NCT00670345

Tranexamic Acid in Urologic Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bleeding
• Prostatectomy

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	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.
DRUG	Placebo	Patients belonging to the control group will receive the same volume of saline infusions.

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2008-05-01
• Last updated: 2014-04-07

Locations

1 site across 1 country: Italy