Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 9:17 AM
Study NCT ID:
NCT05913466
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2023-06-05', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of Blood Loss During Monopolar transurethral resection of the prostate', 'timeFrame': '2 weeks Postoperatively', 'description': 'The efficacy of intraprostatic injection of tranexamic acid in reducing intraoperative bleeding will be assessed in litter.'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin (Hb) level', 'timeFrame': '2 weeks Postoperatively', 'description': 'This outcome evaluates the changes in hemoglobin (Hb) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.'}, {'measure': 'Hematocrit (HCT) Level', 'timeFrame': '2 weeks Postoperatively', 'description': 'This outcome evaluates the changes in hematocrit (HCT) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.'}, {'measure': 'Postoperative hospital stay length', 'timeFrame': '2 weeks Postoperatively', 'description': 'Postoperative hospital stay length will be assessed in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia', 'Transurethral Resection of the Prostate', 'Tranexamic Acid']}, 'referencesModule': {'references': [{'pmid': '38788904', 'type': 'DERIVED', 'citation': 'Diab T, El Hamshary SA, Abou Elezz A, El-Dakhakhny AS. Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar Transurethral Resection of the Prostate: A Randomized Controlled Clinical Trial. Urology. 2024 Sep;191:119-126. doi: 10.1016/j.urology.2024.05.015. Epub 2024 May 22.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during Transurethral resection of the prostate.', 'detailedDescription': 'Benign prostatic hyperplasia (BPH) is a process in which the pathology results in increased number of both stromal and epithelial cells in the area of the prostate around the urethra, which is pathologically known as hyperplasia, and not hypertrophy.\n\nThe accurate cause is not well known; however, "reactivation" of embryonic processes is one of the hypotheses that may cause benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia (BPH) is a common condition that affects elderly men. Recently, many noninvasive and mini-invasive modalities have become popular for the management of men with voiding symptoms.\n\nTransurethral resection of the prostate (TURP) is one of the most common and well-developed techniques used to treat benign prostatic hyperplasia (BPH), recognized as the \'gold standard\' of the surgical treatments of enlarged prostates. The most relevant complications are the inability to void (5.8%), surgical revision (5.6%), urinary tract infection (UTI) (3.6%), bleeding requiring transfusions (2.9%), and Transurethral resection syndrome (1.4%). As the prostate has a rich blood supply, bleeding is one of the most common complications of Transurethral resection of the prostate.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Patient with an age between 50 and 85 years old who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g undergoing Transurethral resection of the prostate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with an age between 50 and 85 years old\n* who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g.\n* undergoing Transurethral resection of the prostate\n\nExclusion Criteria:\n\n* Patient refusal.\n* Patients hypersensitive to Tranexamic Acid, or on antiplatelet and anticoagulant drugs.\n* Patients with a history of thrombotic events, bleeding disorders, chronic kidney disease.\n* Patients with abnormal liver function test.\n* Patients with cardiovascular disease and receiving with a drug-eluting stent, bladder stone, urethral stricture, or with previous prostate surgery, prostate cancer, with a UTI or who receiving 5α-reductase inhibitors.'}, 'identificationModule': {'nctId': 'NCT05913466', 'briefTitle': 'Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP', 'orgStudyIdInfo': {'id': 'Rc 5-5-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid group', 'description': 'Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline', 'interventionNames': ['Drug: Tranexamic Acid group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Distilled water group', 'description': 'This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).', 'interventionNames': ['Drug: Distilled water group']}], 'interventions': [{'name': 'Tranexamic Acid group', 'type': 'DRUG', 'description': 'Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline', 'armGroupLabels': ['Tranexamic Acid group']}, {'name': 'Distilled water group', 'type': 'DRUG', 'description': 'This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).', 'armGroupLabels': ['Distilled water group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tamer Diab, MD', 'role': 'CONTACT', 'email': 'tamer.diab@fmed.bu.edu.eg', 'phone': '01003583264', 'phoneExt': '+2'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'One year after the end of the trial', 'ipdSharing': 'YES', 'description': 'The study protocol will be available under a clear request for the primary investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt', 'investigatorFullName': 'Tamer Abd El-Wahab Diab', 'investigatorAffiliation': 'Benha University'}}}}