Anna Curley1, Simon J Stanworth1, Karen Willoughby1, Susanna F Fustolo-Gunnink1, Vidheya Venkatesh1, Cara Hudson1, Alison Deary1, Renate Hodge1, Valerie Hopkins1, Beatriz Lopez Santamaria1, Ana Mora1, Charlotte Llewelyn1, Angela D'Amore1, Rizwan Khan1, Wes Onland1, Enrico Lopriore1, Karin Fijnvandraat1, Helen New1, Paul Clarke1, Timothy Watts1. 1. From the Department of Neonatology, National Maternity Hospital, Dublin (A.C.), and University Maternity Hospital Limerick, Limerick (R.K.) - both in Ireland; Department of Transfusion Medicine, National Health Service (NHS) Blood and Transplant, the Department of Haematology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, the Radcliffe Department of Medicine, University of Oxford, and Oxford Biomedical Research Centre Haematology Theme, Oxford (S.J.S.), the Department of Obstetrics and Gynaecology, University of Cambridge (K.W.), NHS Blood and Transplant, Clinical Trials Unit (K.W., C.H., A. Deary, R.H., V.H., A.M., C.L.), and the Neonatal Intensive Care Unit, Cambridge University Hospitals NHS Trust (A. D'Amore), Cambridge, the Neonatal Intensive Care Unit, Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust (B.L.S., T.W.), NHS Blood and Transplant (H.N.), and the Department of Hematology, Imperial College London (H.N.), London, and the Neonatal Intensive Care Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, and Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich (P.C.) - all in the United Kingdom; the Center for Clinical Transfusion Research, Sanquin Blood Supply (S.F.F.-G., K.F.), and the Departments of Epidemiology (S.F.F.-G.) and Neonatology (E.L.), Leiden University Medical Center, Leiden, and the Departments of Pediatric Hematology (S.F.F.-G., K.F.) and Neonatology (W.O.), Emma Children's Hospital, Academic Medical Center, Amsterdam - both in the Netherlands; and the Neonatal Intensive Care Unit, Cloudnine Hospital, Bangalore, India (V.V.).
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 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 platelet-count threshold of 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 .).
RCT Entities:
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 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 platelet-count threshold of 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 .).
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