Heart ArrestNCT02832752
BC ECPR Trial for Out-of-Hospital Cardiac Arrest
A study testing ECPR Protocol in people with Heart Arrest, run by University of British Columbia at 3 sites in Canada.
Trial summary
The addition of an Extracorporeal-Cardiopulmonary Resuscitation (ECPR) service to a region may improve the survival of young patients with sudden unexpected cardiac arrest.The primary aim of this study is to determine the benefit of the systematic integration of ECPR services into the out-of-hospital cardiac arrest… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Arrest
- What is being tested?
- ECPR Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jul 2016to 31 May 2019
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intra-arrest treatment by an ALS paramedic
- Age ≥ 18 and ≤ 65 years
- Witnessed arrest
- Bystander CPR required if initial rhythm is pulseless electrical activity (added to the protocol June, 2018 and applied retrospectively)
- Cause of the arrest is presumed to be one of the following:
- No obvious non-cardiac cause is identified
Show all 9Show fewer
- Known overdose of one of the following drugs: beta-blocker, calcium channel blocker, tricyclic antidepressants or other psychiatric medications, or digoxin
- Hypothermia (with T < 32°C)
- The patient remains pulseless after a minimum of 3 cycles of CPR (by any professional provider).
Who cannot join
- An alternate cause of the arrest is most likely
- Do Not Resuscitate status
- Co-morbidities including congestive heart failure, chronic obstructive pulmonary disease or other significant lung disease, dialysis, liver failure (if co-morbidities are unknown to paramedics they will be assumed not present)
- Active malignancy
- Pre-existing major neurological deficit
- Asystole (added to the protocol June, 2018 and applied retrospectively)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Control Region (Kelowna, Victoria, Fraser Valley)
Kelowna, British Columbia
BC Emergency Health Services
Vancouver, British Columbia, V5M 4X6
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: The BC Extracorporeal Cardiopulmonary Resuscitation Trial for Refractory Out-of-Hospital Cardiac Arrest
The addition of an Extracorporeal-Cardiopulmonary Resuscitation (ECPR) service to a region may improve the survival of young patients with sudden unexpected cardiac arrest.The primary aim of this study is to determine the benefit of the systematic integration of ECPR services into the out-of-hospital cardiac arrest management algorithm. The investigators will compare the outcomes of ECPR-eligible patients in the intervention region, in comparison to patients meeting the same criteria in a comparable setting.
Read the detailed description
British Columbia is a province which contains four metropolitan areas, each of which contains at least one tertiary care centre that provides Extracorporeal Membrane Oxygenation (ECMO) and cardiovascular surgery services, in addition to critical cardiology services and a coronary catheterization laboratory. Pre-hospital medical care in all areas is provided by British Columbia Emergency Health Services (BCEHS), which uses a tiered system of basic life support and advanced life support (ALS) paramedics (90% of cases have ALS involvement) in coordination with fire department first responders. Medical providers in the study footprint have extensive experience with interventional trials enrolling patients with out-of-hospital cardiac arrest, through participation in the Resuscitation Outcomes Consortium.
Through collaboration of clinicians from all areas and with BCEHS, this study will examine the benefit of a regional ECPR protocol established in one of the metropolitan areas (the "ECPR Protocol Region"), in comparison to the other areas (the "Usual Care Region"). The primary aim is to determine the benefit of incorporating ECPR services into a regional medical system of care for out-of-hospital cardiac arrest. All patients with out-of-hospital cardiac arrest treated by emergency medical services (EMS) in both regions will be prospectively evaluated for study eligibility.
Secondary aims include:
- To evaluate the effectiveness of ECPR therapy for those with refractory cardiac arrest after 45 minutes of attempted resuscitation.
- To evaluate the effectiveness of a regional ECPR protocol, in comparison to historical controls.
- To evaluate the long-term (5-year) outcomes of patients treated with ECPR.
- To evaluate the quantity of successful organ procurement from those treated with ECPR.
- To evaluate the cost-effectiveness of a regional ECPR protocol.
This study is a parallel group design with group allocation based on region of treatment. The investigators will compare the outcomes of ECPR-eligible patients in the intervention region, in comparison to patients meeting the same criteria in a comparable setting (the control regions group). Medical care in the control regions will be unaltered by this study.
Group outcomes will be compared. The association of treatment group and outcomes will also be assessed using a logistic regression analysis, while adjusting for other important prognosticators in out-of-hospital cardiac arrest (including initial cardiac rhythm, time to emergency medical services [EMS] arrival, bystander cardiopulmonary resuscitation [CPR], EMS-witnessed arrest, and age).
- Conditions
- Heart Arrest
- Being tested
- ECPR Protocol
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECPR ProtocolProcedure or surgery
The regional protocol is activated for eligible patients who remain pulseless after 3 cycles of resuscitation, and intubation. The hospital team is activated at this time, which includes the emergency department team, a perfusionist, and a cardiovascular surgeon. A mechanical CPR device (Lucas chest compression device) is applied at this time and the patient is transported to hospital. The goal times from first professional CPR to ECMO flows is < 60 minutes, and from emergency department (ED) arrival to ECMO flows < 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| ECPR Region | Active comparator | The ECPR region has incorporated ECPR therapy into the out-of-hospital cardiac arrest algorithm. Within the ECPR Protocol, full standard advanced cardiac life support treatments will continue up until the time of ECMO initiation. The anticipated enrolment in this group is 70 patients. All eligible patients in the region will be enrolled, regardless of whether the ECPR protocol is activated or whether the patient is actually treated with ECPR. Receives: Procedure: ECPR Protocol |
| Control Region | No intervention | The control region will continue usual care as per current protocols which include standard advanced cardiac life support. Patients will be enrolled in the control region group at the same juncture of study eligibility. The anticipated enrolment in this group is 350 patients. Within BCEHS practice, transport to hospital without prior return of spontaneous circulation is rare. Termination of resuscitation must be approved by an on-call physician and cannot occur prior to 30 minutes of resuscitation efforts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Status will be assessed at hospital discharge using the Cerebral Performance Category scale
Cerebral Performance Categories 1 and 2 will be considered favourable outcomes. Adjudication for these outcomes will be assessed with a structured algorithm via chart review blinded to treatment group.
Measured: Patients will be followed from the time of cardiac arrest until death or hospital discharge, up to 6 months.
Secondary outcomes (1)
Survival will be assessed at hospital discharge
Measured: Patients will be followed from the time of cardiac arrest until death or hospital discharge, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: Due to changes in Hospital Protocols and COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, Physio-Control, Providence Healthcare
- Responsible party
- Principal investigator, Brian Grunau, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832752
- Sponsor's protocol ID
- H15-01701
- Status last verified
- Apr 2021
- First submitted
- 28 Jun 2016
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BC Extracorporeal Cardiopulmonary Resuscitation Trial for Refractory Out-of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02832752
- Acronym / sponsor ID
- H15-01701
- Conditions
- Heart Arrest
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to changes in Hospital Protocols and COVID-19
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, Physio-Control, Providence Healthcare
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 14 Jul 2016 (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.
The addition of an Extracorporeal-Cardiopulmonary Resuscitation (ECPR) service to a region may improve the survival of young patients with sudden unexpected cardiac arrest.The primary aim of this study is to determine the benefit of the systematic integration of ECPR services into the out-of-hospital cardiac arrest management algorithm. The investigators will compare the outcomes of ECPR-eligible patients in the intervention region, in comparison to patients meeting the same criteria in a comparable setting.
Detailed description
British Columbia is a province which contains four metropolitan areas, each of which contains at least one tertiary care centre that provides Extracorporeal Membrane Oxygenation (ECMO) and cardiovascular surgery services, in addition to critical cardiology services and a coronary catheterization laboratory. Pre-hospital medical care in all areas is provided by British Columbia Emergency Health Services (BCEHS), which uses a tiered system of basic life support and advanced life support (ALS) paramedics (90% of cases have ALS involvement) in coordination with fire department first responders. Medical providers in the study footprint have extensive experience with interventional trials enrolling patients with out-of-hospital cardiac arrest, through participation in the Resuscitation Outcomes Consortium.
Through collaboration of clinicians from all areas and with BCEHS, this study will examine the benefit of a regional ECPR protocol established in one of the metropolitan areas (the "ECPR Protocol Region"), in comparison to the other areas (the "Usual Care Region"). The primary aim is to determine the benefit of incorporating ECPR services into a regional medical system of care for out-of-hospital cardiac arrest. All patients with out-of-hospital cardiac arrest treated by emergency medical services (EMS) in both regions will be prospectively evaluated for study eligibility.
Secondary aims include:
- To evaluate the effectiveness of ECPR therapy for those with refractory cardiac arrest after 45 minutes of attempted resuscitation.
- To evaluate the effectiveness of a regional ECPR protocol, in comparison to historical controls.
- To evaluate the long-term (5-year) outcomes of patients treated with ECPR.
- To evaluate the quantity of successful organ procurement from those treated with ECPR.
- To evaluate the cost-effectiveness of a regional ECPR protocol.
This study is a parallel group design with group allocation based on region of treatment. The investigators will compare the outcomes of ECPR-eligible patients in the intervention region, in comparison to patients meeting the same criteria in a comparable setting (the control regions group). Medical care in the control regions will be unaltered by this study.
Group outcomes will be compared. The association of treatment group and outcomes will also be assessed using a logistic regression analysis, while adjusting for other important prognosticators in out-of-hospital cardiac arrest (including initial cardiac rhythm, time to emergency medical services [EMS] arrival, bystander cardiopulmonary resuscitation [CPR], EMS-witnessed arrest, and age).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECPR Region | Active comparator | Procedure: ECPR ProtocolThe ECPR region has incorporated ECPR therapy into the out-of-hospital cardiac arrest algorithm. Within the ECPR Protocol, full standard advanced cardiac life support treatments will continue up until the time of ECMO initiation. The anticipated enrolment in this group is 70 patients. All eligible patients in the region will be enrolled, regardless of whether the ECPR protocol is activated or whether the patient is actually treated with ECPR. |
| Control Region | No intervention | –The control region will continue usual care as per current protocols which include standard advanced cardiac life support. Patients will be enrolled in the control region group at the same juncture of study eligibility. The anticipated enrolment in this group is 350 patients. Within BCEHS practice, transport to hospital without prior return of spontaneous circulation is rare. Termination of resuscitation must be approved by an on-call physician and cannot occur prior to 30 minutes of resuscitation efforts. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Intra-arrest treatment by an ALS paramedic
- Age ≥ 18 and ≤ 65 years
- Witnessed arrest
- Bystander CPR required if initial rhythm is pulseless electrical activity (added to the protocol June, 2018 and applied retrospectively)
- Cause of the arrest is presumed to be one of the following:
Key exclusion criteria (6 listed)
- An alternate cause of the arrest is most likely
- Do Not Resuscitate status
- Co-morbidities including congestive heart failure, chronic obstructive pulmonary disease or other significant lung disease, dialysis, liver failure (if co-morbidities are unknown to paramedics they will be assumed not present)
- Active malignancy
- Pre-existing major neurological deficit
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 |
|---|---|---|
| ECPR ProtocolThe regional protocol is activated for eligible patients who remain pulseless after 3 cycles of resuscitation, and intubation. The hospital team is activated at this time, which includes the emergency department team, a perfusionist, and a cardiovascular surgeon. A mechanical CPR device (Lucas chest compression device) is applied at this time and the patient is transported to hospital. The goal times from first professional CPR to ECMO flows is < 60 minutes, and from emergency department (ED) arrival to ECMO flows < 30 minutes. | Procedure or surgery | ECPR Region |
Primary outcome
Neurological Status will be assessed at hospital discharge using the Cerebral Performance Category scale
Time frame: Patients will be followed from the time of cardiac arrest until death or hospital discharge, up to 6 months.
Cerebral Performance Categories 1 and 2 will be considered favourable outcomes. Adjudication for these outcomes will be assessed with a structured algorithm via chart review blinded to treatment group.
1 secondary outcome
Survival will be assessed at hospital discharge
Time frame: Patients will be followed from the time of cardiac arrest until death or hospital discharge, up to 6 months.
Results and safety
The study was stopped early (reason given: Due to changes in Hospital Protocols and COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Heart Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECPR Protocol in people with Heart Arrest, run by University of British Columbia at 3 sites in Canada.
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 6 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: stopped early, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
Are results available for this study?
The study was stopped early (reason given: Due to changes in Hospital Protocols and COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological Status will be assessed at hospital discharge using the Cerebral Performance Category scale (time frame: Patients will be followed from the time of cardiac arrest until death or hospital discharge, up to 6 months.). 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 19 Apr 2021.