The Effectiveness of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for Trauma Patients With Uncontrolled Haemorrhage: Study Protocol for a Target Trial and Its Emulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- 30-day in-hospital mortality
研究概览
简要总结
Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) potentially provides a relatively quick means of achieving this temporary control.
In the past years, studies have tried to evaluate the benefit for this method with conflicting results. The previous UK-REBOA trial has not found any benefit in the intervention group and has even hinted at possible harm caused by the intervention. A major limitation of this study is the low number of interventions performed in participating trauma centres and the associated potentially insufficient experience with REBOA.
The aim of this study is to evaluate the effectiveness of REBOA in a setting with already experienced providers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
30-day in-hospital mortality
时间窗: 30 days
次要结局
- 24-hour mortality(24 hours)
- 3-hour mortality(3 hours)
- 6-hour mortality(6 hours)
- Blood product use(48 hours)
- Intensive Care Unit length of stay(within 6 months)
- Rate of complications(within 6 months)
- 90-day mortality(90 days)
- Use of whole body computed tomography(during resuscitation care phase within 3 hours)
- damage control procedure performed(during resuscitation phase within 3 hours)
- Hospital length of stay(within 6 months)
- Time to damage control procedure(during resuscitation phase within 3 hours)
- Cause of death(within 6 months)