Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
308 participants
INTERVENTIONAL
2016-07-01
2019-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation
NCT03685383
ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hospital Cardiac Arrest
NCT04620070
ECPR for Refractory Out-Of-Hospital Cardiac Arrest
NCT03065647
SNPeCPR In Cardiac Arrest REsuscitation
NCT02225561
Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With Extracorporeal Cardiopulmonary Resuscitation
NCT06046339
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. To evaluate the effectiveness of ECPR therapy for those with refractory cardiac arrest after 45 minutes of attempted resuscitation.
2. To evaluate the effectiveness of a regional ECPR protocol, in comparison to historical controls.
3. To evaluate the long-term (5-year) outcomes of patients treated with ECPR.
4. To evaluate the quantity of successful organ procurement from those treated with ECPR.
5. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ECPR Region
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.
ECPR Protocol
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.
Control Region
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ECPR Protocol
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥ 18 and ≤ 65 years
3. Witnessed arrest
4. Bystander CPR required if initial rhythm is pulseless electrical activity (added to the protocol June, 2018 and applied retrospectively)
5. Cause of the arrest is presumed to be one of the following:
* No obvious non-cardiac cause is identified
* 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)
(5) The patient remains pulseless after a minimum of 3 cycles of CPR (by any professional provider).
Exclusion Criteria
2. Do Not Resuscitate status
3. 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)
4. Active malignancy
5. Pre-existing major neurological deficit
6. Asystole (added to the protocol June, 2018 and applied retrospectively)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Provincial Health Services Authority
OTHER
Physio-Control
INDUSTRY
Providence Healthcare
OTHER
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Brian Grunau
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Control Region (Kelowna, Victoria, Fraser Valley)
Kelowna, British Columbia, Canada
BC Emergency Health Services
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H15-01701
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.