A Phase 2, Randomized, Controlled 2x3 Trial Comparing Clinical Outcomes in Patients With Severe Traumatic Brain Injury Using Mild Hypothermia and Concurrent and Supplemental Infusion of Magnesium Sulfate.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- GOS (Glasgow Outcome Score)
研究概览
简要总结
The investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.
This is a study to compare the outcomes of patients with severe traumatic brain injury who have been allocated to one of the following three groups:
Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have their core body temperature lowered to 34C Group 3 - Subjects will have their core body temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium sulfate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult males or females ≥ 18 years of age
- •Subjects with Traumatic Brain Injury and a post-resuscitation Glasgow Coma Score (GCS) ≤ 8
- •In-hospital and screened within 7 hours of injury.
- •Able to obtain legally effective written consent from authorized representative
- •Patients who are intubated and on mechanical ventilation
- •Admitted to ICU
排除标准
- •Bladder or rectal core temperature below 32C (89.6F) upon admission
- •Clinical brain death
- •Patients with open abdomens.
- •Multiple orthopedic injuries (> 2 long bone fractures)
- •Persistent hypotension (systolic blood pressure < 90mmHg)
- •Persistent hypoxia (O2 Saturation < 94%)
- •Persistent metabolic acidosis (Lactic acid > 5 mmol/L, arterial pH < 7.25)
- •Positive serum pregnancy test
- •Cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial damage (as shown on ECG)
- •History of abnormal renal function
- •Significant Co-morbidity (i.e. CAD;COPD; severe coagulopathy)
- •Pediatric patients (< 18 years old)
研究组 & 干预措施
Hypothermia
Subjects will have their core body temperatures lowered to 34C.
干预措施: Arctic Sun (Device)
Hypothermia plus supplemental magnesium sulfate infusion
干预措施: Arctic Sun (Device)
Hypothermia plus supplemental magnesium sulfate infusion
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
GOS (Glasgow Outcome Score)
时间窗: Discharge from Hospital - Within 2 months from Injury
GOS=5 (Good Recovery) - Capacity to resume normal occupational and social activities, although some there may be some minor physical or mental deficits or symptoms. GOS=4 (Moderate Disability) - Independent and can resume almost all activities of daily living. GOS=3 (Severe Disability) - No longer capable of engaging in most previous personal, social or work activities. Typically are partially or totally dependent on assistance from others in daily living. GOS=2 ( Persistent Vegetative State ) GOS=1 (Dead)
次要结局
- GOS(12 months after injury)
- Vasospasm(up to 3 months)
研究者
Greg Zorman
Chief of Neurosurgery
United States Department of Defense