Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: The ARIPI randomized trial

Authors

Dean A. Fergusson, Ottawa Hospital Research Institute
Paul Hébert, Ottawa Hospital Research Institute
Debora L. Hogan, Ottawa Hospital Research Institute
Louise LeBel, Ottawa Hospital Research Institute
Nicole Rouvinez-Bouali, University of Ottawa
John A. Smyth, The University of British Columbia
Koravangattu Sankaran, Royal University Hospital
Alan Tinmouth, Ottawa Hospital Research Institute
Morris A. Blajchman, McMaster University
Lajos Kovacs, Sir Mortimer B. Davis Jewish General Hospital
Christian Lachance, CHU Sainte-Justine - Le Centre Hospitalier Universitaire Mère-Enfant
Shoo Lee, Hospital for Sick Children University of Toronto
C. Robin Walker, Schulich School of Medicine & DentistryFollow
Brian Hutton, Ottawa Hospital Research Institute
Robin Ducharme, Ottawa Hospital Research Institute
Katelyn Balchin, Ottawa Hospital Research Institute
Tim Ramsay, Ottawa Hospital Research Institute
Jason C. Ford, The University of British Columbia
Ashok Kakadekar, Royal University Hospital
Kuppuchipalayam Ramesh, The University of British Columbia
Stan Shapiro, Université McGill

Document Type

Article

Publication Date

10-10-2012

Journal

JAMA - Journal of the American Medical Association

Volume

308

Issue

14

First Page

1443

Last Page

1451

URL with Digital Object Identifier

10.1001/2012.jama.11953

Abstract

Context: Even though red blood cells (RBCs) are lifesaving in neonatal intensive care, transfusing older RBCs may result in higher rates of organ dysfunction, nosocomial infection, and length of hospital stay. Objective: To determine if RBCs stored for 7 days or less compared with usual standards decreased rates of major nosocomial infection and organ dysfunction in neonatal intensive care unit patients requiring at least 1 RBC transfusion. Design, Setting, and Participants: Double-blind, randomized controlled trial in 377 premature infants with birth weights less than 1250 g admitted to 6 Canadian tertiary neonatal intensive care units between May 2006 and June 2011. Intervention: Patients were randomly assigned to receive transfusion of RBCs stored 7 days or less (n=188) vs standard-issue RBCs in accordance with standard blood bank practice (n=189). Main Outcome Measures: The primary outcome was a composite measure of major neonatal morbidities, including necrotizing enterocolitis, retinopathy of prematurity, bronchopulmonary dysplasia, and intraventricular hemorrhage, as well as death. The primary outcome was measured within the entire period of neonatal intensive care unit stay up to 90 days after randomization. The rate of nosocomial infection was a secondary outcome. Results: The mean age of transfused blood was 5.1 (SD, 2.0) days in the fresh RBC group and 14.6 (SD, 8.3) days in the standard group. Among neonates in the fresh RBC group, 99 (52.7%) had the primary outcome compared with 100 (52.9%) in the standard RBC group (relative risk, 1.00; 95% CI, 0.82-1.21). The rate of clinically suspected infection in the fresh RBC group was 77.7% (n=146) compared with 77.2% (n=146) in the standard RBC group (relative risk, 1.01; 95% CI, 0.90-1.12), and the rate of positive cultures was 67.5% (n=127) in the fresh RBC group compared with 64.0% (n=121) in the standard RBC group (relative risk, 1.06; 95% CI, 0.91-1.22). Conclusion: In this trial, the use of fresh RBCs compared with standard blood bank practice did not improve outcomes in premature, very low-birth-weight infants requiring a transfusion. Trial Registration: clinicaltrials.gov Identifier: NCT00326924; Current Controlled Trials Identifier: ISRCTN65939658. ©2012 American Medical Association. All rights reserved.