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Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT)
Final addendum 26 Sep 2014-25 Sep 2015
PITTSBURGH UNIV PA
Pagination or Media Count:
During this seventh year of the project, we were open for enrollment at the University of Pittsburgh until January, 2015, when the cardiac surgeon involved in the project left the University. We therefore suspended enrollment until he can be replaced. During the time the study was open, no appropriate candidates were identified. The investigators discussed ways to expand the eligibility criteria for the study. It was felt that patients who arrive at the hospital with a pulse, but then develop cardiac arrest in the operating room, rather than in the emergency department, represent an appropriate patient population to be included. The Data and Safety Monitoring Board, as well as the Food and Drug Administration, have agreed to this change in the protocol. At the University of Maryland, the IRB asked the study team to submit the proposal as a new project because of changes to the protocol and Dr. Tisherman s conflict of interest. The conflict of interest was vetted with the University s Conflict of Interest Officer. The plan for management of the conflict used at the University of Pittsburgh was adopted. The IRB has approved the community consultation, public disclosure process. Community consultation and training for the trauma surgeons involved in the project are scheduled to begin in October. To better understand the patient population for this study, we have initiated a retrospective study of trauma patients who suffered a cardiac arrest and underwent a thoracotomy in the Trauma Resuscitation Unit of the Shock Trauma Center.
APPROVED FOR PUBLIC RELEASE