Outcomes From Tranexamic Acid (TXA) in Traumatic Intracranial and Torso Hemorrhage: A Prospective Cohort Study in a High Trauma, Austere, Prolonged Care Setting
Abstract
Purpose: The overarching purpose of this study is to compare the morbidity and mortality of patients who receive TXA (administered within the first 24 hours post-injury) versus comparably injured patients who do not receive TXA. We will conduct this research in a real-world, military-relevant, prolonged care setting with a high incidence of severe polytrauma resulting in head and torso hemorrhage. Findings will help fill evidence gaps that can directly inform Clinical Practice Guidelines in both military and civilian contexts. Significance: The most frequent cause of avoidable deaths is trauma associated hemorrhagic shock, with hyperfibrinolysis having been identified as an independent predictor of mortality. There is evidence that 25-35 percent of trauma patients with severe physical injuries undergo coagulopathy of some form early in the event, which further contributes to the lethal triad of death. Coagulopathy is associated with as high as a four-fold greater risk of post-injury mortality. TXA is known to inhibit fibrin cleavage thus reducing the risk of hemorrhage and post-injury death. The rationale for our primary aim hypothesized 7 percent reduced mortality due to TXA is primarily based on prior observational studies of both (military and civilian) head and trauma populations which included patients at risk for major bleeding, defined similarly to the CRASH studies e.g., Luehr et al., 2017 (7 percent mortality improvement at 24-hours; p=0.007); Walker et al., 2020(6.5 percent absolute 48-hour mortality reduction in combat injured; p=0.03). Findings from those observational studies appear more applicable to our proposed TXA study in contrast to findings from randomized clinical trials (e.g., CRASH-2 [2017], 1.5 percent reduction in mortality, p less than 0.01; and STAAMP [2020], 1.8 percent, p=0.17). As noted by a recent systematic review, it remains unclear if administration of TXA is associated with thromboembolic complications.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2023
- Accession Number
- AD1221144
Entities
People
- Nee-Kofi Mould-Millman
Organizations
- University of Colorado Boulder