Accession Number:

AD1048464

Title:

Tranexamic Acid Mechanisms and Pharmacokinetics In Traumatic Injury

Descriptive Note:

Technical Report,15 Sep 2016,14 Sep 2017

Corporate Author:

Washington University Saint Louis United States

Report Date:

2017-10-01

Pagination or Media Count:

10.0

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 collectionentry, 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.

Subject Categories:

  • Medicine and Medical Research
  • Pharmacology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE