Safety and Feasibility of Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT)
Abstract
During this fourth year of the project, we have remained on clinical hold because of concerns about the local blood supply due to the COVID-19 pandemic. In addition, the FDA has raised concerns about whether or not the study meets the requirements for the Exception from Informed Consent for emergency research. Specifically, they are not convinced that EPR provides the potential for benefit for individual subjects based upon the current data, which includes only 6 EPR subjects and 5 controls. We have submitted 2 written responses to their concerns and held a video conference with them to clarify the issues. They have now asked for a comprehensive report of the background of the study, the clinical data, our response to the unexpected clotting issues, and our explanation for why we believe the study should continue. This report, along with some additional background information they requested, will be reviewed by their Exception from Informed Consent panel. This panel has not yet been involved in the EPR review by the FDA. Stroger Hospital of Cook County has received approval for the study from their IRB and the Army HRPO. Given the issues noted above, we have held off on moving forward with training or enrollment at Stroger Hospital of Cook County.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2022
- Accession Number
- AD1190998
Entities
People
- Samuel A. Tisherman
Organizations
- University of Maryland, Baltimore