1.
Randomized Trial of Platelet-Transfusion Thresholds in Neonates
Curley A, Stanworth SJ, Willoughby K, Fustolo-Gunnink SF, Venkatesh V, Hudson C, Deary A, Hodge R, Hopkins V, Lopez Santamaria B, et al
The New England Journal of Medicine. 2019;380:242-251
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Editor's Choice
Abstract
BACKGROUND Platelet transfusions are commonly used to prevent bleeding in preterm infants with thrombocytopenia. Data are lacking to provide guidance regarding thresholds for prophylactic platelet transfusions in preterm neonates with severe thrombocytopenia. METHODS In this multicenter trial, we randomly assigned infants born at less than 34 weeks of gestation in whom severe thrombocytopenia developed to receive a platelet transfusion at platelet-count thresholds of 50,000 per cubic millimeter (high-threshold group) or 25,000 per cubic millimeter (low-threshold group). Bleeding was documented prospectively with the use of a validated bleeding-assessment tool. The primary outcome was death or new major bleeding within 28 days after randomization. RESULTS A total of 660 infants (median birth weight, 740 g; and median gestational age, 26.6 weeks) underwent randomization. In the high-threshold group, 90% of the infants (296 of 328 infants) received at least one platelet transfusion, as compared with 53% (177 of 331 infants) in the low-threshold group. A new major bleeding episode or death occurred in 26% of the infants (85 of 324) in the high-threshold group and in 19% (61 of 329) in the low-threshold group (odds ratio, 1.57; 95% confidence interval [CI], 1.06 to 2.32; P=0.02). There was no significant difference between the groups with respect to rates of serious adverse events (25% in the high-threshold group and 22% in the low-threshold group; odds ratio, 1.14; 95% CI, 0.78 to 1.67). CONCLUSIONS Among preterm infants with severe thrombocytopenia, those randomly assigned to receive platelet transfusions at a platelet-count threshold of less than 50,000 per cubic millimeter had a significantly higher rate of death or major bleeding within 28 days after randomization than those in the group that received less than 25,000 per cubic millimeter. (Funded by the National Health Service Blood and Transplant Research and Development Committee and others; Current Controlled Trials number, ISRCTN87736839 .).
PICO Summary
Population
Infants born at less than 34 weeks of gestation in whom severe thrombocytopenia developed, from centres in Ireland, The Netherlands and UK (n= 660).
Intervention
platelet-count thresholds of 50,000 per cubic millimeter (high-threshold group, n= 328).
Comparison
25,000 per cubic millimeter (low-threshold group, n= 331).
Outcome
In the high-threshold group, 90% of the infants (296 of 328 infants) received at least one platelet transfusion, as compared with 53% (177 of 331 infants) in the low-threshold group. A new major bleeding episode or death occurred in 26% of the infants (85 of 324) in the high-threshold group and in 19% (61 of 329) in the low-threshold group (odds ratio, 1.57; 95% confidence interval [CI], 1.06 to 2.32). There was no significant difference between the groups with respect to rates of serious adverse events (25% in the high-threshold group and 22% in the low-threshold group; odds ratio, 1.14; 95% CI, 0.78 to 1.67).
2.
Adverse effects of red blood cell transfusions in neonates: a systematic review and meta-analysis
Keir A, Pal S, Trivella M, Lieberman L, Callum J, Shehata N, Stanworth SJ
Transfusion. 2016;56((11):):2773-2780
Abstract
BACKGROUND Controversy exists regarding the contribution of blood transfusions to a range of adverse clinical outcomes in neonates. The aim of our systematic review was to identify the broader literature on harmful effects and associations potentially attributable to red blood cell (RBC) transfusions. STUDY DESIGN AND METHODS A comprehensive search of MEDLINE (PubMed) and EMBASE was undertaken. Eligible studies included both randomized controlled trials (RCTs) and nonrandomized studies examining the effects of small volume (10-20 mL/kg) RBC transfusions on neonates. Primary outcomes of interest were mortality, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage. Two independent authors conducted a review of abstracts and then of full-text article reviews as well as data extraction and quality assessments. RESULTS Sixty-one studies were eligible for inclusion, including 16 (26%) randomized studies. The majority of studies were nonrandomized (n = 45; 74%), which included 32 observational studies with and 13 studies without a comparator group. There was no evidence that rates of mortality differed between restrictive and liberal strategies for transfusion (eight RCTs: risk ratio, 1.24; 95% confidence interval, 0.89-1.672, heterogeneity = 0%) or for necrotizing enterocolitis (five RCTs: risk ratio, 1.45; 95% confidence interval, 0.91-2.33; heterogeneity = 0%). A liberal strategy also was not superior to restrictive transfusion practice in the pooled randomized studies for rates of retinopathy of prematurity, chronic lung disease, or intraventricular hemorrhage. CONCLUSIONS Statistically significant differences in a range of harmful outcomes between neonates exposed to restrictive and liberal RBC transfusion practice were not found. However, the risks of bias identified in many studies and the lack of consistent reporting and definitions of events limits our conclusions.