drugset / Trial / NCT01881568

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

NCT01881568

Phase 3 Completed 79 enrolled Hospital Universitario La Paz
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2013-01
Primary completion
2014-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 15 mg/kg Topical
Comparator Tranexamic Acid Small molecule 3 g Topical

Indications

No indication recorded.