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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]

project 160/10

Universal Trial Number (UTN)

Trial acronym

CHEER

Linked study record

Health condition

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

Cardiac Arrest

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

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]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Survival to hospital discharge

Timepoint [1]

At hospital discharge

Secondary outcome [1]

Neurologic recovery

Timepoint [1]

At discharge

Secondary outcome [2]

Time until ECMO insertion

Timepoint [2]

On admission

Secondary outcome [3]

neurologic biomarkers

Timepoint [3]

Day 3

Secondary outcome [4]

Cardiac recovery

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Alfred Hospital - Melbourne

Recruitment hospital [2]

Ambulance Victoria - Melbourne

Recruitment postcode(s) [1]

3161 - Melbourne

Recruitment postcode(s) [2]

- Melbourne

Funding & Sponsors

Primary sponsor type

Government body

Name

Bayside Health

Address

Country

Other collaborator category [1]

Other

Name [1]

The Alfred

Address [1]

Country [1]

Other collaborator category [2]

Government body

Name [2]

Ambulance Victoria

Address [2]

Country [2]

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

Stephen A Bernard, MBBS MD

Address

The Alfred

Country

Phone

Fax

Contact person for public queries

Name

Stephen A bernard, MBBS MD

Address

Country

Phone

9076200

Fax

s.bernard@alfred.org.au

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

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01186614