Tranexamic Acid for Bleeding Reduction During TURP Surgery

Sponsor
Hamza Najout
Study ID
NCT07460518
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tranexamic Acid Group
    Participants receive intravenous tranexamic acid (10 mg/kg) administered approximately 30 minutes before transurethral resection of the prostate under standardized spinal anesthesia.
  • Placebo Comparator: Placebo Group
    Participants receive an identical volume of normal saline placebo administered intravenously prior to surgery under standardized spinal anesthesia.

Primary Outcome Measure

Total Hemoglobin Mass Recovered in Irrigation Effluent [ Time Frame: During surgery (from start of resection to end of procedure, up to 3 hours) ]

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