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NOT YET RECRUITING
NCT07460518
PHASE4

Tranexamic Acid for Bleeding Reduction During TURP Surgery

Sponsor: Hamza Najout

View on ClinicalTrials.gov

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.

Official title: Tranexamic Acid for Perioperative Haemostatic Optimisation During Transurethral Resection of the Prostate: A Randomized Quadruple-Blind Placebo-Controlled Trial

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-03-15

Completion Date

2026-09-01

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

Tranexamic Acid

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.

DRUG

Placebo (Normal Saline)

Intravenous administration of normal saline placebo prepared to be identical in appearance and volume to the tranexamic acid solution to maintain blinding.

Locations (1)

Mohammed V Military Teaching Hospital

Rabat, Rabat, Morocco