Neumar wins NIHLBI grant for EROCA study

Robert Neumar, MD, PhD and Robert Bartlett, MD were recently awarded a $697,500 NIHLBI grant to study alternative treatment strategies for patients with out-of-hospital cardiac arrest.

According to the Sudden Cardiac Arrest Foundation, sudden cardiac arrest (SCA) is a leading cause of death among adults over the age of 40 in the United States and other countries. In the U.S. alone, approximately 326,200 people of all ages experience EMS-assessed out-of-hospital non-traumatic SCA each year and nine out of ten die.  

The current treatment for out-of-hospital SCA is to perform CPR and advanced cardiovascular life support at the scene until the heart is restarted or resuscitation efforts are deemed hopeless and are discontinued. However, Drs. Neumar and Bartlett are interested in promising new experimental strategies that are only possible at the hospital.

One alternative strategy is extracorporeal cardiopulmonary resuscitation or ECPR. ECPR requires placement of catheters (tubes) in large blood vessels and a machine to take over the work of the heart and lungs until the heart can be restarted. The purpose of the study is to examine the feasibility and potential benefit of early transport of out-of-hospital cardiac arrest patients with ongoing CPR to an ECPR-capable emergency department.  

The study, called Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA) will enroll adult sudden cardiac arrest patients in the city of Ann Arbor who do not recover after initial attempts of CPR and ACLS at the scene. Patients will be randomized to either standard care or early transport (investigational). Although ECMO has been used for decades, the Food and Drug Administration (FDA) considers it investigational in cardiac arrest treatment. 
This study meets FDA’s ruling of Exception From Informed Consent (EFIC) where patients will be enrolled in the study without consent.  The use of EFIC is limited to situations where a person’s life is at risk, the best treatment is not known, and the study might help the person and it is not possible to get permission from the person because of their medical condition nor from the person’s guardian because there is a very short amount of time required to treat the medical problem.  Once the patient is able and/or family/legal representative is located, they will be notified of study enrollment and asked to continue participation.

For more information or ways to contact the study team, visit the study’s website.