Status:
NOT_YET_RECRUITING
Study Comparing Platelet Transfusion Volumes in Premature Babies
Lead Sponsor:
University College Dublin
Collaborating Sponsors:
Health Research Board, Ireland
National Maternity Hospital, Ireland
Conditions:
Thrombocytopenia
Transfusion
Eligibility:
All Genders
Up to 32 years
Phase:
NA
Brief Summary
Platelet transfusions can help clotting but may also have risks. Currently when babies get platelet transfusions they get as much as three times (per kilogram of body weight) as much as adults do. The...
Detailed Description
There are almost 6000 babies born weighing less than 1500g every year in the United Kingdom (UK) and Ireland. One in four will have low platelets. Studies prior to 2018 suggested that three quarters o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06095648
Start Date
October 28 2023
End Date
August 1 2028
Last Update
October 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Maternity Hospital
Dublin, Ireland, D02YH21