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

Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)

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.

Study Overview

• Status: Completed
• Conditions: Extracorporeal Membrane Oxygenation; Heart Arrest; Cardiac Arrest; Cardiopulmonary Resuscitation; Death, Sudden, Cardiac; Sudden Cardiac Arrest; Cardiopulmonary Arrest; CPR; Extracorporeal Cardiopulmonary Resuscitation
• Intervention / Treatment: Device: Expedited Transport With Mechanical CPR

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard Care; 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.
EXPERIMENTAL: Expedited Transport; 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).	Device: Expedited Transport With Mechanical CPR; Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department Arrivals Under 30 Minutes	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).	Measured within one hour cardiac arrest onset
ECPR Initiations Under 30 Minutes	Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival	Measured within 2 hours of cardiac arrest onset

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Neurological Outcome: CPC	Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Functional Neurological Outcome: mRS	modified Rankin Score commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability.	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Neuropsychological Outcome Battery: NIH Toolbox	The NIH toolbox includes cognitive testing and can be administered using an iPad	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Neuro Quality of Life: Neuro QoL	Quality of Life in Neurological Disorders is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults living with neurological conditions.	90 days after cardiac arrest
Safety: Composite Prevalence of 6 Specified Adverse Events	Composite safety endpoint of hemorrhage requiring blood transfusion, vessel damage requiring vascular procedure or leading to occlusion, venous/arterial thromboembolism, stroke, renal failure, and infection.	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Food and Drug Administration (FDA); Physio-Control
• Investigators: Principal Investigator: Robert W Neumar, MD, PhD, University of Michigan; Principal Investigator: Robert H Bartlett, MD, University of Michigan

Publications and helpful links

General Publications

• Hsu CH, Meurer WJ, Domeier R, Fowler J, Whitmore SP, Bassin BS, Gunnerson KJ, Haft JW, Lynch WR, Nallamothu BK, Havey RA, Kidwell KM, Stacey WC, Silbergleit R, Bartlett RH, Neumar RW. Extracorporeal Cardiopulmonary Resuscitation for Refractory Out-of-Hospital Cardiac Arrest (EROCA): Results of a Randomized Feasibility Trial of Expedited Out-of-Hospital Transport. Ann Emerg Med. 2021 Jul;78(1):92-101. doi: 10.1016/j.annemergmed.2020.11.011. Epub 2021 Feb 1.

Helpful Links

• EROCA Study Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): March 5, 2020
• Study Completion (ACTUAL): March 5, 2020

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (ACTUAL): February 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Emergency Medical Services; ECMO; CPR; Cardiac Arrest; Heart Arrest; Cardiopulmonary Resuscitation; Extracorporeal Membrane Oxygenation; Out-of-hospital cardiac arrest; EMS; OHCA; ECPR; Sudden Cardiac Arrest; Extracorporeal Cardiopulmonary Resuscitation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death; Heart Arrest; Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac; Death, Sudden
• Other Study ID Numbers: HUM00117553; R34HL130738-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes