Accession Number : AD1000688

Title :   Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury

Descriptive Note : Technical Report,22 Sep 2014,21 Sep 2015

Corporate Author : Washington University St. Louis United States

Personal Author(s) : Spinella,Philip C

Full Text :

Report Date : 01 Oct 2015

Pagination or Media Count : 11

Abstract : Our major accomplishments during the first year of the study include attainment of FDA IND approval, successful execution and completion of the community consultation process, development and validation of the laboratory methods for the trial, development of case report forms and database, attainment of Barnes Jewish Hospital Emergency Medicine Research Committee approval and WU IRB approval of the study pending minor contingencies. In addition, we have worked with Investigational Drug Pharmacy to plan for randomization, study drug preparation and dispensing procedures, and un-blinding procedures (in case of a safety concern). We have developed a process for our Vascular Surgery colleagues to schedule the lower extremity duplexes being performed for this study. Finally, we have established a DSMB and DSMB charter.

Descriptors :   Trauma , wounds and injuries , Hemorrhage , Blood transfusion , Fibrinolysis , Immunosuppression , Pharmacokinetics , Adverse conditions , clinical trials , Blood plasma , Drug testing

Distribution Statement : APPROVED FOR PUBLIC RELEASE