Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-27 @ 10:00 PM
Study NCT ID:
NCT06913595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Molecular Weight Heparin vs Direct Oral Anticoagulant After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065145', 'term': 'N(4)-oleylcytosine arabinoside'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VENOUS THROMBOEMBOLISM', 'timeFrame': '1 year', 'description': 'DVT after bariatric surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Venous Thrombosis']}, 'descriptionModule': {'briefSummary': 'Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant', 'detailedDescription': 'This study aims to compare the effectiveness of rivaroxaban versus low molecular weight heparin in reducing the incidence of PMVT after bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- BARIATRIC PATIENTS\n\nExclusion Criteria:\n\n* BLEEDING TENDENCY'}, 'identificationModule': {'nctId': 'NCT06913595', 'briefTitle': 'Low Molecular Weight Heparin vs Direct Oral Anticoagulant After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant', 'orgStudyIdInfo': {'id': 'N-55-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low Molecular Weight Heparin', 'description': 'Low molecular weight heparin as aprophylaxis after bariatric surgery', 'interventionNames': ['Drug: Low Molecular Weight Heparine']}, {'type': 'EXPERIMENTAL', 'label': 'Direct Oral Anticoagulant.', 'description': 'Direct Oral Anticoagulant as aprophylaxis after bariatric surgery', 'interventionNames': ['Drug: Direct Oral Anticoagulant.']}], 'interventions': [{'name': 'Direct Oral Anticoagulant.', 'type': 'DRUG', 'otherNames': ['RIVROXABAN'], 'description': 'Direct Oral Anticoagulant AFTER BARIATRIC SURGERY', 'armGroupLabels': ['Direct Oral Anticoagulant.']}, {'name': 'Low Molecular Weight Heparine', 'type': 'DRUG', 'otherNames': ['Enoxaparine'], 'description': 'Low molecular weight heparin after bariatric surgery', 'armGroupLabels': ['Low Molecular Weight Heparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11511', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'mohammed elshwadfy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of general surgery', 'investigatorFullName': 'Mohammed Elshwadfy Nageeb', 'investigatorAffiliation': 'Cairo University'}}}}