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BC ECPR Trial for Out-of-Hospital Cardiac Arrest

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by University of British Columbia
Sponsor:
Collaborators:
Provincial Health Services Authority
Physio-Control
Providence HealthCare
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02832752
First received: June 28, 2016
Last updated: August 15, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Heart Arrest Procedure: ECPR Protocol Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The BC Extracorporeal Cardiopulmonary Resuscitation Trial for Refractory Out-of-Hospital Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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. ]

Estimated Enrollment: 420
Study Start Date: July 2016
Estimated Study Completion Date: May 2023
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Treated by an ALS paramedic
  2. Age ≥ 18 and ≤ 65 years
  3. Witnessed arrest
  4. Bystander CPR (performed by laypersons or EMS if the arrest was EMS-witnessed) or EMS arrival in less than 10 minutes
  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 is pulseless after a minimum of 3 cycles of CPR (by any professional provider) and intubation.

Exclusion Criteria:

  1. An alternate cause of the arrest is most likely
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02832752

Contacts
Contact: Helen Connolly, RN 604-806-8753 hconnolly@providencehealth.bc.ca
Contact: Sarah Carrier, MA SCarriere@providencehealth.bc.ca

Locations
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         
Sponsors and Collaborators
University of British Columbia
Provincial Health Services Authority
Physio-Control
Providence HealthCare
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02832752     History of Changes
Other Study ID Numbers: H15-01701
Study First Received: June 28, 2016
Last Updated: August 15, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 21, 2017