Last updated on June 2018

BC ECPR Trial for Out-of-Hospital Cardiac Arrest


Brief description of study

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. This study is a controlled 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.

Detailed Study 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:

  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 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.

Clinical Study Identifier: NCT02832752

Contact Investigators or Research Sites near you

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Devin Harris, MD MHSc

Control Region (Kelowna, Victoria, Fraser Valley)
Kelowna, BC Canada
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