Clinical Trial: BC ECPR Trial for Out-of-Hospital Cardiac Arrest
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The BC Extracorporeal Cardiopulmonary Resuscitation Trial for Refractory Out-of-Hospital Cardiac Arrest
Brief 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 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 Summary:
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) ou
Sponsor: University of British Columbia
Current 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.
Original Primary Outcome: Same as current
Current 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. ]
Original Secondary Outcome: Same as current
Information By: University of British Columbia
Dates:
Date Received: June 28, 2016
Date Started: July 2016
Date Completion: May 2023
Last Updated: August 15, 2016
Last Verified: August 2016
