REBOA in Nontraumatic OHCA

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect Of Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest (REBOA); A Multinational, Multicenter Randomized Controlled Trial

Conditions
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Cardiopulmonary Arrest

Intervention / Treatment
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* Device: REBOA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult nontraumatic OHCA Witnessed arrest Arrival at ER from 9AM to 5PM (in each country) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines. | |
| Experimental: REBOA<br>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. | Device: REBOA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved ROSC (return of spontaneous circulation) | Number of patients who achieves ROSC regardless of sustained time | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Sustained ROSC | Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes) | 24 hours | 
| Survival to Admission | Whether patients who achieve sustained ROSC survives until admission | 48 hours | 
| Survival to Discharge | Whether patients survive until hospital discharge. | 30 days | 
| Neurological Outcome | 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. | 1 month, 3 months, 6 months since ROSC | 
| Changes in Arterial Blood Pressure | Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used. | ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced cardiopulmonary resuscitation (ACLS), Cardiopulmonary resuscitation (CPR), Resuscitative endovascular balloon occlusion of the aorta (REBOA)