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Tranexamic Acid in Urologic Surgery — TRANEX-URO  

Bleeding Clinical Trial

Official title:
Efficacy of Tranexamic Acid in Reducing Perioperative Bleeding in Patients Undergoing Radical Prostatectomy. A Randomized Controlled Double-blind Study.

Clinical Trial Summary

This prospective randomized double-blind placebo vs control study aims at verifying the efficacy of tranexamic acid administration in reducing perioperative bleeding in patients undergoing open radical prostatectomy. Two recent meta-analysis confirmed that tranexamic acid administration does not increase mortality, myocardial infarction, deep venous thrombosis, pulmonary embolism, stroke and renal failure.

200 patients undergoing open radical prostatectomy will be enrolled. Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.

Patients belonging to the control group will receive the same volume of saline infusions.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00670345
Study type Interventional
Source Università Vita-Salute San Raffaele
Contact
Status Completed
Phase Phase 4
Start date April 2008
Completion date June 2010
View Details
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