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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01186614
Registration number
NCT01186614
Ethics application status
Date submitted
20/08/2010
Date registered
23/08/2010
Date last updated
10/03/2014
Titles & IDs
Public title
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
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Scientific title
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
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Secondary ID [1]
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project 160/10
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Universal Trial Number (UTN)
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Trial acronym
CHEER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Automated CPR
Treatment: Devices - ECMO
Treatment: Surgery - Coronary angiography
Treatment: Surgery - Therapeutic Hypothermia
Experimental: Novel treatment paradigm - treatment protocol including - mechanical CPR, therapeutic hypothermia, ECMO, coronary intervention
Treatment: Devices: Automated CPR
Automated CPR utilised by paramedics to facilitate CPR during transport to hospital
Treatment: Devices: ECMO
Insertion of peripheral VA ECMO
Treatment: Surgery: Coronary angiography
Coronary angiography and intervention where necessary will be performed following ECMO insertion
Treatment: Surgery: Therapeutic Hypothermia
Paramedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees)
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Survival to hospital discharge
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Assessment method [1]
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Timepoint [1]
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At hospital discharge
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Secondary outcome [1]
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Neurologic recovery
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Assessment method [1]
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Assessed by cerebral performance category
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Timepoint [1]
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At discharge
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Secondary outcome [2]
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Time until ECMO insertion
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Assessment method [2]
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Timepoint [2]
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On admission
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Secondary outcome [3]
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neurologic biomarkers
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Assessment method [3]
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neuron-specific enolase and S100ß
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Timepoint [3]
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Day 3
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Secondary outcome [4]
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Cardiac recovery
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Assessment method [4]
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measured by echocardiography and cardiac biomakers including troponin, CK and BNP
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Timepoint [4]
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Days 1, 3, 5
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Eligibility
Key inclusion criteria
* Adults 18-59 years
* Out of hospital cardiac arrest due to presumed cardiac caus
* Chest compressions are commenced within 10 minutes by bystanders or emergency medical services
* Initial cardiac arrest rhythm of ventricular fibrillation
* Remains in cardiac arrest at the scene at 20 minutes after standard paramedic advanced cardiac life support (intubation, intravenous adrenaline)
* Autopulse machine is available
* Within 10 minutes ambulance transport time to The Alfred
* During normal working hours (9am-5pm, Monday to Friday)
* ECMO commences within 60 minutes of the initial collapse
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Minimum age
18
Years
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Maximum age
59
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Presumed non-cardiac cause of cardiac arrest such as trauma, hanging, drowning, intracranial bleeding
* Any pre-existing significant neurological disability
* Significant non-cardiac co-morbidities that cause limitations in activities of daily living such as COPD, cirrhosis of the liver, renal failure on dialysis, terminal illness due to malignancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2014
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment hospital [2]
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Ambulance Victoria - Melbourne
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Recruitment postcode(s) [1]
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3161 - Melbourne
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Recruitment postcode(s) [2]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Alfred
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Address [1]
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Country [1]
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Other collaborator category [2]
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Government body
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Name [2]
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Ambulance Victoria
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Sudden out-of-hospital cardiac arrest (OHCA) is a leading cause of death in Australia. The most common cause of OHCA is a heart attack. The current treatment of OHCA is resuscitation by ambulance paramedics involving CPR, electrical shocks to the heart, and injections of adrenaline. In more than 50% of cases, paramedics are unable to start the heart and the patient is declared dead at the scene. Patients with OHCA who do not respond to paramedic resuscitation are not routinely transported to hospital because it is hazardous for paramedics to undertake rapid transport whilst administering chest compressions and there is currently no additional therapy available at the hospital that would assist in starting the heart. However, a number of recent developments suggest that there may be a new approach to the resuscitation of this group of patients who would otherwise die. Firstly, Ambulance Victoria have recently introduced portable battery powered machines that allow chest compressions to be safely and effectively delivered during emergency ambulance transport. Second, The Alfred ICU will shortly be implementing a new protocol whereby the patient in cardiac arrest can immediately be placed on a heart-lung machine. This is known as extra-corporeal membrane oxygenation (ECMO). Third, the brain can now be much better protected against damage due to lack of blood flow using therapeutic hypothermia which is the controlled lowering of body temperature from 37°C to 33°C. Clinical trials have demonstrated that this significantly decreases brain damage after OHCA. Finally, The Alfred Cardiology service has an emergency service for reopening the blocked artery of the heart in patients who present with a sudden blockage of the heart arteries. This is currently not used in patients without a heart beat because of the technical difficulty of undertaking this procedure with chest compressions being undertaken. This study proposes for the first time to implement all the above interventions when patients have failed standard resuscitation after OHCA. When standard resuscitation has proved futile, the patient will be transported to The Alfred with the mechanical chest compression device, cooled to 33°C, placed on ECMO, and then transported to the interventional cardiac catheter laboratory. The patient will then receive therapeutic hypothermia for 24 hours. Subsequent management will follow the standard treatment guidelines of The Alfred Intensive Care Unit.
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Trial website
https://clinicaltrials.gov/study/NCT01186614
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen A Bernard, MBBS MD
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Stephen A bernard, MBBS MD
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Address
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Country
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Phone
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9076200
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Fax
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Email
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[email protected]
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01186614
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