Purpose: The objective of this prospective randomized controlled trial was to assess the efficacy and safety of simultaneous application of tranexamic acid and indirect factor Xa inhibitor following total knee arthroplasty (TKA).
Methods: Seventy-two primary osteoarthritis patients undergoing unilateral TKA using fondaparinux as a basic thromboprophylaxis were randomized to receive either placebo (36 patients) or tranexamic acid (36 patients). Prophylaxis against venous thromboembolism in all patients was administered with subcutaneous doses of 2.5 mg fondaparinux for 5 days post-operatively. Post-operative retransfusion volume, allogenic transfusion volumes and drain amount were recorded for each patient. Level of haemoglobin, prothrombin time, activated partial thromboplastin time and D-dimer were also assessed. Doppler ultrasonography was performed preoperatively and 7 days after surgery.
Results: The rate of transfusion was lower in the tranexamic acid group than in the placebo group (p = 0.007). The drained blood volume during the initial 24 h and until drain removal was smaller in the tranexamic acid group than in the placebo group (p < 0.001). However, the haematologic laboratory results did not show any significant differences between the two groups. The prevalence of deep-vein thrombosis (DVT) was 4 (11.1 %) in the placebo group and 3 (8.3 %) in the tranexamic acid group (p = n.s.). There was no proximal DVT and no symptomatic pulmonary embolism in either group.
Conclusion: The use of tranexamic acid could reduce acute blood loss significantly without any adverse effect resulted from drug interaction with concomitant use of indirect factor Xa inhibitor following TKA. Therefore, simple combination of these drugs can be recommended to reduce post-operative blood loss as well as to reduce DVT following TKA.