Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)

Study Overview
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Brief Summary
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Single center randomized-controlled trial in out-of-hospital cardiac arrest (OHCA) patients. This study will investigate the feasibility and utility of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure using a REBOA catheter device in patients who have experienced an OHCA and have not regained return of spontaneous circulation (ROSC).

Detailed Description
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Victims arriving to, or experiencing witnessed Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT) out of hospital cardiac arrest in, the UAB emergency department with greater than 10 minutes of conventional ACLS will be eligible. The study population will consist of forty (40) subjects randomized to either continued contemporary standard of care (ACLS), or ACLS plus the administration of a REBOA catheter device. The aims of UPFRONT are: To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.

Official Title
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Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)

Conditions
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Cardiac Arrest, Out-Of-Hospital, Ventricular Fibrillation, Ventricular Tachycardia

Intervention / Treatment
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* Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparent age between 18 - 70 years. OHCA defined as receiving professional CPR or AED defibrillation OHCA witnessed by bystanders or professional rescuers / UED personnel VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA Total time pulseless > 10 minutes Exclusion Criteria: Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.) Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest Do-Not-Resuscitate order or comfort care measures in place prior to enrollment Special populations (pregnant, prisoner, or cognitively impaired) Total time pulseless greater than 20 minutes Inability to determine when cardiac arrest occurred (or for OHCA arriving to UED via EMS, time of 911 call) and the time elapsed since

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: A total of 40 subjects will be randomized to standard care, or standard care plus administration of the device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) | |
| Experimental: Standard Care Plus Intervention<br>Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) plus the study intervention | Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device<br>* In-hospital use of a REBOA catheter device during advanced cardiac life support<br>* Other names: REBOA procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to successful deployment of device | The device is successfully deployed when it raises the mean arterial pressure | Up to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of spontaneous circulation (ROSC) | ROSC is when the heart begins beating on its own | Up to 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, out of hospital cardiac arrest, REBOA