ECPR for Refractory Out-Of-Hospital Cardiac Arrest

Not Applicable

Completed

• Conditions: Death, Sudden, Cardiac; Extracorporeal Membrane Oxygenation; CPR; Extracorporeal Cardiopulmonary Resuscitation; Cardiac Arrest; Sudden Cardiac Arrest; Cardiopulmonary Arrest; Cardiopulmonary Resuscitation; Heart Arrest
• Interventions: Device: Expedited Transport With Mechanical CPR

• Registration Number: NCT03065647
• Lead Sponsor: University of Michigan

Brief Summary

In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. An alternative strategy for those with refractory OHCA is expedited transport with ongoing mechanical CPR to an Emergency Department capable of performing extracorporeal cardiopulmonary resuscitation (ECPR). The purpose of study is to test if this strategy is feasible and beneficial.

Detailed Description

Out-of-hospital sudden cardiac arrest (OHCA) is a life-threatening condition in which the heart suddenly stops beating and there is no blood flow to the body. If cardiac arrest is not treated immediately, it causes sudden death. In the U.S. alone, over 300,000 people per year have OHCA, and less than 1 out of 10 survive. Therefore, it is important to study new ways of treating cardiac arrest patients in order to improve survival.

The current standard practice for treating OHCA is to perform CPR and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. This practice is supported by the fact that all currently proven CPR therapies can be delivered by paramedics in the field.

However, promising new strategies have emerged that are more feasible to initiate in the hospital. One such strategy is extracorporeal cardiopulmonary resuscitation (ECPR). ECPR requires placement of catheters in large blood vessels and connected to a machine to take over the work of the heart and lungs.

This purpose of this study is to examine the feasibility and potential benefit of expedited transport with ongoing mechanical CPR for patients with refractory OHCA patients to an Emergency Department capable of initiating ECPR.

FDA approved this study as a staged feasibility study to enroll 15 participants and submit data prior to enrolling the second 15 participants. After enrolling 15 participants, the PI chose not to pursue an amendment to enroll additional participants due to slow accrual and research restrictions related to COVID.

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-28
• Study Start: 2017-05-01
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Results First Submitted: 2021-02-19
• Results First Submitted QC: 2021-02-19
• Results First Posted: 2021-03-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• OHCA of presumed non-traumatic etiology requiring CPR
• Predicted arrival time at ECPR-capable hospital within timeframe specified
• Witnessed arrest or initial shockable rhythm (VT or VF)
• Persistent cardiac arrest after initial cardiac rhythm analysis and shock (if shock is indicated)

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Exclusion Criteria

• Sustained return of spontaneous circulation (ROSC)
• Advanced directive indicating do not attempt resuscitation (DNAR) or do not intubate (DNI)
• Preexisting evidence of opting out of study
• Prisoner
• Pregnant (obvious or known)
• ECPR capable ED is not at the destination hospital as determined by EMS
• Legally authorized representative (LAR) or family member aware of study and refuses study participation at the scene

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expedited Transport	Expedited Transport With Mechanical CPR	Intervention: Expedited Transport with Mechanical CPR. After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).

Primary Outcome Measures

Name	Time	Method
ECPR Initiations Under 30 Minutes	Measured within 2 hours of cardiac arrest onset	Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival
Emergency Department Arrivals Under 30 Minutes	Measured within one hour cardiac arrest onset	Proportion of patients with emergency department (ED) arrival less than or equal to 30 minutes from 911 call (or cardiac arrest onset if witnessed by EMS personnel).

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States