Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Coagulants

All Drugs and Chemicals

Central Nervous System Depressants

Pharmaceutical Solutions

Tranexamic Acid

Anesthetics

Antifibrinolytic Agents

Hemostatics

Patients will receive an attack solution of 1,0 g of tranexamic acid 20 minutes before the surgery beginning, followed by a maintence dose of 1,0 mg/kg/h in pump surgery infusion

Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group.

Patients with prostate cancer and radical video laparoscopy prostatectomy indication will receive 1,0g of Tranexamic Acid solution IV in bolus 20 minutes before of anesthetic induction, followed by a maintenance hose of 1,0mg/kg/h of surgery.

Tranexamic acid

Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally

Placebo

Caio Brambilla, MD

Rafael Ferreira Coelho, MD, PhD

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.

Just ICESP's Clinical Research Pharmacy team will be not blinded. The surgical and anesthetic teams will be blinded in relation to the placebo or tranexamic acid intervention during the preoperative period and during the postoperative follow-up and, if any case loses the blinding, it will be excluded from the analysis. The preparation of packaging, dilution and dispensing or the material containing tranexamic acid or placebo will be carried out by the ICESP's Clinical Research Pharmacy division.

Patients diagnosed with localized prostate cancer

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 serum hemoglobin drop will be evaluated

Total blood loss will be assessed by the volume aspirated during surgery.

The amount of red blood cells concentrate transfused will be evaluated.

The adverse effects tranexamic acid administration will be evaluated.

Spots Global Cancer Trial Database for video laparoscopic prostatectomy