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临床试验/NCT02236819
NCT02236819已完成不适用

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 个研究点 分布在 1 个国家目标入组 10,682 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10,682
试验地点
1
主要终点
incidence of patients still alive 30 days after out of hospital cardiac arrest or patients discharged alive from hospital

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

incidence of patients still alive 30 days after out of hospital cardiac arrest or patients discharged alive from hospital

时间窗: 30 days after OHCA

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

次要结局

  • 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)

研究者

发起方
German Resuscitation Registry
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan-Thorsten Graesner, MD

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

German Resuscitation Registry

研究点 (1)

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