RecruitingPhase 2

Study on BT-114143 Reducing Perioperative Bleeding in Total Knee Arthroplasty（TKA）

China270 participantsStarted 2025-08-27

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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; * Body Mass Index \[BMI = weight (kg)/height² (m²)\] within the range of 20.0-35.0 kg/m² (including critical values); * Patients voluntarily sign the informed consent form. Exclusion Criteria: * 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); * Patients with severe cardiovascular and cerebrovascular diseases (history of myocardial infarction, angina pectoris, stroke, epileptic seizure, subarachnoid hemorrhage, heart failure, etc. within 6 months before screening); * Patients with severe varicose veins or severe peripheral arterial diseases affecting distal bl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total blood loss

Timeframe: The 3rd day after surgery

Trial details

NCT IDNCT07127042

SponsorScinnoHub Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Fuxing Pei, Master

028-85423426 rain_xjw@yeah.net

View on ClinicalTrials.gov More Total Knee Arthroplasty trials