Rationale and Design of the Informing Fresh versus Old Red Cell Management (INFORM) Trial: An International Pragmatic Randomized Trial |
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| Affiliation: | 1. Department of Medicine, McMaster University, Hamilton, ON, Canada;2. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada;3. Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada;4. Population Health Research Institute, Hamilton, ON, Canada;5. Thrombosis & Atherosclerosis Research Institute, Hamilton, ON, Canada;6. Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, ON, Canada;7. Transfusion Medicine Program, McMaster University, Hamilton, ON, Canada;8. Meir Medical Centre, Tel Aviv, Israel;9. Department of Outcomes Research, Cleveland Clinic, Cleveland, OH;10. Flinders Medical Centre, SA, Australia;11. Canadian Blood Services, Hamilton, ON, Canada;1. Department of Anatomy and Cell Biology, University of Wuerzburg, Koellikerstr. 6, 97070 Wuerzburg, Germany;2. Cellular Technology Limited, 20521 Chagrin Blvd, Shaker Heights, OH 44022, USA;1. Department of Medicine, McMaster University, Hamilton, ON, Canada;2. Canadian Blood Services, Ancaster, ON, Canada;3. Department of Medicine, Memorial University, St John''s, NL, Canada;4. Canadian Blood Services, Toronto, ON, Canada;5. Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada |
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| Abstract: | Although red blood cell transfusion is a potentially lifesaving intervention in severely anemic and acutely bleeding patients, some observational studies have suggested that prolonged red cell storage before transfusion is associated with harm. INFORM is a large, pragmatic, randomized controlled trial comparing the effect of the shorter storage with longer storage red blood cell transfusions on inhospital mortality in hospitalized patients who require a blood transfusion. The trial is being conducted in centers in Australia, Canada, Israel, and the United States and is expected to enroll 31 497 patients. If the results of INFORM indicate that shorter storage red blood cell transfusion is associated with superior outcomes compared with standard issue red blood cell transfusion, consideration may be given to shortening blood storage times. If, in contrast, the INFORM trial provides no evidence of harm from longer storage red blood cells, clinicians and patients may be reassured that current blood inventory management strategies are appropriate. |
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