Medical Oncology
Conditions
Interventions
Patients were randomly assigned to two groups: the tranexamic acid treatment group (TXA
n=38) and the control group (CTL
n=36). The TXA group received 100 mL of a 0.95% saline solution containing 1 g of tranexamic acid, while the CTL group received 100 mL of a 0.95% saline solution without the active substance. Both int
Sponsors
Fundação Cristiano Varella
Fundação Cristiano Varella
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Male patients; with a confirmed diagnosis of localized prostate cancer; aged 50 years or older; who are indicated for radical prostate-vesiculectomy by videolaparoscopy; with or without pelvic and/or retroperitoneal lymphadenectomy; Patients must be capable of providing informed consent and signing the Informed Consent Form (ICF); Additionally, patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2
Exclusion criteria
Exclusion criteria: Patients with a known history of allergic reactions to tranexamic acid or any other component of the formulation; patients with severe cardiovascular diseases, including recent myocardial infarction, congestive heart failure, or active venous thromboembolism; patients with severe renal insufficiency or a history of coagulopathies; use of anticoagulants or antiplatelet agents within 7 days prior to surgery; or any medical condition that, in the opinion of the investigator, may compromise patient safety or the integrity of the study data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Prophylactic use of tranexamic acid is expected to reduce intraoperative blood loss by at least 25% in patients undergoing laparoscopic radical prostatevesiculectomy, compared to the control group (placebo). Blood loss will be quantified using direct volumetric measurement, accounting for the subtraction of aspirated saline and urinary output. This primary endpoint was used as the basis for the sample size calculation of the study (n=150).;Observed outcome 1: No statistically significant difference in intraoperative blood loss was observed between the tranexamic acid group (TXA; n = 38) and the placebo group (CTL; n = 36) [U = 706.5; p = 0.8118]. These results indicate that TXA did not reduce intraoperative bleeding in patients undergoing laparoscopic radical prostatevesiculectomy.;Expected outcome 2: Tranexamic acid is expected to reduce the intraoperative need for fluid replacement with crystalloids, colloids, and blood products, compared to the control group. The total volume administered during surgery will be used for assessment.;Observed outcome 2: No statistically significant difference was observed in intraoperative fluid replacement between the TXA group (n = 38) and the control group (n = 36) [U = 529.5; p = 0.08766], indicating that TXA did not influence fluid therapy requirements during surgery.;Expected outcome 3: Tranexamic acid is expected to reduce the intraoperative use of vasoactive drugs (e.g., ephedrine, metaraminol, phenylephrine), reflecting improved hemodynamic stability during the procedure.;Observed outcome 3: No significant differences were found in the volume of ephedrine (U = 633.5; p = 0.5748) or metaraminol (U = 704.5; p = 0.6191) between the TXA and control groups, suggesting that TXA did not affect the need for intraoperative hemodynamic support.;Expected outcome 4: An improvement in surgical field conditions is expected in patients receiving tranexamic acid, as assessed by the surgical team using a four-level scal | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactMarcus Pimentel
Fundação Cristiano Varella
Outcome results
None listed