Condition category
Circulatory System
Date applied
01/12/2014
Date assigned
03/02/2015
Last edited
28/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cardiac arrest occurs when the heart suddenly stops pumping blood around the body. It can be caused by, for example, a heart attack, choking or trauma caused by serious injury. During a cardiac arrest, blood is no longer being circulated to vital organs and consciousness is lost within seconds. Unless steps are taken to get the heart pumping again very quickly (resuscitation), anyone suffering a cardiac arrest will die within a few minutes. In the UK, about thirty thousand people receive resuscitation treatment for a cardiac arrest that occurs outside of a hospital every year (Out of Hospital Cardiac Arrest, or OHCA). Only one in every twenty people that have a cardiac arrest survive to go home from hospital. Information collected by the Department of Health has shown there to be wide geographical variation in the number of people that survive an OHCA. In simple terms people in some parts of the country are twice or three times more likely to survive than in other areas. We want to find out the reasons why this is the case. We will develop a standardised approach to collecting information about OHCA and for finding out if a resuscitation attempt was successful. We will then use statistics to explain the reasons why survival rates vary between regions. It will provide feedback to ambulance services to allow ambulance services to learn from one another and help more patients survive a OHCA.

Who can participate?
Anyone who has had a OHCA for which resuscitation has been attempted by the ambulance service.

What does the study involve?
The study uses existing information collected by ambulance services during the course of their routine duties. Information about patients that receive resuscitation for cardiac arrest are securely transferred to researchers at the University of Warwick. The information is then used to obtain a better understanding of why survival rates vary so widely. It will work out which are the most successful treatments and it will help ambulance services improve the quality of care for victims of cardiac arrest.

What are the possible benefits and risks of participating?
Not applicable as participants are not approached directly. The project proposes to collect data already held by NHS ambulance services. Data will be extracted from existing information sources (e.g. ambulance 999 call records, ambulance clinical records, ambulance vehicle tracking systems).

Where is the study run from?
Warwick Medical School (UK)

When is the study starting and how long is it expected to run for?
October 2012 to October 2018

Who is funding the study?
1. British Heart Foundation (UK)
2. Resuscitation Council (UK)

Who is the main contact?
Ms Claire Jacques
ohcao@warwick.ac.uk

Trial website

http://www.warwick.ac.uk/ohcao

Contact information

Type

Public

Primary contact

Ms Claire Jacques

ORCID ID

Contact details

Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OHCAO

Study information

Scientific title

Epidemiology and Outcome from Out of Hospital Cardiac Arrest

Acronym

OHCAO

Study hypothesis

Cardiac arrest is the term used to describe sudden cessation of heart function. After cardiac arrest occurs, bloodstops being circulated to the vital organs and consciousness is lost within seconds. Unless resuscitation is started promptly death will occur within a few minutes.
Each year about 30,000 people receive resuscitation for an Out of Hospital Cardiac Arrest (OHCA) in the United Kingdom (UK). Only one in every twenty people that have a cardiac arrest survive to go home from hospital. Information collected by the Department of Health has shown there to be wide geographical variation in the number of people that survive an OHCA. In simple terms people in some parts of the country are twice or three times more likely to survive than in other areas.

The main aim of the research study is to determine the key characteristics and outcome of out of hospital cardiac arrest and explore sources of variation in outcome in the UK as a strategy to improve overall health outcomes from out of hospital cardiac arrest in the UK.

Ethics approval

NRES South Central ­ Oxford Committee, 21/06/2013, ref: 13/SC/0361

Study design

Prospective observational study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Community

Trial type

Diagnostic

Patient information sheet

The patient information sheet is not applicable as it is an observational study. We have received approval from the Confidentiality Advisory Group (CAG) to obtain patient identifiable data without consent.

Condition

Out of hospital cardiac arrest

Intervention

To establish the epidemiology and outcome of out of hospital cardiac arrest, we will explore sources of variation in outcome and establish the feasibility of setting up a national OHCA registry.
1. To identify the optimal process for case identification and outcome verification following OHCA
2. To measure the epidemiology and outcome of out of hospital cardiac arrest in the UK
3. To determine which factors influence survival from OHCA in the UK and explore the feasibility to include in risk prediction models
4. To assess the feasibility of establishing a national OHCA registry in the UK

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Summary data collection: For each case we will collect information from the ambulance clinical record about the time and location of the incident, information about the patient(age,sex, race) the time taken for the ambulance to arrive, thepresumed cause of the cardiac arrest, the initial heart rhythm, treatments administered by bystanders and trained ambulance staff.
Main outcome measurements:
1. Initial survival (Return of spontaneous circulation i.e. restoring the heartbeat)
2. Medium – long term survival (30 days – 10 year survival). We will obtain this information from the ambulance service (initial survival) and the Medical Research Information Service (MRIS) (medium to long term survival)

Secondary outcome measures

1. The optimal process for case identification and outcome verification following OHCA
2. Factors which influence survival from OHCA in the UK and are feasible to include in risk prediction modelling
3. Feasibility of establishing a national OHCA registry in the UK

Overall trial start date

01/10/2012

Overall trial end date

31/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be enrolled if after initial screening they fulfil the following criteria:
Inclusion criteria:
1. Out of hospital cardiac arrest
2. Resuscitation is attempted (Advanced or Basic Life Support)commenced/ continued by ambulance service

Participant type

All

Age group

All

Gender

Both

Target number of participants

35,000

Participant exclusion criteria

1. Arrest during inter­hospital transfer or on acute NHS hospital trust premises
2. Patients with clear evidence of death defined by the Joint Royal College Ambulance Liaison Committee (JRCALC)
3. Recognition of life extinct (ROLE) criteria
Criteria for ROLE:
3.1. Massive cranial and cerebral destruction
3.2. Hemicorporectomy
3.3. Massive truncal injury incompatible with life (including decapitation)
3.4. Decomposition/putrefaction
3.5. Incineration
3.6. Hypostasis
3.7. Rigor mortis
4. A valid do not attempt resuscitation (DNAR) order or an Advanced Directive (Living Will) that states the wish of the patient not to undergo attempted resuscitation
5. When the patient’s death is expected due to terminal illness
6. Efforts would be futile, as defined by the combination of all three of the following being present:
6.1. More than 15 minutes since the onset of collapse
6.2. No bystander CPR prior to arrival of the ambulance
6.3. Asystole (flat line) for >30 seconds on the ECG monitor screen. Exceptions are drowning, drug overdose/poisoning, trauma
7. Submersion of adults for longer than 1 hour

Recruitment start date

01/10/2012

Recruitment end date

31/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warwick Clinical Trials Unit
Division of Health Sciences Warwick Medical School University of Warwick
Coventry
CV4 7AL

Sponsor information

Organisation

University of Warwick

Sponsor details

Warwick Medical School
Gibbet Hill
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

Resuscitation Council (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The project will measure and report health outcomes from patients following OHCA in the UK. We have an established and effective dissemination strategy to ensure knowledge mobilisation is effectively integrated into practice. The personal involvement of co-investigators will facilitate opportunities for the output from this research to be widely disseminated to UK health providers, commissioners, standard setting bodies and policy makers. We will publish the results of the study in open access medical journals which will provide a sustainable archive for the results of this work. A professional and lay summary of the findings will be placed on our institutional website. We will produce briefing notes that will summarise the main findings of this research and their implications for policy and distribute these notes to health service commissioners.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 28/01/2016 the overall trial end date was changed from 01/10/2015 to 31/10/2018.