REBOA in Nontraumatic OHCA

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Sep 2, 2023

Keywords

ClinConnect Summary

This clinical trial, called REBOA in Nontraumatic OHCA, is studying a medical procedure known as REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) to see how it helps patients who experience a cardiac arrest outside of a hospital. Cardiac arrest is when the heart suddenly stops beating, which can be life-threatening. In this trial, researchers believe that REBOA may improve blood flow to the heart and brain during these emergencies. The study is taking place in South Korea and Taiwan, and researchers are currently looking for participants.

To be eligible for the study, participants must be adults who had a witnessed cardiac arrest that was not caused by an injury. They must arrive at the emergency room during specific hours: from 9 AM to 5 PM in South Korea and 8 AM to 8 PM in Taiwan. However, some people may not qualify, such as those under 20 or over 80 years old, those who were not seen collapse, or those who have already regained heart function when they reach the hospital. If you or a loved one qualifies and chooses to participate, they can expect to be part of a randomized process, meaning they may receive either the REBOA treatment or standard care to help researchers understand which is more effective in saving lives.

Gender

ALL

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.