Efficacy and Safety of Tranexamic Acid Combined with Absorbable Hemostat in Reducing Perioperative Blood Loss in Total Knee Arthroplasty: A Prospective, Blinded, Randomized Controlled Trial.

Background: Tranexamic acid (TXA) and absorbable hemostat (AH) are widely used to reduce perioperative blood loss in total knee arthroplasty (TKA). However, the efficacy of single-method hemostatic strategies is increasingly insufficient for meeting clinical demands. This study tested the efficacy and safety of TXA combined with AH for perioperative blood management in TKA.

Methods: Hemostatic efficacy was preliminarily evaluated through in vitro dynamic coagulation assays, lactate dehydrogenase activity measurements, and scanning electron microscopy, as well as in vivo using a rabbit liver bleeding model. The in vivo biocompatibility was also measured. Subsequently, the efficacy and safety of TXA combined with AH were further evaluated in a prospective, blinded study involving 149 individuals who were randomized to receive TXA, AH, or TXA+AH during TKA. The primary outcomes were perioperative blood loss, blood transfusion, hemoglobin and hematocrit levels, maximum hemoglobin change, anemia, and postoperative complications. Secondary outcomes included perioperative inflammation, coagulation function, and knee joint function.

Results: Coagulation assays and the liver hemostasis model demonstrated that TXA combined with AH effectively promoted coagulation, with satisfactory biocompatibility. The clinical results of 114 Han Chinese (East Asian) patients indicated that the combination significantly reduced perioperative blood loss in TKA (564.51 ± 136.26 mL in the TXA+AH group, 879.35 ± 85.62 mL in the TXA group, and 692.70 ± 96.06 mL in the AH group; p < 0.001) without an increase in thromboembolic events or wound-related complications. Additionally, the combination accelerated early postoperative knee function recovery without significantly affecting pain scores or inflammatory markers.

Conclusions: The combination of TXA and AH effectively reduced perioperative blood loss in TKA, accelerated early patient recovery, and did not increase the rate of complications.

Level Of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.