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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario La Paz
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Adult patients (greater than 18 years old)

• Patients scheduled for primary unilateral knee arthroplasty

• Patients for La Paz- Cantoblanco Hospital, Madrid, Spain

Exclusion Criteria:

• Patients that refuse to sign the Inform Consent

• Allergy to tranexamic acid

• Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine>2mg/dL if mens and >1.8mg/dL if woman); or hepatic disfunction.

• Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged PPT(>1.4 x normal)

• History of thromboembolic disease: CVA, DVT, PE

• Blood dyscrasias

• Retinopathy (disturbances of color vision)

• Jehovah's witnesses

• Pregnancy

• Breastfeeding

• Been participating or been participated a year ago in another clinical trial