Prehospital Tranexamic Acid Use for Traumatic Brain Injury

Abstract

Abstract : The primary aim is to determine the efficacy (comparing 6 month GOSE) of two dosing regimens of TXA initiated in the pre-hospital setting in patients with moderate to severe TBI (GCS score 3-12).The first year has been spent in preparation for study implementation including approvals by the ROC Protocol Review Committee and Data, Safety Monitoring Board, as well as obtaining an FDA IND and Health Canada CTA. The documents for the first site approval were sent to HRPO on June 19, 2014 and final approval by the Sec. Army is still pending. The blinded study drugs were manufactured and packaged into study kits. A web data entry system to collect the patient data and check for errors (and a detailed Manual of Operations) is being beta tested. An inventory management system to track the study kits and lab/CT/MRI scan data is ready. Training materials have been finalized in order to train the EMS and hospital staff on the study. Ten of 12 sites have submitted the protocol for IRB approval and are either conducting community consultation or have completed it. Five sites have final approval and await HRPO approval before training their EMS and hospital staff.