This is a randomized, double-blind, active-controlled, multicenter, phase II clinical study designed to evaluate the efficacy and safety of BT-114143 Injection in the perioperative treatment of unilateral total knee arthroplasty. It is planned to enroll 270 subjects undergoing elective unilateral open total knee arthroplasty. Subjects will be randomly assigned to the BT-114143 high-dose group, BT-114143 low-dose group, or tranexamic acid treatment group in a 1:1:1 ratio. All subjects will receive intravenous injection of BT-114143 or tranexamic acid before and after surgical incision. The total perioperative blood loss in different treatment groups will be evaluated.
Aged 18-70 years, regardless of gender (including boundary values);
Patients with osteoarthritis who meet the diagnostic criteria of the American College of Rheumatology (ACR), meet the indications for knee replacement, and plan to undergo total knee arthroplasty;
American Society of Anesthesiologists (ASA) physical status classification ≤ Grade 3;
Patients with mild knee deformity: flexion deformity < 20°, varus deformity < 15°-5.No abnormalities in preoperative platelet level and coagulation function;
Uncontrolled systemic or local infections, including but not limited to pulmonary infection, skin infection, urinary tract infection, etc.;
Serum albumin concentration < 35g/L;
Patients with preoperative hemoglobin < 110g/L;
Patients with a known history of severe venous thromboembolism or those with severe thromboembolic risk indicated by lower extremity venous ultrasound (such as popliteal vein and proximal venous thrombosis);