Tranexamic Acid in Urologic Surgery

NCT00670345 | Completed Phase 4

• 1 other identifier: GO/URC/ER/mm 139/DG
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tranexamic acid; prostatectomy; surgery

Study Arms (2)

1

EXPERIMENTAL

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: Tranexamic Acid

2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tranexamic Acid DRUG

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.

Also known as: TRANEX, UGUROL

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• Patients undergoing open radical prostatectomy

You may not qualify if:

• Age \< 18 years
• Patients with drug eluting stent with a double antiplatelet therapy
• Atrial fibrillation
• Thrombophilic diathesis
• Allergy to tranexamic acid

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

Milan, 20132, Italy

Location

Related 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, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.

  PMID: 22012809 RESULT

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Giovanni Landoni, MD

  Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

  STUDY DIRECTOR

• Antonella Crescenti, MD

  Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 7, 2014

Record last verified: 2010-07

Locations

IT (1)