Tranexamic Acid in Urologic Surgery (TRANEX-URO)

This study has been completed.
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT00670345
First received: April 29, 2008
Last updated: April 4, 2014
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Bleeding
Prostatectomy
Drug: Tranexamic Acid
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Tranexamic Acid in Reducing Perioperative Bleeding in Patients Undergoing Radical Prostatectomy. A Randomized Controlled Double-blind Study.

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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.
Other Names:
  • tranexamic acid
  • TRANEX
  • UGUROL
Placebo Comparator: 2
Patients belonging to the control group will receive the same volume of saline infusions.
Drug: Placebo
Patients belonging to the control group will receive the same volume of saline infusions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670345

Locations
Italy
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Milano, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Study Director: Giovanni Landoni, MD Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Principal Investigator: Antonella Crescenti, MD Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00670345     History of Changes
Other Study ID Numbers: GO/URC/ER/mm 139/DG
Study First Received: April 29, 2008
Last Updated: April 4, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
tranexamic acid
prostatectomy
surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014