Therapeutic Strategy for Severe Head Trauma Patients With Mild Hypothermia and Estimation of Medical Expenses in Japan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 86
- 主要终点
- Neurological outcome
研究概览
简要总结
The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.
详细描述
Mild hypothermia therapy shows protective effects for damaged brains of animals and post cardiac arrest patients. However, Clifton et al. reported that mild hypothermia has no protective effect for severe head trauma but has a risk of complications. In this study, all the participants must be treated with continuous monitoring of cardiac output and jugular venous oxygen saturation to get optimal physiological conditions. Adequate anesthesia such as neuroleptanesthesia is essential to maintain organ function and tissue microcirculation. Participants are randomly assigned to two groups of mild hypothermia (32.0 - 34.0 degree Celsius) and anti-hyperthermia (35.5 - 37.0 C). The body temperature must be kept for at least 72 hours. Hypothermia must be induced within 6 hours after traumatic brain injury. Glasgow outcome score at 6 months after injury and the total medical expenses of the two groups will be evaluated.
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
- 15 Years 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic brain injury; Glasgow coma score 4-8 (motor 1-5).
- •Hypothermia or anti-hyperthermia must be induced within 6 hours after injury.
排除标准
- •Systolic blood pressure < 90mmHg (after resuscitation)
- •Thrombocytopenia (platelets [Plt] < 50,000/mm3)
- •Pregnancy
- •Preexisting medical conditions of severe hepatic dysfunction, heart failure or any other severe organ failure
- •Deep drunkenness
结局指标
主要结局
Neurological outcome
时间窗: six months after the onset
Glasgow outcome score and neuropsychological performance at 6 months after injury.
Total medical expenses
时间窗: whole duration of treatment
Total medical expenses would be compared.
次要结局
- Physiological data(each day during the treatment)
- Laboratory data(each day during the treatment)
研究者
Tsuyoshi Maekawa
Honorary Professor
Yamaguchi University Hospital