Clinical trial NCT05236920: Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
Official title: Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Arrest, Out-Of-Hospital
Ventricular Fibrillation
Ventricular Tachycardia
Keywords: cardiac arrest
out of hospital cardiac arrest
REBOA
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 40 subjects will be randomized to standard care, or standard care plus administration of the device.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to successful deployment of device
timeFrame: Up to 10 minutes
Secondary outcomes:
measure: Return of spontaneous circulation (ROSC)
timeFrame: Up to 60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Professor and Vice-Chair for Research, Department of Emergency Medicine
name: Michael C Kurz, MD
role: PRINCIPAL_INVESTIGATOR
References: