ISRCTN87736839
Completed
未知
A randomised controlled trial to compare two different platelet count thresholds for prophylactic platelet transfusion to preterm neonates
ational Blood Service (UK)0 sites660 target enrollmentSeptember 29, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Blood Service (UK)
- Enrollment
- 660
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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