Safety and Feasibility of Emergency Preservation and Resuscitation for Cardiac Arrest From Trauma (EPR-CAT)
Abstract
During this fifth year of the project, we have remained on clinical hold because of concerns about the local blood supply due to the COVID-19 pandemic. The supply has now improved. In addition, the FDA raised concerns about whether or not the study meets the requirements for the Exception from Informed Consent for emergency research. Specifically, they were not convinced that EPR provides the potential for benefit for individual subjects based upon the current data, which includes only 6EPR subjects and 5 controls. We have submitted written responses to their concerns and held two video conference calls with them to clarify the issues. We provided 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. We also made 2 evidence-based changes to the protocol to improve the potential for benefit for the individual subjects. First, we will only cool to 18o C. Second, we will administer whole blood as the last blood products when coming off cardiopulmonary bypass.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2023
- Accession Number
- AD1217457
Entities
People
- Faran Bokhari
- Leslie Sult
- Samuel A. Tisherman
- Thomas Scalea
Organizations
- University of Maryland, Baltimore