Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT)
Abstract
During this fourth year of the project our efforts have continued to focus on the regulatory aspects of this clinictrial. We had already successfully obtained an Investigational Device Exemption from the FDA Center for Devices and Radiological Health Office of Device Evaluation and approval of the proposal from the University of Pittsburgh and University of Maryland Institutional Review Boards (IRB) for study enrollment, pending community consultation and public disclosure. We have initiated this process in Pittsburgh. We met with the Pittsburgh Human Relations Commission. They made suggestions regarding the involvement of minorities in the community consultation process. We have placed a survey instrument in traumclinic and developed a phone survey for the community to comment on the study. We have also developed a simulation training methodology for implementing EPR. The Independent Data Safety and Monitoring Board conducted its annual meetiby conference call in December, 2010. We have completed the paperwork for the USAMRMC Human Research Protection Office to proceed with the formal Department of the Army review.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2011
- Accession Number
- ADA554229
Entities
People
- Patrick M. Kochanek
- Samuel A. Tisherman
Organizations
- University of Pittsburgh