Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study on BT-114143 Reducing Perioperative Bleeding in Total Knee Arthroplasty(TKA)
Sponsor: ScinnoHub Pharmaceutical Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2025-08-27
Completion Date
2026-12-31
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Low-dose BT-114143
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-14143
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)
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.
Locations (1)
Department of Orthopaedics, West China Hospital, SIchuan University
Chengdu, Si'Chuan, China