Clinical trial NCT02236819: A Multi-centre Survey of Epidemiology, Treatment and Outcome of Patients Suffering an Out-of-hospital Cardiac Arrest
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out of Hospital Cardiac Arrest
Lead sponsor: German Resuscitation Registry
Sponsor class: OTHER
Collaborators: name: European Resuscitation Council (ERC)
First posted: 2014-09-11
Enrollment: 10682
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of 27 European countries

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.

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.

Primary outcomes:
measure: incidence of patients still alive 30 days after out of hospital cardiac arrest or patients discharged alive from hospital
timeFrame: 30 days after OHCA
Secondary outcomes:
measure: patient status at handover to a hospital
timeFrame: Hospital admission after EMS treatment (within first 24h after OHCA)
measure: return of spontaneous circulation
timeFrame: during the time period of EMS treatment within the first 24 h after OHCA
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Germany ans 26 other european registries
Study officials:
affiliation: German Resuscitation Registry
name: Jan-Thorsten Gräsner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Wnent J, Masterson S, Grasner JT, Bottiger BW, Herlitz J, Koster RW, Rosell Ortiz F, Tjelmeland I, Maurer H, Bossaert L. EuReCa ONE - 27 Nations, ONE Europe, ONE Registry: a prospective observational analysis over one month in 27 resuscitation registries in Europe - the EuReCa ONE study protocol. Scand J Trauma Resusc Emerg Med. 2015 Jan 24;23:7. doi: 10.1186/s13049-015-0093-3.