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

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ClinicalTrials.gov Identifier: NCT01186614
Recruitment Status : Unknown
Verified March 2014 by Ms. Rowan Frew, Bayside Health.
Recruitment status was:  Recruiting
First Posted : August 23, 2010
Last Update Posted : March 10, 2014
Sponsor:
Collaborators:
The Alfred
Ambulance Victoria
Information provided by (Responsible Party):
Ms. Rowan Frew, Bayside Health

Tracking Information
First Submitted Date  ICMJE August 20, 2010
First Posted Date  ICMJE August 23, 2010
Last Update Posted Date March 10, 2014
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
Survival to hospital discharge [ Time Frame: At hospital discharge ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
  • Neurologic recovery [ Time Frame: At discharge ]
    Assessed by cerebral performance category
  • Time until ECMO insertion [ Time Frame: On admission ]
  • neurologic biomarkers [ Time Frame: Day 3 ]
    neuron-specific enolase and S100β
  • Cardiac recovery [ Time Frame: Days 1, 3, 5 ]
    measured by echocardiography and cardiac biomakers including troponin, CK and BNP
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
Official Title  ICMJE Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrest
Intervention  ICMJE
  • 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)
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 20, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01186614
Other Study ID Numbers  ICMJE project 160/10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ms. Rowan Frew, Bayside Health
Study Sponsor  ICMJE Bayside Health
Collaborators  ICMJE
  • The Alfred
  • Ambulance Victoria
Investigators  ICMJE
Principal Investigator: Stephen A Bernard, MBBS MD The Alfred
PRS Account Bayside Health
Verification Date March 2014

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