ECPR for Refractory Out-Of-Hospital Cardiac Arrest



Status:Enrolling by invitation
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 70
Updated:5/13/2018
Start Date:May 1, 2017
End Date:December 2019

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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.

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.

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
We found this trial at
1
site
Ann Arbor, Michigan 48109
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mi
from
Ann Arbor, MI
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