Study Comparing Platelet Transfusion Volumes in Premature Babies

NCT06095648 | Not Yet Recruiting DMC

• 3 other identifiers: PlaNeT-3DIFA 2020-019EC 15 2023
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Thrombocytopenia; Transfusion

Keywords

Neonatal Platelet Transfusion

Outcome Measures

Primary Outcomes (1)

• Death or Major Bleeding

  This outcome assesses the incidence of Death or Major Bleeding

  28 days

Secondary Outcomes (11)

• Survival

  28 days

• Major bleeding

  28 days

• Survival without Bronchopulmonary dysplasia

  Until baby is discharged from hospital

• Retinopathy of prematurity requiring treatment

  Until baby reaches Term (40 weeks corrected gestation, typically within 8 and 17 weeks from birth) or hospital discharge

• New onset necrotising enterocolitis

  Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or hospital discharge

Other Outcomes (8)

• Levels of CXCL5, TGF beta and CD40

  Pre and post transfusion: Within 60 minutes prior to the transfusion and between 90 and 270 minutes post transfusion.

• Days ventilation following randomization

  Until baby dies, reaches Term (40 weeks corrected gestation, typically within 8-17 weeks of birth) or is discharged from hospital

• Days 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

Study Arms (2)

Usual treatment arm

ACTIVE COMPARATOR

Babies who are randomized to this arm will receive the usual treatment of 15ml/kg platelets when they are getting a platelet transfusion

Other: Dose of platelet transfusion

Intervention arm

EXPERIMENTAL

Babies who are randomized to this arm will receive the experimental treatment of 5ml/kg platelets when they are getting a platelet transfusion

Other: Dose of platelet transfusion

Interventions

Dose of platelet transfusion OTHER

Intervention 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

Intervention arm; Usual treatment arm

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• Health Research Board, Ireland: collaborator
• National Maternity Hospital, Ireland: collaborator
• Irish Blood Transfusion Service: collaborator

Study Sites (1)

National Maternity Hospital

Dublin, D02YH21, Ireland

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Central Study Contacts

Anna E Curley

CONTACT

+35316373198; anna.curley@nmh.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 23, 2023
• Study Start: October 28, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)