Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT)
Abstract
During this second year of the project our efforts have continued to focus on the regulatory aspects of this complex clinical trial. We communicated directly with regulatory experts in the US Army and the US Food and Drug Administration (FDA). We have successfully obtained an Investigational Device Exemption from the FDA Center for Devices and Radiological Health Office of Device Evaluation. We subsequently received approval of the proposal from the University Pittsburgh Institutional Review Board (IRB) as the coordinating center for the trial. The local investigators at the University of Maryland have submitted the proposal to their IRB. They are in the process of responding to questions raised by the IRB, particularly about their plans for community consultation and public disclosure. We have formed the Data Safety and Monitoring Board for this trial. In December, 2008, we conducted the first training session for EPR at the University of Maryland. We have collected retrospective data on trauma patients who underwent emergency department thoracotomies in order to develop the most appropriate inclusion and exclusion criteria for subject selection for this trial. So far, this data has not yielded novel information to revise our protocol.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2009
- Accession Number
- ADA606302
Entities
People
- Patrick M. Kochanek
- Samuel A. Tisherman
Organizations
- University of Pittsburgh