European Registry of Cardiac Arrest Study Two (EuReCa TWO)

February 4, 2020 updated by: German Resuscitation Registry

European Registry of Cardiac Arrest - Study Two (EuReCa TWO) An International, Prospective, Multi-centre, Three-month Survey of Epidemiology, Treatment and Outcome of Patients Suffering an Out-of-hospital Cardiac Arrest in Europe

This study will evaluated the epidemiology and the outcome of patients suffering out-of-hospital cardiac arrest in 27 european nations. The special focus in the EuReCa TWO study is on bystander CPR.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The importance of the establishment of out-of-hospital cardiac arrest (OHCA) registries as a critical step in improving OHCA outcomes is recognised from clinical, academic and political perspectives 1-4. The aim of the EuReCa project is to establish a European Registry of Cardiac Arrest to provide quality benchmarking for OHCA measurement in Europe based on Utstein style data collection, so that variations in OHCA incidence, management and outcomes can be identified 5,6.

The EuReCa ONE project secured the collaboration of 27 European countries. During October 2014, data was collected from each of these countries, resulting in the most comprehensive estimate of OHCA incidence and outcomes to date 7. As expected, the proportion of variation between data collection from individual countries was considerable. While much of this variation is likely to be attributable to patient and system level differences, some variation was a consequence of the difference in proportions of countries covered by data collection, and may also have been caused by differences in how key variables were interpreted.

Improving data quality is an incremental process therefore in EuReCa TWO, we aim to build on the work of EuReCa ONE and further improve understanding of OHCA incidence, management and outcome across the continent. Key to the overall aim of achieving quality benchmarking is to ensure that EuReCa data collection is comprehensive and reliable.

Essential to the aims of the EuReCa project is that the data collected on each link of the Chain of Survival is comparable across participating countries. During EuReCa ONE, it was noted that the term 'bystander CPR' was interpreted differently across countries. A subsequent European survey of interpretation of the term 'bystander' and 'bystander CPR' confirmed this observation.

In order to enhance the key quality requirements of comprehensiveness and reliability, the aims of the EuReCa TWO project will be as follows:

  • Expand the EuReCa network
  • Improve the understanding of the role of bystanders in OHCA in Europe

In order to achieve these aims, the following objectives will be fulfilled:

  • Encourage participating countries to aim for national data collection and encourage additional countries to participate
  • In order to provide more robust estimates of incidence, management and outcome, increase the data collection period, increase the period of data collection to three months (1st October to 31st December 2017)
  • Identify consistency and variation in the use of the term 'bystander CPR'
  • Describe the incidence of 'bystander CPR' and its influence on OHCA outcome

EuReCa TWO is expected to result in the creation of the largest ever database of OHCA European data, which has been collected over a single time period, using consistent data definitions. This will provide the opportunity to generate more robust estimates of OHCA incidence and outcome for particular subgroups.

2. Research Questions

In order to build on previous work and improve the robustness of estimates, the Research Questions in EuReCa TWO will closely mirror those of EuReCa ONE:

  • What proportion of each country's national population is covered by data collection?
  • What is the incidence of confirmed OHCA attended by the EMS in different European regions?
  • What is the incidence of any CPR (cardiopulmonary resuscitation) attempted in OHCA throughout Europe?

  • What proportion of CPR is started by:

    • Bystander - on scene by chance
    • Person alerted to scene by ambulance dispatch
    • EMS?
  • What is the age and gender profile of those who provide CPR before EMS arrival?
  • In OHCA, what is the initial cardiac arrest rhythm of the patients where bystanders or EMS starts CPR or any other resuscitation intervention - shockable or non-shockable?
  • In patients where CPR was started by bystanders or EMS, what is the incidence and rate of any return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest?
  • What is the incidence of patients never transported due to being declared dead on scene?
  • What is the patient status at handover from EMS to emergency department or hospital system with ongoing additional treatment in the next step of care (ROSC, ongoing CPR, dead)?
  • What is the incidence of patients who are still alive 30 days (whether in-hospital or discharged) after their cardiac arrest event and/or what is the incidence of patients who are discharged alive from hospital?

  • In patients with a witnessed collapse (witnessed by bystanders and/or EMS), found in a shockable rhythm and with an event of medical aetiology (i.e. Utstein comparator group):

    • What is the incidence of ROSC at hospital admission (at time of being handed over from EMS to emergency department or hospital system with ongoing additional treatment e.g. PCI) for the Utstein group
    • What is the incidence of patients who are still alive at 30 days (whether in-hospital or discharged) after their cardiac arrest event and/or what is the incidence of patients who are discharged alive from hospital in the Utstein group?
  • What factors determine ROSC, admission and survival (as defined in questions above)?

Secondary Research Questions

  • What is the European incidence of and percentage survival from OHCA with a traumatic aetiology?
  • What is the European incidence of and percentage survival from OHCA in cases brought to hospital with unsustained ROSC and/or ongoing CPR?

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany
        • Germany ans 26 other european registries

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Population in the 27 participatiing nations, suffering out-of-hospital cardiac arrest and are treated/attended by the EMS

Description

Inclusion Criteria:

  • All patients who suffer an out of hospital cardiac arrest * and are attended by the EMS at any stage during the event. This study will include all events that occur between 00:00 on 1st October 2017 and 23:59 on 31st December 2017. Patients will be included irrespective of their age, gender or personal factors.

These inclusion criteria include all patients who receive resuscitation (chest compression and/or defibrillation of any type)

  • By the EMS
  • Before the arrival of the EMS with continued resuscitation by the EMS
  • Before the arrival of the EMS, that is immediately stopped (for any reason) when the EMS arrives
  • Patients who achieve ROSC before the arrival of the EMS It also includes patients found or declared dead (for any reason). Some countries or registries may not be able to provide all necessary data to answer every research question. These registries will not be included in the analysis of the related research questions.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ROSC
Time Frame: latest inclusion December, 31st 2017
return of any circulation after out-of-hopsital cardiac arrest
latest inclusion December, 31st 2017

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
30 day survival
Time Frame: 30 days, latest inclusion January, 31st 2018
status of survival after 30 days after out-of-hospital cardiac arrest
30 days, latest inclusion January, 31st 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
German Resuscitation Registry

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan-Thorsten Graesner, MD, University Hospital Schleswig-Holstein, Department of Anaesthesiology and Intensive Care Medicine, Kiel, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EuReCa TWO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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