Clinical trial NCT05816668: Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy
Official title: Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
radical prostatectomy
video laparoscopic prostatectomy
tranexamic acid
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 122
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in serum Hemoglobin levels from preoperative to post operative levels
timeFrame: Baseline (Before) and 12 and 24 hours after surgery
Secondary outcomes:
measure: Estimated volume of bleeding
timeFrame: During surgery
measure: Transfusion rate of red blood cell concentrates
timeFrame: 12 and 24 hours after surgery
measure: Adverse effects tranexamic acid
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Instituto do Câncer do Estado de São Paulo
name: Rafael Ferreira Coelho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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