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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05236920
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest, Out-Of-Hospital; Ventricular Fibrillation; Ventricular Tachycardia	Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A total of 40 subjects will be randomized to standard care, or standard care plus administration of the device.A total of 40 subjects will be randomized to standard care, or standard care plus administration of the device.
• Masking: None (Open Label)
• Masking Description: None. Masking is not possible.
• Primary Purpose: Treatment
• Official Title: Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Return of spontaneous circulation (ROSC) [Up to 60 minutes]

   ROSC is when the heart begins beating on its own

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Michael C Kurz, MD, Professor and Vice-Chair for Research, Department of Emergency Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael C. Kurz, Professor and Vice Chair for Research, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT05236920
• Other Study ID Numbers: 300007924
• First Posted: Feb 11, 2022
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Michael C. Kurz, Professor and Vice Chair for Research, University of Alabama at Birmingham: cardiac arrest; out of hospital cardiac arrest; REBOA
• Additional relevant MeSH terms: Heart Arrest; Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation; Out-of-Hospital Cardiac Arrest

Study Results

No Results Posted as of May 2, 2022