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Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA — TRANEX1  

Blood Loss Clinical Trial

Official title:
Efficacy of Topical Tranexamic Acid Versus Intravenous Administration to Reduce Blood Transfusion Rate in Total Knee Arthroplasty Surgery: Phase III, Unicentric, Controlled,Double Blind, Randomized Non Inferiority Clinical Trial.

Clinical Trial Summary

The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).

Clinical Trial Description

The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01881568
Study type Interventional
Source Hospital Universitario La Paz
Contact
Status Completed
Phase Phase 3
Start date January 2013
Completion date January 2014
View Details
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