Anemia, Postoperative, Benign Prostatic Hyperplasia, Perioperative Bleeding, Transurethral Resection of the Prostate
Conditions
Keywords
Tranexamic Acid, TURP, Patient Blood Management, Spinal Anesthesia, Randomized Controlled Trial, Hemostasis, Enhanced Recovery After Surgery, Perioperative Medicine
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.
Detailed description
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: 1. total haemoglobin mass recovered in irrigation effluent as an objective measure of intraoperative blood loss, and 2. postoperative haemoglobin concentration measured at 24 hours. 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.
Interventions
DRUGTranexamic 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.
DRUGPlacebo (Normal Saline)
Intravenous administration of normal saline placebo prepared to be identical in appearance and volume to the tranexamic acid solution to maintain blinding.
Sponsors
Hamza Najout
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple-blind design including participants, care providers, investigators, and outcome assessors. Study medication preparation ensured identical appearance of tranexamic acid and placebo solutions.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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 \<30 mL/min) * Coagulation disorders * Current anticoagulant therapy not appropriately discontinued * History of seizure disorder * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Hemoglobin Mass Recovered in Irrigation Effluent | During surgery (from start of resection to end of procedure, up to 3 hours) | Total hemoglobin mass (grams) quantified from irrigation effluent collected during transurethral resection of the prostate as an objective measure of intraoperative blood loss. |
| Postoperative Hemoglobin Concentration | 24 hours after surgery | Systemic hemoglobin concentration (g/dL) measured 24 hours after transurethral resection of the prostate to assess perioperative hemoglobin preservation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Red Blood Cell Transfusion Requirement | From surgery until hospital discharge (up to 7 days) | Requirement for allogeneic red blood cell transfusion during the perioperative period according to institutional transfusion thresholds. |
| Operative Duration | During surgery (from skin incision to end of resection, up to 3 hours) | Total duration of transurethral resection of the prostate measured in minutes from surgical start to completion. |
| Duration of Bladder Catheterization | From end of surgery until urinary catheter removal (up to 7 days) | Number of days from surgery until removal of urinary bladder catheter. |
| Hospital Length of Stay | From end of surgery until hospital discharge (up to 14 days) | Total number of days from surgery to hospital discharge. |
| Perioperative Adverse Events | From surgery until hospital discharge (up to 30 days) | Occurrence of thromboembolic complications, seizures, or other serious adverse events during the perioperative period. |
Countries
Morocco
Outcome results
None listed