Trial Review

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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] 297366 0
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 311501 0
Coronary heart disease 311502 0
Condition category
Condition code
Cardiovascular 310137 310137 0 0
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] 313620 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319033 0
Survival to hospital discharge through data linkage to hospital medical records.
Timepoint [1] 319033 0
At hospital discharge
Primary outcome [2] 319034 0
Neurological recovery using Cerebral Performance Category score
Timepoint [2] 319034 0
At hospital discharge
Secondary outcome [1] 366756 0
ECMO cannulation time using data recorded in the Ambulance Patient Care Records
Timepoint [1] 366756 0
On admission
Secondary outcome [2] 366757 0
ICU length of stay using hospital medical records
Timepoint [2] 366757 0
At hospital discharge
Secondary outcome [3] 366759 0
Mechanical ventilation days using hospital medical records
Timepoint [3] 366759 0
At hospital discharge
Secondary outcome [4] 366762 0
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] 366762 0
At hospital discharge
Secondary outcome [5] 367106 0
ECMO Success Rate obtained from Ambulance and Hospital medical records
Timepoint [5] 367106 0
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?
No
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
25
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13089 0
The Alfred - Prahran
Recruitment postcode(s) [1] 25598 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 301932 0
Charities/Societies/Foundations
Name [1] 301932 0
The Alfred Foundation
Country [1] 301932 0
Australia
Funding source category [2] 301934 0
Government body
Name [2] 301934 0
Ambulance Victoria
Country [2] 301934 0
Australia
Primary sponsor type
Government body
Name
Ambulance Victoria
Address
375 Manningham Road, Doncaster VIC 3108
Country
Australia
Secondary sponsor category [1] 301689 0
Hospital
Name [1] 301689 0
The Alfred Hospital
Address [1] 301689 0
55 Commercial Road, Melbourne VIC 3004
Country [1] 301689 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302616 0
Alfred HREC
Ethics committee address [1] 302616 0
PO Box 315
Prahran VIC 3181
Ethics committee country [1] 302616 0
Australia
Date submitted for ethics approval [1] 302616 0
15/01/2019
Approval date [1] 302616 0
30/09/2019
Ethics approval number [1] 302616 0
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 90830 0
Prof Stephen Bernard
Address 90830 0
Ambulance Victoria
PO Box 2000
Doncaster VIC 3108
Country 90830 0
Australia
Phone 90830 0
+61 398403500
Fax 90830 0
Email 90830 0
[email protected]
Contact person for public queries
Name 90831 0
Prof Stephen Bernard
Address 90831 0
Ambulance Victoria
PO Box 2000
Doncaster VIC 3108
Country 90831 0
Australia
Phone 90831 0
+61 398403500
Fax 90831 0
Email 90831 0
[email protected]
Contact person for scientific queries
Name 90832 0
Prof Stephen Bernard
Address 90832 0
Ambulance Victoria
PO Box 2000
Doncaster VIC 3108
Country 90832 0
Australia
Phone 90832 0
+61 398403500
Fax 90832 0
Email 90832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
SourceTitleYear of PublicationDOI
EmbaseExtracorporeal cardiopulmonary resuscitation for refractory cardiac arrest in Australia: a narrative review.2024https://dx.doi.org/10.5694/mja2.52130
EmbasePrehospital Extracorporeal Cardiopulmonary Resuscitation for Out-of-Hospital Cardiac Arrest: A Systematic Review and Meta-Analysis.2023https://dx.doi.org/10.1053/j.jvca.2022.12.004
N.B. These documents automatically identified may not have been verified by the study sponsor.