Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion (CHEER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Bayside Health
Sponsor:
Collaborators:
The Alfred
Ambulance Victoria
Information provided by (Responsible Party):
Ms. Rowan Frew, Bayside Health
ClinicalTrials.gov Identifier:
NCT01186614
First received: August 20, 2010
Last updated: March 6, 2014
Last verified: March 2014

August 20, 2010
March 6, 2014
November 2010
July 2014   (final data collection date for primary outcome measure)
Survival to hospital discharge [ Time Frame: At hospital discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01186614 on ClinicalTrials.gov Archive Site
  • Neurologic recovery [ Time Frame: At discharge ] [ Designated as safety issue: No ]
    Assessed by cerebral performance category
  • Time until ECMO insertion [ Time Frame: On admission ] [ Designated as safety issue: No ]
  • neurologic biomarkers [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    neuron-specific enolase and S100β
  • Cardiac recovery [ Time Frame: Days 1, 3, 5 ] [ Designated as safety issue: No ]
    measured by echocardiography and cardiac biomakers including troponin, CK and BNP
Same as current
Not Provided
Not Provided
 
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiac Arrest
  • Device: Automated CPR
    Automated CPR utilised by paramedics to facilitate CPR during transport to hospital
    Other Name: Zoll Autopulse
  • Device: ECMO
    Insertion of peripheral VA ECMO
  • Procedure: Coronary angiography
    Coronary angiography and intervention where necessary will be performed following ECMO insertion
  • Procedure: Therapeutic Hypothermia
    Paramedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees)
Experimental: Novel treatment paradigm
treatment protocol including - mechanical CPR, therapeutic hypothermia, ECMO, coronary intervention
Interventions:
  • Device: Automated CPR
  • Device: ECMO
  • Procedure: Coronary angiography
  • Procedure: Therapeutic Hypothermia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2014
July 2014   (final data collection date for primary outcome measure)

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

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
Both
18 Years to 59 Years
No
Contact: Stephen A bernard, MBBS MD 9076200 s.bernard@alfred.org.au
Contact: Dion A Stub, MBBS 90762000 d.stub@alfred.org.au
Australia
 
NCT01186614
project 160/10
Yes
Ms. Rowan Frew, Bayside Health
Bayside Health
  • The Alfred
  • Ambulance Victoria
Principal Investigator: Stephen A Bernard, MBBS MD The Alfred
Bayside Health
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP