Effect of Fresh Red Blood Cell Transfusions on Clinical Outcomes in Premature, Very Low-Birth-Weight Infants: The ARIPI Randomized Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 308; no. 14; pp. 1 - 9
• Main Authors: Fergusson, Dean A, Hébert, Paul, Hogan, Debora L, LeBel, Louise, Rouvinez-Bouali, Nicole, Smyth, John A, Sankaran, Koravangattu, Tinmouth, Alan, Blajchman, Morris A, Kovacs, Lajos, Lachance, Christian, Lee, Shoo, Walker, C. Robin, Hutton, Brian, Ducharme, Robin, Balchin, Katelyn, Ramsay, Tim, Ford, Jason C, Kakadekar, Ashok, Ramesh, Kuppuchipalayam, Shapiro, Stan
• Format: Journal Article
• Language: English
• Published: Chicago, IL American Medical Association 10.10.2012
• Subjects: Biological and medical sciences; Birth Weight; Blood Banks - standards; Blood transfusions; Bronchopulmonary Dysplasia; Clinical trials; Diseases of mother, fetus and pregnancy; Double-Blind Method; Enterocolitis, Necrotizing; Erythrocyte Transfusion - methods; Erythrocytes; Female; General aspects; Gynecology. Andrology. Obstetrics; Humans; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Intensive care; Intensive Care Units, Neonatal; Intracranial Hemorrhages; Male; Medical sciences; Morbidity; Neonatal care; Nosocomial infections; Pregnancy. Fetus. Placenta; Retinopathy of Prematurity; Treatment Outcome; Canada; Human; Premature; Prognosis; Transfusion; Pregnancy disorders; Red blood cell; Infant; Medicine; Very low birthweight; Blood cell; Newborn diseases; Prematurity; Fresh blood; Clinical trial; Evolution
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/2012.jama.11953

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