Tranexamic Acid in Urologic Surgery

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.

Timeline

Start

2008-04

Primary completion

2010-05

Completion

2010-06

Outcome

Met primary endpoint

paper relative risk of receiving transfusions for patients treated with tranexamic acid 0.62 (0.45 to 0.85); number needed to treat 5 (3 to 14); P = 0.004 PMID 22012809 ↗

Publications

• Results Crescenti A, Borghi G, Bignami E, Bertarelli G, Landoni G, Casiraghi GM, Briganti A, Montorsi F, Rigatti P, Zangrillo A. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.

Drugs

Indications