EuReCaONE: A Multi-centre Survey of Epidemiology, Treatment and Outcome of Patients Suffering an Out-of-hospital Cardiac Arrest

Sponsor
German Resuscitation Registry (Other)
Overall Status
Completed
CT.gov ID
NCT02236819
Collaborator
European Resuscitation Council (ERC) (Other)
10,682
1
2
5330.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    10682 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Oct 1, 2014
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. incidence of patients still alive 30 days after out of hospital cardiac arrest or patients discharged alive from hospital [30 days after OHCA]

      co primary outcome is ROSC/admission to hospital in cases, victims have no ROSC or died on scene

    Secondary Outcome Measures

    1. patient status at handover to a hospital [Hospital admission after EMS treatment (within first 24h after OHCA)]

      Timepoint/Timestamp within the first 24 hours after EMS treatment started

    2. return of spontaneous circulation [during the time period of EMS treatment within the first 24 h after OHCA]

      ROSC at any time during the treatment of EMS after OHCA during the first 24 h

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients who suffer an out of hospital cardiac arrest and are attended by the EMS at any stage during the event.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Germany ans 26 other european registries Kiel Germany

    Sponsors and Collaborators

    • German Resuscitation Registry
    • European Resuscitation Council (ERC)

    Investigators

    • Principal Investigator: Jan-Thorsten Gräsner, MD, German Resuscitation Registry

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Jan-Thorsten Graesner, MD, Medical Director Emergency Medicine University Hospital Schleswig-Holstein, Campus Kiel, Germany, German Resuscitation Registry
    ClinicalTrials.gov Identifier:
    NCT02236819
    Other Study ID Numbers:
    • eureca1-2014
    • eureca 2014
    First Posted:
    Sep 11, 2014
    Last Update Posted:
    Jun 19, 2018
    Last Verified:
    Jun 1, 2018
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 19, 2018