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临床试验/NL-OMON45117
NL-OMON45117已完成不适用

Managing Thrombocyte transfusions in a Special Subgroup: NEonates - MATISSE

ational Health Services Blood and Transplant (NHSBT), UK0 个研究点目标入组 315 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
315

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
2 至 11(—)

入选标准

  • 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

排除标准

  • 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.

研究者

发起方
ational Health Services Blood and Transplant (NHSBT), UK

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