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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Dose of platelet transfusion
Other interventionIntervention is using a lower (5ml/kg) compared to usual (15ml/kg) dose of platelets for transfusion in non-bleeding babies born at or before 32 weeks in NICU
Treatment groups
370 Participants
are divided into 2 treatment groupsGroup A: Usual treatment armActive comparator 1 intervention
Group B: Intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Death or Major Bleeding
This outcome assesses the incidence of Death or Major Bleeding
Time frame
28 daysSecondary outcomes
1
Survival
This outcome assesses if baby is alive
Time frame
28 days2
Major bleeding
This outcome assesses if baby has any major bleeding
Time frame
28 days3
Survival without Bronchopulmonary dysplasia
This outcome assesses if baby is alive and does not have Bronchopulmonary dysplasia
Time frame
Until baby is discharged from hospital4
Retinopathy of prematurity requiring treatment
This outcome assesses the incidence of Retinopathy of prematurity requiring treatment
Time frame
Until baby reaches Term (40 weeks corrected gestation, typically within 8 and 17 weeks from birth) or hospital dischargeOther outcomes
1
Levels of CXCL5, TGF beta and CD40
This outcome assesses the levels of CXCL5, TGF beta and CD40 Tested on Olink NPX platform using dried bloodspot
Time frame
Pre and post transfusion: Within 60 minutes prior to the transfusion and between 90 and 270 minutes post transfusion.2
Days ventilation following randomization
This outcome counts the number of days that baby requires ventilation following randomization
Time frame
Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital3
Days non-invasive ventilation following randomization
This outcome counts the number of days that baby requires non-invasive ventilation following randomization
Time frame
Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital4
Days supplemental oxygen following randomization
This outcome counts the number of days of supplemental oxygen that baby requires following randomization
Time frame
Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospitalSponsors and contacts
Click on the lead sponsor to view all of their trials.
University College Dublin
Lead sponsor
Health Research Board, Ireland
Collaborator
National Maternity Hospital, Ireland
Collaborator
Irish Blood Transfusion Service
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: