NCT01881568

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Blood Loss

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
DRUG	Tranexamic Acid	Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-06-19
• Last updated: 2014-12-03

Locations

1 site across 1 country: Spain