Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT03880604
Status:
UNKNOWN
Last Update Posted:
2019-05-13
First Post:
2019-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple Tourniquets With or Without Tranexamic Acid for Reducing Blood Loss at Open Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009214', 'term': 'Myoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A double-blinded randomized placebo-controlled trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A double-blinded randomized placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-10', 'studyFirstSubmitDate': '2019-03-15', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean amount of intraoperative blood loss', 'timeFrame': 'intraoperative', 'description': 'measure the mean amount of intraoperative blood loss by gravimetric methods'}], 'secondaryOutcomes': [{'measure': 'The number of patients needs for blood transfusion', 'timeFrame': '24 hours post delivery', 'description': 'Calculation the number of patients needs for blood transfusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Haemostatic tourniquets', 'tranexamic acid', 'myomectomy'], 'conditions': ['Myoma']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will investigate the effectiveness of an intravenous tranexamic acid plus triple tourniquets compared with triple tourniquets alone for the reduction of blood loss at the time of myomectomy', 'detailedDescription': 'An RCT investigated the efficacy of intravenous tranexamic acid (TA) during abdominal myomectomy. The study was unable to demonstrate any significant impact on blood loss, duration of surgery or need for blood transfusionHemostatic tourniquets to reduce intra-operative bleeding have long been available, but data on their efficacy from controlled trials are lacking. The investigators set out to evaluate the use of triple tourniquets plus tranexamic acid in controlled conditions and for the first time to investigate the hypothesis that adding tranexamic acid to tourniquet around the uterine artery reduces postoperative bleeding from the uterine incisions, a well-recognized sequel to surgery'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'All women who prepared for abdominal myomectomies will be invited to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting for abdominal myomectomy with documented uterine fibroids on ----pelvic imaging\n* Age ≥ 18 years and ≤ 50 years\n* Pre-operative hemoglobin \\>8 g/dl\n* Ability to understand and the willingness to sign a written informed consent.\n* Admissible medical/surgical history\n* Five or less symptomatic uterine myomas\n* All myomas are subserous or intramural.\n* Uterine size less than 24 weeks of pregnancy\n\nExclusion Criteria:\n\n* Patients who have had a prior abdominal myomectomy\n* Post-menopausal women\n* Patients with known bleeding/clotting disorders\n* Patients with a history of gynecologic malignancy\n* Hypertension.\n* Cardiac and Pulmonary Diseases.\n* Obesity (body mass index \\> 30 kg/m2).\n* History of allergic reactions attributed to misoprostol\n* Cases that will require intraoperative conversion of myomectomy to hysterectomy'}, 'identificationModule': {'nctId': 'NCT03880604', 'acronym': 'TTT', 'briefTitle': 'Triple Tourniquets With or Without Tranexamic Acid for Reducing Blood Loss at Open Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Triple Tourniquets With or Without IV Tranexamic Acid for Reducing Blood Loss at Open Myomectomy: A Double-blinded Randomized Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/207/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Triple tourniquets plus TA', 'description': 'A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus1-gram tranexamic acid (10 ml) in 100 ml saline infusion', 'interventionNames': ['Procedure: Triple tourniquets', 'Drug: TA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triple tourniquets plus placebo to TA', 'description': 'A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion', 'interventionNames': ['Procedure: Triple tourniquets', 'Other: placebo to TA']}], 'interventions': [{'name': 'Triple tourniquets', 'type': 'PROCEDURE', 'otherNames': ['Active comparator'], 'description': 'A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels', 'armGroupLabels': ['Triple tourniquets plus TA', 'Triple tourniquets plus placebo to TA']}, {'name': 'TA', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': '1-gram tranexamic acid (10 ml) in 100 ml saline infusion', 'armGroupLabels': ['Triple tourniquets plus TA']}, {'name': 'placebo to TA', 'type': 'OTHER', 'otherNames': ['placebo comparator'], 'description': 'placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion', 'armGroupLabels': ['Triple tourniquets plus placebo to TA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hany f Sallam, MD', 'role': 'CONTACT', 'email': 'hany.farouk@aswu.edu.eg', 'phone': '0122336052', 'phoneExt': '002'}, {'name': 'Nahla W Shady, MD', 'role': 'CONTACT', 'email': 'nahla.elsayed@aswu.edu.eg', 'phone': '01092440504', 'phoneExt': '002'}], 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'hany f sallam, md', 'role': 'CONTACT', 'email': 'hany.farouk@aswu.edu.eg', 'phone': '0102236052', 'phoneExt': '002'}, {'name': 'nahla w shady, md', 'role': 'CONTACT', 'email': 'nahla.elsayed@aswu.edu.eg', 'phone': '01092440504', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'hany f sallam, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aswan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}