ECPR for Refractory Out-Of-Hospital Cardiac Arrest (EROCA)

University of Michigan

Status: Completed

Conditions: Cardiopulmonary Resuscitation; Heart Arrest; Extracorporeal Cardiopulmonary Resuscitation; Cardiopulmonary Arrest; Sudden Cardiac Arrest; Extracorporeal Membrane Oxygenation; Cardiac Arrest; Death, Sudden, Cardiac; CPR

Treatments: Device: Expedited Transport With Mechanical CPR

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry; NIH

Identifiers

NCT03065647

R34HL130738-01A1 (U.S. NIH Grant/Contract)

HUM00117553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.

Expedited Transport

Experimental group

Description:

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).

Treatment:

Device: Expedited Transport With Mechanical CPR