BC ECPR Trial for Out-of-Hospital Cardiac Arrest

NCT02832752 | Terminated

• 1 other identifier: H15-01701
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 3

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. 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.

Conditions

Heart Arrest

Outcome Measures

Primary Outcomes (1)

• Neurological Status will be assessed at hospital discharge using the Cerebral Performance Category scale

  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.

  Patients will be followed from the time of cardiac arrest until death or hospital discharge, up to 6 months.

Secondary Outcomes (1)

• Survival will be assessed at hospital discharge

  Patients will be followed from the time of cardiac arrest until death or hospital discharge, up to 6 months.

Study Arms (2)

ECPR Region

ACTIVE COMPARATOR

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

Control Region

NO INTERVENTION

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.

Interventions

ECPR Protocol PROCEDURE

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.

ECPR Region

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intra-arrest treatment by an ALS paramedic
• Age ≥ 18 and ≤ 65 years
• Witnessed arrest
• Bystander CPR required if initial rhythm is pulseless electrical activity (added to the protocol June, 2018 and applied retrospectively)
• 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).

You may not qualify if:

• An alternate cause of the arrest is most likely
• Do Not Resuscitate status
• 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)
• Active malignancy
• Pre-existing major neurological deficit
• Asystole (added to the protocol June, 2018 and applied retrospectively)

Sponsors & Collaborators

• University of British Columbia: lead
• Provincial Health Services Authority British Columbia: collaborator
• Physio-Control: collaborator
• Providence Healthcare: collaborator

Study Sites (3)

Control Region (Kelowna, Victoria, Fraser Valley)

Kelowna, British Columbia, Canada

Location

BC Emergency Health Services

Vancouver, British Columbia, V5M 4X6, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2016
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)