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New drug aims to cut bleeding in knee replacements

NCT ID NCT07127042

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called BT-114143 to see if it can reduce blood loss during knee replacement surgery better than a standard treatment. About 270 adults with osteoarthritis who need a knee replacement will take part. Participants will receive either a high or low dose of BT-114143 or the standard drug tranexamic acid before and after surgery, and their total blood loss will be measured.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Orthopaedics, West China Hospital, SIchuan University

    RECRUITING

    Chengdu, Si'Chuan, 37 Guoxuexiang, China

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