Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy

Phase 3

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Other: Placebo; Drug: Tranexamic acid

• Registration Number: NCT05816668
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-22
• Status Verified: 2023-04
• Study Start: 2023-04
• Study First Submitted QC: 2023-04-17
• Last Update Submitted: 2023-04-17
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-04
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group.
Tranexamic Acid Group	Tranexamic acid	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

Primary Outcome Measures

Name	Time	Method
Change in serum Hemoglobin levels from preoperative to post operative levels	Baseline (Before) and 12 and 24 hours after surgery	The serum hemoglobin drop will be evaluated

Secondary Outcome Measures

Name	Time	Method
Estimated volume of bleeding	During surgery	Total blood loss will be assessed by the volume aspirated during surgery.
Adverse effects tranexamic acid	Up to 30 days after surgery	The adverse effects tranexamic acid administration will be evaluated.
Transfusion rate of red blood cell concentrates	12 and 24 hours after surgery	The amount of red blood cells concentrate transfused will be evaluated.