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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2022-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None. Masking is not possible.

Study Groups

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Standard Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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REBOA procedure

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No