Study Comparing Platelet Transfusion Volumes in Premature Babies
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 32
SponsorUniversity College Dublin
About this trial
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 goal of this clinical trial is to to find out which volume of platelets should be transfused to premature babies with low platelets and no bleeding. The main question it aims to answer is if a smaller volume for platelet transfusion can help prevent death and severe bleeding and also have fewer side effects for the baby.
Participants will be placed at random into one of two groups: In Group 1, babies will get a platelet transfusion based on the volume of 5mls/kg weight, in Group 2, babies will get a platelet transfusion based on the volume of 15mls/kg weight. Babies will remain in their allocated group during their stay on the neonatal unit so that they always receive the allocated volume unless a clinician decides otherwise.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dose of platelet transfusion
Treatment groups
370 Participants
are divided into 2 treatment groupsSponsors and collaborators
University College Dublin
Lead sponsor
Health Research Board, Ireland
Collaborator
National Maternity Hospital, Ireland
Collaborator
Irish Blood Transfusion Service
Collaborator
Source ClinicalTrials.gov