REBOA in Nontraumatic OHCA

Not Applicable

Recruiting

• Conditions: Cardiopulmonary Arrest
• Interventions: Device: REBOA

• Registration Number: NCT06031623
• Lead Sponsor: Seoul National University Hospital

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. 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.

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 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.

Study Timeline

• Study First Submitted: 2023-09-02
• Study First Submitted QC: 2023-09-02
• Study First Posted: 2023-09-11
• Study Start: 2023-10-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• Adult nontraumatic OHCA
• Witnessed arrest
• Arrival at ER from 9AM to 5PM (in each country)

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REBOA	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved ROSC (return of spontaneous circulation)	24 hours	Number of patients who achieves ROSC regardless of sustained time

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Sustained ROSC	24 hours	Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes)
Survival to Admission	48 hours	Whether patients who achieve sustained ROSC survives until admission
Survival to Discharge	30 days	Whether patients survive until hospital discharge.
Neurological Outcome	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.
Changes in Arterial Blood Pressure	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.

Trial Locations

Locations (1)

Seoul National Univeristy Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of