Status:
RECRUITING
REBOA in Nontraumatic OHCA
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Far Eastern Memorial Hospital
Conditions:
Cardiopulmonary Arrest
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief 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. W...
Detailed Description
Nontraumatic OHCA patients arriving at the 2 participating hospitals between the ages of 20 to 80 will be eligible. If the patient meets the enrollment criteria, he/she will be randomized into the con...
Eligibility Criteria
Inclusion
- Adult nontraumatic OHCA
- Witnessed arrest
- Arrival at ER from 9AM to 5PM (in South Korea) and 8AM to 8PM (in Taiwan)
Exclusion
- age below 20 years old or over 80 years old,
- traumatic cardiac arrest,
- those with unwitnessed cardiac arrest,
- pregnant patients,
- patients who have already achieved ROSC upon arrival at the emergency department
- pre-cardiac arrest cerebral performance category of 3-4
- those showing evidence of cardiac arrest due to bleeding (such as gastrointestinal bleeding)
- 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
- whose legal representative has requested termination of resuscitation efforts before study enrollment
- declared dead at scene before randomization
- 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.
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT06031623
Start Date
October 17 2023
End Date
October 1 2026
Last Update
January 28 2025
Active Locations (1)
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1
Seoul National Univeristy Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620