Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000779572
Ethics application status
Approved
Date submitted
29/06/2015
Date registered
27/07/2015
Date last updated
27/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Study on survival from prolonged cardiac arrest treated with an artificial blood pump (ECMO)
Scientific title
Survival outcomes in patients who have had prolonged cardiac arrest treated with artificial blood pump suppor
Secondary ID [1] 287005 0
none
Secondary ID [2] 287006 0
none
Universal Trial Number (UTN)
U1111-1171-6852
Trial acronym
2CHEER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
refractory cardiac arrest 295471 0
Condition category
Condition code
Cardiovascular 295724 295724 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mechanical chest compressions with a Lucas Device, commenced either in-hospital (cardiac arrest team) or out-of-hospital (by paramedics)
Induced hypothermia with 2L of intravenouse ice-cold saline, commenced by paramedics, Emergency Department or ICU staff.
Peripheral veno-arterial ECMO support (by anaesthetists and surgeons) to facilitate early revascularisation (if indicated) by cardiologists.

Neurological prognostication will be performed at 96 hours to determine limits of therapy.

The overall duration of ECMO support is anticipated to be approximately 2-5 days
Intervention code [1] 292212 0
Treatment: Devices
Comparator / control treatment
no controll group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295431 0
Survival
Timepoint [1] 295431 0
90 days following cardiac arrest
Primary outcome [2] 295625 0
Level of neurological function as assessed by Cerebral Performance Category and modified Rankin Scale
Timepoint [2] 295625 0
90 days following cardiac arrest
Secondary outcome [1] 315572 0
Return of spontaneous circulation as assessed by investigators
Timepoint [1] 315572 0
Time following cardiac arrest (hours)
Secondary outcome [2] 316033 0
Successful weaning from ECMO support as assessed by investigators
Timepoint [2] 316033 0
Time following cardiac arrest (hours)

Eligibility
Key inclusion criteria
In-and out-of-hospital cardiac arrest, refractory to conventional ACLS
Witnessed cardiac arrest
Potentially reversible aetiology
No major known co-morbidities
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known major co-morbidities

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)
In- and out-of-hospital patients who meet study inclusion criteria and who do not have exclusion criteria will be enrolled
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2015
Actual
Date of last participant enrolment
Anticipated
1/06/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3979 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 3980 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 291557 0
Commercial sector/Industry
Name [1] 291557 0
Maquet Getinge Group
Country [1] 291557 0
Germany
Funding source category [2] 291558 0
Commercial sector/Industry
Name [2] 291558 0
PhysioControl
Country [2] 291558 0
Australia
Primary sponsor type
Individual
Name
A/Prof Paul Forrest
Address
Department of Anaesthetics
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 290233 0
Individual
Name [1] 290233 0
Dr. David Lowe
Address [1] 290233 0
Department of Intensive Care
St. Vincent's Hospital
Victoria St
Darlinghurst
NSW 2011
Country [1] 290233 0
Australia
Other collaborator category [1] 278506 0
Other Collaborative groups
Name [1] 278506 0
NSW Ambulance Service
Address [1] 278506 0
NSW Ambulance State Headquarters
Balmain Road
Rozelle
NSW 2040
Country [1] 278506 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293100 0
Sydney Local Health District Ethics Review Committee, RPAH Zone
Ethics committee address [1] 293100 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 293100 0
Australia
Date submitted for ethics approval [1] 293100 0
Approval date [1] 293100 0
15/06/2015
Ethics approval number [1] 293100 0
X14-0337 and HREC/14/RPAH/453

Summary
Brief summary
Only a few patients (less than 10%) survive cardiac arrest that lasts for more than 30 minutes, even if the cause is potentially reversible.
ECMO is a blood pump that can be placed in large blood vessels in the groin and takes over the functions of the heart and lungs.
This study will look at how many people survive persisting cardiac arrest when ECMO is used to support the heart until the cause of the cardiac arrest has been treated and the heart has had time to recover.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 58470 0
A/Prof Paul Forrest
Address 58470 0
Department of Anaesthetics
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 58470 0
Australia
Phone 58470 0
+61 2 9515 8507
Fax 58470 0
Email 58470 0
[email protected]
Contact person for public queries
Name 58471 0
A/Prof Paul Forrest
Address 58471 0
Department of Anaesthetics
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 58471 0
Australia
Phone 58471 0
+61 2 9515 8507
Fax 58471 0
Email 58471 0
[email protected]
Contact person for scientific queries
Name 58472 0
A/Prof paul forrest
Address 58472 0
Department of Anaesthetics
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 58472 0
Australia
Phone 58472 0
+61 2 9515 8507
Fax 58472 0
Email 58472 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.