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

The University of Alabama at Birmingham

Status: Withdrawn

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

Treatments: Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device

Study type: Interventional

Funder types: Other

Identifiers

NCT05236920

300007924

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS)

Standard Care Plus Intervention

Experimental group

Description:

Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) plus the study intervention

Treatment:

Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device