Bleeding, Prostatectomy
Conditions
Keywords
tranexamic acid, prostatectomy, surgery
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.
Interventions
DRUGTranexamic 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.
DRUGPlacebo
Patients belonging to the control group will receive the same volume of saline infusions.
Sponsors
Università Vita-Salute San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
Italy
Outcome results
None listed