Seoul National Univeristy Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Location status: Recruiting
NCT Number: NCT06031623
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.
Interested in participating?
Request Info20 year–80 year
All sexes
Interventional
Not applicable
Seongnam-si, Gyeonggi-do, 13620, South Korea
Location status: Recruiting
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 control group (treatment with conventional ACLS according to the 2020 AHA guideline) or the REBOA group (ACLS according to the 2020 AHA guideline with REBOA application). A sheath catheter is inserted with ultrasound guidance to gain access to the common femoral artery in both groups. This is followed by insertion of the REBOA catheter, if the patient is allocated into the intervention group. The aortic balloon is inflated. If ROSC is achieved, the balloon is deflated slowly. Patients who achieve ROSC will receive post cardiac arrest management according to the 2020 AHA guideline.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 hours
Number of patients who achieves ROSC regardless of sustained time
Time frame: 24 hours
Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes)
Time frame: 48 hours
Whether patients who achieve sustained ROSC survives until admission
Time frame: 30 days
Whether patients survive until hospital discharge.
Time frame: 1 month, 3 months, 6 months since ROSC
The cerebral performance category (CPC) and modified Rankin Score (mRS) of each patient at 28 days, 3 months, and 6 months after achieving ROSC. CPC is measured on a scale of 1 to 5, with 1 being the best neurological performance, and 5 indicating brain death. MRS is measured on a scale of 0 to 6, with 0 indicating no neurological deficit, and 6 indicating death.
Time frame: ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion.
Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used.
Contact information is provided by the study sponsor or research team.
Dong Hyun Jang
CONTACT
Hee Eun Kim
CONTACT
Seoul National University Hospital
Other
Effect Of Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest (REBOA); A Multinational, Multicenter Randomized Controlled Trial
Acronym: REBOA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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