NCT05816668

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Tranexamic acid	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.
OTHER	Placebo	Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-04-01
• Completion: 2024-09-01
• First posted: 2023-04-18
• Last updated: 2023-04-18