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REBOA for Out-of-hospital Cardiac Arrest

Primary Purpose

Cardiac Arrest

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
REBOA
Sponsored by
neurescue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Witnessed cardiac arrest
  • Bystander or professional CPR within 5 minutes
  • Refractory cardiac arrest

Exclusion Criteria:

  • End Tidal CO2 <1,3 kPa
  • Traumatic cardiac arrest
  • Women with known pregnancy
  • Patients with known terminal disease
  • Patients with known do-not-attempt-CPR order
  • Patients with overdose

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    REBOA

    Arm Description

    Outcomes

    Primary Outcome Measures

    Central blood pressure

    Secondary Outcome Measures

    Return of spontaneous circulation (ROSC)
    Changes in cardiac rhythm following balloon inflation
    During procedure - time from first needle stick to successful sheath insertion
    During procedure - time from first needle stick to finalized balloon inflation
    End-tidal CO2 (EtCO2)

    Full Information

    First Posted
    July 22, 2020
    Last Updated
    April 29, 2021
    Sponsor
    neurescue
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04491903
    Brief Title
    REBOA for Out-of-hospital Cardiac Arrest
    Official Title
    REBOA for Out-of-hospital Cardiac Arrest
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn
    Study Start Date
    November 30, 2020 (Anticipated)
    Primary Completion Date
    November 30, 2020 (Anticipated)
    Study Completion Date
    November 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    neurescue

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved. The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.
    Detailed Description
    The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study. Data collected: from enrolment of the patient until hospital arrival every 24 hours at discharge or 7 days post enrollment at 30 days post enrollment The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    REBOA
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    REBOA
    Intervention Description
    Endovascular balloon occlusion of the aorta
    Primary Outcome Measure Information:
    Title
    Central blood pressure
    Time Frame
    1 hour
    Secondary Outcome Measure Information:
    Title
    Return of spontaneous circulation (ROSC)
    Time Frame
    1 hour
    Title
    Changes in cardiac rhythm following balloon inflation
    Time Frame
    1 hour
    Title
    During procedure - time from first needle stick to successful sheath insertion
    Time Frame
    1 hour
    Title
    During procedure - time from first needle stick to finalized balloon inflation
    Time Frame
    1 hour
    Title
    End-tidal CO2 (EtCO2)
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Witnessed cardiac arrest Bystander or professional CPR within 5 minutes Refractory cardiac arrest Exclusion Criteria: End Tidal CO2 <1,3 kPa Traumatic cardiac arrest Women with known pregnancy Patients with known terminal disease Patients with known do-not-attempt-CPR order Patients with overdose

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual request

    Learn more about this trial

    REBOA for Out-of-hospital Cardiac Arrest

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