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OpenTrials
Completed

NCT Number: NCT03065647

ECPR for Refractory Out-Of-Hospital Cardiac Arrest

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.

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Key information

Conditions

Cardiac Arrest CPR Cardiopulmonary Arrest Cardiopulmonary Resuscitation Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Extracorporeal Cardiopulmonary Resuscitation Extracorporeal Membrane Oxygenation Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Arrest

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expedited Transport With Mechanical CPR

Device

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.

Primary outcomes

  1. Emergency Department Arrivals Under 30 Minutes

    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).

  2. ECPR Initiations Under 30 Minutes

    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

Other outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EROCA

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2017
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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