drugset / Trial / NCT07853885

Intraosseous Tranexamic Acid for Reducing Blood Loss in Total Knee Arthroplasty

NCT07853885 ↗

Phase 4 Not yet recruiting 70 enrolled The Second Affiliated Hospital of Kunming Medical University
RandomizedParallel-groupTriple-blindPrevention

Summary

This prospective, single-center, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of local intraosseous tranexamic acid administration for reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). A total of 70 patients with primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to either the tranexamic acid group or the placebo control group. Before skin incision, participants in the experimental group will receive local intraosseous tranexamic acid, while participants in the control group will receive an equal volume of normal saline using the same injection procedure. The primary outcome is total perioperative blood loss. Secondary outcomes include postoperative hemoglobin reduction, transfusion requirements, pain, knee swelling, range of motion, functional recovery, length of hospital stay, and postoperative complications. Participants will be followed for up to 3 months after surgery.

Timeline

Start
2026-10
Primary completion
2027-04
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 2 g Other

Indications