Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:27 PM
Study NCT ID:
NCT07460518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid for Bleeding Reduction During TURP Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Quadruple-blind design including participants, care providers, investigators, and outcome assessors. Study medication preparation ensured identical appearance of tranexamic acid and placebo solutions.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Hemoglobin Mass Recovered in Irrigation Effluent', 'timeFrame': 'During surgery (from start of resection to end of procedure, up to 3 hours)', 'description': 'Total hemoglobin mass (grams) quantified from irrigation effluent collected during transurethral resection of the prostate as an objective measure of intraoperative blood loss.'}, {'measure': 'Postoperative Hemoglobin Concentration', 'timeFrame': '24 hours after surgery', 'description': 'Systemic hemoglobin concentration (g/dL) measured 24 hours after transurethral resection of the prostate to assess perioperative hemoglobin preservation.'}], 'secondaryOutcomes': [{'measure': 'Perioperative Red Blood Cell Transfusion Requirement', 'timeFrame': 'From surgery until hospital discharge (up to 7 days)', 'description': 'Requirement for allogeneic red blood cell transfusion during the perioperative period according to institutional transfusion thresholds.'}, {'measure': 'Operative Duration', 'timeFrame': 'During surgery (from skin incision to end of resection, up to 3 hours)', 'description': 'Total duration of transurethral resection of the prostate measured in minutes from surgical start to completion.'}, {'measure': 'Duration of Bladder Catheterization', 'timeFrame': 'From end of surgery until urinary catheter removal (up to 7 days)', 'description': 'Number of days from surgery until removal of urinary bladder catheter.'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'From end of surgery until hospital discharge (up to 14 days)', 'description': 'Total number of days from surgery to hospital discharge.'}, {'measure': 'Perioperative Adverse Events', 'timeFrame': 'From surgery until hospital discharge (up to 30 days)', 'description': 'Occurrence of thromboembolic complications, seizures, or other serious adverse events during the perioperative period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tranexamic Acid', 'TURP', 'Patient Blood Management', 'Spinal Anesthesia', 'Randomized Controlled Trial', 'Hemostasis', 'Enhanced Recovery After Surgery', 'Perioperative Medicine'], 'conditions': ['Benign Prostatic Hyperplasia', 'Transurethral Resection of the Prostate', 'Perioperative Bleeding', 'Anemia, Postoperative']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nParticipants 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.\n\nThe study aims to determine whether anesthesia-led haemostatic optimization using tranexamic acid improves perioperative physiological stability and recovery efficiency within an enhanced recovery framework.', 'detailedDescription': 'This investigator-initiated, prospective, randomized, quadruple-blind, placebo-controlled clinical trial is conducted at Mohammed V Military Teaching Hospital, Rabat, Morocco.\n\nThe 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.\n\nEligible 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.\n\nThe study includes two complementary co-primary haemostatic endpoints:\n\n1. total haemoglobin mass recovered in irrigation effluent as an objective measure of intraoperative blood loss, and\n2. postoperative haemoglobin concentration measured at 24 hours.\n\nSecondary outcomes evaluate perioperative recovery variables, transfusion requirement, hospital length of stay, adverse events, and exploratory health-economic impact from a hospital perspective.\n\nA 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged 50 years or older\n* Diagnosed with benign prostatic hyperplasia (BPH)\n* Scheduled for elective transurethral resection of the prostate (TURP) under spinal anesthesia\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Provided written informed consent\n\nExclusion Criteria:\n\n* History of thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke)\n* Known hypersensitivity to tranexamic acid\n* Severe renal impairment (creatinine clearance \\<30 mL/min)\n* Coagulation disorders\n* Current anticoagulant therapy not appropriately discontinued\n* History of seizure disorder\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT07460518', 'acronym': 'TXA-TURP', 'briefTitle': 'Tranexamic Acid for Bleeding Reduction During TURP Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Military Teaching Hospital Mohammed V'}, 'officialTitle': 'Tranexamic Acid for Perioperative Haemostatic Optimisation During Transurethral Resection of the Prostate: A Randomized Quadruple-Blind Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'HMIMV-TXA-TURP-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid Group', 'description': 'Participants receive intravenous tranexamic acid (10 mg/kg) administered approximately 30 minutes before transurethral resection of the prostate under standardized spinal anesthesia.', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants receive an identical volume of normal saline placebo administered intravenously prior to surgery under standardized spinal anesthesia.', 'interventionNames': ['Drug: Placebo (Normal Saline)']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Tranexamic Acid Group']}, {'name': 'Placebo (Normal Saline)', 'type': 'DRUG', 'description': 'Intravenous administration of normal saline placebo prepared to be identical in appearance and volume to the tranexamic acid solution to maintain blinding.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10180', 'city': 'Rabat', 'state': 'Rabat', 'country': 'Morocco', 'contacts': [{'name': 'Hamza Najout, MD, PhD', 'role': 'CONTACT', 'email': 'hamza.najout@gmail.com', 'phone': '+212672188155'}, {'name': 'hamza najout, MD, PhD(c)', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mohammed V Military Teaching Hospital', 'geoPoint': {'lat': 34.01325, 'lon': -6.83255}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamza Najout', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology and Intensive Care', 'investigatorFullName': 'Hamza Najout', 'investigatorAffiliation': 'Military Teaching Hospital Mohammed V'}}}}