NCT02117128

The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement

The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement: a Randomized, Double-blind, Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

We will investigate the efficacy and safety of using tranexamic acid by intravenous, intra-articular and combinational administration to reduce blood loss during total knee replacement. We hypothesize a combined intra-articular and single intravenous dose protocol of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and extra-articular bleeding site with little or no systemic absorption and subsequent systemic side effects.

Detailed description

A randomized, double-blind, single-center, controlled and parallel-assigned study comparing the efficacy and safety of intravenous, intra-articular and combinational administration of tranexamic acid to reduce blood loss during total knee replacement. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 3 months postoperatively.

Conditions

• Blood Loss

Interventions

Type	Name	Description
DRUG	Tranexamic acid

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-04-17
• Last updated: 2016-03-04

Locations

1 site across 1 country: China