ECPR for Refractory Out-Of-Hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

— EROCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065647
• Other study ID #: HUM00117553
• Secondary ID: R34HL130738-01A1
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: March 5, 2020

Study information

• Verified date: May 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Arrest
• Cardiopulmonary Resuscitation
• CPR
• Death, Sudden
• Death, Sudden, Cardiac
• Extracorporeal Cardiopulmonary Resuscitation
• Extracorporeal Membrane Oxygenation
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Sudden Cardiac Arrest

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Food and Drug Administration (FDA), National Heart, Lung, and Blood Institute (NHLBI), Physio-Control

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Neurological Outcome: CPC	Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Other	Functional Neurological Outcome: mRS	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.	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Other	Neuropsychological Outcome Battery: NIH Toolbox	The NIH toolbox includes cognitive testing and can be administered using an iPad	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Other	Neuro Quality of Life: Neuro QoL	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.	90 days after cardiac arrest
Other	Safety: Composite Prevalence of 6 Specified Adverse Events	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.	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Primary	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
Primary	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

External Links

•   EROCA Study Website