EROCA: ECPR for Refractory Out-Of-Hospital Cardiac Arrest

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03065647
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), Food and Drug Administration (FDA) (U.S. Fed), Physio-Control (Industry)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 34.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: Mar 5, 2020
• Actual Study Completion Date: Mar 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Emergency Department Arrivals Under 30 Minutes [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).

2. ECPR Initiations Under 30 Minutes [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

Other Outcome Measures

1. Functional Neurological Outcome: CPC [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

2. Functional Neurological Outcome: mRS [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.

3. Neuropsychological Outcome Battery: NIH Toolbox [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

4. Neuro Quality of Life: Neuro QoL [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.

5. Safety: Composite Prevalence of 6 Specified Adverse Events [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Hospital	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Robert W Neumar, MD, PhD, University of Michigan
• Principal Investigator: Robert H Bartlett, MD, University of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 15, 2019

More Information

Additional Information:

• EROCA Study Website

Publications

None provided.

• Responsible Party: Robert Neumar, Professor and Chair, Department of Emergency Medicine, University of Michigan
• ClinicalTrials.gov Identifier: NCT03065647
• Other Study ID Numbers: HUM00117553; R34HL130738-01A1
• First Posted: Feb 28, 2017
• Last Update Posted: Jun 3, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Robert Neumar, Professor and Chair, Department of Emergency Medicine, University of Michigan: 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
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac; Death, Sudden

Study Results

Participant Flow

Arm/Group Title	Standard Care	Expedited Transport
Arm/Group Description	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.	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). 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.
Period Title: Overall Study
STARTED	3	12
COMPLETED	3	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard Care	Expedited Transport	Total
Arm/Group Description	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.	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). 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.	Total of all reporting groups
Overall Participants	3	12	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (3)	62 (8)	62 (7)
Sex: Female, Male (Count of Participants)
Female	1 33.3%	4 33.3%	5 33.3%
Male	2 66.7%	8 66.7%	10 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 8.3%	1 6.7%
White	3 100%	9 75%	12 80%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 16.7%	2 13.3%
Initial cardiac rythm (Count of Participants)
Ventricular fibrilation	3 100%	5 41.7%	8 53.3%
Witnessed pulseless electrical activity (PEA)	0 0%	4 33.3%	4 26.7%
Witnessed asystole	0 0%	3 25%	3 20%
Bystander CPR (Count of Participants)
Count of Participants [Participants]	3 100%	10 83.3%	13 86.7%
Cardiac Arrest Locaion (participants) [Number]
Home	2 66.7%	10 83.3%	12 80%
Public Location	1 33.3%	2 16.7%	3 20%

Outcome Measures

1. Primary Outcome

Title	Emergency Department Arrivals Under 30 Minutes
Description	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).
Time Frame	Measured within one hour cardiac arrest onset

Outcome Measure Data

Analysis Population Description

Standard care participants received EMS protocols at the scene, and thus were not included in this analysis

Arm/Group Title	Standard Care	Expedited Transport
Arm/Group Description	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.	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). 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.
Measure Participants	0	12
Count of Participants [Participants]	5 166.7%

2. Primary Outcome

Title	ECPR Initiations Under 30 Minutes
Description	Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival
Time Frame	Measured within 2 hours of cardiac arrest onset

Outcome Measure Data

Analysis Population Description

Analysis includes participants eligible for ECPR.

Arm/Group Title	Standard Care	Expedited Transport
Arm/Group Description	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.	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). 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.
Measure Participants	0	5
Count of Participants [Participants]	3 100%

3. Other Pre-specified Outcome

Title	Functional Neurological Outcome: CPC
Description	Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome
Time Frame	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	Functional Neurological Outcome: mRS
Description	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.
Time Frame	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

Title	Neuropsychological Outcome Battery: NIH Toolbox
Description	The NIH toolbox includes cognitive testing and can be administered using an iPad
Time Frame	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Neuro Quality of Life: Neuro QoL
Description	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.
Time Frame	90 days after cardiac arrest

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Safety: Composite Prevalence of 6 Specified Adverse Events
Description	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.
Time Frame	At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Participants were followed for 90 days after intervention
Arm/Group Title	Standard Care		Expedited Transport
Arm/Group Description	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.		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). 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.
All Cause Mortality
	Standard Care		Expedited Transport
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		12/12 (100%)
Serious Adverse Events
	Standard Care		Expedited Transport
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		6/12 (50%)
Blood and lymphatic system disorders
Hemorrhagic Shock	0/3 (0%)		1/12 (8.3%)
Cardiac disorders
Failure to establish circuit blood flow	0/3 (0%)		1/12 (8.3%)
Ventricular Fibrillation/Ventricular Tachycardia	0/3 (0%)		1/12 (8.3%)
Cardiogenic Shock	0/3 (0%)		2/12 (16.7%)
Non ST Elevation Myocardial Infarction (NSTEMI)	0/3 (0%)		1/12 (8.3%)
Hemopericardium	0/3 (0%)		1/12 (8.3%)
Gastrointestinal disorders
Gastrointestinal Hemorrhage	0/3 (0%)		1/12 (8.3%)
Hepatobiliary disorders
Acute Liver Injury	0/3 (0%)		1/12 (8.3%)
Infections and infestations
Tracheal aspirate - Methicillin-sensitive Staphylococcus aureus (MSSA)	1/3 (33.3%)		0/12 (0%)
Nervous system disorders
Hemoperitoneum	0/3 (0%)		1/12 (8.3%)
Anoxic brain injury	2/3 (66.7%)		2/12 (16.7%)
Ischemic Stroke	0/3 (0%)		1/12 (8.3%)
Renal and urinary disorders
Acute Kidney Injury (AKI)	1/3 (33.3%)		3/12 (25%)
Reproductive system and breast disorders
Presumed Moderate Acute Respiratory Distress Syndrome (ARDS)	0/3 (0%)		1/12 (8.3%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	0/3 (0%)		2/12 (16.7%)
Skin and subcutaneous tissue disorders
Ischemic Skin Necrosis	0/3 (0%)		1/12 (8.3%)
Surgical and medical procedures
Hemorrhage from cannulation site	0/3 (0%)		1/12 (8.3%)
Other (Not Including Serious) Adverse Events
	Standard Care		Expedited Transport
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.