Tranexamic Acid in Urologic Surgery
- Registration Number
- NCT00670345
- Lead Sponsor
- Università Vita-Salute San Raffaele
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
- Adult patients
- Patients undergoing open radical prostatectomy
- Age < 18 years
- Patients with drug eluting stent with a double antiplatelet therapy
- Atrial fibrillation
- Thrombophilic diathesis
- Allergy to tranexamic acid
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 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. 2 Placebo Patients belonging to the control group will receive the same volume of saline infusions.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
🇮🇹Milano, Italy