Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury
Technical Report,22 Sep 2014,21 Sep 2015
Washington University St. Louis United States
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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.