<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/NCT03759210</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01488</org_study_id>
    <nct_id>NCT03759210</nct_id>
  </id_info>
  <brief_title>Outcome After Out of Hospital Cardiac Arrest in Bern, Switzerland</brief_title>
  <official_title>Outcome After Out of Hospital Cardiac Arrest in Bern, Switzerland</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      Sudden cardiac arrests is one of the most frequent causes of death. In Switzerland every year&#xD;
      8000-10.000 people suffer from a cardiac arrest. The EuReCa ONE Study showed regional&#xD;
      differences in incidence and chances of survival after cardiac arrests in Europe. The current&#xD;
      European Resuscitation Council (ERC) resuscitation guidelines 2015 recommend extracorporeal&#xD;
      membrane oxygenation (ECMO) as treatment option for therapy refractory out-of-hospital&#xD;
      cardiac arrests (OHCA). ECMO used under cardiopulmonary resuscitation (CPR) is called eCPR&#xD;
      (extracorporeal CPR). In the year 2018 eCPR is started to be used in Bern, Switzerland. This&#xD;
      study investigates retrospectively the survival and neurologic outcome of patients after OHCA&#xD;
      in the region of Bern, Switzerland from 2015-2018. The data will be used as baseline for a&#xD;
      prospective evaluation of eCPR cases.&#xD;
&#xD;
      The prospective Evaluation of e CPR will last from 2018 - 2022.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neurologic Outcome after 30 days</measure>
    <time_frame>30 days after OHCA</time_frame>
    <description>CPC 1 - 5 (Cerebral Performance Category Scale)</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Resuscitation</condition>
  <condition>Outcome, Fatal</condition>
  <condition>Out-Of-Hospital Cardiac Arrest</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All OHCA cases in the region of Bern, Switzerland in the year 2015-2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All OHCA in the region of Bern, Switzerland in the year 2015-2017&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if patient has previously declined to be included in a study (advance directive)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Greif, Prof., M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Bern, Bern, Switzerland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sabine Nabecker, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Bern, Bern, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sabine Nabecker, M.D.</last_name>
    <phone>+41 31 632 39 65</phone>
    <email>sabine.nabecker@insel.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Anaesthesiology and Pain Medicine</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabine Nabecker</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</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>
  </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/NCT03759210
org study id: 2018-01488
nct id: NCT03759210
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sudden cardiac arrests is one of the most frequent causes of death. In Switzerland every year
      8000-10.000 people suffer from a cardiac arrest. The EuReCa ONE Study showed regional
      differences in incidence and chances of survival after cardiac arrests in Europe. The current
      European Resuscitation Council (ERC) resuscitation guidelines 2015 recommend extracorporeal
      membrane oxygenation (ECMO) as treatment option for therapy refractory out-of-hospital
      cardiac arrests (OHCA). ECMO used under cardiopulmonary resuscitation (CPR) is called eCPR
      (extracorporeal CPR). In the year 2018 eCPR is started to be used in Bern, Switzerland. This
      study investigates retrospectively the survival and neurologic outcome of patients after OHCA
      in the region of Bern, Switzerland from 2015-2018. The data will be used as baseline for a
      prospective evaluation of eCPR cases.

      The prospective Evaluation of e CPR will last from 2018 - 2022.
observational model: Cohort
time perspective: Prospective
measure: Neurologic Outcome after 30 days
time frame: 30 days after OHCA
description: CPC 1 - 5 (Cerebral Performance Category Scale)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Greif, Prof., M.D.
role: Study Chair
affiliation: University Hospital Bern, Bern, Switzerland
last name: Sabine Nabecker, M.D.
role: Principal Investigator
affiliation: University Hospital Bern, Bern, Switzerland
last name: Sabine Nabecker, M.D.
phone: +41 31 632 39 65
email: sabine.nabecker@insel.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
sharing ipd: No