Clinical trial · Interventional
Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy
Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy: a Randomized, Double-blind, Placebo-controlled Trial
NCT05816668CI-TRIAL-00065729TransaminunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Tranexamic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tranexamic Acid 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
- interventionNames
- Drug: Tranexamic acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Change in serum Hemoglobin levels from preoperative to post operative levels
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (33)
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- BACKGROUNDD'Amico AV, Whittington R, Malkowicz SB, Cote K, Loffredo M, Schultz D, Chen MH, Tomaszewski JE, Renshaw AA, Wein A, Richie JP. Biochemical outcome after radical prostatectomy or external beam radiation therapy for patients with clinically localized prostate carcinoma in the prostate specific antigen era. Cancer. 2002 Jul 15;95(2):281-6. doi: 10.1002/cncr.10657. PMID 12124827
- BACKGROUNDBekelman JE, Rumble RB, Chen RC, Pisansky TM, Finelli A, Feifer A, Nguyen PL, Loblaw DA, Tagawa ST, Gillessen S, Morgan TM, Liu G, Vapiwala N, Haluschak JJ, Stephenson A, Touijer K, Kungel T, Freedland SJ. Clinically Localized Prostate Cancer: ASCO Clinical Practice Guideline Endorsement of an American Urological Association/American Society for Radiation Oncology/Society of Urologic Oncology Guideline. J Clin Oncol. 2018 Nov 10;36(32):3251-3258. doi: 10.1200/JCO.18.00606. Epub 2018 Sep 5. PMID 30183466
- Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.