Using REBOA for nontraumatic cardiac arrest

Effect Of Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest (REBOA); A Multinational, Multicenter Randomized Controlled Trial

This study is testing if using a special balloon technique during CPR can help people who have a sudden cardiac arrest outside of the hospital feel better and have better chances of survival.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 234 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Seoul National University Hospital (other)
• Locations: 1 site (Seongnam-si, Gyeonggi-do)
• Trial ID: NCT06031623 on ClinicalTrials.gov

What this trial studies

This multicenter randomized controlled trial aims to evaluate the clinical effects of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in patients experiencing nontraumatic out-of-hospital cardiac arrest (OHCA). Eligible patients aged 20 to 80 will be randomized into two groups: one receiving conventional advanced cardiopulmonary life support (ACLS) and the other receiving ACLS with REBOA application. The study will take place in South Korea and Taiwan, focusing on improving coronary and brain perfusion during resuscitation efforts. The trial will assess the effectiveness of REBOA in enhancing patient outcomes compared to standard care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 80 who have experienced a witnessed nontraumatic out-of-hospital cardiac arrest.

Not a fit: Patients with traumatic cardiac arrest, those who have already achieved return of spontaneous circulation (ROSC), or those outside the age criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and neurological outcomes for patients experiencing nontraumatic cardiac arrest.

How similar studies have performed: While REBOA has been traditionally used in trauma settings, its application in nontraumatic cardiac arrest is relatively novel and has shown promising preliminary results.

Eligibility criteria

Inclusion Criteria:

* Adult nontraumatic OHCA
* Witnessed arrest
* Arrival at ER from 9AM to 5PM (in South Korea) and 8AM to 8PM (in Taiwan)

Exclusion Criteria:

1. age below 20 years old or over 80 years old,
2. traumatic cardiac arrest,
3. those with unwitnessed cardiac arrest,
4. pregnant patients,
5. patients who have already achieved ROSC upon arrival at the emergency department
6. pre-cardiac arrest cerebral performance category of 3-4
7. those showing evidence of cardiac arrest due to bleeding (such as gastrointestinal bleeding)
8. those suspected of having aortic disease, such as dissection, intramural hematoma, or aneurysm, by bedside ultrasound performed immediately after ED arrival or have a previous history of aortic disease
9. whose legal representative has requested termination of resuscitation efforts before study enrollment
10. declared dead at scene before randomization
11. Patients who meet the criteria for extracorporeal cardiopulmonary resuscitation (ECPR), and therefore the decision is made to perform ECPR, will not be enrolled. The ECPR criteria applies when all of the following criteria are met: pre-cardiac arrest CPC of 1-2, witnessed cardiac arrest with bystander CPR, ages between 20-70, initial shockable rhythm, ECMO pump-on available within 60 minutes of onset of cardiac arrest, and patients without end-stage diseases such as cancer, liver cirrhosis, or end-stage renal failure.

Where this trial is running

Seongnam-si, Gyeonggi-do

• Seoul National Univeristy Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)

Study contacts

• Study coordinator: Hee Eun Kim

Conditions: Cardiopulmonary Arrest, Advanced cardiopulmonary resuscitation, Cardiopulmonary resuscitation, Resuscitative endovascular balloon occlusion of the aorta