drugset / Trial / NCT07127042
Study on BT-114143 Reducing Perioperative Bleeding in Total Knee Arthroplasty（TKA）
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-08-27
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BT-114143 | Unknown | — | Intravenous |
| Comparator | Tranexamic Acid | Small molecule | 20 mg/kg | Intravenous |
| Comparator | Tranexamic Acid | Small molecule | 1 g | Intravenous |
Indications
No indication recorded.