Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy

Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy: a Randomized, Double-blind, Placebo-controlled Trial

The study is randomized, placebo-controlled, double-blind clinical trial that aims to check whether tranexamic acid's use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of blood's transfusion.

The study aims to check whether tranexamic acid's use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of blood's transfusion.

Therefore it will be a randomized, placebo-controlled, double-blind clinical trial that intends to recruit 122 patients with radical prostatectomy indication who agreed to consent study inclusion.

Patients randomized to intervention group will receive 1,0g of tranexamic acid IV during anesthetic induction, followed by a maintenance dose of 1,0 mg/kg/hour of surgery. Control group will be operated normally.

Data as hemoglobin drop, estimated bleeding volume, need to transfusion, side effects, and presence of lymphocele will be compared between the two groups.

Inclusion Criteria:

• Patients over 18 years olds;
• Who accept to participate and sign the consent form;
• Compliance with the study follow-up protocol;
• Diagnosed with localized prostate cancer with surgical indication without or with lymphadenectomy.

Exclusion Criteria:

• Coronary artery disease treated with drug-using stent;
• Previous coronary procedures or coronary disease using a stent;
• Acute or chronic liver failure;
• Severe chronic renal failure (ClCr < 30 mL/Kg.h, according to the Modification of Diet in Renal Disease formula);
• Suspected allergy to tranexamic acid;
• Known coagulopathies and refusal to sign consent form.