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
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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
- 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
- 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.
- 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
- 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.
- 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.
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
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Robert W Neumar, MD, PhD||University of Michigan|
|Principal Investigator:||Robert H Bartlett, MD||University of Michigan|