Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-04 @ 11:00 PM
Study NCT ID:
NCT02630095
Status:
UNKNOWN
Last Update Posted:
2015-12-15
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis：A Multicenter RCT
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'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}], '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'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, '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': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2015-12-08', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recanalization rate of PVT', 'timeFrame': 'through study completion，an average of 18 months', 'description': 'Patients will receive Doppler ultrasound and CT before enrolled and followed up by Doppler ultrasound every 3 months ,by CT every 6 months after enrolled，untill the end of the study.'}], 'secondaryOutcomes': [{'measure': 'Rebleeding rate', 'timeFrame': 'through study completion，an average of 18 months', 'description': 'The investigators observe the variceal rebleeding events during the study'}, {'measure': 'Incidence rate of complications', 'timeFrame': 'through study completion，an average of 18 months', 'description': 'The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anticoagulation'], 'conditions': ['Portal Vein Thrombosis', 'Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality.', '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. The investigators need more high-quality research such as randomized controlled trials. This is a Zelen-designed multicenter randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then the investigator 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 or other cancer;\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 x10\\^9/L);\n* Taking immunosuppressive agent;\n* Coagulation disorders other than the liver disease related;\n* Variceal bleeding failed to control.'}, 'identificationModule': {'nctId': 'NCT02630095', 'briefTitle': 'The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis：A Multicenter RCT', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis：A Zelen-design Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CSY-LSX02-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control.', 'description': 'No anticoagulation，just routine follow up.', 'interventionNames': ['Device: Doppler ultrasound and CT']}, {'type': 'EXPERIMENTAL', 'label': 'Anticoagulation', 'description': 'Nadroparin Calcium and Warfarin', 'interventionNames': ['Drug: Nadroparin Calcium and Warfarin', 'Device: Doppler ultrasound and CT']}], '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, and during the of perioperative period of Endoscopic treatment changing to use Nadroparin Calcium 4100IU／d，subcutaneous.', 'armGroupLabels': ['Anticoagulation']}, {'name': 'Doppler ultrasound and CT', 'type': 'DEVICE', 'description': 'all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。', 'armGroupLabels': ['Anticoagulation', 'Control.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', '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'}, 'collaborators': [{'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Shanghai Public Health Clinical Center', 'class': 'OTHER_GOV'}, {'name': 'ShuGuang Hospital', 'class': 'OTHER'}, {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Shanghai Pudong New Area Gongli Hospital', 'class': 'OTHER'}, {'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of department of Gastroenterology, Zhongshan Hospital', 'investigatorFullName': 'Shiyao Chen', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}