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REBOA in Nontraumatic OHCA (REBOA)

Primary Purpose

Cardiopulmonary Arrest

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
REBOA
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiopulmonary Arrest focused on measuring Advanced cardiopulmonary resuscitation (ACLS), Cardiopulmonary resuscitation (CPR), Resuscitative endovascular balloon occlusion of the aorta (REBOA)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult nontraumatic OHCA Witnessed arrest Arrival at ER from 9AM to 5PM (in each country) Exclusion Criteria: age below 20 years old or over 80 years old, traumatic cardiac arrest, those with unwitnessed cardiac arrest, pregnant patients, patients who have already achieved ROSC upon arrival at the emergency department pre-cardiac arrest cerebral performance category of 3-4 those showing evidence of cardiac arrest due to bleeding (such as gastrointestinal bleeding) those suspected of having aortic disease, such as dissection, intramural hematoma, or aneurysm, by bedside ultrasound performed immediately after ED arrival or have a previous history of aortic disease whose legal representative has requested termination of resuscitation efforts before study enrollment declared dead at scene before randomization Patients who meet the criteria for extracorporeal cardiopulmonary resuscitation (ECPR), and therefore the decision is made to perform ECPR, will not be enrolled. The ECPR criteria applies when all of the following criteria are met: pre-cardiac arrest CPC of 1-2, witnessed cardiac arrest with bystander CPR, ages between 20-70, initial shockable rhythm, ECMO pump-on available within 60 minutes of onset of cardiac arrest, and patients without end-stage diseases such as cancer, liver cirrhosis, or end-stage renal failure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    REBOA

    Arm Description

    Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines.

    After enrollment and randomization, patients allocated to this arm receives REBOA in addition to conventional ACLS according to the 2020 AHA CPR guidelines. The common femoral artery is accessed with ultrasound guidance. A sheath catheter is inserted, followed by a REBOA catheter. The REBOA is ballooned with 20cc of normal saline or until resistance is felt.

    Outcomes

    Primary Outcome Measures

    Number of Participants Who Achieved ROSC (return of spontaneous circulation)
    Number of patients who achieves ROSC regardless of sustained time

    Secondary Outcome Measures

    Number of Participants Who Achieved Sustained ROSC
    Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes)
    Survival to Admission
    Whether patients who achieve sustained ROSC survives until admission
    Survival to Discharge
    Whether patients survive until hospital discharge.
    Neurological Outcome
    The cerebral performance category (CPC) and modified Rankin Score (mRS) of each patient at 28 days, 3 months, and 6 months after achieving ROSC. CPC is measured on a scale of 1 to 5, with 1 being the best neurological performance, and 5 indicating brain death. MRS is measured on a scale of 0 to 6, with 0 indicating no neurological deficit, and 6 indicating death.
    Changes in Arterial Blood Pressure
    Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used.

    Full Information

    First Posted
    September 2, 2023
    Last Updated
    September 9, 2023
    Sponsor
    Seoul National University Hospital
    Collaborators
    Far Eastern Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06031623
    Brief Title
    REBOA in Nontraumatic OHCA
    Acronym
    REBOA
    Official Title
    Effect Of Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest (REBOA); A Multinational, Multicenter Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2025 (Anticipated)
    Study Completion Date
    October 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    Far Eastern Memorial Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The investigators propose a multicenter randomized controlled trial in South Korea and Taiwan to observe the clinical effects of REBOA on nontraumatic out-of-hospital-cardiac-arrest (OHCA) patients. While REBOA has been traditionally used in trauma for hemorrhage control, it has also shown promising results in nontraumatic cardiac arrests by rerouting circulation to increase perfusion in the coronary and brain.
    Detailed Description
    Nontraumatic OHCA patients arriving at the 2 participating hospitals between the ages of 20 to 80 will be eligible. If the patient meets the enrollment criteria, he/she will be randomized into the control group (treatment with conventional ACLS according to the 2020 AHA guideline) or the REBOA group (ACLS according to the 2020 AHA guideline with REBOA application). A sheath catheter is inserted with ultrasound guidance to gain access to the common femoral artery in both groups. This is followed by insertion of the REBOA catheter, if the patient is allocated into the intervention group. The aortic balloon is inflated. If ROSC is achieved, the balloon is deflated slowly. Patients who achieve ROSC will receive post cardiac arrest management according to the 2020 AHA guideline.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiopulmonary Arrest
    Keywords
    Advanced cardiopulmonary resuscitation (ACLS), Cardiopulmonary resuscitation (CPR), Resuscitative endovascular balloon occlusion of the aorta (REBOA)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    234 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines.
    Arm Title
    REBOA
    Arm Type
    Experimental
    Arm Description
    After enrollment and randomization, patients allocated to this arm receives REBOA in addition to conventional ACLS according to the 2020 AHA CPR guidelines. The common femoral artery is accessed with ultrasound guidance. A sheath catheter is inserted, followed by a REBOA catheter. The REBOA is ballooned with 20cc of normal saline or until resistance is felt.
    Intervention Type
    Device
    Intervention Name(s)
    REBOA
    Intervention Description
    Resuscitative endovascular balloon occlusion of the aorta (REBOA)is a device composed of a catheter attached to an inflatable balloon. It is inserted through the common femoral artery and guided to the thoracic aorta.
    Primary Outcome Measure Information:
    Title
    Number of Participants Who Achieved ROSC (return of spontaneous circulation)
    Description
    Number of patients who achieves ROSC regardless of sustained time
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Number of Participants Who Achieved Sustained ROSC
    Description
    Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes)
    Time Frame
    24 hours
    Title
    Survival to Admission
    Description
    Whether patients who achieve sustained ROSC survives until admission
    Time Frame
    48 hours
    Title
    Survival to Discharge
    Description
    Whether patients survive until hospital discharge.
    Time Frame
    30 days
    Title
    Neurological Outcome
    Description
    The cerebral performance category (CPC) and modified Rankin Score (mRS) of each patient at 28 days, 3 months, and 6 months after achieving ROSC. CPC is measured on a scale of 1 to 5, with 1 being the best neurological performance, and 5 indicating brain death. MRS is measured on a scale of 0 to 6, with 0 indicating no neurological deficit, and 6 indicating death.
    Time Frame
    1 month, 3 months, 6 months since ROSC
    Title
    Changes in Arterial Blood Pressure
    Description
    Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used.
    Time Frame
    ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult nontraumatic OHCA Witnessed arrest Arrival at ER from 9AM to 5PM (in each country) Exclusion Criteria: age below 20 years old or over 80 years old, traumatic cardiac arrest, those with unwitnessed cardiac arrest, pregnant patients, patients who have already achieved ROSC upon arrival at the emergency department pre-cardiac arrest cerebral performance category of 3-4 those showing evidence of cardiac arrest due to bleeding (such as gastrointestinal bleeding) those suspected of having aortic disease, such as dissection, intramural hematoma, or aneurysm, by bedside ultrasound performed immediately after ED arrival or have a previous history of aortic disease whose legal representative has requested termination of resuscitation efforts before study enrollment declared dead at scene before randomization Patients who meet the criteria for extracorporeal cardiopulmonary resuscitation (ECPR), and therefore the decision is made to perform ECPR, will not be enrolled. The ECPR criteria applies when all of the following criteria are met: pre-cardiac arrest CPC of 1-2, witnessed cardiac arrest with bystander CPR, ages between 20-70, initial shockable rhythm, ECMO pump-on available within 60 minutes of onset of cardiac arrest, and patients without end-stage diseases such as cancer, liver cirrhosis, or end-stage renal failure.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hee Eun Kim
    Phone
    82-31-787-7579
    Email
    hekim9111@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dong Hyun Jang
    Phone
    82-31-787-7819
    Email
    jang0621@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35870557
    Citation
    Jang DH, Lee DK, Jo YH, Park SM, Oh YT, Im CW. Resuscitative endovascular occlusion of the aorta (REBOA) as a mechanical method for increasing the coronary perfusion pressure in non-traumatic out-of-hospital cardiac arrest patients. Resuscitation. 2022 Oct;179:277-284. doi: 10.1016/j.resuscitation.2022.07.020. Epub 2022 Jul 21.
    Results Reference
    background
    PubMed Identifier
    31707942
    Citation
    Brede JR, Lafrenz T, Klepstad P, Skjaerseth EA, Nordseth T, Sovik E, Kruger AJ. Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2019 Nov 19;8(22):e014394. doi: 10.1161/JAHA.119.014394. Epub 2019 Nov 11.
    Results Reference
    background
    PubMed Identifier
    35160193
    Citation
    Mazzoli CA, Chiarini V, Coniglio C, Lupi C, Tartaglione M, Gamberini L, Semeraro F, Gordini G. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Non-Traumatic Cardiac Arrest: A Narrative Review of Known and Potential Physiological Effects. J Clin Med. 2022 Jan 29;11(3):742. doi: 10.3390/jcm11030742.
    Results Reference
    background
    PubMed Identifier
    28117180
    Citation
    Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12.
    Results Reference
    background
    PubMed Identifier
    33145513
    Citation
    Nowadly CD, Johnson MA, Hoareau GL, Manning JE, Daley JI. The use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for non-traumatic cardiac arrest: A review. J Am Coll Emerg Physicians Open. 2020 Aug 30;1(5):737-743. doi: 10.1002/emp2.12241. eCollection 2020 Oct.
    Results Reference
    background
    PubMed Identifier
    34002305
    Citation
    Hutin A, Levy Y, Lidouren F, Kohlhauer M, Carli P, Ghaleh B, Lamhaut L, Tissier R. Resuscitative endovascular balloon occlusion of the aorta vs epinephrine in the treatment of non-traumatic cardiac arrest in swine. Ann Intensive Care. 2021 May 17;11(1):81. doi: 10.1186/s13613-021-00871-z.
    Results Reference
    background

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    REBOA in Nontraumatic OHCA

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