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

Not Applicable

Withdrawn

• Conditions: Cardiac Arrest, Out-Of-Hospital; Ventricular Fibrillation; Ventricular Tachycardia
• Interventions: Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device

• Registration Number: NCT05236920
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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:

1. To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA

2. To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Study Start: 2022-10-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Apparent age between 18 - 70 years.
2. OHCA defined as receiving professional CPR or AED defibrillation
3. OHCA witnessed by bystanders or professional rescuers / UED personnel
4. VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA
5. Total time pulseless > 10 minutes

Exclusion Criteria

1. Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living
2. Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.)
3. Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest
4. Do-Not-Resuscitate order or comfort care measures in place prior to enrollment
5. Special populations (pregnant, prisoner, or cognitively impaired)
6. Total time pulseless greater than 20 minutes
7. Inability to determine when cardiac arrest occurred (or for OHCA arriving to UED via EMS, time of 911 call) and the time elapsed since

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care Plus Intervention	Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device	Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) plus the study intervention

Primary Outcome Measures

Name	Time	Method
Time to successful deployment of device	Up to 10 minutes	The device is successfully deployed when it raises the mean arterial pressure

Secondary Outcome Measures

Name	Time	Method
Return of spontaneous circulation (ROSC)	Up to 60 minutes	ROSC is when the heart begins beating on its own