Efficacy of Topical Tranexamic Acid in Reducing Blood Loss after Laminectomy and Posterolateral Fusion of the Spine: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

Abstract

Background: Multi-level spine surgeries are associated with high bleeding during and after surgery. A majority of studies have previously evaluated the effect of tranexamic acid (TXA) in reducing bleeding with a focus on intravenous (IV) administration. The aim of the study was to evaluate the efficacy of topical TXA in decreasing bleeding after laminectomy and spinal fusion.
 Methods: In this randomized, double-blinded, placebo-controlled clinical trial, 80 patients were enrolled from January 2017 to January 2019. The patients were eligible for laminectomy (2 or more levels) and posterolateral fusion with a pedicle screw. Patients were randomly divided into two equal groups; single-dose TXA (1 g/50 ml) and normal saline. Intergroup comparison was performed for the amount of bleeding during and after surgery, received packed cells, and the number of hospitalization days.
 Results: The mean age of the patients was 55.51 ± 10.27 years, and 50 of them were women. 18 and 20 patients in control and TXA groups had intraoperative bleeding more than 400 ml, respectively (P ˃ 0.05). The only significant difference was observed in the first and second 12 hours, and total bleeding after surgery in patients who had bleeding above 400 ml (P = 0.011, P = 0.039, P = 0.015, respectively).
 Conclusion: The application of topical TXA was effective in patients with high amount of hemorrhage during spine surgery for reducing the bleeding rate in the first and second 12 hours, as well as the mean total bleeding rate after surgery. It had no significant effect on total intraoperative hemorrhage, total packed cells, and total hospitalization length.