P-PRO Study Version 1.0
Research type
Research Study
Full title
Pre-Hospital Zone 1 Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for injured patients with exsanguinating sub-diaphragmatic haemorrhage.
IRAS ID
271728
Contact name
Robbie A Lendrum
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
Haemorrhage (bleeding) is the most common cause of preventable death after injury. It is responsible for approximately one-third of all trauma deaths, of which one third of these are thought to be preventable. In patients where haemorrhage is very rapid, exsanguination (bleeding to death) often occurs before definitive surgical haemorrhage control can be achieved.
Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a procedure that involves temporary occlusion of the aorta (main blood vessel supplying blood to the body) with a balloon, providing control above the site of vascular injury and supporting blood flow to the brain and heart.
Emergency Department (ED) use of REBOA is feasible and associated with improved outcomes. However, It is evident that the peak death rate from haemorrhage occurs within 30 minutes of injury, well before the majority of injured patients can reach hospital. Therefore, 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 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 ischaemia (reduced blood flow) that is created below the inflated balloon. The use of a technique called Partial REBOA (P-REBOA), which involves allowing titrated distal flow past the balloon, may offer a solution by mitigating this effect.
This study therefore aims to establish whether Zone I P-REBOA can be achieved in the pre-hospital resuscitation of eight adult trauma patients at risk of cardiac arrest and death due to exsanguination.
Summary of study results:
Question: Is it feasible to deploy prehospital Zone 1 Partial Resuscitative Endovascular Balloon Occlusion of the Aorta (Z1 P-REBOA) in the resuscitation of adult trauma patients at risk of cardiac arrest and death due to exsanguination (severe bleeding)?
The intervention of Z1 P-REBOA involves partially occluding the aorta (large blood vessel in the chest) with a balloon mounted on a catheter (semi rigid plastic tube) which is inserted via the femoral artery (blood vessel at the top of the leg) via an arterial sheath (small plastic tube). The aim of the intervention is to improve blood pressure above the balloon and therefore perfusion of the heart and the brain, while also reducing bleeding at the site of injury below.
Findings: In this cohort study of patients with severe injuries and shock (very low blood pressure caused by severe bleeding), prehospital Z1 R-REBOA was delivered in eight of the eleven patients (73%) who underwent Z1 REBOA. This strategy was associated with improved proximal (above the balloon) blood pressure and early mortality.
Meaning : The findings indicate that in the prehospital resuscitation of adult trauma patients at risk of cardiac arrest and death due to exsanguination, Z1 P-REBOA is feasible and may enable early survival, but with a significant incidence of late death.
REC name
London - South East Research Ethics Committee
REC reference
20/LO/0013
Date of REC Opinion
21 Jan 2020
REC opinion
Favourable Opinion