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

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).

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; 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; 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; In-hospital use of a REBOA catheter device during advanced cardiac life support; Other Names: REBOA procedure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Michael C Kurz, MD, Professor and Vice-Chair for Research, Department of Emergency Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cardiac arrest; out of hospital cardiac arrest; REBOA
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Arrest; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 300007924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigator has no plans to share individual participant data with other researchers. Any future use of the data will be proposed to and approved by the Principal Investigator, and will require IRB approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No