ECPR for Refractory Out-Of-Hospital Cardiac Arrest

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

Interventions

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Food and Drug Administration (FDA)

  collaborator FED

• Physio-Control

  collaborator INDUSTRY

• University of Michigan

  lead OTHER

Principal Investigators

• Robert W Neumar, MD, PhD · University of Michigan

• Robert H Bartlett, MD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-01

Primary Completion

2020-03-05

Completion

2020-03-05

FDA Device

Yes

Countries

• United States

Study Locations