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);
Parallel
Low-dose BT-114143
DrugIntravenous infusion of BT-114143 Injection is started 10-15 minutes before skin incision at a Low-dose BT-114143, and 50mL of normal saline is administered intravenously 3 hours (±10 minutes) after the end of the surgery.
High-dose BT-14143
DrugIntravenous infusion of BT-114143 Injection is started 10-15 minutes before skin incision at a High-dose BT-114143, and 50mL of normal saline is administered intravenously 3 hours (±10 minutes) after the end of the surgery.
Tranexamic Acid (IV)
DrugIntravenous infusion of TXA is started 10-15 minutes before skin incision at a dose of 20mg/kg, and intravenous infusion of TXA is initiated 3 hours (±10 minutes) after the end of the surgery at a dose of 1g.
Total blood loss
The blood loss was calculated using the Gross formula based on changes in hematocrit (HCT) from the subjects' preoperative and postoperative blood routine tests.
Occult blood loss
Occult blood loss = Total blood loss - Intraoperative blood loss (no drainage tube is placed postoperatively)
Total blood loss on the first day after surgery
The blood loss was calculated using the Gross formula based on changes in hematocrit (HCT) from the subjects' preoperative and postoperative blood routine tests.
Allogeneic blood transfusion rate
Allogeneic blood transfusion volume
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