Effect Of Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest (REBOA); A Multinational, Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:
• Adult nontraumatic OHCA
• Witnessed arrest
• Arrival at ER from 9AM to 5PM (in South Korea) and 8AM to 8PM (in Taiwan)
Locations
Other Locations
Republic of Korea
Seoul National Univeristy Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Hee Eun Kim
hekim9111@gmail.com
82-31-787-7579
Backup
Dong Hyun Jang
jang0621@gmail.com
82-31-787-7819
Time Frame
Start Date: 2023-10-17
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 234
Treatments
No_intervention: Control
Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines.
Experimental: REBOA
After enrollment and randomization, patients allocated to this arm receives REBOA in addition to conventional ACLS according to the 2020 AHA CPR guidelines. The common femoral artery is accessed with ultrasound guidance. A sheath catheter is inserted, followed by a REBOA catheter. The REBOA is ballooned with 20cc of normal saline or until resistance is felt.
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital
Collaborators: Far Eastern Memorial Hospital