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临床试验/NCT00152685
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

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

发起方
University Hospital, Angers
申办方类型
Other Gov

研究点 (6)

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