Condition category
Circulatory System
Date applied
21/12/2016
Date assigned
28/12/2016
Last edited
14/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A cardiac arrest is a serious medical condition in which the heart suddenly stops beating and is a major cause of death in people across all age groups. An out-of-hospital cardiac arrest (OHCA) is where this happens when a person is not in hospital, and is the most common type of cardiac arrest. Sufferers usually require rapid resuscitation in order to restart their heart and improve chances of survival. Despite best efforts, survival rates are low. In many cases, time from spotting that a person is having a cardiac arrest to the arrival of emergency medical services (EMS) is long, leaving bystanders in a critical position to potentially save a person’s life by starting resuscitation themselves. However, only a minority of cardiac arrests receive this. The Danish Cardiac Arrest Registry is a nationwide initiative to monitor and examine trends in survival and treatment of cardiac arrest in Denmark in order to improve overall prognosis and outcome in cardiac arrest victims. The aim of this study is to examine survival after out-of-hospital cardiac arrest in Denmark on a nationwide scale.

Who can participate?
All persons in Denmark suffering from an OHCA where a bystander or EMS tries to resuscitate them.

What does the study involve?
Data on all out-of-hospital cardiac arrest are collected by using pre-specified form filled out by ambulance personnel and paramedics arriving at the scene of cardiac arrest and initiating resuscitation attempts. Data are entered in electronic database and linked to the Danish Death Registry so that patient survival at 30 days can be recorded.

What are the possible benefits and risks of participating?
There are no benefits or risks to participants

Where is the study run from?
1. Copenhagen University Hospital Herlev and Gentofte (Denmark)
2. Five Prehospital Emergency Medical Services (Denmark)
3. The Institute of Health, Science and Technology, Aalborg University (Denmark)

When is the study starting and how long is it expected to run for?
January 2001 to December 2035

Who is funding the study?
The Tryg Foundation (Denmark)

Who is the main contact?
Professor Christian Torp-Pedersen

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christian Torp-Pedersen

ORCID ID

Contact details

Institute of Health Science and Technology
Aalborg University
Søndre Skovvej 15
Aalborg
9000
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The Danish Cardiac Arrest Registry

Acronym

Study hypothesis

The aim of this study is to examine survival after out-of-hospital cardiac arrest in Denmark on a nationwide scale.

Ethics approval

Ethics approval is not required for retrospective registry studies in Denmark.

Study design

Retrospective epidemiological registry study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Out-of-hospital cardiac arrests

Intervention

The Danish Cardiac Arrest Registry is a collaboration between the five regional Prehospital Emergency Medical Services in Denmark. Data is collected prospectively by paramedics and ambulance personnel as part of the emergency medical services documentation of effort to improve the quality of cardiac arrest treatment in Denmark.

Data on all out-of-hospital cardiac arrest are collected by using pre-specified form filled out by ambulance personnel and paramedics arriving at the scene of cardiac arrest and initiating resuscitation attempts. Data are entered in electronic database and linked to the Danish Death Registry to monitor 30-day survival.

Intervention type

Other

Phase

Drug names

Primary outcome measures

30-day survival after out-of-hospital cardiac arrest is measured by linking data to the Danish National Death Registry, where all deaths are registered within 14 days of occurrence.

Secondary outcome measures

1. Initiation of CPR by laypersons, defibrillation by AED’s is measured using a pre-specified form filled out by ambulance personnel and paramedics
2. Return of spontaneous circulation (ROSC) on arrival at hospital is measured using a pre-specified form filled out by ambulance personnel and paramedics

Overall trial start date

01/01/2001

Overall trial end date

31/12/2035

Reason abandoned

Eligibility

Participant inclusion criteria

All persons in Denmark suffering from out-of-hospital cardiac arrest where resuscitation efforts are initiated either by bystanders (with activation of the EMS system) or by EMS personnel.

Participant type

All

Age group

All

Gender

Both

Target number of participants

Currently there are approximately 50 thousand individuals in the registry and there are approximately additionally 3.600 new individuals registered each year. There is no upper limit of participants as registration is continuous.

Participant exclusion criteria

Cases with obvious late signs of death (e.g. rigor mortis) for which resuscitative efforts are not initiated

Recruitment start date

01/01/2001

Recruitment end date

31/12/2035

Locations

Countries of recruitment

Denmark

Trial participating centre

Copenhagen University Hospital Herlev and Gentofte
Department of Cardiology Kildegaardsvej 28
Hellerup
2900
Denmark

Trial participating centre

The Prehospital Emergency Medical Services, The Capital Region of Denmark
Telegrafvej 5
Ballerup
2750
Denmark

Trial participating centre

The Institute of Health, Science and Technology, Aalborg University
Søndre Skovvej 15
Aalborg
9000
Denmark

Sponsor information

Organisation

The Tryg Foundation

Sponsor details

Hummeltoftevej 49
Virum
2830
Denmark

Sponsor type

Charity

Website

trygfonden.dk

Funders

Funder type

Charity

Funder name

The Tryg Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

There are already numerous publications and the registry is a continuous source of data for new studies. There are publications in JAMA, Circulation, Resuscitation, European Heart Journal based on data from the registry. An overall report of the registry is published each year (in Danish) by the Danish Resuscitation Council and can be downloaded at http://genoplivning.dk/wp-content/uploads/2016/05/Rapport-fra-Dansk-Hjertestopregister-2001-2014.pdf.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Christian Torp-Pedersen at Aalborg University, Faculty of Health, Science and Technology, Søndre Skovvej 15, 9000 Aalborg, Denmark. His e-mail is ctp@heart.dk and telephone +45 99403802

Intention to publish date

31/12/2035

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes