Two-year outcomes following a randomised platelet transfusion trial in preterm infants

School of Medicine, University College Dublin, Dublin, Ireland carmel.moore@ucdconnect.ie. Neonatology, National Maternity Hospital, Dublin, Ireland. Neonatology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. Clinical Transfusion Research, Sanquin, Amsterdam, The Netherlands. Clinical Trials Unit, NHS Blood and Transplant, Bristol, UK. Neonatology, Guy's and St Thomas' NHS Foundation Trust, London, UK. NICU, Cloudnine Hospital, Bengaluru, Karnataka, India. NICU, University Maternity Hospital Limerick, Limerick, Ireland. Neonatology, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands. Pediatrics, Emma Children's Hospital, Pediatric Hematology, University of Amsterdam, Amsterdam, The Netherlands. Paediatric Transfusion Medicine, NHS Blood and Transplant, London, UK. Neonatal Intensive Care Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK. Norwich Medical School, University of East Anglia, Norwich, UK. Neonatology, Leiden Universitair Medisch Centrum, Leiden, The Netherlands. Neonatal Intensive Care Unit, Guy's and St Thomas' NHS Foundation Trust, London, UK. National Health Service Blood and Transplant, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. School of Medicine, University College Dublin, Dublin, Ireland.

Archives of disease in childhood. Fetal and neonatal edition. 2023
PICO Summary

Population

Preterm infants enrolled in the PlaNeT-2/MATISSE trial, at 43 neonatal intensive care units across UK, Netherlands and Ireland (n= 660).

Intervention

Higher platelet transfusion threshold (n= 296).

Comparison

Lower platelet transfusion threshold (n= 305).

Outcome

The prespecified long-term follow-up outcome was a composite of death or neurodevelopmental impairment (developmental delay, cerebral palsy, seizure disorder, profound hearing or vision loss) at 2 years of corrected age. Follow-up data were available for 601 of 653 (92%) eligible participants. Of the 296 infants assigned to the higher threshold group, 147 (50%) died or survived with neurodevelopmental impairment, as compared with 120 (39%) of 305 infants assigned to the lower threshold group (OR: 1.54; 95% CI [1.09, 2.17]).
Abstract
OBJECTIVE Assess mortality and neurodevelopmental outcomes at 2 years of corrected age in children who participated in the PlaNeT-2/MATISSE (Platelets for Neonatal Transfusion - 2/Management of Thrombocytopenia in Special Subgroup) study, which reported that a higher platelet transfusion threshold was associated with significantly increased mortality or major bleeding compared to a lower one. DESIGN Randomised clinical trial, enrolling from June 2011 to August 2017. Follow-up was complete by January 2020. Caregivers were not blinded; however, outcome assessors were blinded to treatment group. SETTING 43 level II/III/IV neonatal intensive care units (NICUs) across UK, Netherlands and Ireland. PATIENTS 660 infants born at less than 34 weeks' gestation with platelet counts less than 50×10(9)/L. INTERVENTIONS Infants were randomised to undergo a platelet transfusion at platelet count thresholds of 50×10(9)/L (higher threshold group) or 25×10(9)/L (lower threshold group). MAIN OUTCOMES MEASURES Our prespecified long-term follow-up outcome was a composite of death or neurodevelopmental impairment (developmental delay, cerebral palsy, seizure disorder, profound hearing or vision loss) at 2 years of corrected age. RESULTS Follow-up data were available for 601 of 653 (92%) eligible participants. Of the 296 infants assigned to the higher threshold group, 147 (50%) died or survived with neurodevelopmental impairment, as compared with 120 (39%) of 305 infants assigned to the lower threshold group (OR 1.54, 95% CI 1.09 to 2.17, p=0.017). CONCLUSIONS Infants randomised to a higher platelet transfusion threshold of 50×10(9)/L compared with 25×10(9)/L had a higher rate of death or significant neurodevelopmental impairment at a corrected age of 2 years. This further supports evidence of harm caused by high prophylactic platelet transfusion thresholds in preterm infants. TRIAL REGISTRATION NUMBER ISRCTN87736839.
Study details
Language : eng
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