RecruitingNAINTERVENTIONAL

Emergency Resuscitative Endovascular Balloon Occlusion of the Aorta in Out of Hospital Cardiac Arrest

This study is exploring a new emergency procedure called REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) for people who suffer a sudden heart stop outside of hospital. When someone's heart stops, it's called a cardiac arrest. REBOA involves temporarily blocking the main artery (aorta) with a small balloon to direct blood flow to vital organs like the brain and heart. Researchers want to see if this technique can be safely and effectively used by emergency teams alongside standard life support. They will also look at how it affects the body during these critical moments. The goal is to understand if this could be a promising treatment to improve survival rates, which are currently lower in the UK compared to other countries.

At a glance

Status

Recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

Start

04 Jun 2024

Estimated completion

31 Dec 2026

Out-Of-Hospital Cardiac Arrest Cardiac Arrest Cardiac Arrhythmia Ventricular Fibrillation Ventricular Arrythmia Pulseless Electrical Activity

What is this study about?

Imagine your heart suddenly stops beating outside of a hospital, perhaps at home or in a public place. This is called an Out-of-Hospital Cardiac Arrest, and it's a very serious medical emergency. Getting immediate help, like chest compressions and using a defibrillator (a device that can shock the heart back into rhythm), is crucial.

This study is looking at a new technique called 'REBOA' (Resuscitative Endovascular Balloon Occlusion of the Aorta) that emergency teams might use in these situations. REBOA involves carefully inserting a small tube with a balloon into a large blood vessel in the leg, guiding it up to the main artery in the body, called the aorta. Once in place, the balloon is briefly inflated to block the artery. This temporarily pushes blood flow mainly to the brain and heart, which are the most important organs to protect during a cardiac arrest.

The main goal of this research is to see if it's practical for emergency teams to use REBOA safely and quickly when they arrive on the scene. They also want to understand if this method helps to keep blood flowing to critical organs, which could potentially improve a person's chances of survival and recovery. Currently, survival rates for out-of-hospital cardiac arrest in England are lower than in some other countries, so finding new ways to help is very important. This study is a small first step to see if this technique holds promise for larger trials in the future.

Key takeaways

This study explores a new emergency procedure (REBOA) for sudden heart stops outside hospital.
REBOA uses a balloon in the main artery to help blood flow to the brain and heart.
The goal is to see if this method is practical and beneficial alongside standard emergency care.
The study focuses on non-traumatic cardiac arrests in the East of England.
It's a small initial study to assess the technique's potential before larger trials.
Improving survival rates from out-of-hospital cardiac arrest is a main priority.

Who may be eligible?

To be considered for this study, you would need to have a sudden heart stop (cardiac arrest) outside of a hospital, and this heart stop must not be due to a serious injury like a car accident. You would also need to be within a specific area in the East of England where the specialist Air Ambulance REBOA team is able to respond.

Participants must be between 18 and 80 years old. The emergency team would also need to confirm that there hasn't been a long period (less than 10 minutes) where your heart stopped and no one was performing CPR. Additionally, if the team arrives and your heart is still stopped, you might be considered.

You would not be able to take part if you are under 18 or over 80. Also, if you have a known serious illness that is expected to shorten your life, or multiple other significant health problems, you would not be included. If your heart stopped due to a severe injury, if mechanical CPR cannot be performed, or if you are pregnant (or pregnancy is suspected), you would also be excluded.

Quick self-check

Did you experience a sudden heart stop outside of a hospital?
Was the heart stop NOT caused by a serious injury?
Were you between 18 and 80 years old at the time?
Did the specialist emergency team arrive quickly (within 10 minutes of CPR stopping)?
Were you located in the East of England where the REBOA team operates?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This study involves patients who have a sudden heart stop outside of hospital and are already in a life-threatening emergency. If you meet the criteria and the specialist team is present, the REBOA procedure would be performed as an emergency measure alongside standard advanced life support and CPR. This is not a study where you would typically plan to enrol or attend specific visits. The assessment of whether you meet the study criteria and the intervention itself happens very quickly at the scene of the emergency. There are no additional assessments or medications beyond what is immediately needed for your emergency care and what is being studied. The total duration of your participation would relate to the emergency intervention itself and the immediate effects observed.

Potential risks and benefits

This study is an exploration of a new emergency technique. Potential benefits might include improved blood flow to vital organs during a cardiac arrest, which could potentially increase the chances of survival and recovery, although this is what the study aims to investigate. As with any medical procedure, especially in an emergency, there are potential risks, which would be explained if you were able to consent or to your next of kin. You always have the right to withdraw from the study at any point, though in emergency situations, this is often handled by medical staff and family members.

Locations (1)

East Anglian Air Ambulance
Norwich, United Kingdom· Recruiting

Common questions

What is a 'cardiac arrest'?

A cardiac arrest is when your heart suddenly stops pumping blood around your body. This is different from a heart attack, where blood flow to the heart muscle is blocked.

What is 'REBOA'?

REBOA stands for Resuscitative Endovascular Balloon Occlusion of the Aorta. It's a technique where a small balloon is temporarily inflated in the body's main artery (aorta) to help direct blood to the brain and heart during an emergency.

Is this a new treatment?

REBOA has been used in some emergency situations, but this study is looking at using it in a new way – specifically for people who have a sudden heart stop outside of hospital in the UK.

Will I know if I'm in the study?

Because this study happens during a life-threatening emergency, you would not be able to give your consent beforehand. Information about your treatment would be collected by the medical team.

Why is this research important?

Survival rates for sudden heart stops outside of hospital are quite low. This research aims to find better ways to help people in this critical situation and potentially save more lives.

How to find out more

Paul Rees, MD(Res)

paul.rees@eaaa.org.uk 07976 406496 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.