1.
Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial
Fergusson DA, Hébert P, Hogan DL, LeBel L, Rouvinez-Bouali N, Smyth JA, Sankaran K, Tinmouth A, Blajchman MA, Kovacs L, et al
JAMA: the Journal of the American Medical Association. 2012;308((14):):1443-51.
Abstract
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.
2.
The age of red blood cells in premature infants (ARIPI) randomized controlled trial: study design
Fergusson D, Hutton B, Hogan DL, LeBel L, Blajchman MA, Ford JC, Hebert P, Kakadekar A, Kovacs L, Lee S, et al
Transfusion Medicine Reviews. 2009;23((1):):55-61.
Abstract
Despite recent trends in decreasing transfusion thresholds and the development of technologies designed to avoid allogeneic exposure, allogeneic red blood cell (RBC) transfusions remain an important supportive and life-saving measure for neonatal intensive care patients experiencing illness and anemia. Reluctantly, a number of laboratory and observational studies have indicated that the amount of time RBCs are stored can affect oxygen delivery to tissues. Consequently, older RBCs may result in higher rates of organ dysfunction, nosocomial infection, and lengths of stay. Because of such harmful effects, an evaluation of the association between age of blood and nosocomial infection and organ dysfunction is warranted. The aim of the study was to determine if RBCs stored for 7 days or less (fresh RBCs) compared to current standard transfusion practice decreases major nosocomial infection and organ dysfunction in neonates admitted to the neonatal intensive care unit and requiring at least one RBC transfusion. This study is a double-blind, multicenter, randomized controlled trial design. The trial will be an effectiveness study evaluating the effectiveness of stored vs fresh RBCs in neonates requiring transfusion. Neonatal patients requiring at least one unit of RBCs will be randomized to receive either (1) RBCs stored no longer than 7 days or (2) standard practice. The study was conducted in Canadian university-affiliated level III (tertiary) neonatal intensive care units. The primary outcome for this study will be a composite measure of major neonatal morbidities (necrotizing enterocolitis, retinopathy of prematurity, bronchopulmonary dysplasia, intraventricular hemorrhage, and mortality). Secondary outcomes include individual items of the composite measure and nosocomial infection (bacteremia, septic shock, and pneumonia). The sample size calculations have been estimated based on the formula for 2 independent proportions using an alpha of . 05, a (1-beta) of . 80, and a 10% noncompliance factor. The baseline rate for our composite measure is estimated to be 65% as indicated by the literature. Assuming a 15% absolute risk reduction with the use of RBCs stored 7 days or less, our estimated total sample size required will be 450 (225 patients per treatment arm). The Age of Red Blood Cells in Premature Infants (ARIPI) trial is registered at the US National Institutes of Health (ClinicalTrials. gov) no. NCT00326924 and current controlled trials ISRCTN65939658.