Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy

Instituto do Cancer do Estado de São Paulo122 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

122

Conditions

Prostate Cancer

Interventions

Tranexamic acidDRUG

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.

PlaceboOTHER

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in serum Hemoglobin levels from preoperative to post operative levels

The serum hemoglobin drop will be evaluated

Time frame: Baseline (Before) and 12 and 24 hours after surgery

Secondary Outcomes

Estimated volume of bleeding

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

Time frame: During surgery

Transfusion rate of red blood cell concentrates

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

Time frame: 12 and 24 hours after surgery

Adverse effects tranexamic acid

The adverse effects tranexamic acid administration will be evaluated.

Time frame: Up to 30 days after surgery

Central Contacts

Caio Brambilla, MD

CONTACT

+554499167029 caiobram@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.