Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy: a Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Tranexamic acid
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid Group<br>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 | Drug: Tranexamic acid<br>* 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.<br>* Other names: Transamin;|
| Placebo Comparator: Placebo Group<br>Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group. | Other: Placebo<br>* Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum Hemoglobin levels from preoperative to post operative levels | The serum hemoglobin drop will be evaluated | Baseline (Before) and 12 and 24 hours after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, radical prostatectomy, video laparoscopic prostatectomy, tranexamic acid