Document Detail


Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial.
MedLine Citation:
PMID:  23045213     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Dean A Fergusson; Paul Hébert; Debora L Hogan; Louise LeBel; Nicole Rouvinez-Bouali; John A Smyth; Koravangattu Sankaran; Alan Tinmouth; Morris A Blajchman; Lajos Kovacs; Christian Lachance; Shoo Lee; C Robin Walker; Brian Hutton; Robin Ducharme; Katelyn Balchin; Tim Ramsay; Jason C Ford; Ashok Kakadekar; Kuppuchipalayam Ramesh; Stan Shapiro
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  308     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-11     Completed Date:  2012-10-15     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1443-51     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00326924; ISRCTN/ISRCTN65939658
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MeSH Terms
Descriptor/Qualifier:
Birth Weight
Blood Banks / standards
Bronchopulmonary Dysplasia
Double-Blind Method
Enterocolitis, Necrotizing
Erythrocyte Transfusion / methods*
Female
Humans
Infant, Newborn
Infant, Premature*
Infant, Very Low Birth Weight*
Intensive Care Units, Neonatal
Intracranial Hemorrhages
Male
Morbidity
Retinopathy of Prematurity
Treatment Outcome
Grant Support
ID/Acronym/Agency:
MCT 75527//Canadian Institutes of Health Research
Comments/Corrections
Comment In:
JAMA. 2013 Feb 13;309(6):544-5   [PMID:  23403668 ]
JAMA. 2013 Feb 13;309(6):545   [PMID:  23403669 ]

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