ECPR for Refractory Out-Of-Hospital Cardiac Arrest

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Expedited Transport With Mechanical CPR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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