NL-OMON52831招募中2 期
Complement Inhibition: Attacking the Overshooting Inflammation @fter Traumatic Brain Injury ( A phase II trial on the safety and efficacy of C1 esterase inhibitor Cinryze for the acute management of severe traumatic brain injury) - CIAO@TBI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 106
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
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Age at admission >= 18 years;
- •- Clinical diagnosis of traumatic brain injury with GCS < 13 (with intra
- •cranial deviations);
- •- Catheter placement for monitoring and management of increased ICP for at
- •least 24 hours;
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- A clear, non-traumatic cause of low GCS (e.g. toxic, cardial) on
- •- 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.
研究者
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