ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000303145

Ethics application status

Approved

Date submitted

12/02/2019

Date registered

27/02/2019

Date last updated

8/11/2021

Date data sharing statement initially provided

27/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A pilot study of patients in cardiac arrest utilising a heart-lung bypass machine prior to transport to hospital to improve survival rates.

Scientific title

CPR, pre-Hospital ECMO and Early Reperfusion (CHEER 3 Trial) for patients in refractory cardiac arrest to improve survival to hospital discharge.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1228-3535

Trial acronym

CHEER 3

Linked study record

NCT01186614 (CHEER). CHEER 3 is a follow-up study to NCT01186614.

Health condition

Health condition(s) or problem(s) studied:

Cardiac Arrest

Coronary heart disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All patients enrolled in the trial will undergo CPR at the scene prior to and after enrolment into the trial until ECMO is functioning. All enrolled patients will have ECMO attempted and if successful, these patients will then be transported to hospital for further management including transfer to the catheterisation lab if appropriate. Both pre-hospital ambulance care records and Alfred Hospital records will be reviewed by investigators for compliance, to identify any problems and for data collection.

Treatment: Device - Extracorporeal Membrane Oxygenation (ECMO)
Insertion of peripheral veno-arterial ECMO at scene of cardiac arrest by ECMO team including two Intensive Care Consultants

Treatment: Cardiopulmonary Resuscitation (CPR)
CPR will be given to the patient until ECMO has been implemented.

Treatment: Early Reperfusion
Once the patient has been transported to hospital, they will be taken directly to the Catheterisation Lab if appropriate.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Survival to hospital discharge through data linkage to hospital medical records.

Timepoint [1]

At hospital discharge

Primary outcome [2]

Neurological recovery using Cerebral Performance Category score

Timepoint [2]

At hospital discharge

Secondary outcome [1]

ECMO cannulation time using data recorded in the Ambulance Patient Care Records

Timepoint [1]

On admission

Secondary outcome [2]

ICU length of stay using hospital medical records

Timepoint [2]

At hospital discharge

Secondary outcome [3]

Mechanical ventilation days using hospital medical records

Timepoint [3]

At hospital discharge

Secondary outcome [4]

Complications of ECMO using hospital medical records. These include mechanical complications with equipment, haemorrhage, neurological complications, renal impairment, pneumothorax, tamponade, infection and metabolic complications.

Timepoint [4]

At hospital discharge

Secondary outcome [5]

ECMO Success Rate obtained from Ambulance and Hospital medical records

Timepoint [5]

On admission

Eligibility

Key inclusion criteria

Age 18 to 65 years
Witnessed cardiac arrest (bystander or paramedic)
Time from arrest to commence chest compressions of less than 5 minutes
Duration of cardiac arrest between 20 and 45 minutes
Initial cardiac rhythm of Ventricular Fibrillation/pulseless Ventricular Tachycardia/Pulseless Electrical Activity
In cardiac arrest on arrival of ECMO team

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Traumatic arrest including hanging
Known to have significant life-limiting co-morbidities (eg COPD/cirrhosis/dementia) or terminal illness

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

As a feasibility study, this project plans to enrol 25 patients over a 12 month period.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/03/2021

Actual

28/04/2021

Date of last participant enrolment

Anticipated

30/06/2022

Actual

Date of last data collection

Anticipated

31/07/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3004 - Prahran

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Alfred Foundation

Address [1]

55 Commercial Road, Melbourne VIC 3004

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Ambulance Victoria

Address [2]

375 Manningham Road, Doncaster VIC 3108

Country [2]

Australia

Primary sponsor type

Government body

Name

Ambulance Victoria

Address

375 Manningham Road, Doncaster VIC 3108

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

The Alfred Hospital

Address [1]

55 Commercial Road, Melbourne VIC 3004

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred HREC

Ethics committee address [1]

PO Box 315
Prahran VIC 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/01/2019

Approval date [1]

30/09/2019

Ethics approval number [1]

HREC/46089/Alfred-2018

Summary

Brief summary

The CHEER 3 Trial is a treatment strategy aimed at providing hope for patients who are otherwise very likely to die. In patients who suffer cardiac arrest, a range of interventions such as CPR, defibrillation and injection of drugs are provided at the scene by paramedics to attempt to restart the heart. If paramedics are unsuccessful, there is very little hope of recovery and the patient is usually declared deceased at scene. Transport to hospital with CPR may be attempted but previous research indicates this is usually unsuccessful due to the time taken to arrive at hospital for further treatments. This trial will evaluate an alternative approach involving doctors from The Alfred Hospital being transported to the scene and placing the patient on a heart-lung machine called ECMO. Once stabilised on ECMO, the patient will then be taken to the Alfred Hospital for further investigations and treatment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Stephen Bernard

Address

Ambulance Victoria
PO Box 2000
Doncaster VIC 3108

Country

Australia

Phone

+61 398403500

Fax

steve.bernard@ambulance.vic.gov.au

Contact person for public queries

Name

Stephen Bernard

Address

Ambulance Victoria
PO Box 2000
Doncaster VIC 3108

Country

Australia

Phone

+61 398403500

Fax

steve.bernard@ambulance.vic.gov.au

Contact person for scientific queries

Name

Stephen Bernard

Address

Ambulance Victoria
PO Box 2000
Doncaster VIC 3108

Country

Australia

Phone

+61 398403500

Fax

steve.bernard@ambulance.vic.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Requests for access to trial data will be considered if required.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prehospital Extracorporeal Cardiopulmonary Resuscitation for Out-of-Hospital Cardiac Arrest: A Systematic Review and Meta-Analysis.	2023	https://dx.doi.org/10.1053/j.jvca.2022.12.004
Embase	Extracorporeal cardiopulmonary resuscitation for refractory cardiac arrest in Australia: a narrative review.	2024	https://dx.doi.org/10.5694/mja2.52130

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically