NL-OMON29423尚未招募不适用
A phase II trial on the safety and efficacy of C1 esterase inhibitor Cinryze for the acute management of severe traumatic brain injury
eiden University Medical Center0 个研究点目标入组 106 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age at admission = 18 years and < 65 years;
- •- Clinical diagnosis of traumatic brain injury with GCS < 13 (with intracranial deviations);
- •- Catheter placement for monitoring and management of increased ICP for at least 24 hours.
排除标准
- •- A clear, non-traumatic cause of low GCS (e.g. toxic, cardial) on admission;
- •- Not expected to survive more than 24 hours after admission;
- •- Brain death on arrival in the participating centres;
- •- Severe pre-trauma disability, defined as being dependent on other people;
- •- Known prior history of sensibility to blood products or Cinryze;
- •- Patients with a history of hereditary angioedema;
- •- Patients with a history of thrombosis;
- •- Pregnant women.
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