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RECRUITING Phase 4 ClinicalTrials.gov

Tranexamic Acid for Bleeding Reduction During TURP Surgery

Sponsor: Hamza Najout • ClinicalTrials.gov ID: NCT07460518

Registry updated: 2026-10-09
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Description

Transurethral resection of the prostate (TURP) is commonly performed in elderly patients and may be associated with perioperative bleeding leading to postoperative anemia and delayed recovery. Tranexamic acid (TXA), an antifibrinolytic agent, may reduce surgical bleeding by inhibiting fibrin degradation. This prospective randomized quadruple-blind placebo-controlled clinical trial evaluates whether perioperative administration of intravenous tranexamic acid reduces intraoperative blood loss and preserves postoperative hemoglobin concentration in patients undergoing TURP under standardized spinal anesthesia. Participants are randomly assigned to receive either intravenous tranexamic acid or placebo prior to surgery. The primary outcomes assess objective measures of perioperative blood loss and postoperative hemoglobin levels. Secondary outcomes include recovery parameters, perioperative safety, and exploratory hospital-level economic impact. The study aims to determine whether anesthesia-led haemostatic optimization using tranexamic acid improves perioperative physiological stability and recovery efficiency within an enhanced recovery framework.

Interventions

  • Tranexamic Acid (Drug)
    Intravenous tranexamic acid administered at a dose of 10 mg/kg approximately 30 minutes before surgical resection to reduce perioperative bleeding during transurethral resection of the prostate.
  • Placebo (Normal Saline) (Drug)
    Intravenous administration of normal saline placebo prepared to be identical in appearance and volume to the tranexamic acid solution to maintain blinding.

Eligibility criteria

Inclusion Criteria: * Male patients aged 50 years or older * Diagnosed with benign prostatic hyperplasia (BPH) * Scheduled for elective transurethral resection of the prostate (TURP) under spinal anesthesia * American Society of Anesthesiologists (ASA) physical status I-III * Provided written informed consent Exclusion Criteria: * History of thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke) * Known hypersensitivity to tranexamic acid * Severe renal impairment (creatinine clearance \<30 mL/min) * Coagulation disorders * Current anticoagulant therapy not appropriately discontinued * History of seizure disorder * Refusal to participate

Conditions

Benign Prostatic Hyperplasia Transurethral Resection of the Prostate Perioperative Bleeding Anemia, Postoperative

Locations

  • Mohammed V Military Teaching Hospital — Rabat, Morocco
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record