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Tranexamic Acid in Urologic Surgery (TRANEX-URO)

Primary Purpose

Bleeding, Prostatectomy

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bleeding focused on measuring tranexamic acid, prostatectomy, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 29, 2008
Last Updated
April 4, 2014
Sponsor
Università Vita-Salute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT00670345
Brief Title
Tranexamic Acid in Urologic Surgery
Acronym
TRANEX-URO
Official Title
Efficacy of Tranexamic Acid in Reducing Perioperative Bleeding in Patients Undergoing Radical Prostatectomy. A Randomized Controlled Double-blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Università Vita-Salute San Raffaele

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Prostatectomy
Keywords
tranexamic acid, prostatectomy, surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Patients belonging to the control group will receive the same volume of saline infusions.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
TRANEX, UGUROL
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients belonging to the control group will receive the same volume of saline infusions.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Landoni, MD
Organizational Affiliation
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antonella Crescenti, MD
Organizational Affiliation
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
City
Milano
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22012809
Citation
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.
Results Reference
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Tranexamic Acid in Urologic Surgery

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