title: Rationale and Design of the Informing Fresh versus Old Red Cell Management (INFORM) Trial: An International Pragmatic Randomized Trial.
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 31497 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.
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Thrombosis & Atherosclerosis Research Institute, Hamilton, ON, Canada. Electronic address: eikelbj@mcmaster.ca.
authors.forename: John W
authors.initials: JW
authors.lastname: Eikelboom
authors.affiliation: Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, ON, Canada.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Cook
authors.affiliation: Transfusion Medicine Program, McMaster University, Hamilton, ON, Canada.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Barty
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Yang
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada; Canadian Blood Services, Hamilton, ON, Canada.
authors.forename: Donald M
authors.initials: DM
authors.lastname: Arnold
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Crowther
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Devereaux
authors.affiliation: Meir Medical Centre, Tel Aviv, Israel.
authors.forename: Martin
authors.initials: M
authors.lastname: Ellis
authors.affiliation: Department of Outcomes Research, Cleveland Clinic, Cleveland, OH.
authors.forename: Priscilla
authors.initials: P
authors.lastname: Figueroa
authors.affiliation: Flinders Medical Centre, SA, Australia.
authors.forename: Alex
authors.initials: A
authors.lastname: Gallus
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Jack
authors.initials: J
authors.lastname: Hirsh
authors.affiliation: Department of Outcomes Research, Cleveland Clinic, Cleveland, OH.
authors.forename: Andrea
authors.initials: A
authors.lastname: Kurz
authors.affiliation: Flinders Medical Centre, SA, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Roxby
authors.affiliation: Department of Outcomes Research, Cleveland Clinic, Cleveland, OH.
authors.forename: Daniel I
authors.initials: DI
authors.lastname: Sessler
authors.affiliation: Meir Medical Centre, Tel Aviv, Israel.
authors.forename: Yehudit
authors.initials: Y
authors.lastname: Sharon
authors.affiliation: Flinders Medical Centre, SA, Australia.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Sobieraj-Teague
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada; Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Theodore E
authors.initials: TE
authors.lastname: Warkentin
authors.affiliation: Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada; Canadian Blood Services, Hamilton, ON, Canada.
authors.forename: Kathryn E
authors.initials: KE
authors.lastname: Webert
authors.affiliation: Transfusion Medicine Program, McMaster University, Hamilton, ON, Canada; Canadian Blood Services, Hamilton, ON, Canada.
authors.forename: Nancy M
authors.initials: NM
authors.lastname: Heddle
mesh_terms: D000328:Adult; D001315:Australia; D001793:Blood Preservation / Q000379:methods* / Q000592:standards; D002170:Canada; D017707:Erythrocyte Transfusion / Q000379:methods* / Q000592:standards; D006801:Humans; D007557:Israel; D018579:Patient Selection; D011908:Rationalization; D012107:Research Design; D016896:Treatment Outcome; D014481:United States
keywords: Blood; Randomized controlled trial; Storage; Transfusion