Osteoarthritis
Conditions
Interventions
Low Dose Group:Intravenous infusion of BT-114143 injection at a dose of 5 mg/kg will be administered 10–15 minutes before skin incision, followed by a 50-mL normal saline infusion administered at 3 ho
High Dose Group:Intravenous infusion of BT-114143 injection at a dose of 15 mg/kg will be administered 10–15 minutes before skin incision, followed by a 50-mL normal saline infusion administered at 3
Control Group:Intravenous infusion of TXA at a dose of 20 mg/kg will be administered 10-15 minutes before skin incision, and intravenous infusion of TXA at a dose of 1 g shall be administered at 3 hou
Sponsors
West China Hospital, Sichuan university
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 70 years old (inclusive), regardless of gender. 2.Patients with osteoarthritis meeting the diagnostic criteria of the American College of Rheumatology (ACR), with indications for knee arthroplasty, and planned for total knee replacement. 3.American Society of Anesthesiologists (ASA) physical status classification <= grade 3. 4.Patients with mild knee deformity, flexion deformity < 20°, varus deformity < 15°, and valgus deformity < 10°. 5.Normal preoperative platelet level and coagulation function. 6.Body mass index [BMI = weight (kg)/height² (m²)] within the range of 18.5 to 35.0 kg/m^2 (inclusive). 7.Patients who voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Uncontrollable infection systemically or locally, including but not limited to pulmonary infection, skin infection, urinary tract infection, etc. 2.Serum albumin concentration = 140 mmHg and/or diastolic blood pressure (DBP) >= 90 mmHg), or requiring concomitant use of thiazide diuretics, loop diuretics, potassium-sparing diuretics, etc. 9.Poorly controlled diabetic patients (fasting blood glucose > 10 mmol/L). 10.History of severe allergies affecting study evaluation, or allergy to tranexamic acid and its analogs. 11.Previous open knee surgery on the same side (arthroscopic surgery is permitted). 12.Planning to undergo other surgeries within 1 month (including simultaneous bilateral total knee arthroplasty). 13.Patients with hepatic or renal insufficiency (eGFR 2 times the upper limit of normal range). 14.Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antigen/antibody, or syphilis antibody during the screening period. 15.Patients who used drugs affecting coagulation function (such as aspirin, clopidogrel, ticlopidine, dipyridamole, ginkgo biloba preparations, heparin, warfarin, citrate, hemocoagulase, vitamin K, antifibrinolytics, etamsylate, etc.) within 1 week before surgery. 16.Patients who used drugs with the risk of causing bleeding and thrombosis within 1 week before surgery, such as oral contraceptives, estrogen, or prothrombin complex concentrates, etc. 17.Patients who used drugs increasing hemoglobin levels (such as erythropoietin (EPO)) within 4 weeks before surgery. 18.Patients who took iron supplements within 1 week before surgery or used intravenous iron within 4 weeks. 19.Presence of mental or neurological diseases that the investigator deems may affect participation in the study, or history of drug abuse or alcoholism, i.e., consuming more than 14 standard units of alcohol per week within 3 months before screening (1 standard unit = 14 g alcohol, such as 360 mL beer, 45 mL spirits with 40% alcohol content, or 150 mL wine). 20.Patients who have participated in or are currently participating in another clinical trial within 3 months before screening (the definition of participating in a clinical trial is based on the patient receiving an intervention). 21.Pregnant or lactating women, or fertile patients who cannot ensure the use of at least one acceptable contraceptive method during the study period and within 3 months after the study ends. 22.Patients who the investigator deems unsuitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Blood Loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative Blood Loss;Hidden Blood Loss;Change in Hemoglobin from Baseline;Change in Hematocrit from Baseline;Changes in Coagulation Function Indicators from Baseline;Changes in Inflammatory Markers from Baseline;Change in FDP from Baseline;Change in D-Dimer from Baseline;Change in Plasminogen Level from Baseline; | — |
Countries
China
Contacts
Public ContactPei Fuxing
Department of Orthopaedics, West China Hospital, SIchuan University
Outcome results
None listed