Use of Viscoelastic Tests in the Treatment of Trauma-induced Coagulopathy: a Pragmatic Randomized Clinical Trial Comparing Viscoelastic Tests With Conventional Assays.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Fresh frozen plasma consumption
研究概览
简要总结
Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC) encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR).
POC tests are thought to have a better performance on mortality and bleeding control than conventional tests. The aim of this study is to compare POC and conventional assays with plasma consumption as a primary outcome and 28 days mortality as a secondary one.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all adult (> 18 years old) trauma patients treated in our Emergency Department with a TASH score > 18
排除标准
- •dead on arrival
- •no blood product administered after randomization
结局指标
主要结局
Fresh frozen plasma consumption
时间窗: 3 years
In the POC group plasma consumption is estimated 20% less than in conventional assays group
次要结局
- Mortality(28 days)
研究者
Stefano Magnone
Attending General Surgeon
A.O. Ospedale Papa Giovanni XXIII