Thrombocytopenia Clinical Trial
— PlaNeT-3Official title:
Platelets for Neonatal Transfusion - 3: (PlaNeT-3) a Randomised Controlled Trial of Platelet Transfusion Volumes in Babies Born at Less Than or Equal to 32+0 Weeks Gestation or Less Than 1500g
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.
Status | Not yet recruiting |
Enrollment | 370 |
Est. completion date | August 2028 |
Est. primary completion date | August 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 32 Weeks |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ireland | National Maternity Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
University College Dublin | Health Research Board, Ireland, Irish Blood Transfusion Service, National Maternity Hospital, Ireland |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | Pre and post transfusion: Within 60 minutes prior to the transfusion and between 90 and 270 minutes post transfusion. | |
Other | Days ventilation following randomization | This outcome counts the number of days that baby requires ventilation following randomization | Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital | |
Other | Days non-invasive ventilation following randomization | This outcome counts the number of days that baby requires non-invasive ventilation following randomization | Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital | |
Other | Days supplemental oxygen following randomization | This outcome counts the number of days of supplemental oxygen that baby requires following randomization | Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital | |
Other | Total number of red call transfusions | This outcome counts the total number of red call transfusions that baby requires during the study | Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital | |
Other | Transfusion associated circulatory overload | This outcome assesses the incidence of Transfusion associated circulatory overload (TACO) present after platelet transfusion as part of the study. Definitions will be modified from paediatric definitions. | 12 hours post transfusion | |
Other | Transfusion-related acute lung injury | This outcome assesses the incidence of Transfusion-related acute lung injury (TRALI) after a platelet transfusion as part of this study. Definitions will be modified from paediatric definitions. | 6 hours post transfusion | |
Other | Transfusion Associated Dyspnoea | This outcome assess the incidence of Transfusion Associated Dyspnoea (TAD) after a platelet transfusion as part of this study. Definitions will be modified from paediatric definitions. | 12 hours post transfusion | |
Primary | Death or Major Bleeding | This outcome assesses the incidence of Death or Major Bleeding | 28 days | |
Secondary | Survival | This outcome assesses if baby is alive | 28 days | |
Secondary | Major bleeding | This outcome assesses if baby has any major bleeding | 28 days | |
Secondary | Survival without Bronchopulmonary dysplasia | This outcome assesses if baby is alive and does not have Bronchopulmonary dysplasia | Until baby is discharged from hospital | |
Secondary | Retinopathy of prematurity requiring treatment | This outcome assesses the incidence of Retinopathy of prematurity requiring treatment | Until baby reaches Term (40 weeks corrected gestation, typically within 8 and 17 weeks from birth) or hospital discharge | |
Secondary | New onset necrotising enterocolitis | This outcome assesses the incidence of Necrotising Enterocolitis at Bells stage IIa or higher | Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or hospital discharge | |
Secondary | Survival | This outcome assesses if baby is alive at 2 years corrected age | 2 years corrected age | |
Secondary | Survival without breathing support or oxygen | This outcome assesses if baby is alive and does not require breathing support or oxygen at two years corrected age | 2 years corrected age | |
Secondary | Survival without neurodevelopment impairment | This outcome assesses if baby is alive and does not have neurodevelopmental impairment (As per PlaNeT-2/MATISSE study) | 2 years corrected age | |
Secondary | Number of platelet transfusions | This outcome counts how many platelet transfusions a baby has had while they are in the study | Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital | |
Secondary | Number of platelet donors that baby is exposed to | This outcome assesses the number of platelet donors that baby is exposed to | Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital | |
Secondary | Total volume of platelets per kg transfused over the study | This outcome assesses the total volume of platelets per kg of body weight transfused to baby over the study, based on weight at time of transfusion | Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital |
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