Managing Thrombocyte transfusions in a Special Subgroup: NEonates

Completed

• Conditions: bleeding; Hemorrhage; 10035534; 10010335; 10028920

• Registration Number: NL-OMON45117
• Lead Sponsor: ational Health Services Blood and Transplant (NHSBT), UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 315

Inclusion Criteria

1. Written informed consent obtained
2. Admission to a participating NICU (includes postnatal transfer)
3. <34 weeks gestational age at birth
4. A platelet count of <50 x10^9/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

Exclusion Criteria

1. Major/life-threatening congenital malformations (e.g. chromosomal anomalies, Fanconi*s anaemia, Thrombocytopenia Absent Radius syndrome (TAR));
2. The occurrence of a major/ severe bleed within the previous 72 hours. However, the neonate may be eligible for randomisation later, once 72 hours has elapsed, provided there are no further major bleeds and the baby meets all the inclusion criteria;
3. All foetal intracranial haemorrhages excluding subependymal haemorrhage from any antenatal ultrasound scan;
4. Known immune thrombocytopenia or family history of alloimmune thrombocytopenia or maternal antiplatelet antibodies or maternal idiopathic thrombocytopenic purpura;
5. Neonates judged by the attending neonatologist to be unlikely to survive more than a few hours at the time of proposed randomisation;
6. Neonates who were not given parenteral Vitamin K after birth.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of patients who either die or experience a major bleed up to and<br /><br>including study day 28. </p><br>