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

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Automated CPR
ECMO
Coronary angiography
Therapeutic Hypothermia
Sponsored by
Bayside Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, ECMO, hypothermia, automated CPR, coronary intervention

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alfred HospitalRecruiting
  • Ambulance Victoria

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Novel treatment paradigm

Arm Description

treatment protocol including - mechanical CPR, therapeutic hypothermia, ECMO, coronary intervention

Outcomes

Primary Outcome Measures

Survival to hospital discharge

Secondary Outcome Measures

Neurologic recovery
Assessed by cerebral performance category
Time until ECMO insertion
neurologic biomarkers
neuron-specific enolase and S100β
Cardiac recovery
measured by echocardiography and cardiac biomakers including troponin, CK and BNP

Full Information

First Posted
August 20, 2010
Last Updated
March 6, 2014
Sponsor
Bayside Health
Collaborators
The Alfred, Ambulance Victoria
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1. Study Identification

Unique Protocol Identification Number
NCT01186614
Brief Title
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
Acronym
CHEER
Official Title
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bayside Health
Collaborators
The Alfred, Ambulance Victoria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, ECMO, hypothermia, automated CPR, coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novel treatment paradigm
Arm Type
Experimental
Arm Description
treatment protocol including - mechanical CPR, therapeutic hypothermia, ECMO, coronary intervention
Intervention Type
Device
Intervention Name(s)
Automated CPR
Other Intervention Name(s)
Zoll Autopulse
Intervention Description
Automated CPR utilised by paramedics to facilitate CPR during transport to hospital
Intervention Type
Device
Intervention Name(s)
ECMO
Intervention Description
Insertion of peripheral VA ECMO
Intervention Type
Procedure
Intervention Name(s)
Coronary angiography
Intervention Description
Coronary angiography and intervention where necessary will be performed following ECMO insertion
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Hypothermia
Intervention Description
Paramedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees)
Primary Outcome Measure Information:
Title
Survival to hospital discharge
Time Frame
At hospital discharge
Secondary Outcome Measure Information:
Title
Neurologic recovery
Description
Assessed by cerebral performance category
Time Frame
At discharge
Title
Time until ECMO insertion
Time Frame
On admission
Title
neurologic biomarkers
Description
neuron-specific enolase and S100β
Time Frame
Day 3
Title
Cardiac recovery
Description
measured by echocardiography and cardiac biomakers including troponin, CK and BNP
Time Frame
Days 1, 3, 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen A bernard, MBBS MD
Phone
9076200
Email
s.bernard@alfred.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Dion A Stub, MBBS
Phone
90762000
Email
d.stub@alfred.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen A Bernard, MBBS MD
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3161
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Bernard, MBBS MD
Phone
90762000
First Name & Middle Initial & Last Name & Degree
Stephen A Bernard, MBBS MD
First Name & Middle Initial & Last Name & Degree
Dion A Stub, MBBS
First Name & Middle Initial & Last Name & Degree
Vincent Pellegrino, MBBS
First Name & Middle Initial & Last Name & Degree
Lisen Hockings, MBBS
First Name & Middle Initial & Last Name & Degree
Matthew Reid, RN
First Name & Middle Initial & Last Name & Degree
David M Kaye, MBBS PhD
First Name & Middle Initial & Last Name & Degree
Stephen J Duffy, MBBS PhD
First Name & Middle Initial & Last Name & Degree
Peter Cameron, MBBS MD
First Name & Middle Initial & Last Name & Degree
De Villiers Smit, MBBS
Facility Name
Ambulance Victoria
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Smith, BSc PhD
Phone
9840 3752
Email
karen.smith@ambulance.vic.gov.au
First Name & Middle Initial & Last Name & Degree
Karen Smith, BSc PhD
First Name & Middle Initial & Last Name & Degree
Tony Walker, HlthSci MICA

12. IPD Sharing Statement

Learn more about this trial

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

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