Cardiac ArrestPhase 1CHEERNCT01186614
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
A Phase 1 study testing Automated CPR, ECMO and Coronary angiography in people with Cardiac Arrest, run by Bayside Health at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Automated CPR, ECMO and Coronary angiography
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesAustralia
- Study dates
- Nov 2010to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3161
Stephen Bernard, MBBS MD, 90762000
Stephen A Bernard, MBBS MD
- Not yet recruiting
Ambulance Victoria
Melbourne, Victoria
Karen Smith, BSc PhD, 9840 3752, karen.smith@ambulance.vic.gov.au
Karen Smith, BSc PhD
About this study
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.
Read more
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.
- Conditions
- Cardiac Arrest
- Being tested
- Automated CPR, ECMO, Coronary angiography, Therapeutic Hypothermia
- Keywords
- cardiac arrest, ECMO, hypothermia, automated CPR, coronary intervention
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated CPRDevice
Also called Zoll Autopulse
Automated CPR utilised by paramedics to facilitate CPR during transport to hospital
ECMODevice
Insertion of peripheral VA ECMO
Coronary angiographyProcedure or surgery
Coronary angiography and intervention where necessary will be performed following ECMO insertion
Therapeutic HypothermiaProcedure or surgery
Paramedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees)
| Study group | Role | What they receive |
|---|---|---|
| Novel treatment paradigm | Experimental | treatment protocol including - mechanical CPR, therapeutic hypothermia, ECMO, coronary intervention Receives: Device: Automated CPR; Device: ECMO; Procedure: Coronary angiography; Procedure: Therapeutic Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to hospital discharge
Measured: At hospital discharge
Secondary outcomes (4)
Neurologic recovery
Assessed by cerebral performance category
Measured: At discharge
Time until ECMO insertion
Measured: On admission
neurologic biomarkers
neuron-specific enolase and S100β
Measured: Day 3
Cardiac recovery
measured by echocardiography and cardiac biomakers including troponin, CK and BNP
Measured: Days 1, 3, 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- The Alfred, Ambulance Victoria
- Responsible party
- Principal investigator, Ms. Rowan Frew, Bayside Health
- Investigators
- Stephen A Bernard, MBBS MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186614
- Sponsor's protocol ID
- project 160/10
- Acronym
- CHEER
- Status last verified
- Mar 2014
- First submitted
- 20 Aug 2010
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
- ClinicalTrials.gov ID
- NCT01186614
- Acronym / sponsor ID
- CHEER / project 160/10
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, ECMO, hypothermia, automated CPR, coronary intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- The Alfred, Ambulance Victoria
- Study start
- Nov 2010
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel treatment paradigm | Experimental | Device: Automated CPR, Device: ECMO, Procedure: Coronary angiography, Procedure: Therapeutic Hypothermiatreatment protocol including - mechanical CPR, therapeutic hypothermia, ECMO, coronary intervention |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated CPRAlso: Zoll AutopulseAutomated CPR utilised by paramedics to facilitate CPR during transport to hospital | Device | Novel treatment paradigm |
| ECMOInsertion of peripheral VA ECMO | Device | Novel treatment paradigm |
| Coronary angiographyCoronary angiography and intervention where necessary will be performed following ECMO insertion | Procedure or surgery | Novel treatment paradigm |
| Therapeutic HypothermiaParamedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees) | Procedure or surgery | Novel treatment paradigm |
Primary outcome
Survival to hospital discharge
Time frame: At hospital discharge
4 secondary outcomes
Neurologic recovery
Time frame: At discharge
Time until ECMO insertion
Time frame: On admission
neurologic biomarkers
Time frame: Day 3
Cardiac recovery
Time frame: Days 1, 3, 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A Bernard, MBBS MD principal investigator
The Alfred
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Automated CPR, ECMO and Coronary angiography in people with Cardiac Arrest, run by Bayside Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen A bernard, MBBS MD (9076200, s.bernard@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to hospital discharge (time frame: At hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2014.