Using a balloon to help resuscitate patients with cardiac arrest outside the hospital
A Randomised Trial on Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
This study is testing if using a special balloon during CPR can help people who have a cardiac arrest outside the hospital get their heart beating again better than just standard CPR alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 11 sites (Aarhus and 10 other locations) |
| Trial ID | NCT04596514 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an additional treatment alongside advanced cardiovascular life support (ACLS) for patients experiencing out-of-hospital cardiac arrest (OHCA). Participants will be randomly assigned to either receive standard ACLS or ACLS plus the REBOA procedure, which is intended to improve blood flow to vital organs during resuscitation efforts. The study is being conducted across multiple centers with trained medical teams performing the intervention. The primary outcome will be the rate of return of spontaneous circulation (ROSC) among participants.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced non-traumatic out-of-hospital cardiac arrest and can receive advanced cardiac life support within 10 minutes of the event.
Not a fit: Patients with traumatic cardiac arrest, accidental hypothermia, or other specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and outcomes for patients experiencing out-of-hospital cardiac arrest.
How similar studies have performed: This is the first prospective trial assessing the efficacy of REBOA in non-traumatic cardiac arrest, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * out-of-hospital cardiac arrest * non-traumatic cardiac arrest * less than 10 minutes from debut of arrest to start of basic or advanced cardiac life support * advanced cardiac life support is established and can be continued Exclusion Criteria: * traumatic cardiac arrest, including strangulation, electrocution and patients rescued from avalanches * accidental hypothermia with temperature \< 32 0C * suspected cerebral hemorrhage as etiology of the arrest * suspected non-traumatic hemorrhage as etiology of the arrest * pregnancy, obvious or suspected * patient included to the study site's E-CPR protocol * other factors as decided by the treatment team (environmental factors, safety factors and others)
Where this trial is running
Aarhus and 10 other locations
- Aarhus Base — Aarhus, Denmark (Recruiting)
- Billund HEMS-base — Billund, Denmark (Recruiting)
- Ringsted HEMS-base — Ringsted, Denmark (Recruiting)
- Skive HEMS — Skive, Denmark (Recruiting)
- Maggiore Hospital — Bologna, Italy (Recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Drammen Hospital — Drammen, Norway (Recruiting)
- Lørenskog HEMS Unit — Oslo, Norway (Recruiting)
- Rapid response car - 119 Oslo — Oslo, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
- St Olavs Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Study coordinator: Andreas J Krüger, MD, PhD
- Email: Andreas.kruger@ntnu.no
- Phone: 004790862586
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.