Randomized Trial of Platelet-Transfusion Thresholds in Neonates.
Anna Curley1, Simon J Stanworth1, Karen Willoughby1
1From 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.).
A higher threshold for prophylactic platelet transfusions in preterm infants with severe thrombocytopenia did not reduce, but increased, the risk of death or major bleeding. Lowering transfusion thresholds is recommended for these vulnerable neonates.
Area of Science:
- Neonatal Medicine
- Hematology
- Clinical Trials
Background:
- Platelet transfusions are a common intervention for thrombocytopenia in preterm infants.
- Current guidelines lack clear thresholds for prophylactic platelet transfusions in preterm neonates with severe thrombocytopenia.
Purpose of the Study:
- To compare the efficacy of two different platelet-count thresholds for prophylactic platelet transfusions in preterm infants with severe thrombocytopenia.
Main Methods:
- A multicenter trial randomized infants (<34 weeks gestation) with severe thrombocytopenia to transfusion thresholds of 50,000/mm³ (high) or 25,000/mm³ (low).
- Bleeding was assessed using a validated tool, and the primary outcome was death or new major bleeding within 28 days.
Main Results:
- 660 infants were randomized; 90% in the high-threshold group received transfusions vs. 53% in the low-threshold group.
- Death or new major bleeding occurred in 26% of the high-threshold group vs. 19% in the low-threshold group (OR, 1.57; P=0.02).
- No significant difference in serious adverse events was observed between groups.
Conclusions:
- Preterm infants receiving prophylactic platelet transfusions at a 50,000/mm³ threshold had a higher rate of death or major bleeding compared to those at a 25,000/mm³ threshold.
- These findings suggest that a lower threshold for platelet transfusions may be safer for preterm infants with severe thrombocytopenia.
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