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Out-Of-Hospital Cardiac ArrestEuReCa TWONCT03130088

European Registry of Cardiac Arrest Study Two

An observational study of Out-Of-Hospital Cardiac Arrest and Resuscitation Registry, run by German Resuscitation Registry at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
How many people
35,000 participants
Where
1 siteGermany
Study dates
1 Oct 2017to 30 Apr 2018
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Germany ans 26 other european registries

    Kiel

Other trials in Germany

About this study

Official title: 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.

Read the 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.

  1. 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?
Being tested
no intervention planed
Keywords
Out-Of-Hospital Cardiac Arrest, Resuscitation Registry, EuReCa TWO
Medical subject headings
Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no intervention planedOther

    no intervention planed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ROSC

    return of any circulation after out-of-hopsital cardiac arrest

    Measured: latest inclusion December, 31st 2017

Secondary outcomes (1)
  1. 30 day survival

    status of survival after 30 days after out-of-hospital cardiac arrest

    Measured: 30 days, latest inclusion January, 31st 2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2017
  2. Study start1 Oct 2017
  3. Primary completion31 Dec 2017
  4. Study completion30 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
35,000 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03130088
Sponsor's protocol ID
EuReCa TWO
Acronym
EuReCa TWO
Status last verified
Feb 2020
First submitted
21 Apr 2017
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zadlo A, Bednarek-Chaluda M, Karpinska IA, Cebula G, Tokarek T; www.linkedin.com/in/anna-zadlo230789. Association between time of day and outcomes after out-of-hospital cardiac arrest in Poland: an analysis of the EuReCa registry. BMJ Open. 2025 Oct 20;15(10):e105187. doi: 10.1136/bmjopen-2025-105187.

    PubMed 41120136

Questions about this trial

What is this clinical trial studying?

An observational study of Out-Of-Hospital Cardiac Arrest and Resuscitation Registry, run by German Resuscitation Registry at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ROSC (time frame: latest inclusion December, 31st 2017). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03130088, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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