The Utility of Thromboelastography for Predicting the Risk of Coagulation-Related Damages Secondary to Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Glasgow Outcome Scale scores
研究概览
简要总结
Hemocoagulation disorder is recognized to have crucial effects on hemorrhagic or ischemic diseases. Coagulation-related damages secondary to traumatic brain injury are common and severe secondary insults of head trauma and often leads to a poor prognosis. In this study, we sought to assess if posttraumatic hemocoagulation disorders determined using thromboelastography are associated with coagulation-related damages secondary to traumatic brain injury, and evaluate their influence on outcome among patients with head trauma. Based on above results, prediction models or risk scoring systems will be further developed and validated to predict coagulation-related damages secondary to traumatic brain injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are delivered to hospital within 24 hours after head trauma
- •Patients whose abbreviated injury score (AIS) for other body regions is 3 or less are considered to be isolated traumatic brain injury
排除标准
- •Patients with existing prior neurological disease
- •Patients with known coagulation disorders
- •Patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma
- •Patients receiving blood components prior to blood draw
- •Patients who deteriorate and die before determining whether coagulation- related damage exists
结局指标
主要结局
Glasgow Outcome Scale scores
时间窗: Six months
Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. Unfavorable outcome is defined as a Glasgow Outcome Scale score of ≤ 3, and favorable outcome is defined as a Glasgow Outcome Scale score of \> 3.
次要结局
未报告次要终点
研究者
Hao Chen, MD, PhD
Associate Clinical Professor
Shanghai 6th People's Hospital