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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
Intravenous 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.
Intravenous 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.
Intravenous 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.
Department of Orthopaedics, West China Hospital, SIchuan University
Chengdu, Si'Chuan, China
RECRUITINGTotal 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.
Time frame: The 3rd day after surgery
Occult blood loss
Occult blood loss = Total blood loss - Intraoperative blood loss (no drainage tube is placed postoperatively)
Time frame: The 3rd day after surgery
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.
Time frame: The first day after surgery
Allogeneic blood transfusion rate
Time frame: The 3rd day after surgery
Allogeneic blood transfusion volume
Time frame: The 3rd day after surgery
Changes in hemoglobin levels from baseline
Time frame: The 3rd day after surgery
Changes in hematocrit levels from baseline
Time frame: The 3rd day after surgery
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