Study Comparing Platelet Transfusion Volumes in Premature Babies

Launched by UNIVERSITY COLLEGE DUBLIN · Oct 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the best amount of platelets to transfuse in premature babies who have low platelet counts, a condition known as thrombocytopenia. Platelets are important for helping blood to clot, but giving too many can have risks. The trial aims to see if giving a smaller volume of platelets can help prevent serious problems, like severe bleeding or even death, while also reducing side effects for the babies.

To participate in this study, babies need to be born very early (at or before 32 weeks) or weigh less than 1500 grams at birth, and have low platelet levels. Parents will need to provide written consent for their baby to join the trial. Once enrolled, babies will be randomly placed into one of two groups: one will receive a smaller volume of platelets (5 ml per kilogram of their weight), and the other group will receive a larger volume (15 ml per kilogram). This will help researchers find out which amount works best for these vulnerable infants. It’s important to note that babies will stay in their assigned group for the duration of their stay in the neonatal unit, unless their doctor decides otherwise.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Infants born at or before 32+0 weeks' gestation or less than 1500g at birth
• • Written informed consent obtained from parent
• • Admission to a participating NICU (includes postnatal transfers)
• • Severe Thrombocytopenia (platelet count \<25 x109/L)
• • Cranial ultrasound scan undertaken less than 24 hours prior to randomisation shows no recent major intraventricular haemorrhage (IVH) or significant extension of previous haemorrhage.
• Exclusion Criteria:
• • Major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/VSD), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g., T21, T13, T18, Fanconi's anaemia, Thrombo-cytopenia Absent Radius syndrome).
• • Infants on a palliative care pathway
• • Neonates within 72 hours of major bleed
• • All fetal intracranial haemorrhages excluding subependymal haemorrhage from any antenatal ultrasound scan.
• • Known immune thrombocytopenia or family history of allo-immune thrombocytopenia or maternal anti platelet antibodies or maternal idiopathic thrombocytopenic purpura
• • Neonates who did not receive parenteral vitamin K