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

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ClinicalTrials.gov Identifier: NCT03065647
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Food and Drug Administration (FDA)
Physio-Control
Information provided by (Responsible Party):
Robert Neumar, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Heart Arrest Sudden Cardiac Arrest Cardiopulmonary Arrest Death, Sudden, Cardiac Cardiopulmonary Resuscitation CPR Extracorporeal Cardiopulmonary Resuscitation Extracorporeal Membrane Oxygenation Device: Expedited Transport With Mechanical CPR Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : March 5, 2020
Actual Study Completion Date : May 28, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. ED arrival interval [ Time Frame: 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).

  2. ECPR initiation interval [ Time Frame: 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


Other Outcome Measures:
  1. Functional Neurological Outcome: CPC [ Time Frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest ]
    Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome

  2. Functional Neurological Outcome: mRS [ Time Frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest ]
    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.

  3. Neuropsychological Outcome Battery: NIH Toolbox [ Time Frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest ]
    The NIH toolbox includes cognitive testing and can be administered using an iPad

  4. Neuro Quality of Life: Neuro QoL [ Time Frame: 90 days after cardiac arrest ]
    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.

  5. Safety: Composite prevalence of 6 specified adverse events [ Time Frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065647


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Food and Drug Administration (FDA)
Physio-Control
Investigators
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Principal Investigator: Robert W Neumar, MD, PhD University of Michigan
Principal Investigator: Robert H Bartlett, MD University of Michigan
More Information
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Additional Information:

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Responsible Party: Robert Neumar, Professor and Chair, Department of Emergency Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03065647    
Other Study ID Numbers: HUM00117553
R34HL130738-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Robert Neumar, University of Michigan:
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
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Death, Sudden, Cardiac
Death, Sudden
 Heart Diseases
Cardiovascular Diseases
Death
Pathologic Processes