Tranexamic Acid in Urologic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bleeding Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type 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.

2

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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TRANEX UGUROL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No