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

NCT05236920 | Withdrawn DMC FDA Device

• 1 other identifier: 300007924
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

cardiac arrest; out of hospital cardiac arrest; REBOA

Outcome Measures

Primary Outcomes (1)

• Time to successful deployment of device

  The device is successfully deployed when it raises the mean arterial pressure

  Up to 10 minutes

Secondary Outcomes (1)

• Return of spontaneous circulation (ROSC)

  Up to 60 minutes

Study Arms (2)

Standard Care

NO INTERVENTION

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

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

Interventions

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

In-hospital use of a REBOA catheter device during advanced cardiac life support

Also known as: REBOA procedure

Standard Care Plus Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation; Tachycardia, Ventricular; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Michael C Kurz, MD

  Professor and Vice-Chair for Research, Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None. Masking is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair for Research

Model Details: A total of 40 subjects will be randomized to standard care, or standard care plus administration of the device.

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 11, 2022
• Study Start: October 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share