Clinical trial NCT03065647: ECPR for Refractory Out-Of-Hospital Cardiac Arrest
Official title: Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Food and Drug Administration (FDA)
name: Physio-Control
First posted: 2017-02-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Emergency Department Arrivals Under 30 Minutes
timeFrame: Measured within one hour cardiac arrest onset
measure: ECPR Initiations Under 30 Minutes
timeFrame: Measured within 2 hours of cardiac arrest onset
Secondary outcomes:
Other outcomes:
measure: Functional Neurological Outcome: CPC
timeFrame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
measure: Functional Neurological Outcome: mRS
timeFrame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
measure: Neuropsychological Outcome Battery: NIH Toolbox
timeFrame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
measure: Neuro Quality of Life: Neuro QoL
timeFrame: 90 days after cardiac arrest
measure: Safety: Composite Prevalence of 6 Specified Adverse Events
timeFrame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Robert W Neumar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Robert H Bartlett, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.