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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Total Knee Arthroplasty
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.

Trial Locations (1)

37 Guoxuexiang

Department of Orthopaedics, West China Hospital, SIchuan University, Chengdu

All Listed Sponsors
lead

ScinnoHub Pharmaceutical Co., Ltd.

INDUSTRY