Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-03-27 @ 12:44 AM
Study NCT ID:
NCT02715492
Status:
UNKNOWN
Last Update Posted:
2017-12-27
First Post:
2016-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with portal vein thrombosis', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HCC']}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma (HCC) is a major health problem worldwide, and most cases are inoperable because of late presentation and underlying cirrhosis. It represents the fifth most common tumor in the world and the third most frequent cause of mortality amongst patients with cancer.\n\nDue to the worldwide difficulties in finding liver for transplantation, hepatic resection (HR) represents the main stay of curative treatment for patients with HCC. Transcatheter arterial chemoembolization (TACE) is widely used as alternative treatments for unresectable HCC or for patients not eligible to be operated on .\n\nTACE also could be an adjuvant therapy for resectable HCC patients after hepatectomy, which could prevent recurrence and improve long-term survival .', 'detailedDescription': 'Thromboembolism is a well-recognised complication of malignant disease. Clinical manifestations vary from venous thromboembolism to disseminated intravascular coagulation and arterial embolism. Disseminated intravascular coagulation is most commonly observed in patients with haematological malignant disorders and those with wide spread metastatic cancer, whereas arterial embolism is most commonly observed in patients undergoing chemotherapy and in those with non-bacterial thrombotic endocarditis .\n\nThe goals of using antithrombotic therapy with TACE in HCC are to minimize mortality and to improve survival rate without provoking excessive bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HCC which was not amenable to surgical resection, liver transplantation or local ablative therapy.\n* The lesion had not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.\n* Reasonable performance status as adequate hematologic function; adequate hepatic function and adequate renal function.\n* Child-Pugh class A or B and no portal vein thrombosis.\n\nExclusion Criteria:\n\n* Child C patients Portal vein thrombosis'}, 'identificationModule': {'nctId': 'NCT02715492', 'briefTitle': 'Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.', 'orgStudyIdInfo': {'id': 'LMWH TACE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transarterial Chemoembolization', 'description': '1st group: included 20 patients with HCC treated by TACE only.', 'interventionNames': ['Procedure: TACE']}, {'type': 'EXPERIMENTAL', 'label': 'TACE and LMWH', 'description': '2nd group: included 20 patients with HCC treated by TACE and adjuvant dose of Low Molecular Weight Heparins (LMWH).', 'interventionNames': ['Drug: LMWH', 'Procedure: TACE']}], 'interventions': [{'name': 'LMWH', 'type': 'DRUG', 'otherNames': ['Enoxaparin'], 'description': '(Enoxheparin) 1 IU/kg per dose twice daily for 2 weeks from the 1st day of TACE', 'armGroupLabels': ['TACE and LMWH']}, {'name': 'TACE', 'type': 'PROCEDURE', 'description': 'Trans arterial chemoembolization', 'armGroupLabels': ['TACE and LMWH', 'Transarterial Chemoembolization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta university - faculty of medicine', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, Lecturer', 'role': 'CONTACT', 'email': 'Sheriefabdelsalam@yahoo.com', 'phone': '00201095159522'}], 'overallOfficials': [{'name': 'Osama Negm, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. liver diseases-Tanta university'}, {'name': 'Sabry Abou Saif, Ass. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ass/ Prof. liver diseases-Tanta university'}, {'name': 'Mohamed El Gharib, Ass. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ass. Prof. interventional radiology - Ain-shams university'}, {'name': 'Sherief Abd-Elsalam, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MD liver diseases - Tanta university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD liver diseases', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}