NCT01354509Unknown不适用
Normothermia Protocol for Traumatic Brain Injury Patients: An Outcome Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Effectiveness of the Normothermia protocol
研究概览
简要总结
Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets)
- Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs from admission to Neuro ICU)
- Normothermia is translated into improved neurologic Outcome and survival compared to standard of care (Physician management)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe TBI patients(GCS 3-9) admitted to ICU
排除标准
- •Less than 18 years OLD.
- •Bleeding disorders.
- •Pregnancy/Breastfeeding.
- •Hepatic Encephalopathy.
- •Spinal cord injury (know or new)
- •Fever >100 F prior to randomization.
- •Blood Alcohol level >80
- •Participation in other Research trial.
- •Inability/unwilling to obtain Informed consent.
- •Terminal illness(not expected to survive 3-6 months)
- •Not expected to survive 24 hrs.
结局指标
主要结局
Effectiveness of the Normothermia protocol
时间窗: 5 days
Number of times patient's temp was above 37°C during this 96 hr period
Temperature vs ICP
时间窗: 5 days
Number of times ICP \> 20 in patients with ICP monitors
Neurologic Outcome of the 2 patient populations
时间窗: 1month, 3 months, 6 months
Modified Rankin Scale at Hospital discharge, 3 months, and 6 months
次要结局
- Mortality(5 days, 3 months, 6 months)
研究者
研究点 (1)
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