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Recruiting Not applicable

REBOA in Nontraumatic OHCA

NCT06031623 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2023-10-17
Last updated
2025-01-28

Condition(s) studied

Cardiopulmonary Arrest

Investigational drug(s) / intervention(s)

REBOA

REBOA: Resuscitative endovascular balloon occlusion of the aorta (REBOA)is a device composed of a catheter attached to an inflatable balloon. It is inserted through the common femoral artery and guided to the thoracic aorta.

Study summary

The investigators propose a multicenter randomized controlled trial in South Korea and Taiwan to observe the clinical effects of REBOA on nontraumatic out-of-hospital-cardiac-arrest (OHCA) patients. While REBOA has been traditionally used in trauma for hemorrhage control, it has also shown promising results in nontraumatic cardiac arrests by rerouting circulation to increase perfusion in the coronary and brain.

Eligibility

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of Participants Who Achieved ROSC (return of spontaneous circulation) — 24 hours
    Number of patients who achieves ROSC regardless of sustained time

Trial sites (1)

FacilityCityRegionStatus
Seoul National Univeristy Bundang Hospital Seongnam-si Gyeonggi-do Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06031623 on ClinicalTrials.gov ↗ ← All trials in South Korea