<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/NCT04491903</url>
  </required_header>
  <id_info>
    <org_study_id>SafeStudy2</org_study_id>
    <nct_id>NCT04491903</nct_id>
  </id_info>
  <brief_title>REBOA for Out-of-hospital Cardiac Arrest</brief_title>
  <official_title>REBOA for Out-of-hospital Cardiac Arrest</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>neurescue</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>neurescue</source>
  <oversight_info>
    <has_dmc>No</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>
      Cardiac arrest is a major health problem that carries a high mortality rate. Substantial&#xD;
      research and development have been put into changing the outcome of cardiac arrest and&#xD;
      despite the advent of automated external defibrillators (AED), increase in bystander&#xD;
      Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of&#xD;
      patient survival to hospital discharge has only minimally improved.&#xD;
&#xD;
      The objective is to investigate safety and performance of the Resuscitative Endovascular&#xD;
      Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS)&#xD;
      for treatment of refractory cardiac arrest.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The scope of the study is to collect data on patients with refractory out of hospital cardiac&#xD;
      arrest (OHCA) for this feasibility study.&#xD;
&#xD;
      Data collected:&#xD;
&#xD;
        -  from enrolment of the patient until hospital arrival&#xD;
&#xD;
        -  every 24 hours&#xD;
&#xD;
        -  at discharge or 7 days post enrollment&#xD;
&#xD;
        -  at 30 days post enrollment&#xD;
&#xD;
      The investigation is initiated to investigate the safety and performance of the REBOA&#xD;
      procedure for patients experiencing refractory OHCA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Withdrawn&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 30, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central blood pressure</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Return of spontaneous circulation (ROSC)</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cardiac rhythm following balloon inflation</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>During procedure - time from first needle stick to successful sheath insertion</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>During procedure - time from first needle stick to finalized balloon inflation</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End-tidal CO2 (EtCO2)</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>REBOA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>REBOA</intervention_name>
    <description>Endovascular balloon occlusion of the aorta</description>
    <arm_group_label>REBOA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Witnessed cardiac arrest&#xD;
&#xD;
          -  Bystander or professional CPR within 5 minutes&#xD;
&#xD;
          -  Refractory cardiac arrest&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End Tidal CO2 &lt;1,3 kPa&#xD;
&#xD;
          -  Traumatic cardiac arrest&#xD;
&#xD;
          -  Women with known pregnancy&#xD;
&#xD;
          -  Patients with known terminal disease&#xD;
&#xD;
          -  Patients with known do-not-attempt-CPR order&#xD;
&#xD;
          -  Patients with overdose&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>Denmark</country>
  </removed_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual request</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04491903
org study id: SafeStudy2
nct id: NCT04491903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Central blood pressure
time frame: 1 hour
measure: Return of spontaneous circulation (ROSC)
time frame: 1 hour
measure: Changes in cardiac rhythm following balloon inflation
time frame: 1 hour
measure: During procedure - time from first needle stick to successful sheath insertion
time frame: 1 hour
measure: During procedure - time from first needle stick to finalized balloon inflation
time frame: 1 hour
measure: End-tidal CO2 (EtCO2)
time frame: 1 hour
arm group label: REBOA
arm group type: Experimental
intervention type: Procedure
intervention name: REBOA
description: Endovascular balloon occlusion of the aorta
arm group label: REBOA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
country: Denmark
responsible party type: Sponsor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
sharing ipd: No
ipd description: Individual request