Cassandra D Josephson1, Simone Glynn2, Sunitha Mathew3, Rebecca Birch3, Sonia Bakkour4, Lisa Baumann Kreuziger5, Michael P Busch4, Kathleen Chapman3, Carla Dinardo6, Jeanne Hendrickson7, Eldad A Hod8, Shannon Kelly9, Naomi Luban10, Alan Mast5, Philip Norris4, Brian Custer4, Ester Sabino11, Bruce Sachais12, Bryan R Spencer13, Mars Stone4, Steve Kleinman14. 1. Departments of Pathology and Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA. 2. National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA. 3. Public Health and Epidemiology Practice, Westat, Rockville, Maryland, USA. 4. Vitalant Research Institute, University of California San Francisco, San Francisco, California, USA. 5. Versiti Blood Research Institute, Versiti, Milwaukee, Wisconsin, USA. 6. Immunohematology, Faculdade de Medicina da Universidade de Sao and Fundacao Pro-Sangue, São Paulo, Brazil. 7. Departments of Pediatrics and Laboratory Medicine, Yale University School of Medicine, New Haven, Connecticut, USA. 8. Department of Pathology & Cell Biology, Columbia University Irving Medical Center, New York, New York, USA. 9. Department of Pediatric Hematology & Oncology, UCSF Benioff Children's Hospital, Oakland, California, USA. 10. Children's Research National Institute, Children's National Hospital, Washington, District of Columbia, USA. 11. Department of Infectious Disease, Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Brazil. 12. New York Blood Center, New York, New York, USA. 13. Scientific Affairs, American Red Cross, Dedham, Massachusetts, USA. 14. Department of Pathology and Laboratory Medicine, University of British Columbia, Victoria, British Columbia, Canada.
Abstract
BACKGROUND: The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is a new iteration of prior National Heart, Lung, and Blood Institute (NHLBI) REDS programs that focus on improving transfusion recipient outcomes across the lifespan as well as the safety and availability of the blood supply. STUDY DESIGN AND METHODS: The US program includes blood centers and hospitals (22 including 6 free-standing Children's hospitals) in four geographic regions. The Brazilian program has 5 participating hemocenters. A Center for Transfusion Laboratory Studies (CTLS) and a Data Coordinating Center (DCC) support synergistic studies and activities over the 7-year REDS-IV-P program. RESULTS: The US is building a centralized, vein-to-vein (V2V) database, linking information collected from blood donors, their donations, the resulting manufactured components, and data extracts from hospital electronic medical records of transfused and non-transfused patients. Simultaneously, the Brazilian program is building a donor, donation, and component database. The databases will serve as the backbone for retrospective and prospective observational studies in transfusion epidemiology, transfusion recipient outcomes, blood component quality, and emerging blood safety issues. Special focus will be on preterm infants, patients with sickle cell disease, thalassemia or cancer, and the effect of donor biologic variability and component manufacturing on recipient outcomes. A rapid response capability to emerging safety threats has resulted in timely studies related to Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2). CONCLUSIONS: The REDS-IV-P program endeavors to improve donor-recipient-linked research with a focus on children and special populations while also maintaining the flexibility to address emerging blood safety issues.
BACKGROUND: The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is a new iteration of prior National Heart, Lung, and Blood Institute (NHLBI) REDS programs that focus on improving transfusion recipient outcomes across the lifespan as well as the safety and availability of the blood supply. STUDY DESIGN AND METHODS: The US program includes blood centers and hospitals (22 including 6 free-standing Children's hospitals) in four geographic regions. The Brazilian program has 5 participating hemocenters. A Center for Transfusion Laboratory Studies (CTLS) and a Data Coordinating Center (DCC) support synergistic studies and activities over the 7-year REDS-IV-P program. RESULTS: The US is building a centralized, vein-to-vein (V2V) database, linking information collected from blood donors, their donations, the resulting manufactured components, and data extracts from hospital electronic medical records of transfused and non-transfused patients. Simultaneously, the Brazilian program is building a donor, donation, and component database. The databases will serve as the backbone for retrospective and prospective observational studies in transfusion epidemiology, transfusion recipient outcomes, blood component quality, and emerging blood safety issues. Special focus will be on preterm infants, patients with sickle cell disease, thalassemia or cancer, and the effect of donor biologic variability and component manufacturing on recipient outcomes. A rapid response capability to emerging safety threats has resulted in timely studies related to Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2). CONCLUSIONS: The REDS-IV-P program endeavors to improve donor-recipient-linked research with a focus on children and special populations while also maintaining the flexibility to address emerging blood safety issues.
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