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Clinical Trials/NCT02236819
NCT02236819
Completed
Not Applicable

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

German Resuscitation Registry1 site in 1 country10,682 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Out of Hospital Cardiac Arrest
Sponsor
German Resuscitation Registry
Enrollment
10682
Locations
1
Primary Endpoint
incidence of patients still alive 30 days after out of hospital cardiac arrest or patients discharged alive from hospital
Status
Completed
Last Updated
7 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
December 2014
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
German Resuscitation Registry
Responsible Party
Principal Investigator
Principal Investigator

Jan-Thorsten Graesner, MD

Medical Director Emergency Medicine University Hospital Schleswig-Holstein, Campus Kiel, Germany

German Resuscitation Registry

Eligibility 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • patient status at handover to a hospital(Hospital admission after EMS treatment (within first 24h after OHCA))
  • return of spontaneous circulation(during the time period of EMS treatment within the first 24 h after OHCA)

Study Sites (1)

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