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

NCT07127042 | Recruiting Phase 2

• 1 other identifier: BT-114143-II-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Total 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.

  The 3rd day after surgery

Secondary Outcomes (6)

• Occult blood loss

  The 3rd day after surgery

• Total blood loss on the first day after surgery

  The first day after surgery

• Allogeneic blood transfusion rate

  The 3rd day after surgery

• Allogeneic blood transfusion volume

  The 3rd day after surgery

• Changes in hemoglobin levels from baseline

  The 3rd day after surgery

Study Arms (3)

High-dose Group

EXPERIMENTAL

High-dose BT-114143

Drug: High-dose BT-14143

Low-dose Group

EXPERIMENTAL

Low-dose BT-114143

Drug: Low-dose BT-114143

Control Group

ACTIVE COMPARATOR

Tranexamic acid

Drug: Tranexamic Acid (IV)

Interventions

Low-dose BT-114143 DRUG

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.

Low-dose Group

High-dose BT-14143 DRUG

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.

High-dose Group

Tranexamic Acid (IV) DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.);

Sponsors & Collaborators

• ScinnoHub Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Department of Orthopaedics, West China Hospital, SIchuan University

Chengdu, Si'Chuan, 37 Guoxuexiang, China

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Fuxing Pei, Master

CONTACT

028-85423426; rain_xjw@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 17, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)