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

Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. dafergusson@ohri.ca

JAMA: the Journal of the American Medical Association. 2012;308((14):):1443-51.
CONTEXT Even though red blood cells (RBCs) are lifesaving in neonatal intensivecare, 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 ofmajor nosocomial infection and organ dysfunction in neonatal intensive care unitpatients requiring at least 1 RBC transfusion. DESIGN, SETTING, AND PARTICIPANTS Double-blind, randomized controlled trial in 377 premature infants with birthweights less than 1250 g admitted to 6 Canadian tertiary neonatal intensive careunits between May 2006 and June 2011. INTERVENTION Patients were randomlyassigned to receive transfusion of RBCs stored 7 days or less (n = 188) vsstandard-issue RBCs in accordance with standard blood bank practice (n = 189). MAIN OUTCOME MEASURES The primary outcome was a composite measure of majorneonatal morbidities, including necrotizing enterocolitis, retinopathy ofprematurity, bronchopulmonary dysplasia, and intraventricular hemorrhage, as wellas death. The primary outcome was measured within the entire period of neonatalintensive care unit stay up to 90 days after randomization. The rate ofnosocomial infection was a secondary outcome. RESULTS The mean age of transfusedblood was 5.1 (SD, 2.0) days in the fresh RBC group and 14.6 (SD, 8.3) days inthe standard group. Among neonates in the fresh RBC group, 99 (52.7%) had theprimary outcome compared with 100 (52.9%) in the standard RBC group (relativerisk, 1.00; 95% CI, 0.82-1.21). The rate of clinically suspected infection in thefresh RBC group was 77.7% (n = 146) compared with 77.2% (n = 146) in the standardRBC group (relative risk, 1.01; 95% CI, 0.90-1.12), and the rate of positivecultures 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 practicedid not improve outcomes in premature, very low-birth-weight infants requiring atransfusion. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00326924;Current Controlled Trials Identifier: ISRCTN65939658.
Study details
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