CTRI/2009/091/000893进行中（未招募）2 期
A Randomized Placebo controlled trial (Factorial design) of Progesterone with or without hypothermia in subjects with acute severe traumatic brain injury.
DEPARTMENT OF BIOTECHNOLOGY0 个研究点目标入组 250 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
入选标准
- •i.Male or female patients between the ages of 18 and 65 years with suspected TBI
- •ii.Glasgow Coma Scale (GCS) score 4-8 after resuscitation and stabilization
- •iii.Patients who arrived within 8 hrs of injury
排除标准
- •i.Patients who had received any investigational drugs 30 days prior to the enrollment, such as progesterone, estrogen and any other investigational compound
- •ii.Patients with severe anoxic intracerebral damage or brain death
- •iii.Patients whose clinical condition is unstable (partial pressure of oxygen 60 mmHg or a systolic blood pressure 90 mmHg, or both)
- •iv.Pregnant or lactating female patients
- •v.Doubt whether the altered neurological status resulted from head trauma or acute or chronic spinal cord injury.
研究者
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