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RECRUITING
NCT07127042
PHASE2

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

Sponsor: ScinnoHub Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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