Pre-Hospital Zone 1 Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Injured Patients With Exsanguinating Sub-diaphragmatic Haemorrhage (P-PRO-Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Zone 1 REBOA
研究概览
简要总结
It is unknown whether this evolved strategy (Pre-Hospital Zone I P-REBOA) is feasible and with an acceptable safety profile. This study will address this question, therefore informing the design of a prospective multicentre exploratory cohort study followed by a pilot/feasibility multicenter RCT (IDEAL 2B). The IDEAL Framework is an internationally recognised standard, that describes the stages through which interventional therapy innovation normally passes, the characteristics of each stage and the study design types recommended for each
详细描述
Haemorrhage (bleeding) is the most common cause of preventable death after injury and is responsible for approximately one-third of trauma deaths (of which between 16-29% of such deaths are thought to be preventable).
Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a minimally invasive damage control procedure for life-threatening abdominal and/or pelvic haemorrhage. It involves temporary occlusion of the aorta with an endovascular balloon, providing proximal control to the site of vascular injury whilst supporting cerebral and myocardial perfusion.
Emergency Department (ED) use of REBOA appears to be feasible and associated with improved outcomes. However, bleeding trauma patients die quickly and it's evident that the peak death rate from haemorrhage occurs within 30 minutes of injury. This is well before the majority of patients can reach hospital, it's therefore likely this resuscitation strategy may have greatest benefit for patients when used in the pre-hospital environment.
We have demonstrated that Pre-Hospital Zone III REBOA (distal aortic occlusion) for exsanguinating pelvic haemorrhage is a feasible resuscitation strategy that significantly improves blood pressure and may reduce the risk of hypovolaemic cardiac arrest and early death due to exsanguination.
To evolve this resuscitation strategy, it is important to establish whether it can be delivered in patients with more proximal haemorrhage in the abdomen (Zone I REBOA). However, this development may be associated with increased risk of harm due to the visceral ischaemia that is created. The use of a technique called Partial REBOA (P-REBOA) may offer a solution by mitigating the ischaemia/reperfusion injury created.
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
- 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
Zone 1 REBOA
时间窗: 1 day
The proportion of patients where Pre-Hospital Zone 1 REBOA is achieved, defined as: * Balloon insertion depth between 35 - 55 cm * Proximal arterial blood pressure transduced * Balloon inflation
Partial REBOA (P-REBOA)
时间窗: 1 day
The proportion of Pre-Hospital Zone 1 REBOA patients where P-REBOA is achieved, defined as: * Evidence of an increase in distal mean arterial pressure (MAP) of at least 5mm - 10mmHg above post inflation baseline; * and/or a return of distal pulsatility; * or distal pulsatility never absent post initial balloon inflation.
次要结局
- • Incidence of pre-hospital balloon migration(1 Day)
- • Incidence of balloon reinflation or the requirement for additional balloon volume, post institution or recognition of P-REBOA.(1 Day)
- • Incidence of pre-hospital, ED, or operating theatre resuscitative thoracotomy (RT).(1 Day)
- • Survival to hospital discharge.(90 Days)
- • Incidence of Zone I balloon positioning in the ED(1 Days)
- • Total duration of REBOA (inflation to final deflation).(1 Day)
- • Incidence of balloon repositioning (proximal or distal) pre or in-hospital.(1 Day)
- • Incidence of failed femoral arterial access(1 Day)
- • Time elapsed from balloon inflation to the institution or recognition of P-REBOA.(1 Day)
- • Mortality rate - Pre-hospital, one hour, 3 hours, 24 hours, 30 and 90 days.(90 days.)
- • Method of achieving Partial REBOA(1 Day)
- • Systolic blood pressure response to institution of REBOA(1 day)
- • Length of critical care and hospital stay.(90 Days)
- • Incidence of all adverse events related to patient injury, resulting critical illness and treatment as well as femoral cannulation, REBOA catheter insertion and/or the anticipated effects of aortic occlusion:(90 Days)
- • Causes of death (in-hospital and pre-hospital) of patients who received Pre-Hospital REBOA or did not following a failed attempt.(1 year)
- • Incidence of pre-hospital cardiac arrest(1 day)