NCT00152685Unknown2 期
High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury
University Hospital, Angers6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年9月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Reduction of the daily median value of intracranial pressure
研究概览
简要总结
Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe head injury (GCS < 9) Next of kin informed consent
排除标准
- •Cranio cerebral wound Pregnancy Hypoxemia (PaO2/FiO2< 300 mmHg) Blood loss > 1/2 blood mass Renal or cardiac failure,uncontrolled hypertension Head injury dating from more than 24 hours at the time of inclusion
结局指标
主要结局
Reduction of the daily median value of intracranial pressure
次要结局
未报告次要终点
研究者
研究点 (6)
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