Abstract

A randomized, double-blind, placebo-controlled clinical trial. To evaluate the efficacy and safety of tranexamic acid (TXA) administered during the surgical correction of thoracolumbar fracture-dislocation. Thoracolumbar fracture-dislocation surgery is generally associated with substantial blood loss and a high risk of deep vein thrombosis. TXA has been shown to improve hemostasis in surgical procedures. We investigated 80 patients with thoracolumbar fracture-dislocation who underwent transforaminal thoracic interbody fusion between March 2014 and December 2016. The patients were randomized into the TXA (n = 39) and Placebo (n = 41) groups, according to whether they did or did not receive pre- and intraoperative TXA treatment. The two groups were compared for demographic characteristics as well as pre- and postoperative levels of prethrombosis-state molecular markers and visible and hidden blood loss volumes. Additionally, the prevalence of TXA-related complications was determined. The two groups did not differ significantly in demographic characteristics. The visible blood loss (intra- and postoperative bleeding during the first 24 h), hidden blood loss, and true total blood loss during surgery in the TXA group were significantly lower than those in the Placebo group (835 ± 180.3 mL, 351 ± 82.3 mL, 1385 ± 102.3 mL vs. 1155 ± 175.3 mL, 564 ± 170.5 mL, 1683 ± 121.0 mL, respectively; P < 0.01). Furthermore, the levels of the prethrombosis-state molecular markers GMP-140, fibrinogen, fibrin degradation products, and D-dimer were higher in the TXA group than in the Placebo group, although the differences were not significant (P > 0.05). No significant intergroup differences were noted in the prevalence of deep venous thrombosis and pulmonary embolus during the study period. TXA significantly reduced visible and hidden blood loss without affecting the prethrombosis-state molecular markers in transforaminal thoracic interbody fusion or causing any notable adverse effects. 3.

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