Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

Total Blood Loss Clinical Trial

Official title: Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study

Status Completed

Clinical Trial Summary

Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.

Clinical Trial Description

Objectives:To assess the efficacy and safety between the two different applying routes.

Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.

All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened. ;

Related Conditions & MeSH terms

• Hemorrhage
• Total Blood Loss

• NCT number: NCT02393300
• Study type: Interventional
• Source: Shanghai Jiao Tong University School of Medicine
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Completion date: October 2015