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NCT07460518
Tranexamic Acid for Bleeding Reduction During TURP Surgery
Conditions: Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate, Perioperative Bleeding, Anemia, Postoperative
Sex: Male
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 80
Sponsor: Hamza Najout
Location: Mohammed V Military Teaching Hospital Rabat
Summary
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.
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 \
Source: ClinicalTrials.gov (NCT07460518). StuddyBuddy aggregates publicly available trial information.