Total Knee ArthroplastyPhase 2TKANCT07127042
Study on BT-114143 Reducing Perioperative Bleeding in Total Knee Arthroplasty（TKA）
A Phase 2 study testing Low-dose BT-114143, High-dose BT-14143 and Tranexamic Acid (IV) in people with Total Knee Arthroplasty, run by ScinnoHub Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Low-dose BT-114143, High-dose BT-14143 and Tranexamic Acid (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Orthopaedics, West China Hospital, SIchuan University
Chengdu, Si'Chuan, 37 Guoxuexiang
绍梅 曾, 02885423237, shaomei.zeng@scinnohub.com
About this study
Official title: 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 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
- Being tested
- Low-dose BT-114143, High-dose BT-14143, Tranexamic Acid (IV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose BT-114143Drug
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.
High-dose BT-14143Drug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| High-dose Group | Experimental | High-dose BT-114143 Receives: Drug: High-dose BT-14143 |
| Low-dose Group | Experimental | Low-dose BT-114143 Receives: Drug: Low-dose BT-114143 |
| Control Group | Active comparator | Tranexamic acid Receives: Drug: Tranexamic Acid (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The 3rd day after surgery
Secondary outcomes (6)
Occult blood loss
Occult blood loss = Total blood loss - Intraoperative blood loss (no drainage tube is placed postoperatively)
Measured: The 3rd day after surgery
Total blood loss on the first day after surgery
The blood loss was calculated using the Gross formula based on changes in hematocrit (HCT) from the subjects' preoperative and postoperative blood routine tests.
Measured: The first day after surgery
Allogeneic blood transfusion rate
Measured: The 3rd day after surgery
Allogeneic blood transfusion volume
Measured: The 3rd day after surgery
Changes in hemoglobin levels from baseline
Measured: The 3rd day after surgery
Changes in hematocrit levels from baseline
Measured: The 3rd day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start27 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127042
- Sponsor's protocol ID
- BT-114143-II-01
- Acronym
- TKA
- Status last verified
- Dec 2025
- First submitted
- 18 Jul 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07127042
- Acronym / sponsor ID
- TKA / BT-114143-II-01
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose Group | Experimental | Drug: High-dose BT-14143High-dose BT-114143 |
| Low-dose Group | Experimental | Drug: Low-dose BT-114143Low-dose BT-114143 |
| Control Group | Active comparator | Drug: Tranexamic Acid (IV)Tranexamic acid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (22 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose BT-114143Intravenous 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. | Drug | Low-dose Group |
| High-dose BT-14143Intravenous 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. | Drug | High-dose Group |
| Tranexamic Acid (IV)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. | Drug | Control Group |
Primary outcome
Total blood loss
Time frame: The 3rd day after surgery
The blood loss was calculated using the Gross formula based on changes in hematocrit (HCT) from the subjects' preoperative and postoperative blood routine tests.
6 secondary outcomes
Occult blood loss
Time frame: The 3rd day after surgery
Total blood loss on the first day after surgery
Time frame: The first day after surgery
Allogeneic blood transfusion rate
Time frame: The 3rd day after surgery
Allogeneic blood transfusion volume
Time frame: The 3rd day after surgery
Changes in hemoglobin levels from baseline
Time frame: The 3rd day after surgery
Changes in hematocrit levels from baseline
Time frame: The 3rd day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose BT-114143, High-dose BT-14143 and Tranexamic Acid (IV) in people with Total Knee Arthroplasty, run by ScinnoHub Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuxing Pei, Master (028-85423426, rain_xjw@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total blood loss (time frame: The 3rd day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.