A Phase 4 interventional study of Tranexamic Acid and Placebo (Normal Saline) in Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate and Perioperative Bleeding, sponsored by Hamza Najout. Recruiting at 1 site in Morocco. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Hamza Najout · Phase 4, Interventional, and Treatment
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.
This investigator-initiated, prospective, randomized, quadruple-blind, placebo-controlled clinical trial is conducted at Mohammed V Military Teaching Hospital, Rabat, Morocco.
The study evaluates tranexamic acid as a perioperative blood management intervention during transurethral resection of the prostate performed under standardized spinal anesthesia within an enhanced recovery pathway. TURP surgery is characterized by local fibrinolytic activation that may contribute to continuous microvascular bleeding. Tranexamic acid inhibits plasminogen activation and may therefore reduce intraoperative haemoglobin loss.
Eligible participants undergoing elective TURP are randomized in a 1:1 ratio to receive either intravenous tranexamic acid (10 mg/kg) administered prior to surgical resection or placebo. Allocation concealment and quadruple blinding include participants, care providers, investigators, and outcome assessors.
The study includes two complementary co-primary haemostatic endpoints:
Secondary outcomes evaluate perioperative recovery variables, transfusion requirement, hospital length of stay, adverse events, and exploratory health-economic impact from a hospital perspective.
A prespecified interim analysis evaluates feasibility, treatment effect estimation, and safety signals without early stopping rules. Final confirmatory analysis will be performed after completion of planned enrollment.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 80 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →This is the only study on the registry with Hamza Najout as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive intravenous tranexamic acid (10 mg/kg) administered approximately 30 minutes before transurethral resection of the prostate under standardized spinal anesthesia.
Drug: Tranexamic Acid
Participants receive an identical volume of normal saline placebo administered intravenously prior to surgery under standardized spinal anesthesia.
Drug: Placebo (Normal Saline)
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.
Intravenous administration of normal saline placebo prepared to be identical in appearance and volume to the tranexamic acid solution to maintain blinding.
Total Hemoglobin Mass Recovered in Irrigation Effluent
Total hemoglobin mass (grams) quantified from irrigation effluent collected during transurethral resection of the prostate as an objective measure of intraoperative blood loss.
Time frame: During surgery (from start of resection to end of procedure, up to 3 hours)
Postoperative Hemoglobin Concentration
Systemic hemoglobin concentration (g/dL) measured 24 hours after transurethral resection of the prostate to assess perioperative hemoglobin preservation.
Time frame: 24 hours after surgery
Perioperative Red Blood Cell Transfusion Requirement
Requirement for allogeneic red blood cell transfusion during the perioperative period according to institutional transfusion thresholds.
Time frame: From surgery until hospital discharge (up to 7 days)
Operative Duration
Total duration of transurethral resection of the prostate measured in minutes from surgical start to completion.
Time frame: During surgery (from skin incision to end of resection, up to 3 hours)
Duration of Bladder Catheterization
Number of days from surgery until removal of urinary bladder catheter.
Time frame: From end of surgery until urinary catheter removal (up to 7 days)
Hospital Length of Stay
Total number of days from surgery to hospital discharge.
Time frame: From end of surgery until hospital discharge (up to 14 days)
Perioperative Adverse Events
Occurrence of thromboembolic complications, seizures, or other serious adverse events during the perioperative period.
Time frame: From surgery until hospital discharge (up to 30 days)
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tranexamic Acid