TY - JOUR
T1 - Randomized Trial of Platelet-Transfusion Thresholds in Neonates
AU - Curley, Anna
AU - Stanworth, Simon J.
AU - Willoughby, Karen
AU - Fustolo-Gunnink, Susanna F.
AU - Venkatesh, Vidheya
AU - Hudson, Cara
AU - Deary, Alison
AU - Hodge, Renate
AU - Hopkins, Valerie
AU - Santamaria, Beatriz Lopez
AU - Mora, Ana
AU - Llewelyn, Charlotte
AU - D'Amore, Angela
AU - Khan, Rizwan
AU - Onland, Wes
AU - Lopriore, Enrico
AU - Fijnvandraat, Karin
AU - New, Helen
AU - Clarke, Paul
AU - Watts, Timothy
AU - PlaNeT2 MATISSE Collaborators
AU - van der Hoeven, Mark
N1 - Funding Information:
Supported by the National Health Service Blood and Transplant Research and Development Committee (Ref No: BS06/1); Sanquin Research, Amsterdam (grant PPOC-12-012027); Adden-brooke’s Charitable Trust; the Neonatal Breath of Life Fund 9145; and the National Institute for Health Research Clinical Research Network.
Publisher Copyright:
Copyright © 2018 Massachusetts Medical Society.
PY - 2019/1/17
Y1 - 2019/1/17
N2 - BACKGROUNDPlatelet 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.METHODSIn 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.RESULTSA 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 highthreshold group and 22% in the low-threshold group; odds ratio, 1.14; 95% CI, 0.78 to 1.67).CONCLUSIONSAmong preterm infants with severe thrombocytopenia, those randomly assigned to receive platelet transfusions at a platelet-count threshold of 50,000 per cubic millimeter had a significantly higher rate of death or major bleeding within 28 days after randomization than those who received platelet transfusions at a plateletcount threshold of 25,000 per cubic millimeter.
AB - BACKGROUNDPlatelet 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.METHODSIn 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.RESULTSA 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 highthreshold group and 22% in the low-threshold group; odds ratio, 1.14; 95% CI, 0.78 to 1.67).CONCLUSIONSAmong preterm infants with severe thrombocytopenia, those randomly assigned to receive platelet transfusions at a platelet-count threshold of 50,000 per cubic millimeter had a significantly higher rate of death or major bleeding within 28 days after randomization than those who received platelet transfusions at a plateletcount threshold of 25,000 per cubic millimeter.
KW - UNITED-STATES
KW - HEMORRHAGE
KW - THROMBOCYTOPENIA
KW - BIRTH
U2 - 10.1056/nejmoa1807320
DO - 10.1056/nejmoa1807320
M3 - Article
C2 - 30387697
SN - 0028-4793
VL - 380
SP - 242
EP - 251
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 3
ER -