Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-29 @ 3:00 AM
Study NCT ID:
NCT02398357
Status:
UNKNOWN
Last Update Posted:
2015-12-09
First Post:
2015-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017762', 'term': 'Nadroparin'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2015-03-19', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recanalization rate of PVT', 'timeFrame': '8 weeks', 'description': 'Patients will receive Doppler ultrasound before enrolled and after followed up for 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Rebleeding rate', 'timeFrame': '8 weeks', 'description': 'The investigators observe the variceal rebleeding events during 8 weeks.'}, {'measure': 'Incidence rate of complications', 'timeFrame': '8 weeks', 'description': 'The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anticoagulation', 'Zelen-designed randomized controlled trial'], 'conditions': ['Portal Vein Thrombosis', 'Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore whether it can decrease the short-term rebleeding rate.', 'detailedDescription': 'The treatment of cirrhotic patients with PVT (portal vein thrombosis) is clearly recommended in guideline now. Several published studies has confirm the effect and safety of anticoagulation therapy in cirrhotic patients with PVT.The present studies are most observation studies with small sample size and low quality.We need more high-quality research such as randomized controlled trials. This is a Zelen-designed randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then we will make sure wether their are fond of the group and make decision by themselves. The recanalization rate and complications will be analyzed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-70 years old;\n* A clinical, radiological or histologic diagnosis of Liver cirrhosis and portal hypertension;\n* Diagnosed of Portal vein thrombosis;\n* Capable of understanding the purpose and risks of the study and informed consent to participate in the study;\n* Have undergone endoscopy to prevent variceal rebleeding.\n\nExclusion Criteria:\n\n* Age \\<18 or \\>70 years;\n* Portal vein thrombosis diagnosed before 6 months;\n* Patients with signs of acute PVT such as fever，abdominal pain or intestinal obstruction，who should be treated immediately;\n* Pregnant or nursing;\n* Hepatocellular carcinoma;\n* Severe cardiopulmonary diseases or concomitant renal insufficiency;\n* cavernous transformation of the portal vein;\n* Contradictions to endoscopy;\n* Contradictions to anticoagulation,such as:allergy to LMWH or warfarin, severe uncontrolled hypertension, history of hemorrhagic cerebral vascular accident, recent peptic ulcer disease, bacterial endocarditis, ulcerative colitis，sustained platelet count \\< 50 x103/uL);\n* Taking immunosuppressive agent;\n* Coagulation disorders other than the liver disease related;\n* Variceal bleeding failed to control.'}, 'identificationModule': {'nctId': 'NCT02398357', 'briefTitle': 'The Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'A Zelen-design Randomized Controlled Trial of the Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis', 'orgStudyIdInfo': {'id': 'CSY-LSX-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No anticoagulation，just routine follow-up'}, {'type': 'EXPERIMENTAL', 'label': 'Anticoagulation', 'description': 'Nadroparin Calcium and Warfarin', 'interventionNames': ['Drug: Nadroparin Calcium and Warfarin']}], 'interventions': [{'name': 'Nadroparin Calcium and Warfarin', 'type': 'DRUG', 'description': 'Patients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3,alone with Nadroparin Calcium 4100IU／d，subcutaneous, when taking endoscopy therapy .', 'armGroupLabels': ['Anticoagulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shenxin Lu, Doctor', 'role': 'CONTACT', 'email': '08301010239@fudan.edu.cn', 'phone': '86-13611843734'}, {'name': 'Shiyao Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shenxin Lu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jian Wang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shiyao Chen, Professor', 'role': 'CONTACT', 'email': 'chen.shiyao@zs-hospital.sh.cn', 'phone': '86-13601767310'}], 'overallOfficials': [{'name': 'Shiyao Chen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'department of Gastroenterology', 'investigatorFullName': 'Shiyao Chen', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}