BC ECPR Trial for Out-of-Hospital Cardiac Arrest
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|ClinicalTrials.gov Identifier: NCT02832752|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : August 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Heart Arrest||Procedure: ECPR Protocol||Phase 2 Phase 3|
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 controlled 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 effect of treatment group will be assessed 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). In addition, as the region of the cardiac arrest may be an independent predictor of outcomes, this will be included in the final adjustment. The investigators prospectively collected data on patients that fit the study criteria in both regions between 2012 and 2015. Outcomes in this historical data will be compared between regions, as well as historical data from each region individually compared to the study period, in order to estimate the independent effect of region of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The BC Extracorporeal Cardiopulmonary Resuscitation Trial for Refractory Out-of-Hospital Cardiac Arrest|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||May 2023|
Active Comparator: 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.
Procedure: 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.
No Intervention: 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.
- 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.
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832752
|Contact: Helen Connolly, RNemail@example.com|
|Contact: Sarah Carrier, MA||SCarriere@providencehealth.bc.ca|
|Canada, British Columbia|
|Control Region (Kelowna, Victoria, Fraser Valley)||Recruiting|
|Kelowna, British Columbia, Canada|
|Principal Investigator: Devin Harris, MD MHSc|
|Sub-Investigator: Richard Vandegriend, MD|
|Sub-Investigator: Hussein Kanji, MD MPH|
|Sub-Investigator: Nick Kuzak, MD|
|Sub-Investigator: Jim Goulding, MD|
|BC Emergency Health Services||Recruiting|
|Vancouver, British Columbia, Canada, V5M 4X6|
|Contact: William Dick, MD MSc Ryder.Brook@bcehs.ca|
|Principal Investigator: William Dick, MD MSc|
|Sub-Investigator: Brian Twaites, ALS|
|Sub-Investigator: Ron Straight, MA ALS|
|Sub-Investigator: David Agulnik, MD|
|St. Paul's Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Contact: Brian E Grunau, MD Brian.Grunau2@vch.ca|
|Principal Investigator: Brian Grunau, MD|
|Sub-Investigator: Anson Cheung, MD|
|Sub-Investigator: Jamil Bashir, MD|
|Sub-Investigator: Jim Christenson, MD|
|Sub-Investigator: Luke Harris, MSc|
|Sub-Investigator: Robert Boone, MD MSc|
|Sub-Investigator: Sarah Carrier, MA|
|Sub-Investigator: Ruth MacRedmond, MD|
|Sub-Investigator: Navreet Johal, BSc|
|Sub-Investigator: Joel Singer, PhD|
|Sub-Investigator: Frank Scheuermeyer, MD MHSc|