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

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest, Out-Of-Hospital focused on measuring cardiac arrest, out of hospital cardiac arrest, REBOA

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard Care

    Standard Care Plus Intervention

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Time to successful deployment of device
    The device is successfully deployed when it raises the mean arterial pressure

    Secondary Outcome Measures

    Return of spontaneous circulation (ROSC)
    ROSC is when the heart begins beating on its own

    Full Information

    First Posted
    January 14, 2022
    Last Updated
    March 16, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05236920
    Brief Title
    Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
    Acronym
    UP-FRONT
    Official Title
    Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study will not take place at this time.
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    October 31, 2022 (Actual)
    Study Completion Date
    October 31, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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).
    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: To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest, Out-Of-Hospital, Ventricular Fibrillation, Ventricular Tachycardia
    Keywords
    cardiac arrest, out of hospital cardiac arrest, REBOA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS)
    Arm Title
    Standard Care Plus Intervention
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) plus the study intervention
    Intervention Type
    Device
    Intervention Name(s)
    Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device
    Other Intervention Name(s)
    REBOA procedure
    Intervention Description
    In-hospital use of a REBOA catheter device during advanced cardiac life support
    Primary Outcome Measure Information:
    Title
    Time to successful deployment of device
    Description
    The device is successfully deployed when it raises the mean arterial pressure
    Time Frame
    Up to 10 minutes
    Secondary Outcome Measure Information:
    Title
    Return of spontaneous circulation (ROSC)
    Description
    ROSC is when the heart begins beating on its own
    Time Frame
    Up to 60 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael C Kurz, MD
    Organizational Affiliation
    Professor and Vice-Chair for Research, Department of Emergency Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.

    Learn more about this trial

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

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