TRANEX-URO: Tranexamic Acid in Urologic Surgery

Sponsor

Università Vita-Salute San Raffaele (Other)

Overall Status

Completed

CT.gov ID

NCT00670345

Collaborator

(none)

Location

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bleeding Prostatectomy	Drug: Tranexamic Acid Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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: 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.

Arm

Intervention/Treatment

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:

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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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