Actively Recruiting
Study on BT-114143 Reducing Perioperative Bleeding in Total Knee Arthroplasty（TKA）
Led by ScinnoHub Pharmaceutical Co., Ltd. · Updated on 2025-12-15
270
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on BT-114143 Reducing Perioperative Bleeding in Total Knee Arthroplasty（TKA）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-70 years, regardless of gender (including boundary values)
- Diagnosed with osteoarthritis meeting American College of Rheumatology criteria
- Scheduled for unilateral total knee arthroplasty
- American Society of Anesthesiologists (ASA) physical status classification Grade 3 or better
- Mild knee deformity: flexion deformity less than 20, varus deformity less than 15
- No abnormalities in preoperative platelet level and coagulation function
- Body Mass Index (BMI) within 20.0-35.0 kg/m
- Voluntarily signed informed consent form
You will not qualify if you...
- Uncontrolled systemic or local infections such as pulmonary, skin, or urinary tract infections
- Serum albumin concentration less than 35 g/L
- Preoperative hemoglobin less than 110 g/L
- History of severe venous thromboembolism or high risk indicated by lower extremity ultrasound
- Severe cardiovascular or cerebrovascular diseases within 6 months before screening
- Severe varicose veins or peripheral arterial diseases affecting distal blood supply
- Cancer within 5 years before screening except cured skin basal cell carcinoma
- Poorly controlled hypertension or requiring combined use of certain diuretics
- Poorly controlled diabetes with fasting blood glucose above 8 mmol/L
- Known severe allergic reactions affecting study evaluation or allergy to tranexamic acid
- Previous open knee surgery on the same knee (arthroscopic surgery allowed)
- Planned other surgeries within 1 month including simultaneous bilateral knee replacement
- Severe liver or kidney dysfunction as defined by eGFR or liver enzyme levels
- Positive for hepatitis B, hepatitis C, HIV, or syphilis during screening
- Use of drugs affecting coagulation or with bleeding/thrombosis risk within 1 week before surgery
- Use of drugs increasing hemoglobin within 4 weeks before screening
- Recent use of iron supplements within specified time frames
- Mental or neurological diseases, drug abuse history, alcoholism exceeding 14 standard units per week
- Participation in other clinical trials with intervention within 3 months before screening
- Pregnant or lactating women or patients unable to use contraception during study and 3 months after
- Investigator judgment deeming patient unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Orthopaedics, West China Hospital, SIchuan University
Chengdu, Si'Chuan, China, 37 Guoxuexiang
Actively Recruiting
Research Team
F
Fuxing Pei, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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