NCT06622317招募中不适用
Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage: a Prospective Observational Pilot Study
Medical University of Graz1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- effective placement of the device
研究概览
简要总结
This study seeks to evaluate the feasibility of a Abdominal Aortic Balloon Occlusion of the Aorta (AAJT-S) in exanguinating trauma patients with non-compressible truncal haemorrhage in the emergency room and the pre-hospital setting.
详细描述
The study is designed as a prospective observational study to accomapany the impementation of this device in clinical routine. However, the device has already been used in the emergency room and AAJT-S application is no study specific intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •aged, or believed to be aged, 18 years or above,
- •confirmed or suspected life-threatening lower body trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
- •is thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III
排除标准
- •suspected additional bleeding source proximal to the umbilicus, or
- •known or suspected pregnancy at presentation, or
- •known abdominal aortic aneurysm
结局指标
主要结局
effective placement of the device
时间窗: 1 hour
cessation of bloodflow distal to the device
次要结局
- 30-day mortality(30 days)
- Complications(90 days)
- Heart rate(1 hour)
- Base excess(1hour)
- Blood pressure (systolic and diastolic)(1 hour)
研究者
研究点 (1)
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