ECPR for Refractory Out-Of-Hospital Cardiac Arrest

NCT03065647 | Completed Results DMC FDA Device

• 2 other identifiers: HUM00117553R34HL130738-01A1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest; Heart Arrest; Sudden Cardiac Arrest; Cardiopulmonary Arrest; Death, Sudden, Cardiac; Cardiopulmonary Resuscitation; CPR; Extracorporeal Cardiopulmonary Resuscitation; Extracorporeal Membrane Oxygenation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (5)

• Functional Neurological Outcome: CPC

  At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest

• Functional Neurological Outcome: mRS

  At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest

• Neuropsychological Outcome Battery: NIH Toolbox

  At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest

Study Arms (2)

Standard Care

NO INTERVENTION

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.

Expedited Transport

EXPERIMENTAL

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

Interventions

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.

Expedited Transport

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Hsu CH, Meurer WJ, Domeier R, Fowler J, Whitmore SP, Bassin BS, Gunnerson KJ, Haft JW, Lynch WR, Nallamothu BK, Havey RA, Kidwell KM, Stacey WC, Silbergleit R, Bartlett RH, Neumar RW. Extracorporeal Cardiopulmonary Resuscitation for Refractory Out-of-Hospital Cardiac Arrest (EROCA): Results of a Randomized Feasibility Trial of Expedited Out-of-Hospital Transport. Ann Emerg Med. 2021 Jul;78(1):92-101. doi: 10.1016/j.annemergmed.2020.11.011. Epub 2021 Feb 1.

  PMID: 33541748 DERIVED

Related Links

• EROCA Study Website

MeSH Terms

Conditions

Heart Arrest; Death, Sudden, Cardiac; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert Neumar
• Organization: University of Michigan

neumar@umich.edu

734-936-0253

Study Officials

• Robert W Neumar, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Robert H Bartlett, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Emergency Medicine

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 28, 2017
• Study Start: May 1, 2017
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: June 3, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)