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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
Scientific title
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
Secondary ID [1] 0 0
project 160/10
Universal Trial Number (UTN)
Trial acronym
CHEER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival to hospital discharge
Timepoint [1] 0 0
At hospital discharge
Secondary outcome [1] 0 0
Neurologic recovery
Timepoint [1] 0 0
At discharge
Secondary outcome [2] 0 0
Time until ECMO insertion
Timepoint [2] 0 0
On admission
Secondary outcome [3] 0 0
neurologic biomarkers
Timepoint [3] 0 0
Day 3
Secondary outcome [4] 0 0
Cardiac recovery
Timepoint [4] 0 0
Days 1, 3, 5

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
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2014
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Ambulance Victoria - Melbourne
Recruitment postcode(s) [1] 0 0
3161 - Melbourne
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Ambulance Victoria
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01186614
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen A Bernard, MBBS MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stephen A bernard, MBBS MD
Address 0 0
Country 0 0
Phone 0 0
9076200
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01186614