Efficacy and Safety of Postoperative Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Prospective Randomized Controlled Study

OBJECTIVE: To assess the efficacy and safety of postoperative intravenous tranexamic acid (TXA) in patients undergoing total knee arthroplasty (TKA). METHODS: From March 2020 to August 2020, all patients undergoing primary unilateral TKA in our hospital were considered in prospective randomized controlled study. Included patients were randomized into three groups to receive either two doses of 15 mg/kg intravenous TXA postoperatively, at 2 and 24 h after closing the incision (group A), or a single dose of 15 mg/kg intravenous TXA 2 h postoperatively (group B), or placebo (group C). The calculated total blood loss (TBL) and hidden blood loss (HBL), incidence of venous thromboembolism (VTE), and transfusion rate were compared among groups. The levels of prothrombotic state parameters including thrombomodulin (TM), thrombin‐anti‐thrombin complex (TAT), plasmin‐anti‐plasmin complex (PIC), and tissue‐type plasminogen activator‐plasminogen activator inhibitor complex (t‐PAI·C) in plasma were measured during the perioperative period. Patients were compared depending on the Kellgren‐Lawrence classification (K‐L types III and IV). RESULTS: All patients were followed up for at least 4 weeks. The mean TBL and HBL in group C (1,182.45 ± 160.50; and 965.47 ± 139.61 mL, respectively) were significantly higher than those in groups A (944.34 ± 130.88 mL, P < 0.05; and 712.45 ± 129.82mL, P < 0.05, respectively) or B (995.20 ± 154.00 mL, P < 0.05; and 757.20 ± 134.39 mL, P < 0.05, respectively), but no significant differences were found between groups A and B (P > 0.05 and P > 0.05, respectively). None of the patients of three groups received blood transfusion, so there were no significant differences in blood transfusion rate among groups. Similar results were obtained with subgroups of patients who had the K‐L types III and IV. The DVT frequencies were four, three, and three in groups A, B, and C, respectively, with no significant differences after comparison (P > 0.05). There were no significant differences in the levels of prothrombotic state parameters (TM, TAT, PIC, t‐PAI·C) or incidence of VTE among groups (P > 0.05). Wound leakage was observed in five patients during the hospital stay (two patients in group A, one patient in group B, and two patients in group C), and no statistical difference was found in wound leakage or other complications among groups (P > 0.05). CONCLUSIONS: Short‐term application of postoperative intravenous TXA in TKAs resulted in reduced HBL without a measured increase in the actual incidence of VTE or the potential risk of thrombosis, but administration of TXA after the first 24 h had no significant effect.