Tranexamic Acid in Urologic Surgery

Bleeding Clinical Trial

— TRANEX-URO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670345
• Other study ID #: GO/URC/ER/mm 139/DG
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2008
• Last updated: April 4, 2014
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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

• Bleeding
• Prostatectomy

Intervention

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

Locations

Country	Name	City	State
Italy	Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation