Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy (Transamin)

Instituto do Cancer do Estado de São Paulo

Status and phase: Not yet enrolling; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Tranexamic acid; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05816668

NP2011/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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122 participants in 2 patient groups, including a placebo group

Tranexamic Acid Group

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo