BT-114143 to reduce bleeding during total knee replacement

A Randomized, Double-blind, Active-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of BT-114143 Injection in Reducing Perioperative Blood Loss in Unilateral Total Knee Arthroplasty

This trial will test whether two doses of BT-114143 given before and after surgery reduce blood loss in adults having a single total knee replacement compared with standard tranexamic acid.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: ScinnoHub Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Chengdu, Si'Chuan)
• Trial ID: NCT07127042 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, active-controlled phase II trial enrolling about 270 adults undergoing elective unilateral total knee arthroplasty. Participants are randomly assigned in a 1:1:1 ratio to high-dose BT-114143, low-dose BT-114143, or intravenous tranexamic acid, with doses given before and after the surgical incision. The primary outcome is total perioperative blood loss, and safety and adverse events will be recorded throughout the perioperative period. The trial is multicenter and aims to define an effective and safe dosing strategy for BT-114143 compared with the current standard antifibrinolytic therapy.

Who should consider this trial

Good fit: Adults 18–70 years with osteoarthritis meeting ACR criteria who are planned for elective unilateral total knee arthroplasty, ASA class ≤3, BMI 20.0–35.0 kg/m², normal preoperative platelet and coagulation tests, and only mild knee deformity are ideal candidates.

Not a fit: Patients with uncontrolled infection, low serum albumin (<35 g/L), preoperative hemoglobin <110 g/L, significant coagulation or platelet abnormalities, or severe knee deformity are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, BT-114143 could lower perioperative blood loss and reduce the need for transfusions in patients having total knee replacement.

How similar studies have performed: Antifibrinolytic therapy such as tranexamic acid is well established to reduce blood loss in TKA, while BT-114143 is a novel agent with limited published clinical data.

Eligibility criteria

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 blood supply (lower extremity arterial stenosis, occlusion);
* Patients with cancer within 5 years before screening, except for cured skin basal cell carcinoma;
* Hypertensive patients with poorly controlled blood pressure (SBP ≥ 140mmHg and/or DBP ≥ 90mmHg), or those requiring combined use of thiazide diuretics, loop diuretics, potassium-sparing diuretics, etc;
* Patients with poorly controlled diabetes (fasting blood glucose \> 8 mmol/L);
* Patients with known severe history of allergic reactions that may affect the evaluation of the study, or those allergic to tranexamic acid and its similar drugs;
* Patients who have undergone open knee surgery on the ipsilateral knee (arthroscopic surgery is allowed);
* Patients planning to undergo other surgeries within 1 month (including simultaneous bilateral total knee arthroplasty);
* Patients with combined severe liver or kidney dysfunction (eGFR \< 60 mL/min/1.73 m², ALT and/or AST \> 2 times the upper limit of normal range);
* Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antigen/antibody, or syphilis antibody during screening;
* Patients who have used drugs affecting coagulation function within 1 week before surgery (such as aspirin, clopidogrel, ticlopidine, dipyridamole, ginkgo biloba preparations, heparin, warfarin, citrate, hemocoagulase, vitamin K, antifibrinolytic agents, etamsylate, etc.);
* Patients who have used drugs with risks of bleeding and thrombosis within 1 week before surgery, such as oral contraceptives, estrogens, or prothrombin complex concentrates;
* Patients who have used drugs that can increase hemoglobin levels (such as erythropoietin, EPO) within 4 weeks before screening;
* 1-Patients who have taken iron supplements within 1 week before surgery or used intravenous iron supplements within 4 weeks before surgery.
* Patients with mental or neurological diseases, a history of drug abuse, or a history of alcoholism that, in the investigator's opinion, could affect their -participation in the study,specifically, those who consumed more than 14 standard units of alcohol per week within 3 months before screening (1 standard unit equals 14g of alcohol, such as 360ml of beer, 45ml of spirits with 40% alcohol content, or 150ml of wine);
* Patients who have participated in or are currently participating in other clinical trials within 3 months before screening (participation in a clinical trial is defined as the patient receiving an intervention);
* Pregnant or lactating women, or patients of childbearing potential who cannot ensure the use of at least one acceptable form of contraception during the study and for 3 months after the end of the study;
* Patients whom the investigator deems unsuitable for participation in this clinical trial.

Where this trial is running

Chengdu, Si'Chuan

• Department of Orthopaedics, West China Hospital, SIchuan University — Chengdu, Si'Chuan, China (Recruiting)

Study contacts

• Study coordinator: Fuxing Pei, Master

Conditions Total Knee Arthroplasty