Tranexamic Acid for Bleeding Reduction During TURP Surgery

NCT07460518 | Not Yet Recruiting Phase 4

• 1 other identifier: HMIMV-TXA-TURP-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Tranexamic Acid; TURP; Patient Blood Management; Spinal Anesthesia; Randomized Controlled Trial; Hemostasis; Enhanced Recovery After Surgery; Perioperative Medicine

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 hours after surgery

Secondary Outcomes (5)

• Perioperative Red Blood Cell Transfusion Requirement

  From surgery until hospital discharge (up to 7 days)

• Operative Duration

  During surgery (from skin incision to end of resection, up to 3 hours)

• Duration of Bladder Catheterization

  From end of surgery until urinary catheter removal (up to 7 days)

• Hospital Length of Stay

  From end of surgery until hospital discharge (up to 14 days)

• Perioperative Adverse Events

  From surgery until hospital discharge (up to 30 days)

Study Arms (2)

Tranexamic Acid Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

Participants receive an identical volume of normal saline placebo administered intravenously prior to surgery under standardized spinal anesthesia.

Drug: Placebo (Normal Saline)

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.

Tranexamic Acid Group

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.

Placebo Group

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamza Najout: lead

Study Sites (1)

Mohammed V Military Teaching Hospital

Rabat, Rabat, 10180, Morocco

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Anemia

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple-blind design including participants, care providers, investigators, and outcome assessors. Study medication preparation ensured identical appearance of tranexamic acid and placebo solutions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Intensive Care

Model Details: Participants are randomized in a 1:1 ratio to receive intravenous tranexamic acid or placebo prior to transurethral resection of the prostate under standardized spinal anesthesia.

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 10, 2026
• Study Start: March 15, 2026
• Primary Completion: June 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)