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

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

Tracking Information

• First Submitted Date: August 20, 2010
• First Posted Date: August 23, 2010
• Last Update Posted Date: March 10, 2014
• Study Start Date: November 2010
• Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 20, 2010): Survival to hospital discharge [ Time Frame: At hospital discharge ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cardiac Arrest

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 20, 2010): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2014
• Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT01186614
• Other Study ID Numbers: project 160/10
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ms. Rowan Frew, Bayside Health
• Study Sponsor: Bayside Health

Collaborators

• The Alfred
• Ambulance Victoria

Investigators

• Principal Investigator: Stephen A Bernard, MBBS MD; The Alfred

• PRS Account: Bayside Health
• Verification Date: March 2014