEditing of enhancers approaching complete allelic arrest in HSCs appears to be a feasible therapeutic strategy to produce long-lasting induction of HbF. In this presentation, I will compare and contrastBCL11Aediting of enhancers to other autologous curative gene therapies and gene editing approaches in various stages of clinical and preclinical evaluation.

PL‐03‐03

WATT WORMS – TAKE A DEEP BREATH

FZal

Hemarina SA, Morlaix, France

Oxygen is vital for life. Without oxygen, death is assured for aerobic organisms. Although everyone knows this fact, many medical acts forget to take care of it, leading to many potential problems. Indeed, during cellular respiration the oxidation of glucose by oxygen gives carbon dioxide, water and energy. This energy, also called ATP, is necessary for cell metabolism and consequently for life. We have identified an extracellular hemoglobin from a marine worm, calledArenicola marina, which is capable of supplying oxygen to this animal that lives in the intertidal zones of the Atlantic coast of France between the North Sea and Biarritz. This molecule called M101 was developed into the medical device called HEMO2life.®. We have shown that this product was very efficient in protecting organs before transplantation. A multicenter clinical trial conducted under the supervision of Pr. Le Meur of the CHU Brest, in 60 patients awaiting kidney grafts showed a delayed graft function reduced by approximately three between the two kidneys harvested from the same donor with and without HEMO2life®and grafted onto the recipients. In 2018, a world first was carried out in France by Pr. Ltieri at the Georges Pompidou hospital in Paris, France. In fact, it was the first time that a patient received a second face graft. This surgery was performed with HEMO2life®and it showed a very good result according to Pr Lantieri, the anastomoses were very easy and no edema was observed. In addition, we have developed a dressing that incorporates M101 making a product called HEMHealing.®. Preclinical data in diabetic mice showed an increase in the healing process. HEMOXY Carrier®, a therapeutic oxygen carrier, is also under development to treat ischemic diseases such as sickle cell disease, myocardial infarction, and stroke. This non-blood type universal oxygen carrier, which is the ancestor of our hemoglobin-containing red blood cell, has been shown to be capable of delivering oxygen to different biological, cellular, tissue and organ levels and could address a multitude of medical applications.

Management and Organization - Organizational issues

P-001

WHO IS A DONOR RECRUITER; AN UPDATED PERSPECTIVE

n.n.solaz, Bayik M, Uluhan R, Emekdas G, Pelit N

Turkish Blood Foundation, Istanbul, Türkiye

Bottom:The main objective of transfusion is to save lives and/or improve the health status of humans by “safe blood” who needs regular, voluntary, unpaid blood donors. Donor recruitment is becoming a more sensitive and challenging part of the blood supply system under real world socioeconomic conditions. Achieving sufficient voluntary unpaid blood donations (VNRBD) can be established through efficient donor recruitment. The efficiency of donor recruitment still has a close relationship with the blood donor recruiter, although there are many new tools. The occupational specifications, rights and responsibilities of the blood donor recruiter have wide differences between countries that cannot be fully explained by the specific conditions of each country. In addition, there was no specific document that had an international consensus on this issue. The Turkish Blood Foundation (TBF) has been organizing an international workshop since 2012; Anatolian Blood Days (ABD). “Who is a blood donor recruiter?” was the theme of ABD-VII from March 9 to 11, 2018.

Goals:The main objective of the workshop was to verify and evaluate the existing systems of the participating countries. They create a template to clearly define the occupational specifications, responsibilities, and rights of the blood donor recruiter.

Methods:Experts from 25 countries participated in the workshop. Those countries are Albania, Algeria, Bosnia-Herzegovina, Estonia, France, Germany, Hungary, India, Kazakhstan, Lithuania, Macedonia, Montenegro, Oman, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Tajikistan. . , Türkiye, Uganda, Uzbekistan. These countries reflect almost every religious, ethnic, social, cultural, and economic situation in the world. A questionnaire that analyzed the existing systems in the participating countries sent before the workshop. After the country presentations, 4 different focus groups were organized. The topics listed below were announced in the final declaration.

Results:Donor Recruiter:

  1. You must have a university degree preferably in the field of Marketing and Business Administration.

  2. must have a certificate and/or professional experience in Public Relations

  3. must have efficient conversation skills, sociability, independence, self-confidence, reliability, resilience and conscientiousness, as well as teamwork

  4. you need to get special training which includes not only social issues like public relations, marketing etc. and medical issues related to BB&TM before practicing solely as a donor recruiter

  5. must be a permanent staff

  6. Must have base salary and performance bonus may be given

  7. is eligible to monitor and modify the work period of the mobile team in the blood donation drive

  8. must participate in the mobile blood drive he/she has organized

  9. the group that will create promotional materials for the national blood service must participate

  10. The number in each blood establishment should be defined based on the annual blood draw, such as 5 employees for 50,000 whole blood draws per year in Germany.

Summary/Conclusions:In conclusion; Both recruiting and retaining donors are not easy tasks to perform as the public ages and birth rates are declining around the world. The dedicated blood donor recruiter whose occupational specifications, rights and responsibilities are clearly defined will be the cornerstone of success in providing enough safe blood for transfusions.

P-002

IS AFRICA ON THE PATH TOWARDS A SAFE AND SUFFICIENT BLOOD SUPPLY?

CT Smit Sibinga1, J Emmanuel2

1IQM Consulting, ZUIDHORN, The Netherlands2BTS Consultants, Harare, Zimbabwe

Bottom:Africa is a large continent with 55 independent states and a total population of 1,275,710,034 (February 2018). Health care policies and strategies are developed through WHO advocacy, guidance and support from headquarters in Geneva and the 2 WHO regional offices; Eastern Mediterranean Regional Office (EMRO) supporting 8 Arabic-speaking countries and the African Regional Office (AFRO) responsible for 47 sub-Saharan countries. The distribution of the population is approximately 40.6% urban. A large number of different local dialects and languages ​​are spoken. The main languages ​​spoken are English, French, Portuguese, Spanish and Arabic. The countries are mainly classified by the UNDP as having a low and medium human development index.

The African Society for Blood Transfusion (AfSBT) has members in most countries, advocates for the development of sustainable and effective blood services, and has developed a stepwise 3-tier accreditation program.

In 2016, EMRO held a consensus meeting to develop a "Strategic Framework for the Availability and Safety of Blood 2016-2025" with a set of priority interventions focused on leadership and governance, cooperation and collaboration, safe supply of blood and blood products, proper clinical use of Blood, and Quality System Management.

In 2001, the 54 member states of the African Union (AU) countries, in Abuja, Nigeria, committed themselves that the national budget for health should be at least 15% of the national fiscal budget.

In 2013, the Ministers of Health of the WHO Member States approved the inclusion of blood and blood products in the List of Essential Medicines; these endorsements and WHO's Universal Health Coverage (UHC) have yet to be fully implemented.

Goals:Analyze (gap analysis) the extent to which countries in Africa implement World Health Assembly Resolution WHA63.12 on the availability, safety and quality of blood products, which urges governments to ensure safe, accessible, affordable supplies and available blood and components from voluntary unpaid blood donors, who meet clinical transfusion requirements and achieve national self-sufficiency, following WHO guidelines and recommendations.

Methods:To provide an overview of the current state of the blood supply in Africa: strengths and weaknesses, data from the WHO 2016 Global Status Report on Blood Safety and Availability was analyzed and used. The study has been descriptive and exploratory.

Results:The 2016 Report identified a number of areas requiring attention; beginning among these were

  • inadequate financing;

  • lack of governance and leadership;

  • ineffective public education about donating blood;

  • lack of capacity building for clinicians on the rational use of blood;

  • lack of Hemovigilance and implementation of quality management systems;

  • the need for regulatory or supervisory mechanisms.

Summary/Conclusions:National Authorities must address the areas that require attention if progress is to be made in ensuring a sustainable, safe and sufficient supply of blood products. The key is the commitment and support of national governments, which must implement the Resolutions and Recommendations agreed by the Ministers of Health in the WHA and the African Union.

P-003

REVISION OF THE PERSONNEL LIST FOR THE BLOOD DONATION TESTING LABORATORY (BDT)

B Mohamed Siddique, K Chia, C Goh, Z Huang, W Tan, J Liew, X Su, T Leong, S Chua, S Lam

Blood Services Group, Health Sciences Authority, Singapore, Singapore

Bottom:The central function of the Blood Donation Testing (BDT) Laboratory is to test each unit of blood collected from a donor for blood type and infectious disease markers to ensure the safety of the national blood supply prior to transfusion. The laboratory operates daily in two work shifts, made up of 4 employees in the morning shift (AM) (from 8:00 a.m. to 5:30 p.m.) and 5 employees in the afternoon shift (PM) (from 1:00 p.m. to 10:00 p.m.) from Monday to Friday and 3 employees in the morning shift and 5 employees in the afternoon shift on weekends. BDT Lab has a staff of 15 people for the 2 work shifts. Each staff member has a five-day work week and has to work shifts from 11 p.m. m. and shifts from 9 a.m. to 5 p.m. m. per month on average. The increased number of afternoon shifts generates feedback from staff that they do not have enough time in the evenings for family, social or leisure activities. A Lean Six Sigma project was initiated to revise the work roster to improve the work/life balance of staff.

Goals:The project aims to reduce the number of staff working on the PM shift without affecting downstream processes and continues to comply with the timely release of blood supply to hospitals.

Methods:Lean Six Sigma tools were used to study the BDT Lab workflow process and to identify the factors that contribute to the increased number of PM shifts that staff must take on. Data on response time and human effort required for each screening test performed were analyzed. A survey was also conducted to understand staff preference for the acceptable number of PM shifts per month.

Results:The main factor contributing to the need for more staff to run the afternoon shift is that most of the daily donation samples are received only at night. As this factor is out of the control of the BDT laboratory, redistribution of work from the afternoon shift to the morning shift was ultimately selected as the solution to reduce the number of staff needed for the afternoon shift. The screening test that was changed was determined based on the test system that has the shortest turnaround time and can allow for continued publication of results. At the same time, most of the personnel must be trained for that test system. A test was conducted on the new roster involving 5 employees on the morning shift and 4 on the afternoon shift. The total number of PM shifts per month has been reduced from 124 to 112 using the redefined process. The 10% reduction translates to fewer PM shifts staff need to perform and was able to meet staff expectations.

Summary/Conclusions:By adopting the new process workflow, BDT Lab was able to reduce the number of preventative maintenance shifts staff need to onboard using the evidence-based process improvement method. Most importantly, the lab has a team of satisfied staff with a better work-life balance.

P-004

A MODEL FOR CRISIS MANAGEMENT IN EMERGENCY TRANSFUSION: EMERGENCY TRANSFUSION KIT FOR DISASTER AND CRISIS SITUATIONS

Fiscal Year Ayhan1,2, H Sarihan2

1transfusion center2Hemovigilance Department, Dr Behcet Uz Children's Hospital, Izmir, Türkiye

Bottom:The preparation of blood transfusion services for emergencies and crisis situations is an important issue related to patient and transfusion safety.

Goals:Having an experience of delay in the supply of blood components in an emergency situation due to partial interruption of the Hospital Information System (HIS), it is intended to create a crisis kit and establish an alternative workflow for emergencies in crisis situations.

Methods:It is stipulated that the failure of the HIS, which normally performs the entire transfusion process, would be disabled in a disaster or crisis situation. Brainstormed on potential challenges associated with HIS disability during transfusion emergencies. According to the scenarios, a kit was developed for the management of transfusion emergency processes.

Results:A suitable flowchart was designed using the WHO definitions of transfusion emergency and instructions were written to explain the flowchart. All the forms categorized with different color codes are designed to be filled out by handwriting. The kit consists of a flowchart and instructions, test request forms (blue), blood component request forms (pink), procedure forms (green), pens, and blood sample tubes. with EDTA which were placed in a plastic folder labeled Transfusion Emergency Disaster and Crisis Kit (TEDC). In addition, the kit is placed in a sealed clear plastic bag and shipped to all pediatric and surgical inpatient and intensive care units.

A training program related to transfusion emergency situations and the use of the TEDC kit was developed for health workers involved in the blood transfusion process. Pre and post assessment tests were developed to assess the effectiveness of the training program.

Summary/Conclusions:It is a challenge to improve the response capacity of blood transfusion services during emergencies and crisis situations.

P-005

Summary withdrawn.

P-006

COMPUTERIZATION IN BLOOD BANKS: CHALLENGES AND SOLUTIONS

t chandra1, D. Agarwal2, M. Agarwal3, R. Agarwal4

1Department of Transfusion Medicine, King George Medical University, Lucknow, Lucknow2GSVM Medical College3Era Medical College, Kanpur4St. Francis’ College, Lucknow, India

Bottom:India is a developing country with 2,760 licensed blood banks. Most have manual documentation that causes inaccuracies and errors in blood bank activities. Monitoring is a Herculean task. Computerization is the need of the hour, but this goal involves many obstacles and challenges.

Goals:The aim of this study is to discuss the challenges faced during the computerization of blood bank activities and the solutions to remedy them.

Methods:Department of Transfusion Medicine, King George Medical University, Lucknow is one of the largest blood banks in the country with an annual collection of 70,000 units of blood. Two years ago, the blood bank worked in a totally manual system. Computerization brought challenges associated with the installation of hardware and software and the training of personnel. The hardware was installed in two phases. Initially HP system, but later switched to Apple iMac due to frequent crashes. With HP server. Installing the software (Easy software) resulted in erratic internet connectivity, so it was changed to LAN. Personalization involved radical changes according to our needs. Sometimes we had to change our way of working to adapt it to the software. Biometric linkage, medical record, cash ID generation, donation, serological crossmatching, automatic blood grouping, labeling, chemiluminescence and NAT testing, blood component preparation, and campouts were all included. with challenges at all levels. Small to large corrective actions were taken. The training of staff was the most essential part of the implementation of computerization, who initially showed considerable resistance and sometimes feigned ignorance due to fear that their mistakes would be highlighted and they would be penalized for it. It was a Herculean task to create their password-protected identity and force them to use it. Gradually, the staff realized that computerization made their job easier, as it reduced red tape and redundancy, and also prevented serious errors from occurring. Hard copies were still kept in certain essential areas to continue work in the event of a major computer failure.

Results:Computerization helped us regulate the movement of the donor that was sometimes repetitive due to manual input. The data transfer guaranteed a secure supply and errors could be corrected very easily. The implementation, which included installation, training and compliance, took a period of 6 months. After overcoming all the challenges, we minimized the printouts to 6 records and started printing the other necessary details.

Employee turnover time due to computerization decreased by 20%. Wait time for attendant decreased by 10%. The traceability of all units became 100%. The supervision of the activities carried out was 90% accurate. Donor identification was easy thanks to biometrics that included thumb print and iris scanning. Donor decision-making time was reduced by 50%, making the system more efficient.

Summary/Conclusions:The manual for computerization implies participation from the source to the supply and it is essential to anticipate the challenges and be prepared for the solutions for its implementation to be successful.

P-007

BLOOD SYSTEMS OF THE COUNTRIES OF THE WHO EASTERN MEDITERRANEAN REGION: EXISTING LEGISLATIVE INSTRUMENTS

CT Smit Sibinga1, Y Abdela2, F. Konings2

1IQM Consulting, ZUIDHORN, The Netherlands2WHO Eastern Mediterranean Office, Cairo, Egypt

Bottom:The WHO defined essential medicines (EMs) as medicines that meet the health care needs of the majority of the population. They must be available at all times, in adequate quantities, in appropriate dosage forms, with assured quality and affordability. In 2013, blood and blood products (whole blood, red blood cells, platelets, plasma, and plasma-derived products) were added to the WHO MS Model List. authority (RA) is crucial for the management of blood products such as MS. However, particularly in the less developed world, these prerequisites have barely been implemented.

Goals:Analyze and advise on existing legislation and regulations.

Existing legislative instruments from the 22 Member States of the WHO Eastern Mediterranean Region (EMR) were compiled and analyzed to determine their relevance and adequacy for the preparation and use of blood and blood products, as well as the use of associated substances. and relevant medical devices. A literature search was conducted on matching combinations of regulatory system, regulatory framework, legislation, regulation, with production and use of blood and blood products, resulting in references almost exclusively to national and international legislation. Parameter: WHO recommendations (Aide Mémoires) and EU directives.

Methods:Existing legislative instruments from the 22 Member States of the WHO Eastern Mediterranean Region (EMR) were compiled and analyzed to determine their relevance and adequacy for the preparation and use of blood and blood products, as well as the use of associated substances. and relevant medical devices. A literature search was conducted on matching combinations of regulatory system, regulatory framework, legislation, regulation, with production and use of blood and blood products, resulting in references almost exclusively to national and international legislation. Parameter: WHO recommendations (Aide Mémoires) and EU directives.

Results:Governments enforce various formal legislative documents from only 9/22 countries [1960 (Egypt) to 2017 (Pakistan - Sindh)]. Most are detailed descriptions of RAs, operating locations, and specific requirements. However, none of these legislations comply with the formats and contents recommended by the WHO and the EU, and will not support effective regulatory oversight to promote and improve the quality, safety and availability of these MEs.

Summary/Conclusions:The government must provide effective leadership and governance in the development of a national blood system (NBS), fully integrated into the national health care system. The essential functions of an SNB include an appropriate regulatory framework with laws, regulations and other non-legislative instruments administered by an RA These documents should detail the principles and charts, standard setting and organization of the blood system to ensure an adequate supply of blood and blood products and a safe clinical transfusion for which a Model was designed.

The structure of the NBS will depend on the organization and level of development of the health care system. However, all critical activities within the NBS must be coordinated at the national level to promote uniform standards, economies of scale, consistency in staff competency, quality and safety of these EMs, and best transfusion practices. The key is the formulation of an appropriate regulatory framework administered by an RA responsible for regulating the vein-to-vein chain in the preparation and use of these EMs.

P‐008

BLOOD TRANSFUSION SERVICE IN POLAND IN THE PERIOD 2008–2017

and Rosiek, J Antoniewicz-Papis, E Lachert, A Tomaszewska, M Letowska

Department of Transfusion Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland

Bottom:The ability of the blood transfusion service to provide an adequate supply of blood components is a matter of concern to healthcare providers throughout the world; longer-term observations of trends in this regard are therefore of crucial value.

Goals:The aim of the study was the analysis of some basic activities of the Polish Blood Transfusion Service in 2008-2017, including organizational changes, the number of donors, donations and blood components, as well as activities aimed at increasing their safety. .

Methods:Retrospective analysis of the data supplied by the regional Blood Transfusion Centers (BTC).

Results:In the period discussed, blood and blood components were collected at 21 BTC regional and local collection sites, as well as during mobile collections.

While the number of local collection sites decreased from 170 in 2008 to 133 in 2017 in favor of mobile collections, which increased from 8,672 to 13,189, the former remains the number one place for blood donations. On average, 47.36% of all donations were made at local collection sites.

The total number of blood donors both at the beginning and at the end of the commented period was similar (583,908 in 2008 and 588,184 in 2017); more than 99% of all donors were unpaid. However, the number of first-time donors dropped significantly (from 237,658 in 2008 to 143,038 in 2017).

The total number of donations went from 1,076,655 in 2008 to 1,249,655 in 2017; the most frequent were whole blood extractions (from 1,016,411 in 2008 to 1,171,302 in 2017). Some blood components (mainly plasma and platelet concentrates) were also collected by apheresis.

The most frequently prepared blood components were red blood cell concentrates: red blood cells (996,678 to 1,154,239 units per year), fresh frozen plasma: FFP (1,090,369 to 1,289,021 units), and platelet concentrates: PC (81 692 to 129,143 units, with a significantly increasing trend).

Additional processing methods, such as leukocyte depletion and irradiation, were more frequently applied to PCs (52–57.6% in respective years irradiated, 75.18–92.07% leukocyte depleted) than to red blood cells (4.46–8.46% irradiated, 7.65–20.7% leukocytes). exhausted).

Plasma pathogen reduction technologies and PCs were implemented in 2010. However, to date, the use of these technologies is limited in most BTCs. In 2017, approximately 11.5% of PCs and 8% of FFP units issued for transfusion underwent pathogen reduction technologies.

Summary/Conclusions:The data from our study can contribute to the evaluation of some long-term trends observed in the Polish Blood Transfusion Service and can serve as a practical reference. This, in turn, can be beneficial to the transfusion community as a whole.

P-009

DEVELOPMENT OF GUIDELINES FOR CHANGE MANAGEMENT IN THE BLOOD TRANSFUSION SERVICE FOR A MORE EFFICIENT BLOOD SUPPLY USING BIG DATA AND DATA MINING METHODS - STAGE 1

and Mikołowska, J. Antoniewicz-Papis

Department of Transfusion Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland

Bottom:In Poland, 80% of hospitals depend on blood for the treatment of patients; more than 1.5 million units of blood components are transfused annually. Therefore, it is useful to expand the knowledge about the factors that impact the blood transfusion service (BTS). The Institute of Hematology and Transfusion Medicine (IHTM), as the competent authority, is responsible for the collection of data related to the activity of all Blood Transfusion Centers (BCT) in Poland. These data are exploited to a much lesser degree than newly available statistical methods and data processing tools would allow. In addition, the research survey in the field of public health indicates an insignificant part of issues related to BTS. Therefore, it seemed necessary to "fill the gap" with a real evaluation of the performance of Polish BCTs in order to improve BTS activity. 1calleThe stage of our research refers to the collection, fusion of data from different sources, their unification and preparation (big data) for further analysis using methods of multidimensional statistical analysis and data mining.

Goals:Evaluation of the activity of Polish BTCs during the 20-year period (1997-2017) in two stages.

goals to 1callescenery:

  1. data digitization; scanning of paper documents.

  2. Development of a uniform template for collecting digital data from various sources.

  3. Standardization, unification, and improvement of the quality of the available data: filling in missing data, elimination of errors, duplicate records, etc., that may distort the results of the analysis.

  4. Selection of data for analysis.

Methods:Digitization and big data methods for processing various types of data:

  1. stored on paper (1997-2004),

  2. digital stored in two types of files (.doc and .xls, for the years 2005–2010 and 2011–2017, respectively).

For each data type, a separate Excel file template was created. The models were then merged into an analytical table with data processing methods.

Results:

  • 1

    1,344 pages of paper documents were scanned.

  • 2

    Models developed for data from 3 different sources:

    1. The data on paper was rewritten and attached to his model; result: 3 tables, 272 columns, 10,400 rows.

    2. .doc and .xls. files: data was attributed to 2 other models; result: 6 tables, 1656 columns, 788 rows.

  • 3

    The 3 models were merged into 1 analytical table to create a 588 MB database (comparable to approximately 784 minutes of music).

  • 4

    The data was subjected to standardization, unification and quality improvement: filling in missing data, elimination of errors and duplicate records that could distort the results of the analysis.

  • 5

    Selection of data for 2-way analysisNorth Dakotascenery.

Summary/Conclusions:the 1callestage provided a selected data set for analysis in the 2North Dakotastage that will be based on multidimensional statistical analysis and data mining methods.

The result of this analysis will contribute to the optimal achievement of the objectives:

  1. gaining in-depth knowledge about the fundamental phenomena that shape Polish BTS,

  2. identification of potential BCT changes,

  3. development of general guidelines for change management.

P-010

POSITIVE IMPACT OF THE NATIONAL TRANSFUSION SOCIETY; 20 YEARS OF EXPERIENCE OF BLOOD BANKS AND TRANSFUSION SOCIETY OF Türkiye

n.n.solaz, Bayik M, Uluhan R, Emekdas G, Pelit N

Turkish Blood Banks and Transfusion Society, Istanbul, Türkiye

Bottom:Although Turkey has practiced blood transfusion since the early 1920s, until 2000 there has been no specific education for Blood Bank and Transfusion Medicine (BB&TM) either in undergraduate or postgraduate medical education. The negative impact of this situation became a great threat to the safety of patients. blood transfusion. A group of dedicated doctors who were involved in the BB&TM field decided to solve this problem through a civil initiative and established a national blood society; “Blood Banks and Transfusion Society of Türkiye(BBST)” in 1996. Today; BBTST has 718 members. 75% of BBTST members are doctors, the rest are technicians, nurses, etc.

Goals:The main objectives were based on:

  1. Closing the knowledge gap between the blood bank and clinical staff

  2. Establishment of official and academic educational programs.

  3. Creation of informative publications in Turkish, such as textbooks, manuals, magazines, guidelines, etc.

  4. Establish close collaboration with the national health authority and other related parties

  5. Integrated with the international company BB&TM

Methods:

  1. Close collaboration was established with the Ministry of Health (MoH), the Turkish Red Crescent (TRC) and universities.

  2. With the collaborators, different curricula were created for national residential courses, daily courses, symposiums, workshops, etc.

  3. Translate EU Guidelines, prepare national guidelines,

  4. Several committees participate in MoH, TRC.

  5. Organize national congresses.

  6. Establish close contact with international organizations.

Results:

  1. So far 21 national courses, 11 national congresses, 20 seminars, 105 symposiums and 15 special sessions have been held at the national congresses of different clinical branches in different parts of Turkey.

  2. 2 international congresses; VIII. ISBT European Congress 2003 and XII. CAHTA-XX. BBTST Congress 2016

  3. 3rdInternational Thalassemia Summer School 2004, Curso conjunto con ESTM

  4. World Health Organization (WHO) Workshop in 2008. Participated in WHO Global Forms in 2007 and 2013.

  5. Annual international workshops started since 2012; Anatolian Blood Days; intended to play intact or less played BB&TM tracks. So far 8 workshops have been organized and each year about 30 countries from almost all religious, ethnic, social, cultural and economic backgrounds of the world have participated.

  6. Supported major changes at BB&TM in Türkiye;

    1. convince people and medical agencies, mainly the Ministry of Health, to give BB&TM due consideration

    2. promote the recognition and establishment of a national blood program

    3. issuing a new act of blood and numerous necessary statutes, etc.

    4. create an appropriate standard donor questionnaire form

    5. change the blood transfusion practice from 96% whole blood (in 1996) to 5%.

    6. change the screening criteria for donated blood; while HCV screening became mandatory Malaria, screening was canceled

    7. preparation of national guidelines

    8. promoting Hemovigilance nurse position

    9. promote patient blood management

  7. Around 11,000 blood bankers attended national courses, 7,000 attended national congresses, 18,000 attended national symposiums.

Summary/Conclusions:BBTST can be accepted as a sample of how a non-governmental scientific organization can have a very positive impact on the development and progress of BB&TM activities in close collaboration with the Ministry of Health and other related organizations.

P-011

Summary withdrawn.

Information technology

P-012

IMPLEMENTATION OF THE INFORMATION TECHNOLOGY GOVERNANCE FRAMEWORK FOR BLOOD SERVICES IN RESOURCE LIMITED CONTEXTS

T Crucified1, C Zaugg2, L. Marowa3, R Credit4

1Planning, Information and Research Department, Zimbabwe National Blood Service, Harare, Zimbabwe2Blood Safety Program, Swiss Red Cross International Cooperation, Bern, Switzerland3Coordination Department4Finance Department, Zimbabwe National Blood Service, Harare, Zimbabwe

Bottom:Globally, there is increasing investment in information technology (IT) in business. This similar trend has been observed in blood establishment computerized systems (BECS). IT investment can be high, so IT decisions need to be properly informed. The African Society for Blood Transfusion (AfSBT) encourages the use of IT in African blood services as this optimizes quality blood services and therefore improves patient outcomes. AfSBT established an IT working group (AfSBT ITWG) in 2016 with the support of the Swiss Red Cross (SRC) to lead IT standards among member blood services. Several priority IT topic areas were identified. These include IT governance that focuses on creating (strategic alignment) and preserving (risk management) business value. There is no published literature on how a structured IT governance framework can be implemented in a resource constrained environment. A review of the IT governance of the Zimbabwe National Blood Service (NBSZ) was conducted based on the published IT governance framework.

Goals:Explore how structured IT governance can be developed, implemented, and monitored in a resource-constrained environment.

Methods:A published MIT-CISR framework that has six components was used to assess the strength, gaps, and opportunities of IT governance.

Results:NBSZ has been implementing an evolving structured IT governance system. In terms of strategy and organization of the Service, there is a well-established IT function which is reflected in NBSZ's strategic plans. This ensures IT's annual budget support, which averages 4.3% of the total budget. IT governance arrangements are such that decision rights are assigned to different members of the IT staff (executives, IT specialists, and users). A variety of IT solutions have been integrated within NBSZ operations, such as BECS, financial and donor mobile apps, social media, temperature monitoring, and human resources. Business performance objectives are defined and consistent across the various business units. The IT organization and desirable behaviors are documented in the ICT policies and procedures and, should corrective actions be needed, they are available through the code of conduct. IT metrics are included within NBSZ's monitoring and evaluation system that uses a four-color traffic light reporting system. It was observed that IT responsibilities lean undesirably towards the IT specialist, thus some ICT projects tend to have late deliveries. IT governance mechanisms are supported by tools such as service level agreements and established communication approaches. Simple Excel-based solutions are used to track critical performance metrics, such as the status of interactive blood supply management, which averages 122.8% (2018) based on anticipated supply and storage levels for 5 days. NBSZ needs to properly document the return on investments in all these ICT initiatives, which is estimated (2016/2017) at 3.2% of annual savings.

Summary/Conclusions:Blood services in resource constrained settings can implement properly structured IT governance and this will ensure maximum return on IT investments. The NBSZ approach will be shared and further developed in the AfSBT ITWG to help other blood services improve their IT governance.

P-013

IMPACT OF THE INTRODUCTION OF AN INTEGRATED ELECTRONIC MEDICAL RECORD OF HOSPITALIZED PATIENTS ON THE QUALITY OF PATHOLOGY SAMPLES

Haberfield, S Morgan, G Kelsey, J Box, H Schneider

Hematology/Blood Transfusion, Alfred Health, Melbourne, Australia

Bottom:In October 2018, an integrated electronic medical record (EMR) was implemented at a health service across several Australian metropolitan campuses using Cerner Millennium™, with the goal of achieving HIMSS (Healthcare Society) level 6. Health Information and Management Systems). Prior to implementation, a large number of patient blood samples were unnecessarily collected and sent to Pathology without an accompanying test request (No Blood Test Requested - NTR). These samples required additional processing in the laboratory. Electronic sample collection with Cerner Specimen Collect™ enabled sample processing to be streamlined by eliminating paper requests. As part of the new workflow, individual sample labels are printed with the specified blood test and correct tube type. This helps to avoid the practice of collecting additional specimens due to the uncertainty of the collection requirements.

Goals:

  • Quantify the expected reduction in NTR samples following the introduction of electronic sample collection and describe the benefits

  • To determine the impact on collection errors and Wrong Blood In Tube (WBIT) events

Methods:Data was obtained directly from Cerner Millennium™ using a CCL (Cerner Command Language) query that is run monthly by IT Pathology staff. These data include all specimens recorded for the month with indication of rejected specimens, WBIT samples, and NTR. "Rejected specimens" include incomplete samples and/or application certification, unlabeled samples/applications, and non-matching samples. More information about WBIT events was gathered from Riskman's reports and interviews with staff.

Results:Data from the 12 months prior to EMR implementation were compared to the 3 months after. NTR numbers dropped from 4,220/month to 2,019/month (52% reduction), freeing up more storage space in fridges. Rejected samples due to improper labeling of the patient request dropped from a median of 27/month to 6/month. WBIT numbers have increased slightly: before they were median 1 (range 0–2), then they were median 2 (range 0–3). Although it was hoped that the incidence of WBIT could be reduced with the new EMR, 4 of the 6 post-implementation WBITs involved electronic sample collection. Deviation from planned protocols involving no working printers, causing staff to print patient labels away from the patient's bedside, as well as printing multiple patient labels on individual printers, appears to be the root cause of EMR WBITs.

Summary/Conclusions:EMR implementation has led to a reduction in NTRs and rejected samples due to improper request labeling, as well as increased storage space in laboratory refrigerators. Associated benefits include: • Decreased financial costs of wasted equipment • Decreased staff time to collect and process unusable specimens • Decreased environmental impact of manufacturing and disposal of unused specimens • Decreased potential for iatrogenic anemia Work is in progress to prevent further WBIT from occurring, by ensuring label printers are in good working order, plentiful, and easily accessible to staff; and it also remains a priority to ensure positive patient identification and bedside blood collection.

P-014

IMPLEMENTATION OF A PAPERLESS ELECTRONIC BLOOD BANK TEST REQUEST SYSTEM IN A GENERAL AND ACUTE CARE HOSPITAL

JM Mustafa1, K Teo2, S. Tsai1,P Heng1, R Sagun1, M Wong1

1laboratory medicine2Hospital Khoo Teck Puat, Singapore, Singapore

Bottom:Khoo Teck Puat Hospital (KTPH) is a 761-bed general and acute care hospital, opened in 2010, serving over 800,000 people living in the northern sector of Singapore. The KTPH Department of Laboratory Medicine Blood Bank provides sample analysis and blood transfusion services for KTPH as well as the neighboring Yishun Community Hospital (YCH), one of the largest community hospitals in Singapore, which provides Intermediate care for recovering patients, including rehabilitation services. The transfusion-related test request process at both hospitals is through paper forms.

Goals:In line with the hospital's directive to move towards electronic patient management, the KTPH Blood Bank intended to implement an electronic Type and Screen (e‐T&S) system. The goal of the project is to ensure zero patient identification errors and maintain full traceability and accountability of the blood collection process for all transfusion-related tests. Another goal of the system is to reduce repeat venipunctures when samples are rejected due to missing essential patient information on paper forms by implementing mandatory fields on the e-T&S form.

Methods:The e-T&S was implemented in phases. Phase 1: An online version of the paper form was electronically signed by the requesting physician and a witness within the electronic medical record system, the Sunrise Clinical Manager (SCM) system with the physician verifying the countersignature by signing on the specimen label to ensure correct patient identification .Phase 2: The requesting physician is not required to sign on the sample label, as biometric fingerprint data is required for electronic recording. Phase 3: elimination of the control step for blood collection. Sample collection and rejection data from 2016 to 2018 were analyzed. The specimen rejection rate was presented as a percentage of rejected specimens (mislabeled, unlabeled, and clerical errors) over the total specimen count for each month.

Results:Between January 2016 and March 2017, prior to the implementation of e‐T&S Phase 1, the average reject rate for blood bank samples was 0.16% and 1.14% for misidentification and administrative, respectively. During phases 1 and 2 of implementation, the rejection rate increased due to unfamiliarity with the new work processes. In February 2018, with the implementation of the final phase of the e-T&S system, the sample rejection rate was 0.38% and 0.12% due to identification and administrative errors, respectively. The rejected specimens came mainly from the few sites that had to use the paper application due to workflow or infrastructure constraints.

Summary/Conclusions:The e-T&S system was successfully implemented at KTPH. Full traceability and accountability of the blood collection process was maintained with the fully electronic system. The adoption of electronic documentation has also reduced the number of preventable repeat venipunctures that were due to incomplete ordering information on paper forms. Future developments in technology and full implementation of the e-T&S system at all hospital locations can make patient identification error zero and ensure transfusion safety for all patients in the near future.

P-015

ELECTRONIC RECORD OF TRANSFUSION: A PILOT STUDY FOR SCWEB®APPLICATION OF THE TRANSFUSION SYSTEM AT THE CABIN SIDE

C melli, D Camilot, C Dolfini, M Medeot, C Battaglia, P Zamaro, A Bertolutti, S Urban, S Pigani, S Gallo, V De Angelis

Transfusional Medicine, University Hospital of Udine, Udine, Italy

Bottom:The administration of blood components represents a critical phase due to the possible occurrence of errors during the different steps from patient identification to product infusion. The occurrence of errors can be reduced by implementing validated information systems. We tested the SCWeb®Bedside system in an outpatient transfusion clinic.

Goals:The objective of the study is to validate a system designed to help and control step by step the administration of blood through electronic devices that guarantee the traceability and documentation of the process.

Methods:The SCWeb®The system is based on IT-monitored checklists that guide staff to follow the procedure, according to best practices; the system must be initially activated by the operator who is recognized by an automatic signature system based on Bluetooth Low Energy that prevents the operator from having to identify himself previously. Adequate privacy protection is provided. From there, the system assumes the task of giving instructions and verifying compliance, requesting an active confirmation of the correct fulfillment of the activities; The system performs continuous recording and documentation. Standards and specifications have been set up for each step of the procedure in SCWeb®Detailed monitoring system for the identification of the operator and the patient, presence of informed consent to the transfusion, recording of blood pressure, pulse and temperature, access to the vein, verification of the blood unit. An alarm has been set after 15 minutes, to ensure control of patient conditions. For each step, active confirmation of action is required and both operators must actively confirm direct nurse and physician involvement on the device. The system has been tested at the bedside in 30 patients admitted to the outpatient clinic for 45 transfusions of packed red blood cells; Staff compliance and organizational impact have been recorded.

Results:The System required a very short training: SCWeb facility®The system allows its implementation without negative impact on the organization of the outpatient transfusion clinic and without difficulties on the part of the operators (nurses and doctors), who appreciated the help provided by the IT verification system. The electronic checklist record offered a reliable tool for the traceability of the transfusion procedure, also guaranteeing a paperless and timely available documentation of the entire process through a record in electronic format of all operator actions in each phase. of the transfusion process. . When prescribed, the confirmation of the checklist was only possible in the presence and with the active confirmation of two operators (physician and nurse).

Summary/Conclusions:The SCWeb®the system is useful as a barrier against transfusion mismatch (preventive measure), as a traceability and documentation measure, and as a tool for staff training in the administration of blood transfusions; avoids paper registration during the transfusion process, due to the timely registration of the activities carried out by the operators recognized by the system thanks to the Bluetooth Low Energy automatic signature device. The SCWeb®The system will be connected to the transfusion data management system, to monitor the entire process from the arrival of the unit from the blood bank.

P-016

ANALYSIS AND DESIGN OF AN ELECTRONIC MEDICAL RECORD SYSTEM IN BLOOD TRANSFUSION SERVICES IN A GOVERNMENT. HOSPITAL

t chandra1, D. Agarwal2, M. Agarwal3, R. Agarwal4

1Department of Transfusion Medicine, King George Medical University, Lucknow, Lucknow2GSVM College of Medicine, Kanpur, Kanpur3medical school of the era4St Francis College, Lucknow, India

Bottom:Blood banks aim to reduce costs and increase customer satisfaction by providing quality service. Service quality can be achieved by streamlining processes and restructuring the organization's supply chain through the implementation of computer tools.

Goals:The goal is to understand the complex flow of information and processes within the blood bank supply chain. The requirement of such a study is part of the integrated ERP modeling for the integrated operation of a blood bank.

Methods:The approach used to understand and map the process sequence and job responsibilities of each process and the operational decisions involved in each step is process mapping and data flow diagramming for front-end system modeling and analysis. The processes are mapped and represented in a schematic diagram. DFD (Data Flow Diagram) are built to represent the system. A context diagram is also built to understand the entities that interact with the system. EMR systems are intended to replace (or support) paper medical records. The entire system model is divided into two parts: Front-end and Back-end. Front-end design and analysis is done by EPC (Event Driven Process Chains), Resource Views, Data Flow Diagram for data view. The reports concerned donor selection, blood bag collection and financing, the blood collection process, component preparation, blood testing, and blood distribution.

Results:Process mapping using the event-driven process chain generated a complete view of the processes involved. The resource view gave an organizational structure and the personnel involved. The data view using the context diagram and the data flow diagram provide a flow of data and the amount of data involved. This framework can be used for re-engineering business processes for blood banks by conducting a time study and eliminating non-value-added activities. The data view helps to analyze redundant data in each process. It also assists in the training and orientation of staff within the department.

Summary/Conclusions:A systematic description presented in this document facilitates the elimination of non-value-added processes, duplication of data, bottlenecks, reduction of cycle time and therefore improves the quality of service in blood banks.

Cost effectiveness

P-017

COSTS ASSOCIATED WITH TRANSFUSION IN A PEDIATRIC INTENSIVE CARE UNIT

G Atakul1,Fiscal Year Ayhan2

1Pediatric Intensive Care Unit2Transfusion Center, Hospital Infantil Dr. Behcet Uz, Izmir, Turkey

Bottom:The transfusion of blood components, one of the most prevalent interventions in clinical practice, is an important expense item in health services that has tended to increase in recent years.

Goals:It is intended to investigate the impact of costs associated with transfusion on hospital costs in patients in the Pediatric Intensive Care Unit (PICU).

Methods:During a period of one year (January 2017-December 2017), 76 patients were included in the study, 40 women and 36 men who received a transfusion of blood components during their stay in the PICU. Transfusion-associated costs and total costs of healthcare services for children treated in the PICU were collected using the Hospital Information System (HIS). Statistical analysis of the data was performed using SPSS software (version 22.0, SPSS Inc., Chicago, IL, USA). The Mann-Whitney U test and the Kruskal-Wallis test were performed for the comparison of independent categorical variables and numerical data; A chi-square analysis was performed for the comparison of two numerical variables and a Spearman correlation analysis for the associations.

Results:The median age of the patients was 12.0 months (interquantile range‐IQR 26). The mean stay was 16 days (IQR 30). In total, 400 blood components were transfused, of which 227 red blood cell concentrates, 114 apheresis platelet concentrates, 6 granulocyte concentrates, 51 fresh frozen plasma, 1 cryoprecipitate and 1 whole blood.

The ratios of transfusion-associated expenses to hospital costs were categorized into percentage ranges such as <5%, 5-10%, 11-15%, and >15%. Most of the patients (63.2%) were classified in the lowest interval. Median hospital cost and cost associated with transfusion were 5,478.76 euros (IQR=11,280.02) and 130.57 euros (IQR=354.86), respectively.

A strong significant positive correlation was detected between the number of transfusions and the cost of PICU hospitalization (r: 0.674, P < 0.01). Although a significant weak positive correlation was found between transfusion-associated cost and hospital cost (r: 0.247, P = 0.032), there was also a significant weak positive correlation between age and transfusion-associated cost (P = 0.048, r: 0.227). A significant difference was found between patients with and without hematologic malignancies (P<0.01) for the cost associated with transfusion.

The reason why pediatric doses are mainly preferred is that the hospital provides medical care only to children and the splitting of blood components was common in the hospital. But unexpectedly, a significant increase in transfusion-associated costs was detected that is related to split-blood components (P<0.05).

Summary/Conclusions:Studies on the economics of blood transfusions have been conducted primarily in patients who require chronic or multiple transfusions. Neonatal intensive care units, specialized facilities that provide care for patients with serious, life-threatening illnesses, are important departments that often require multiple transfusions..There are many variables to assess the impact of transfusion-associated cost on hospital cost in PICU patients, but the main factors are underlying conditions, admission diagnoses, and transfusion strategies. Although there are unexpected data in our study demonstrating the increasing impact on transfusion-associated cost of splitting blood components for pediatric use, no significant relationship was found to explain this situation. Further studies on the economics of blood transfusions should be conducted to clarify the cost variables associated with transfusions.

P-018

THE INFLUENCE OF STRATEGIES TO LIMIT THE NUMBER OF PRE-TRANSFUSION TESTS TOWARDS EFFECTIVENESS IN RELATION TO THE COSTS OF REQUESTING PACKED RED BALLOONS AT DR. HASAN SADIKIN HOSPITAL BLOOD BANK, BANDUNG-INDONESIA

LL Kosim1,2, L. Rokayah1, R. Suhartini1

1Clinical Pathology, Hasan Sadikin Hospital2Clinical Pathology, Padjadjaran University School of Medicine, Bandung, Indonesia

Bottom:Approximately 55.7% of the transfused blood component is packed red blood cells (PRC). Over-ordering of the PRC unit is common practice and excessive pre-transfusion testing was wasting resources and had adverse cost consequences. A high rate of crossmatching per transfusion (C/T) as an indicator of blood bank quality implies that crossmatching was performed unnecessarily.

Goals:The objectives of this study were to assess the cost-effectiveness of strategies to limit the number of pretransfusion tests to order PRC.

Methods:All PRC units that applied to Dr. Hasan Sadikin Hospital from January 2016 to December 2018 were collected in this retrospective study. The number of PRC units that requested, the completed pre-transfusion tests of the PRC units that requested, and the PRC units that were transfused were recorded. Restrictive strategies of pre-transfusion tests based on the hemoglobin level and diagnosis were used as criteria for indicating transfusion. Cost-effectiveness was measured by multiplying the unit cost of pre-transfusion tests and the number of PRC units.

Results:Of the total 177,370 PRC units requested, 166,910 (94.1%) underwent pre-transfusion testing and 63.1% (105,260) of the PRC units requested that are pre-transfusion tests were transfused. This means that 5.9% (10,460) of the requesting CRP unit did not undergo the pretransfusion test. This showed savings of Rs 1,098,300,000. The C/T ratio was 1.6, showing a good order pattern. However, 16.4% (27,451) of the requesting PRC unit's completed pre-transfusion tests were not transfused, resulting in a loss to the blood bank of Rs 2,882,355,000.

Summary/Conclusions:Strategies to limit the number of pretransfusion tests in the good C/T ratio were still associated with cost-effective savings.

training and education

P-019

IMPACT OF AN EDUCATIONAL INTERVENTION ON THE KNOWLEDGE AND AWARENESS OF NURSES AT A TERRITORY CARE TEACHING HOSPITAL ABOUT BLOOD TRANSFUSION SERVICES AND PRACTICES

S. Talati1, A Gupta1, of un Jain2

1hospital administration2Transfusion Medicine, Graduate Institute of Medical Education and Research, Chandigarh, India

Bottom:Blood is a precious resource to save the lives of patients. The purpose of blood and blood component therapy is to provide appropriate and safe blood products to achieve the best clinical results. Nurses have an important role in ensuring safe blood transfusion. It is crucial that nurses have sufficient knowledge about blood donation and collection, storage, component preparation, potential adverse effects of blood transfusion, and necessary handling and care.

Goals:The aim of this study was to assess the impact of an educational intervention on nurses' knowledge and awareness of blood transfusion services and practices.

Methods:At our institute hospital, which is a tertiary care teaching center, the baseline study was conducted to assess the knowledge and awareness of blood transfusion services and practices among nurses assigned to various areas of the hospital, including rooms, operating rooms and critical care areas. The nurses were then sensitized and educated regarding blood transfusion services and practices during their daily activities by referring them to the institute's blood transfusion guidelines. Subsequently, a self-developed questionnaire that was used for the initial evaluation of the knowledge and awareness of the nurses was used again to re-evaluate them. A total of 19 questions were included in the questionnaire related to: general knowledge (two questions), blood donation (two questions), analysis and preparation of related blood components (two questions), storage of blood/blood components (two questions) and pre-transfusion checks and bedside transfusion practices (eleven questions). Fifty nurses were included for baseline and post-sensitization assessment. For different categories of questions, the correct response rates were compared with those obtained in the initial study using the Mann‐Whitney test. The total duration of the study was distributed over a period of three months (December 2014 to February 2015).

Results:The overall mean percentage of "correct" answers for 19 questions in the reference study was 61.75%, while after priming it was 77.21%. The mean percentage increase in questions related to general awareness was 21.49%, 13.95% for questions related to blood/blood component storage, 17.37% for questions related to pre-test checks. transfusion and bedside transfusion practices, 21.33% for questions related to blood component testing and preparation, and 27.27% for questions related to blood donation. The percentage increase in the correct answer was found to be statistically significant for each of the five question categories. The overall mean percent increase in the rate of correct answers was also statistically significant (P<0.001).

Summary/Conclusions:This study revealed that after the sensitization and educational intervention there was a significant improvement in nurses' knowledge and awareness of blood transfusion services and practices.

P-020

Summary withdrawn.

P-021

TRAINING AND COMPETENCE ASSESSMENT TOOL (TACT): A GAP ANALYSIS OF THE TACT PROGRAM VERSUS PRE-TRANSFUSION TESTING GUIDELINES AND PRACTICES ABROAD: ADAPTATION OF TACT FOR INTERNATIONAL APPLICATION

CL Whitham, J White,R. Haggas

BTLP, UK NEQAS, Watford, UK

Bottom:Introduced in the UK in 2014 to support managers, TACT provides continuous, 'real-time' monitoring that saves resources from knowledge-based competition of staff in transfusion laboratories. TACT is available online 24/7 and complements existing practical competence schemes and external quality assessment. Multiple variations on a standard pretransfusion testing scenario are generated by restricted randomisation; the logical rules for automated evaluation of sample acceptance, ABO/D, antibody detection and identification (AS/ID), and component issuance are based on BSH guidance. During 2018, TACT was offered internationally to transfusion laboratory managers for trial, and was accepted in five countries. The TACT core program, based on UK guidelines, is under review for programming conversion to make it customizable for the international community.

Goals:Assess the feasibility of converting TACT programming to meet the requirements of country-specific pretransfusion testing guidelines and direct future programming based on feedback from international users.

Methods:Guidelines were obtained from 3/5 international users and translated where necessary. These were compared to the core assessment items of the current TACT programming. International users were asked for feedback on the current version of TACT, compared to their local policies and practices.

Results:The following criteria were crossed: specification of transfusion request forms, sample label acceptance criteria, reagents used for ABO/D and AS/ID, resolution of grouping anomalies, confirmation/exclusion of alloantibodies, and selection criteria. of blood components for transfusion dependent patients. patients and women of childbearing age. Apparent differences included:‐

Australia:-

‐Selection of red blood cells for patients with anti‐D immunodeficiency.

Greece:-

‐Inclusion of the name of the patient's father in the transfusion request.

Italia:-

‐Testing all new patients with one anti‐A,B reagent and two different anti‐D monoclonal reagents.

International users in the same three countries provided feedback. This included suggestions for: increased complexity of the cases presented, provision of patient history, inclusion of follow-up tests, e.g. phenotyping and cells for antibody confirmation/exclusion, wider range of reaction force classification, and official professional CPD credits. The following differences were noted: the nomenclature used, the format and content of the request form, the use of English abbreviations of the patient's clinical details, and the availability, supply, and specification of blood components.

Summary/Conclusions:This analysis has shown very few cases where the current iteration of TACT differs from the revised guidelines, and that it is feasible to expand the use of TACT on a more international basis. The current iteration of TACT has been developed to represent an abbreviated scope of pre-transfusion testing practices, which can be applied to non-UK laboratory practice without difficulty. More work is required to allow international users to configure TACT so that the system represents all laboratory practices internationally.

P-022

IMPROVING NEONATAL AND PEDIATRIC CLINICAL OUTCOMES THROUGH EDUCATION IN PATIENT BLOOD MANAGEMENT

peterson, S Ogley, L Inglés, T Verrall, T Clark

Education and Training Centre, BloodSafe eLearning Australia, North Adelaide, Australia

Bottom:BloodSafe eLearning Australia (BEA) is a government-funded blood transfusion education program that offers courses on clinical transfusion practice and patient blood management.

In mid-2018, BloodSafe eLearning Australia launched a suite of neonatal and pediatric e-learning courses based on the Australian Guidelines for the Management of Patient Blood: Neonatal and Pediatric Module 6:

  • PBM for Neonates and Pediatrics (Introduction)

  • Neonatal: premature

  • Trombocitopenia aloinmune fetal y neonatal (FNAIT)

  • Pediatrics: Hematology-Oncology

  • Pediatric: Surgical

  • Pediatric: major bleeding

  • Pediatric: iron deficiency anemia

Goals:These courses provide education to clinicians on patient blood management and safe transfusion in neonatal and pediatric settings to improve patient outcomes and increase awareness of national patient blood management guidelines. This analysis aimed to investigate the acceptance, practical use and perceived value of the courses by students.

Methods:A retrospective analysis of course completion statistics and course evaluation data.

Results:2,376 pediatric and neonatal courses have been completed from March 6, 2018 to February 28, 2019, and 89.6% of the students are nurses and/or midwives.

Analysis of the course evaluation data (n=33) showed that these courses:

  • Provide knowledge (96.9%)

  • Improve patient safety and outcomes (84.9%)

  • Result in change to clinical practice (69.9%)

  • Are relevant to clinical practice (70.9%)

  • They are easy to use (67.7%)

  • They are easily accessible (58.1%).

Examples students provided of how they can apply this learning to their clinical practice include:

  • “[I am now] more aware of the special requirements for neonatal blood transfusion”

  • “[I] feel more secure, especially when I talk to parents”

  • “[I will now be] reviewing the patient's blood results and defending unnecessary blood samples”

  • “[It is good that] when there is ambiguity in clinical practice [this] is very well demonstrated by the explanation of experts in the field”

  • "We don't do a lot of transfusions [and this is] a reminder that transfusions are not always the first response to a baby's condition."

Summary/Conclusions:Analysis of user and course evaluation data demonstrates that these courses are being used by nurses and physicians working in neonatal and pediatric settings and that they provide PBM knowledge that can be applied to clinical practice, thereby contributing to improved patient care.

P‐023

EVALUATION OF TRANSFUSION KNOWLEDGE AND PRACTICES IN NURSES ACCORDING TO THEIR TIME OF EXERCISE

S Mahjoub1, D. Bahri2,R Hidoussi2, N. Ben Romdhane1

1Hematology2Hospital La Rabta, Tunis, Tunisia

Bottom:Blood transfusion is a high-risk clinical activity that must be mastered both theoretically and practically to guarantee the desired result without incidents or complications. Mastery of transfusion knowledge among nurses represents a very important link in the transfusion chain.

The objective of this work is to compare the theoretical and practical knowledge of transfusion between two groups of nurses divided according to their seniority.

Goals:This is a cross-sectional descriptive study conducted over a period of 1 month [1calleApril 30thheApril] 2017. We selected two groups of healthcare personnel: on 1callegroup made up of 50 students at the end of their training at the Higher Institute of Nursing Sciences. The 2North DakotaIt is made up of 50 nurses who work in 5 Tunisian university hospitals, currently practicing blood transfusion. The evaluation instrument used was a questionnaire with 15 single or multiple choice questions, 7 related to theoretical knowledge of labile blood products and 8 to transfusion practice. Ten questions were deemed "life-threatening" if their answers were false. A comparative study was carried out between the two groups.

Methods:This is a cross-sectional descriptive study conducted over a period of 1 month [1calleApril 30thheApril] 2017. We selected two groups of healthcare personnel: on 1callegroup made up of 50 students at the end of their training at the Higher Institute of Nursing Sciences. The 2North DakotaIt is made up of 50 nurses who work in 5 Tunisian university hospitals, currently practicing blood transfusion. The evaluation instrument used was a questionnaire with 15 single or multiple choice questions, 7 related to theoretical knowledge of labile blood products and 8 to transfusion practice. Ten questions were deemed "life-threatening" if their answers were false. A comparative study was carried out between the two groups.

Results:The participation rate in the survey was 100%. The 2North Dakotagroup participants had a mean age of 9 years [0-30]. More than half of them (64%) were less than 10 years old. Only 12% had more than 20 years of experience.

The correct response rate for all items combined was 44.4% for students versus 42.5% for practicing nurses. The theoretical knowledge part was mastered more in 1callegroup than that of practicing nurses (44.8% vs. 33.4% of correct answers). On the other hand, control of the transfusion act was better in 2North Dakotagroup (44% vs. 50.5%).

The overall "dangerous" response rate was 47% for students and 41.7% for practicing nurses. False practical knowledge was more common in group 1 (59.5% vs. 41.5%).

Summary/Conclusions:Theoretical and practical knowledge is not yet well mastered by care staff. Our study highlighted the best theoretical domain for young students and practical domain for practicing nurses. This could be explained by the freshness of the knowledge in the first group and the daily practice in the second group.

Risk models, standards and regulation

P-024

INCONSISTENCY IN THE SELECTION CRITERIA FOR WHOLE BLOOD DONORS EVALUATED BY EXPERTS IN THE TRANSPOSE PROJECT COMPARED TO DIRECTIVE 2004/33/EC

s fontana1, J Castrén2, S Van Walraven3, S. Zahra4, A Chandrasekar5, E Veropalumbo6, K. Seidel7, M Kvist8, C Mikkelsen9, H Any9, G. Mori10, M. Van Kraaij3

1Interregional Blood Transfusion SRC, Bern, Switzerland2Finnish Red Cross Blood Service, Helsinki, Finland3Sanquin Bloodbank, Amsterdam, The Netherlands4Scottish National Blood Transfusion Service, Edinburgh5NHS Blood and Transplant, Bristol, Reino Unido6Italian National Blood Center, Rome, Italy7CSL Plasma GmbH, Marburg, Germany8Clinical Immunology and Transfusion Medicine, Karolinska University Hospital, Stockholm, Sweden9Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark10Sanquin Bloodbank, Amsterdam, The Netherlands

Bottom:Directive 2004/33/EC of the European Commission (EC) on the selection criteria for blood donors is 15 years old. Meanwhile, knowledge about the risks related to the selection of blood donors has progressed and challenged several mandatory rules. TRANSPOSE – TRANSfusion and transplantation: Protection and selection of donors, is a project co-financed by the European Commission with the participation of more than 24 stakeholders from private and non-profit organizations that provide substances of human origin (SoHO). The project aims to provide evidence-based donor selection criteria and guiding principles for risk assessment of SoHO security threats. As part of this work, the experts working on this project conducted an inventory of current blood donor selection criteria in Europe and an assessment of the evidence behind current practice.

Goals:To identify the gap between the EC Directive 2004/33/EC on the selection criteria for whole blood donors and a current assessment of the clinical relevance of the criteria based on the scientific literature carried out by a panel of European experts within the project Transpose.

Methods:In 2018, we conducted a risk inventory for blood donors and transfusion recipients in participating European countries. Project members were asked to provide existing donor selection criteria related to these risks and to perform a risk-based assessment for each of them. The assessment was based on the available scientific literature and on a risk assessment template based on the ABO Risk-Based Decision-Making Framework, developed by Transpose. All risks with divergent assessments within the panel were resolved by discussion; in all cases an expert consensus was established. Subsequently, we compare the results with the content of the EC Directive 2004/33/EC for each risk, thus identifying discrepancies and missing elements in the Directive.

Results:The panel identified 64 risks considered significant, distributed between donors and recipients. For 35/64 (55%) of them, the expert assessment deviated from the content of the EC Directive, or the EC Directive did not provide information on decision making. In particular, a discrepancy was observed for 9/20 criteria related to general health and medication, 12/22 for transfusion-transmissible infections, 10/13 for high-risk behavior and travel, and 4/9 for other diseases.

Summary/Conclusions:Our results highlight a significant gap between the whole blood donor selection criteria set out in EC Directive 2004/33/EC and the scientific assessment by a panel of Transpose participating experts. This gap includes both new risks not addressed in the EC Directive as well as addressed risks that are, however, assessed differently. This involves both the safety of the blood donor and the recipient of transfusions, and various medical and epidemiological issues that cover various aspects of blood donation criteria.

We strongly recommend a change in European legislation, allowing for a procedure to ensure that blood donor selection criteria are regularly updated within the framework of the European institutions, to keep in line with scientific progress, epidemiology and changes in the medical practice, to allow for an updated risk and evidence-based framework for donor selection criteria. The risk assessment method developed in the TRANSPOSE Project is a valuable tool for this purpose.

P‐025

RISK MANAGEMENT OF BLOOD SERVICES: THE RESULTS OF A 10-YEAR BRAZILIAN EXPERIENCE

CD Costa, J Junior, R Martins, H Sousa, U Junior

GSTCO, Anvisa, Brasilia, Brazil

Bottom:The Brazilian Health Regulatory Agency – Anvisa developed the Potential Risk Assessment Method in Hemotherapy Services (MARPSH), which is based on data collected during inspections of blood services carried out by regulatory authorities. Using MARPSH, any blood service can be classified into one of 5 possible categories of potential risk: high, medium-high, medium, medium-low, and low risk. Each category represents a different level of potential risk, depending on the proportion of compliance with established regulatory requirements. MARPSH has been used since 2007, showing a risk reduction trend in blood services evaluated throughout the country.

Goals:This paper aims to describe the use of MARPSH as a tool for an integrated risk management model. In addition, it shows the main results obtained after 10 years of data monitoring and coordination of regulatory actions and policies by Anvisa, with a view to the quality and safety of blood products.

Methods:The use of MARPSH follows a network risk management model, since inspections are carried out by decentralized bodies in the 27 states and some municipalities. The inspectors comply with a standardized inspection guide that contains the regulatory requirements, where each item is associated with a risk level, varying from I to III as the risk increases. At the end of the inspection, after a statistical calculation, the service is categorized. This classification gives an estimate of its quality profile, guiding the adoption of appropriate risk management measures by local authorities and services. These data are sent to the states (if they are carried out by municipalities) and to Anvisa, which carries out the consolidation at the national level. States or Anvisa use data to coordinate risk management measures on a broader spectrum. The data is continuously monitored by Anvisa as part of its strategic panel of indicators. Anvisa especially accompanies blood services in High and Medium-High Risk with the aim of helping or complementing the actions of local authorities. In addition, Anvisa periodically sends this information to the Brazilian Ministry of Health and to the local government bodies of the Brazilian National Blood System that also support actions to improve the quality of their blood service networks.

Results:Since 2007, when the evaluation covered 109 blood services, MARPSH reached 1,218 blood services in 2017 (57% of registered blood services), which corresponds to almost 100% of inspection coverage this year. During this period (2007-2017) it is possible to notice a drastic decrease in the trend of the proportion of blood services classified as high and medium-high risk, which varies from 26% to 9%.

Summary/Conclusions:MARPSH generates the data necessary for the categorization of blood services into five levels of potential risk. Consequently, regulatory actions are applied by local bodies with the purpose of reducing or eliminating the risks involved in the production and use of blood components. Data have shown a significant reduction in risk over 10 years of MARPSH use. In addition, the monitoring of these data at the national level has allowed adequate planning and prioritization of integrated strategies aimed at risk management and the strengthening of blood services in Brazil.

P-026

ANALYSIS OF THE EFFECT OF FAILURE MODE ON PATIENT SAFETY IN THE BLOOD TRANSFUSION CHAIN ​​IN THE DEMOCRATIC REPUBLIC OF THE CONGO

New Mexico Ndalingosu1, Heroes2,3, Van Cauwenberg4, J Jacobs2,3J Kabinda5,6, P. Vandekerckhove7,8, or Lunguya9,10

1Quality Assurance, National Center for Blood Transfusion, Kinshasa, Congo, Democratic Republic of2Department of Microbiology and Immunology, KU Leuven, Leuven3Department of Clinical Sciences4Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium5Headquarters, national blood transfusion center6Health Sciences, National Pedagogical University, Kinshasa, Congo, Democratic Republic of7Department of Public Health and Primary Care, KU Leuven, Leuven8Red Cross-Flanders, Mechelen, Belgium9National Institute of Biomedical Research10University of Kinshasa, Kinshasa, Kinshasa, Congo, Democratic Republic of

Bottom:Sub-Saharan Africa has the greatest need for blood transfusions in the world, mainly for women of childbearing age and children suffering from malaria. Meeting basic quality and operational requirements to provide patients with safe blood remains a challenge in these settings.

Goals:The goal was to identify and prioritize potential hazards to patients in blood bank practices in the Democratic Republic of the Congo (DRC). We focused on two subsets: (i) donor awareness and selection, and (ii) qualification and production of blood products, using Failure Mode and Effect Analysis (FMEA).

Methods:Two risk analysis workshops were organized at the National Center for Blood Transfusion in Kinshasa, Democratic Republic of the Congo. In both workshops, a multidisciplinary team was invited to represent different hospitals and profiles in transfusion management in the DRC: quality coordinators (n=2), training coordinator (n=1), donor selection physician (n=2). , hemovigilance officer (n=1), laboratory technicians performing donor sampling, qualification and production of blood (n=7), biomedical scientists (n=3), microbiologist (n=1), clinical biologist (n= 1), nurse (n=3). The FMEA principle was applied, which involves the identification of potential hazards (failures) in a process flow, followed by the rating of each hazard based on its impact, probability, detection, and feasibility. In both workshops, the participants were guided by an external facilitator who ensured a common understanding of the methodology. The main focus of the risk analysis was the potential harm to the transfused patient in the process of (i) awareness and selection of donors, and (ii) qualification and production of blood products. All ideas were written on colored cards and mapped on a chart according to their impact score, probability, detectability, and feasibility. Hazards were ranked according to their final risk score by multiplying these four scores.

Results:In the donor awareness and selection process, the three dangers with the highest final score for impact, probability, detection, and feasibility were: (i) recruitment of a paid donor after awareness-raising by the patient's relatives, (ii) donor selection on staff approve an ineligible donor for blood donation due to personal/financial motivation, (iii) blood donors are not properly informed about donating blood during sensitization of family members of patients.

In the blood product qualification flow, the highest scores were obtained for: (i) no double check for validation and classification of qualified blood products, (ii) stock-outs of reagents, (iii) no match check between results of the tests recorded and tested the blood tube.

Regarding the production of blood products, the first three consisted of: (i) the transport time between blood extraction and processing is >8 h, (ii) storage of qualified and quarantined blood products in the same refrigerator (only in some places), (iii) power cuts

Summary/Conclusions:The risk analysis resulted in three prioritized dangers in the process of selection/awareness of donors and qualification/production of blood products. Some are very specific to the sub-Saharan African environment and have already been described previously (power outage, relatives and paid donors, stock out,...). You need to put an action plan in place to lower your final risk score. The risk analysis should continue for the remaining blood transfusion flows.

Management and utilization of the blood supply

P‐027

BLUSTAR.NRW: A PROJECT TO TYPE REFUGEES AND MIGRANTS AS POTENTIAL BLOOD AND STEM CELL DONORS IN NORTH RHINE-WESTPHALIA

A Lenz1, B Wagner1, C. Baumgart1, L. Kordelas2, C. Jiménez Klingberg2, K. Gebhardt2, T. Reimer3, T Zeiler3, J Fischer4, J. Enczmann4, A Balz4, Horn P1

1Institute for Transfusion Medicine, Essen University Hospital, Essen2West German Donor Headquarters, Ratingen3Blood Service of the West German Red Cross, Hagen, Breitscheid, Munster, Bad Salzuflen4Institute for Transplant Diagnostics and Cellular Therapeutics, Düsseldorf University Hospital, Düsseldorf, Germany

Bottom:19.3 million of Germany's population, so just under a quarter of residents have a migration background. Most of these have their roots in regions where the population has a pattern of distribution of blood group and HLA antigens that differs considerably from that predominant in the German population. Sufficient supply of red blood cells (RBC) and platelet concentrates (TC) from these individuals will remain a major challenge in the future, as blood donors with compatible blood group antigens are dramatically underrepresented in local donor pools.

Many migrants have severe blood disorders, such as β-thalassemia or sickle cell disease, and will require not only matching blood transfusions, but also an allogeneic stem cell transplant in the foreseeable future. Since healthy family donors are often not available, suitable stem cell donors with similar genetic backgrounds can currently only be found in international donor registries.

Goals:This project was started to recruit new donors with a migratory background for blood donation and to increase the number of blood stem cell donors among this group.

Methods:Extended serological blood group phenotyping was performed using the automated gel card technique (Fa. Grifols, Erytra) and included AB0, Rh (CcDEe), Kk, Fy(ab), Jk(ab), Lu(ab), M, N, S, yes.

HLA typing for HLA-A, -B, -C, -DR, -DQ, and -DP was performed using Next Generation Sequencing. Allele frequencies were analyzed using Genepop Version 4.2; rare and very rare alleles were defined according to the allele frequency database (www.allelefrequencies.net)

Red blood cell genotyping using next-generation sequencing is currently being established and will include additional antigens with the most frequent distribution pattern differences between migrant and resident populations based on the literature.

Results:So far, more than 8,800 blood donors with an immigration background have been recruited for a blood drive in this project. Among this group, more than 1,000 blood donors from more than 20 non-European countries registered as potential stem cell donors.

An initial evaluation of the data revealed a very similar distribution of blood groups compared to the current population of blood donors in North Rhine‐Westphalia. Of 600 migrant donors, ten Fy(a‐b‐) donors were identified, corresponding to a percentage of 1.6%.

Among 509 potential HLA-matched stem cell donors, we found 28 (5.5%) with rare and very rare alleles.

Summary/Conclusions:Blood donors with rare blood groups and HLA phenotypes (for example, null types such as Fy(a‐b‐)) are in demand for appropriate medical care for people with a migration history. The technological development of next-generation sequencing blood typing will significantly improve the supply for all recipients of blood transfusions in Germany.

This project is financed by the European Development Fund 2014-2020 (FEDER) and the European Union.

P‐028

TRANSFUSION PRACTICES IN MAJOR TRAUMA PATIENTS IN AN EMERGENCY DEPARTMENT: EXPERIENCE AT LEVEL 1 TRAUMA CENTER IN INDIA

R Chaurasia1, un Krishna1, a sub-bramanian2, T Sinha3

1transfusion medicine2laboratory medicine3Emergency Medicine, JPNATC, AIIMS, NEW DELHI, India

Bottom:Mortality due to uncontrolled bleeding after trauma is the most important cause of potentially preventable deaths. Trauma care systems in low- and middle-income countries such as India are still developing. Furthermore, the role of blood component therapy in improving patient outcomes has been derived primarily from combat settings. The application of these protocols in an urban setting has not been well established and there is marked variation in practice. Therefore, this study aims to identify key components of transfusion practices to optimize the transfusion protocol in trauma settings.

Goals:To study current transfusion practices in severely injured trauma patients admitted to the red area/resuscitation bay after initial triage in the emergency department.

Methods:This prospective observational study was conducted over a 1-year period from June 2017 to May 2018 at the Department of Transfusion Medicine in collaboration with the Emergency Department of JPNATC, AIIMS, New Delhi. The study included severely injured patients (ISS≥16) who were admitted within 24 h to the red area/resuscitation bay after triage. Data collected included demographic, injury, laboratory, and transfusion details of these patients.

Results:During the study period, 885 patients (83.5% male) were enrolled. The mean ISS score was 21.89 (IQR 16-25). The mean hospital admission time after the injury was 9:03 (IQR 3.38-13:48) hours. The median time to first RBC transfusion after admission was 2:09 (IQR 0:27–2:45) hours. Approximately 49.3% (436) of the patients were in shock (SBP <90 mm Hg and/or pulse rate >110/min). While 160 (18.1%) patients were coagulopathic (PT≥1.5 times normal). During the initial 24 hours of admission, these patients received transfusions with 2,929 (69.7%) RBC, 1,986 (51.8%) FFP, 2,327 (42.9%) RDP, and 384 (81.5%) cryoprecipitate components. total blood samples used for these patients. Massive transfusion (defined as a transfusion of ≥5 units/4 h) was administered to 190 (21.4%) patients.

Summary/Conclusions:A significant amount of blood components were required during initial resuscitation in severely injured patients. Prehospital transfusion can significantly reduce the time to transfusion. Further studies are needed to assess the utility of prehospital transfusion in severely injured patients.

P‐029

THE MANAGEMENT OF THE SUPPLY OF PLATELET CONCENTRATE FOR RECIPIENTS OF ALLOGENIC STEM CELLS IS A REAL CHALLENGE FOR A BLOOD BLOOD CENTER: THE EXPERIENCE OF THE UNIVERSITY HOSPITAL OF GENEVA

N Lambeng1, A Altmeyer2, S Huguet2, C Chaduc Lemoine2, S. Waldvogel3

1Diagnostic Department2Department of Medicine3Department of Diagnostics and Department of Medicine, University Hospital of Geneva, Geneva, Switzerland

Bottom:Allogeneic stem cell transplant recipients are known to be the major consumers of platelet concentrates (PCs). The University Hospital of Geneva is one of three allogeneic haematopoietic stem cell transplantation (HSCT) centers in Switzerland. Since the blood center is also part of the hospital, PC consumption data is readily available. With needs increasing steadily for several years, averaging 9% per year, PC supply is a serious concern for our center.

Goals:In this study we tried to assess whether any pre-transplant indicator could help predict the number of PCs needed after allogeneic hematopoietic stem cell transplantation.

Methods:This retrospective observational study was conducted at the Geneva hospital in 78 patients suffering from various hereditary or acquired disorders of the hematopoietic system who were treated by HSCT in 2016. CP consumption was examined from January 2016 to December 2018. The five indicators were: gender, stem cell source (bone marrow (BM) vs. peripheral blood stem cells (PBSC)), donor type (HLA matched (10–8/10) vs. haploidentical), conditioning regimen (standard vs. at reduced intensity) and recipient CMV serology.

Results:Data from a total of 78 patients with ages between 3 and 74 years were analyzed; 48 (62%) were men and 30 (38%) women; 35 (45%) were CMV negative and 43 (55%) were CMV positive. Of a total of 78 transplants, 14 (17.9%) were haploidentical and 64 (82.1%) HLA compatible. According to the source of stem cells, MO was transplanted in 22 cases (28.2%) and PBSC in 56 cases (71.8%). Two patients also received a CD34+ stem cell boost.

Our analysis showed that, with a mean follow-up of 652 days, the number of PCs transfused to our HSCT-treated patients ranged from 0 to 383 units, with a mean of 37 and a median of 15, illustrating high variability. Results indicated that gender, stem cell source (BM vs. PBSC), conditioning regimen (standard vs. reduced intensity), and recipient CMV serology had no statistical impact on platelet consumption. However, we observed a trend for a greater need for platelet transfusion when patients were CMV positive. Our results also showed a statistically significant (P = 0.034) higher number of PCs transfused for patients treated with a haploidentical transplant (89) versus HLA-matched transplant (26).

Summary/Conclusions:This study highlights the high variability of platelet consumption after HSCT, which limits the prognosis of platelet production required to support allogeneic HSCT recipients. A larger cohort would be needed to confirm a potentially higher platelet consumption in CMV-positive patients and to consolidate our results showing a higher PC consumption for patients treated with haploidentical transplantation.

P‐030

Summary withdrawn.

P‐031

WASTE REDUCTION THROUGH THE CARDIAC SURGERY BLOOD COOLER INITIATIVE

K opened1, Mohamed1, A. Lerner2, B Vidal1, C Luffman1, L Uhl1

1Pathology2Anesthesiology, Beth Israel Deaconess Medical Center, Boston, MA, Boston, United States

Bottom:Historically, at our institution, a minimum of four red blood cell (RBC) units were crossed for all cardiac surgery cases, regardless of the type of surgical case or patient characteristics. Two units of red blood cells were packed in validated blood product coolers and brought to the operating room (OR); the balance of crossed units remained in the blood bank. A retrospective review revealed that very few RBCs were transfused (2016: 20% (371/1813), 2017: 19% (322/1742)). Additionally, approximately 8 products were wasted each month as a direct result of this practice. Therefore, we recognized an opportunity to improve inventory management in terms of personnel activities and blood component utilization.

Goals:The objective of this study was to reduce the prior preparation of coolers in cases of cardiac surgery without compromising patient care and safety. We limited our intervention to those patients who were eligible for electronic crossmatching. We maintained the aforementioned historical practice for those patients with a history of and/or those who currently demonstrate clinically significant red cell alloantibodies.

Methods:In October 2017, a multidisciplinary group comprised of representatives from the department of blood banking, cardiac surgery, cardiac nursing, cardiac anesthesia, and surgical quality met to determine if a practice modification was reasonable and safe. Group members evaluated site-specific Society for Thoracic Surgery (STS) cardiac surgical data between July 2014 and December 2016 to establish intraoperative RBC transfusion rates classified by type and urgency of surgery. The primary goal of the group was to discontinue default refrigerator preparation for electronic crossmatch-eligible patients who were scheduled for all types of non-emergency cardiac surgery cases in which ≤25% of historical cases required at least one red blood cell transfusion. Additionally, team members simulated the multiple protocols by which red blood cells could be prepared and delivered to the operating room and estimated the time for each scenario.

Results:Review of the STS data showed that the following cases met the criteria of ≤25%: elective primary coronary artery bypass grafting (CABG), urgent primary CABG, elective mitral valve repairs, and elective aortic valve replacements. . The simulation showed that, in patients eligible for electronic crossmatching, setup from receipt of order to completion of unit packaging for delivery took 2.5 minutes using the pneumatic tube system (maximum 2 units per tube) and 4.5 minutes using the delivery of a cooler using a human. delivery courier.

Summary/Conclusions:Based on the simulation results and with the consensus agreement of the multidisciplinary group, preparation of the default chiller for elective primary CABG, urgent primary CABG, elective MVR, and elective AVR was disc