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

Primary Purpose

Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expedited Transport With Mechanical CPR
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Out-of-hospital cardiac arrest, Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation, CPR, ECPR, ECMO, Emergency Medical Services, EMS, OHCA

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Expedited Transport

Arm 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.

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).

Outcomes

Primary Outcome Measures

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).
ECPR Initiations Under 30 Minutes
Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival

Secondary Outcome Measures

Full Information

First Posted
February 16, 2017
Last Updated
May 10, 2021
Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Food and Drug Administration (FDA), Physio-Control
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1. Study Identification

Unique Protocol Identification Number
NCT03065647
Brief Title
ECPR for Refractory Out-Of-Hospital Cardiac Arrest
Acronym
EROCA
Official Title
Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Food and Drug Administration (FDA), Physio-Control

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest, Cardiopulmonary Arrest, Death, Sudden, Cardiac, Cardiopulmonary Resuscitation, CPR, Extracorporeal Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation
Keywords
Out-of-hospital cardiac arrest, Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation, CPR, ECPR, ECMO, Emergency Medical Services, EMS, OHCA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm 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.
Arm Title
Expedited Transport
Arm Type
Experimental
Arm 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).
Intervention Type
Device
Intervention Name(s)
Expedited Transport With Mechanical CPR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emergency Department Arrivals Under 30 Minutes
Description
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).
Time Frame
Measured within one hour cardiac arrest onset
Title
ECPR Initiations Under 30 Minutes
Description
Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival
Time Frame
Measured within 2 hours of cardiac arrest onset
Other Pre-specified Outcome Measures:
Title
Functional Neurological Outcome: CPC
Description
Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome
Time Frame
At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Title
Functional Neurological Outcome: mRS
Description
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.
Time Frame
At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Title
Neuropsychological Outcome Battery: NIH Toolbox
Description
The NIH toolbox includes cognitive testing and can be administered using an iPad
Time Frame
At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Title
Neuro Quality of Life: Neuro QoL
Description
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.
Time Frame
90 days after cardiac arrest
Title
Safety: Composite Prevalence of 6 Specified Adverse Events
Description
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.
Time Frame
At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Neumar, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert H Bartlett, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33541748
Citation
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.
Results Reference
derived
Links:
URL
https://www.medicine.umich.edu/dept/emergency-medicine/eroca-study
Description
EROCA Study Website

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ECPR for Refractory Out-Of-Hospital Cardiac Arrest

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