NCT00810940Unknown1 期
Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- reduction in intracranial pressure
研究概览
简要总结
This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis TBI
- •Age 16-70
排除标准
- •Multiple trauma resulting in shock
- •Bilateral absent pupil response
- •Time from injury > 6 hours
- •Brain tumor or mass effect secondary to hemorrhage or brain surgery
- •Pregnancy
- •Confounding condition or injury
- •Spinal cord injury
- •Sustained high blood pressure or arterial oxygen saturation
研究组 & 干预措施
1
Active Comparator
Control: Standard treatment for severe head trauma including mannitol
干预措施: mannitol (Drug)
2
Experimental
Study drug plus standard treatment
干预措施: AbelaDrug200 (Drug)
结局指标
主要结局
reduction in intracranial pressure
时间窗: 24 hours, 5 days
次要结局
- Glasgow Outcome Scale(3 months)
- mortality(3 months)
研究者
研究点 (3)
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