A randomised controlled trial to compare two different platelet count thresholds for prophylactic platelet transfusion to preterm neonates

Not Applicable

Completed

• Conditions: Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics; Pregnancy and Childbirth; Fetal blood loss

• Registration Number: ISRCTN87736839
• Lead Sponsor: ational Blood Service (UK)

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30387697 results 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36810309/ Two-year follow-up data (added 24/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-29
• Study Completion: 2020-08-31
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

1. Written informed consent obtained
2. Admission to a participating neonatal intensive care unit (NICU) (includes postnatal transfers)
3. <34 weeks gestational age at birth
4. A platelet count of < 50x10^9/L
5. Cranial ultrasound scan must have been undertaken less than 6 hours prior to randomisation in order to rule out recent major intraventricular hemorrhage (IVH)

IVH defined as any haemorrhage (H1, H2 or H3) with ventricular dilatation (V1) (Grade 3 Papile grading, (Papile et al 1978) or any haemorrhage (H1,H2,H3) with parenchymal involvement (P1, P2 or P3) (Grade 4 Papile grading,) within the past 72 hours. If a cranial ultrasound scan (which typically takes a few minutes to complete) has not been undertaken less than 6 hours prior to randomisation it must be performed before the baby can be randomised.

Target Gender: Male & Female; Upper Age Limit 34 weeks ; Lower Age Limit 23 weeks

Exclusion Criteria

1. Major/lifethreatening congenital malformations (e.g. chromosomal anomalies, Fanconi?s anaemia, Thrombocytopenia Absent Radius syndrome)
2. Recent major IVH within the last 72 hours i.e. any haemorrhage (H1, H2 or H3) with ventricular dilatation (V1) (Grade
3. Papile grading, or any haemorrhage (H1, H2 or H3) with parenchymal involvement (P1, P2 or P3) (Grade 4 Papile grading)
4. All fetal intracranial haemorrhages excluding subependymal haemorrhage from any antenatal ultrasound scan
5. Known immune thrombocytopenia or family history of alloimmune thrombocytopenia or maternal antiplatelet antibodies or maternal idiopathic thrombocytopenic purpura
6. Neonates judged by the attending neonatologist to be unlikely to survive more than a few hours at the time of proposed randomisation
7. Neonates who were not given parenteral Vitamin K after birth

Study & Design

• Study Type: Interventional
• Study Design: Not specified