<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/NCT02236819</url>
  </required_header>
  <id_info>
    <org_study_id>eureca1-2014</org_study_id>
    <secondary_id>eureca 2014</secondary_id>
    <nct_id>NCT02236819</nct_id>
  </id_info>
  <brief_title>A Multi-centre Survey of Epidemiology, Treatment and Outcome of Patients Suffering an Out-of-hospital Cardiac Arrest</brief_title>
  <acronym>EuReCaONE</acronym>
  <official_title>EuReCa ONE : An International, Prospective, Multi-centre, One Month Survey of Epidemiology, Treatment and Outcome of Patients Suffering an Out-of-hospital Cardiac Arrest in Europe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Resuscitation Registry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Resuscitation Council (ERC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>German Resuscitation Registry</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is considerable variation in the incidence of out-of-hospital cardiac arrest (OHCA)&#xD;
      across Europe. The likelihood of attempted resuscitation also varies. To better understand&#xD;
      the factors that contribute to variation, more data on incidence, management and outcomes&#xD;
      from OHCA is required. A European, multi-centre study provides the opportunity to uncover&#xD;
      differences throughout Europe and may help find explanations for these differences. Results&#xD;
      may also have potential to support the development of quality benchmarking between European&#xD;
      Emergency Medical Services (EMS).&#xD;
&#xD;
      This prospective European study will involve 27 different countries. It provides a common&#xD;
      Utstein-based dataset, data collection methodology and a common data collection period for&#xD;
      all participants, thereby potentially increasing comparability.&#xD;
&#xD;
      Study research questions will address the following: OHCA incidence in different European&#xD;
      regions; incidence of cardiopulmonary resuscitation (CPR) attempted; initial presenting&#xD;
      rhythm in patients where bystanders or EMS starts CPR or any other resuscitation&#xD;
      intervention; rate of any return of spontaneous circulation (ROSC); patient status at&#xD;
      handover to a hospital i.e. ROSC, ongoing CPR, dead; incidence of patients still alive 30&#xD;
      days after OHCA; incidence of patients discharged alive from hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participating registries will transfer unprocessed anonymised data. Transmission of&#xD;
      aggregated data should be avoided whenever possible; only in case of limitations due to&#xD;
      national laws or ethical requirements should a participating registry transmit aggregated&#xD;
      data. Every single case requires a data sheet (DS). Data will be collected within the&#xD;
      national, regional or local participating registries (either as a computer-based export from&#xD;
      the national, regional or local registry or as a paper-based DS. After validation and&#xD;
      anonymisation of data by participating registries the data will then be transferred only via&#xD;
      the national coordinator (computer-based) to the study centre. National coordinators are&#xD;
      responsible for quality control i.e. the completeness reliability and accuracy of the of&#xD;
      data, including timely submission of data to the study management group. Every DS will be&#xD;
      identified by a unique number, including the country and region of origin. Registries that&#xD;
      cannot transfer unprocessed original data due to the reasons mentioned above will collect&#xD;
      data themselves. These registries will then send aggregated data to the study centre.&#xD;
      Participating registries must collect basic EMS data on the region and population served.&#xD;
      This registry-specific information must only be transmitted once during the study period.&#xD;
      Data (computer and paper-based) will be handled according to national laws concerning data&#xD;
      security; the national coordinator is responsible for maintaining the necessary standards.&#xD;
      Access to the data will be protected by username and password.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>incidence of patients still alive 30 days after out of hospital cardiac arrest or patients discharged alive from hospital</measure>
    <time_frame>30 days after OHCA</time_frame>
    <description>co primary outcome is ROSC/admission to hospital in cases, victims have no ROSC or died on scene</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient status at handover to a hospital</measure>
    <time_frame>Hospital admission after EMS treatment (within first 24h after OHCA)</time_frame>
    <description>Timepoint/Timestamp within the first 24 hours after EMS treatment started</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>return of spontaneous circulation</measure>
    <time_frame>during the time period of EMS treatment within the first 24 h after OHCA</time_frame>
    <description>ROSC at any time during the treatment of EMS after OHCA during the first 24 h</description>
  </secondary_outcome>
  <enrollment type="Actual">10682</enrollment>
  <condition>Out of Hospital Cardiac Arrest</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Residents of 27 European countries&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who suffer an out of hospital cardiac arrest and are attended by the EMS&#xD;
             at any stage during the event.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan-Thorsten Gräsner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>German Resuscitation Registry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Germany ans 26 other european registries</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.eureca-one.eu</url>
    <description>Official study website</description>
  </link>
  <reference>
    <citation>Grasner JT, Bottiger BW, Bossaert L; European Registry of Cardiac Arrest (EuReCa) ONE Steering Committee; EuReCa ONE Study Management Team. EuReCa ONE - ONE month - ONE Europe - ONE goal. Resuscitation. 2014 Oct;85(10):1307-8. doi: 10.1016/j.resuscitation.2014.08.001. Epub 2014 Aug 15. No abstract available.</citation>
    <PMID>25132474</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>June 18, 2018</last_update_submitted>
  <last_update_submitted_qc>June 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>German Resuscitation Registry</investigator_affiliation>
    <investigator_full_name>Jan-Thorsten Graesner, MD</investigator_full_name>
    <investigator_title>Medical Director Emergency Medicine University Hospital Schleswig-Holstein, Campus Kiel, Germany</investigator_title>
  </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>
  <!-- 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/NCT02236819
org study id: eureca1-2014
secondary id: eureca 2014
nct id: NCT02236819
lead sponsor: 
collaborator: 
has dmc: No
There is considerable variation in the incidence of out-of-hospital cardiac arrest (OHCA)
      across Europe. The likelihood of attempted resuscitation also varies. To better understand
      the factors that contribute to variation, more data on incidence, management and outcomes
      from OHCA is required. A European, multi-centre study provides the opportunity to uncover
      differences throughout Europe and may help find explanations for these differences. Results
      may also have potential to support the development of quality benchmarking between European
      Emergency Medical Services (EMS).

      This prospective European study will involve 27 different countries. It provides a common
      Utstein-based dataset, data collection methodology and a common data collection period for
      all participants, thereby potentially increasing comparability.

      Study research questions will address the following: OHCA incidence in different European
      regions; incidence of cardiopulmonary resuscitation (CPR) attempted; initial presenting
      rhythm in patients where bystanders or EMS starts CPR or any other resuscitation
      intervention; rate of any return of spontaneous circulation (ROSC); patient status at
      handover to a hospital i.e. ROSC, ongoing CPR, dead; incidence of patients still alive 30
      days after OHCA; incidence of patients discharged alive from hospital.
The participating registries will transfer unprocessed anonymised data. Transmission of
      aggregated data should be avoided whenever possible; only in case of limitations due to
      national laws or ethical requirements should a participating registry transmit aggregated
      data. Every single case requires a data sheet (DS). Data will be collected within the
      national, regional or local participating registries (either as a computer-based export from
      the national, regional or local registry or as a paper-based DS. After validation and
      anonymisation of data by participating registries the data will then be transferred only via
      the national coordinator (computer-based) to the study centre. National coordinators are
      responsible for quality control i.e. the completeness reliability and accuracy of the of
      data, including timely submission of data to the study management group. Every DS will be
      identified by a unique number, including the country and region of origin. Registries that
      cannot transfer unprocessed original data due to the reasons mentioned above will collect
      data themselves. These registries will then send aggregated data to the study centre.
      Participating registries must collect basic EMS data on the region and population served.
      This registry-specific information must only be transmitted once during the study period.
      Data (computer and paper-based) will be handled according to national laws concerning data
      security; the national coordinator is responsible for maintaining the necessary standards.
      Access to the data will be protected by username and password.
observational model: Cohort
time perspective: Prospective
measure: incidence of patients still alive 30 days after out of hospital cardiac arrest or patients discharged alive from hospital
time frame: 30 days after OHCA
description: co primary outcome is ROSC/admission to hospital in cases, victims have no ROSC or died on scene
measure: patient status at handover to a hospital
time frame: Hospital admission after EMS treatment (within first 24h after OHCA)
description: Timepoint/Timestamp within the first 24 hours after EMS treatment started
measure: return of spontaneous circulation
time frame: during the time period of EMS treatment within the first 24 h after OHCA
description: ROSC at any time during the treatment of EMS after OHCA during the first 24 h
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jan-Thorsten Gräsner, MD
role: Principal Investigator
affiliation: German Resuscitation Registry
facility: 
country: Germany
url: http://www.eureca-one.eu
description: Official study website
citation: Grasner JT, Bottiger BW, Bossaert L; European Registry of Cardiac Arrest (EuReCa) ONE Steering Committee; EuReCa ONE Study Management Team. EuReCa ONE - ONE month - ONE Europe - ONE goal. Resuscitation. 2014 Oct;85(10):1307-8. doi: 10.1016/j.resuscitation.2014.08.001. Epub 2014 Aug 15. No abstract available.
PMID: 25132474
responsible party type: Principal Investigator
investigator affiliation: German Resuscitation Registry
investigator full name: Jan-Thorsten Graesner, MD
investigator title: Medical Director Emergency Medicine University Hospital Schleswig-Holstein, Campus Kiel, Germany
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest