Tranexamic Acid Mechanisms and Pharmacokinetics In Traumatic Injury
Abstract
Our major accomplishments during the third year of the study include attainment of FDA IND renewal approval, successful execution and completion of training all study team members for the clinical, data collection/entry, and laboratory procedures for the trial. We obtained WU IRB and DoD HRPO continuing approval of the study. The DSMB continued to meet quarterly to review safety data for study participants. Finally, we enrolled 100% of the expected total enrollment of 150 patients. PK and PK sample analyses have been performed on 100 participants and the immunology, PK, and data analyses are currently under way.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2017
- Accession Number
- AD1048464
Entities
People
- Grant V. Bochicchio
- Philip C Spinella
Organizations
- Washington University in St. Louis