Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage A Prospective Multicentre-study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 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
Much like REBOA, AAJT-S can potentially stop blood flow distal to the device and therefore improve proximal aortic perfusion, minimize haemorrhage and stabilize patients until definite surgical repair/bleeding control is feasible. In contrast to REBOA, there is no need of femoral access and therefore, appropriate training is easily achieved.
This study seeks to gather further information on the benefits and potential harms of this intervention on a multicentre level.
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
- •Written consent of the participant after being informed
- •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)
- •Thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III
- •Traumatic cardiac arrest
排除标准
- 未提供
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
- hemodynamic improvement after application(1 hour)
- Outcome Measure(30 days)
- Complications(90 days)