Tranexamic Acid in Urologic Surgery

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università Vita-Salute San Raffaele
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Adult patients

• Patients undergoing open radical prostatectomy

Exclusion Criteria:

• Age < 18 years

• Patients with drug eluting stent with a double antiplatelet therapy

• Atrial fibrillation

• Thrombophilic diathesis

• Allergy to tranexamic acid