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Tranexamic Acid in Urologic Surgery

NCT00670345 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-04-07

No results posted yet for this study

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

Interventions

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Principal Investigators

  • Giovanni Landoni, MD · Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

  • Antonella Crescenti, MD · Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00670345 on ClinicalTrials.gov