Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 24 for:    CARDIAC ARREST and Europe
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236819
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
European Resuscitation Council (ERC)
Information provided by (Responsible Party):
Jan-Thorsten Graesner, MD, German Resuscitation Registry

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
Out of Hospital Cardiac Arrest

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 10682 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
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 : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]
    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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents of 27 European countries
Criteria

Inclusion Criteria:

  • All patients who suffer an out of hospital cardiac arrest and are attended by the EMS at any stage during the event.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236819


Locations
Layout table for location information
Germany
Germany ans 26 other european registries
Kiel, Germany
Sponsors and Collaborators
German Resuscitation Registry
European Resuscitation Council (ERC)
Investigators
Layout table for investigator information
Principal Investigator: Jan-Thorsten Gräsner, MD German Resuscitation Registry
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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 ( Other Identifier: German Resuscitation Registry )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases