Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-29 @ 6:17 AM
Study NCT ID:
NCT03541057
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2018-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vienna Vascular Liver Disease Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006502', 'term': 'Budd-Chiari Syndrome'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood, stool, urine, liver tissue, tissue from the lower / upper gastrointestinal tract (biopsy)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-30', 'studyFirstSubmitDate': '2018-05-06', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic Decompensation', 'timeFrame': 'Up to 10 years (=Study Period)', 'description': 'Any first hepatic decompensation: variceal bleeding, new onset of ascites, new onset of hepatic encephalopathy, new onset of jaundice'}], 'secondaryOutcomes': [{'measure': 'Liver-related death', 'timeFrame': 'Up to 10 years (=Study Period)', 'description': 'Death from a liver-related cause'}, {'measure': 'Coagulation status', 'timeFrame': 'Up to 10 years (=Study Period)', 'description': 'Coagulation status of the Patient as assessed by advanced coagulation tests (including TEG-ROTEM and TGA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Liver Disease', 'Portal Vein Thrombosis', 'Budd-Chiari Syndrome', 'Non-Cirrhotic Portal Hypertension', 'Rendu Osler Weber', 'Cardiac Cirrhosis', 'Porto-sinusoidal Vascular Disorder']}, 'descriptionModule': {'briefSummary': "The aim of this Register Trial is to systematically study the epidemiology, risk factors, liver function as well prognosis of patients with vascular liver diseases. Furthermore, important clinical parameters will be assessed in order to evaluate patients' coagulation status and in order to develop new biomarkers derived from blood, urine, stool or ascites of patients as well as histological samples from the upper / lower GI-tract or the liver in order to better understand the natural history of vascular liver diseases.", 'detailedDescription': 'We will include patients with vascular liver diseases, including\n\n* portal vein thrombosis (PVT)\n* Budd-Chiari Syndrome (BCS)\n* Heredetary Hemorrhagic Teleangiectasia (HHT, or Osler-Rendu Disease)\n* Noncirrhotic-portal hypertension (NCPH) and Porto-sinusoidal vascular disorder\n* Cirrhosis cardiaque if the fulfill inclusion/exclusion criteria and provide written informed consent. Participation in the biobank is optional for the patients. In particular, we will study the natural course of the patients in regard to hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), need for intensified treatment (TIPS, ICU, liver transplantation) and survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients with a vascular liver disease (as specified above) presenting at the outpatient department / inpatient ward of the Medical University of Vienna.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a vascular liver disease by imaging (sonography, CT, MRI), transient elastography or liver histology\n* PVT: Portal vein thrombosis\n* NCPH: non-cirrhotic Portal Hypertension\n* PSVD: porto-sinusoidal vascular disorder\n* BCS: Budd-Chiari-Syndrome\n* SOS: sinusoidal occlusive disease\n* HHT: hereditary hemorrhagic teleangiectasia\n* CIRCAD: cirrhosis cardiaque\n* Age \\>18 years and \\<100 years\n* Written informed consent obtained\n\nExclusion Criteria:\n\n\\- withdrawal of written informed consent'}, 'identificationModule': {'nctId': 'NCT03541057', 'acronym': 'VALID', 'briefTitle': 'Vienna Vascular Liver Disease Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Vienna Vascular Liver Disease Study: Characterization of Patients With Vascular Liver Disease - a Registry With Biobank', 'orgStudyIdInfo': {'id': 'VALID 1928/2017'}}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Thomas Reiberger, MD', 'role': 'CONTACT', 'email': 'thomas.reiberger@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '47410'}, {'name': 'Bernhard Scheiner, MD', 'role': 'CONTACT', 'email': 'bernhard.scheiner@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '47410'}, {'name': 'Thomas Reiberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bernhard Scheiner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mattias Mandorfer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philipp Schwabl, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Theresa Bucsics, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katharina Lampichler, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthias Pinter, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Thomas Reiberger, MD', 'role': 'CONTACT', 'email': 'thomas.reiberger@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '47410'}, {'name': 'Bernhard Scheiner, MD', 'role': 'CONTACT', 'email': 'bernhard.scheiner@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '47410'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.-Prof. Priv.-Doz. Dr.', 'investigatorFullName': 'Thomas Reiberger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}