xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06031623</url>
    </required_header>
    <id_info>
      <org_study_id>Interventional</org_study_id>
      <nct_id>NCT06031623</nct_id>
    </id_info>
    <brief_title>REBOA in Nontraumatic OHCA</brief_title>
    <acronym>REBOA</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Far Eastern Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Seoul National University Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators propose a multicenter randomized controlled trial in South Korea and Taiwan&#xD;
        to observe the clinical effects of REBOA on nontraumatic out-of-hospital-cardiac-arrest&#xD;
        (OHCA) patients. While REBOA has been traditionally used in trauma for hemorrhage control, it&#xD;
        has also shown promising results in nontraumatic cardiac arrests by rerouting circulation to&#xD;
        increase perfusion in the coronary and brain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nontraumatic OHCA patients arriving at the 2 participating hospitals between the ages of 20&#xD;
        to 80 will be eligible. If the patient meets the enrollment criteria, he/she will be&#xD;
        randomized into the control group (treatment with conventional ACLS according to the 2020 AHA&#xD;
        guideline) or the REBOA group (ACLS according to the 2020 AHA guideline with REBOA&#xD;
        application). A sheath catheter is inserted with ultrasound guidance to gain access to the&#xD;
        common femoral artery in both groups. This is followed by insertion of the REBOA catheter, if&#xD;
        the patient is allocated into the intervention group. The aortic balloon is inflated. If ROSC&#xD;
        is achieved, the balloon is deflated slowly. Patients who achieve ROSC will receive post&#xD;
        cardiac arrest management according to the 2020 AHA guideline.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants Who Achieved ROSC (return of spontaneous circulation)</measure>
      <time_frame>24 hours</time_frame>
      <description>Number of patients who achieves ROSC regardless of sustained time</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Who Achieved Sustained ROSC</measure>
      <time_frame>24 hours</time_frame>
      <description>Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival to Admission</measure>
      <time_frame>48 hours</time_frame>
      <description>Whether patients who achieve sustained ROSC survives until admission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival to Discharge</measure>
      <time_frame>30 days</time_frame>
      <description>Whether patients survive until hospital discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neurological Outcome</measure>
      <time_frame>1 month, 3 months, 6 months since ROSC</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Arterial Blood Pressure</measure>
      <time_frame>ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion.</time_frame>
      <description>Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">234</enrollment>
    <condition>Cardiopulmonary Arrest</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>REBOA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>REBOA</intervention_name>
      <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.</description>
      <arm_group_label>REBOA</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult nontraumatic OHCA&#xD;
  &#xD;
            -  Witnessed arrest&#xD;
  &#xD;
            -  Arrival at ER from 9AM to 5PM (in each country)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. age below 20 years old or over 80 years old,&#xD;
  &#xD;
            2. traumatic cardiac arrest,&#xD;
  &#xD;
            3. those with unwitnessed cardiac arrest,&#xD;
  &#xD;
            4. pregnant patients,&#xD;
  &#xD;
            5. patients who have already achieved ROSC upon arrival at the emergency department&#xD;
  &#xD;
            6. pre-cardiac arrest cerebral performance category of 3-4&#xD;
  &#xD;
            7. those showing evidence of cardiac arrest due to bleeding (such as gastrointestinal&#xD;
               bleeding)&#xD;
  &#xD;
            8. those suspected of having aortic disease, such as dissection, intramural hematoma, or&#xD;
               aneurysm, by bedside ultrasound performed immediately after ED arrival or have a&#xD;
               previous history of aortic disease&#xD;
  &#xD;
            9. whose legal representative has requested termination of resuscitation efforts before&#xD;
               study enrollment&#xD;
  &#xD;
           10. declared dead at scene before randomization&#xD;
  &#xD;
           11. Patients who meet the criteria for extracorporeal cardiopulmonary resuscitation&#xD;
               (ECPR), and therefore the decision is made to perform ECPR, will not be enrolled. The&#xD;
               ECPR criteria applies when all of the following criteria are met: pre-cardiac arrest&#xD;
               CPC of 1-2, witnessed cardiac arrest with bystander CPR, ages between 20-70, initial&#xD;
               shockable rhythm, ECMO pump-on available within 60 minutes of onset of cardiac arrest,&#xD;
               and patients without end-stage diseases such as cancer, liver cirrhosis, or end-stage&#xD;
               renal failure.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hee Eun Kim</last_name>
      <phone>82-31-787-7579</phone>
      <email>hekim9111@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dong Hyun Jang</last_name>
      <phone>82-31-787-7819</phone>
      <email>jang0621@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <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.</citation>
      <PMID>35870557</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>31707942</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>35160193</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>28117180</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33145513</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>34002305</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
      <investigator_full_name>Dong Keon Lee</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>Advanced cardiopulmonary resuscitation (ACLS)</keyword>
    <keyword>Cardiopulmonary resuscitation (CPR)</keyword>
    <keyword>Resuscitative endovascular balloon occlusion of the aorta (REBOA)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Arrest</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06031623
  org study id: Interventional
  nct id: NCT06031623
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants Who Achieved ROSC (return of spontaneous circulation)
  time frame: 24 hours
  description: Number of patients who achieves ROSC regardless of sustained time
  measure: Number of Participants Who Achieved Sustained ROSC
  time frame: 24 hours
  description: Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes)
  measure: Survival to Admission
  time frame: 48 hours
  description: Whether patients who achieve sustained ROSC survives until admission
  measure: Survival to Discharge
  time frame: 30 days
  description: Whether patients survive until hospital discharge.
  measure: Neurological Outcome
  time frame: 1 month, 3 months, 6 months since ROSC
  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.
  measure: Changes in Arterial Blood Pressure
  time frame: ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion.
  description: Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used.
  arm group label: Control
  arm group type: No Intervention
  description: Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines.
  arm group label: REBOA
  arm group type: Experimental
  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: REBOA
  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.
  arm group label: REBOA
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hee Eun Kim
  phone: 82-31-787-7579
  email: hekim9111@gmail.com
  last name: Dong Hyun Jang
  phone: 82-31-787-7819
  email: jang0621@gmail.com
  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.
  PMID: 35870557
  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.
  PMID: 31707942
  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.
  PMID: 35160193
  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.
  PMID: 28117180
  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.
  PMID: 33145513
  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.
  PMID: 34002305
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Dong Keon Lee
  investigator title: Associate professor
  mesh term: Heart Arrest
  sharing ipd: No