NCT00676104已完成3 期
Discrete Hypothermia in the Management of Traumatic Brain Injury
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Perform a comparative analysis of outcome (Glasgow Outcome Score)
研究概览
简要总结
The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral Hypothermia System holds a great potential for protecting the brain from the devastating secondary complications of trauma without the associated deleterious system effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is treated for severe traumatic brain injury at Grady Health System, GCS < 8
- •Patient is >18 years of age
- •Patient requires an Intracranial Pressure (ICP) Probe (part of their routine treatment)
- •Patient is able to receive Discrete Cerebral Hypothermia within 48-hours of hospital admission
- •Patient and/or guardian must speak English (in order to ensure proper Informed Consent)
- •Patient and/or guardian/family must sign an Informed Consent
排除标准
- •Unwillingness or inability of patient and/or guardian/ family to sign an informed consent
- •Physical placement of cooling cap impedes routine treatment
- •Patient has a core body temperature of 36 degrees C or less at time of assessment
结局指标
主要结局
Perform a comparative analysis of outcome (Glasgow Outcome Score)
时间窗: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
次要结局
- The effectiveness of the Discrete Cerebral Hypothermia System by CoolSystems in maintaining a significant gradient between the core and brain temperatures in study population.(within 3 days after injury)
- Functional Independence Measure(Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury)
- Mortality(Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury)
- Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature(within 3 days after injury)
研究者
Monique Surles
Designated Investigator
Emory University
研究点 (2)
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