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

Out of Hospital Cardiac Arrest Clinical Trial

— EuReCaONE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236819
• Other study ID #: eureca1-2014
• Secondary ID: eureca 2014
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2018
• Source: German Resuscitation Registry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10682
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Heart Arrest
• Out of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Locations

Country	Name	City	State
Germany	Germany ans 26 other european registries	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
German Resuscitation Registry	European Resuscitation Council (ERC)

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Gräsner JT, Böttiger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of patients still alive 30 days after out of hospital cardiac arrest or patients discharged alive from hospital	co primary outcome is ROSC/admission to hospital in cases, victims have no ROSC or died on scene	30 days after OHCA
Secondary	patient status at handover to a hospital	Timepoint/Timestamp within the first 24 hours after EMS treatment started	Hospital admission after EMS treatment (within first 24h after OHCA)
Secondary	return of spontaneous circulation	ROSC at any time during the treatment of EMS after OHCA during the first 24 h	during the time period of EMS treatment within the first 24 h after OHCA

External Links

•   Official study website