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Vienna Vascular Liver Disease Study (VALID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541057
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Reiberger, Medical University of Vienna

Brief Summary:
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.

Condition or disease
Vascular Liver Disease Portal Vein Thrombosis Budd-Chiari Syndrome Non-Cirrhotic Portal Hypertension Rendu Osler Weber Cardiac Cirrhosis

Detailed Description:

We will include patients with vascular liver diseases, including

  • portal vein thrombosis (PVT)
  • Budd-Chiari Syndrome (BCS)
  • Heredetary Hemorrhagic Teleangiectasia (HHT, or Osler-Rendu Disease)
  • Noncirrhotic-portal hypertension (NCPH)
  • 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Vienna Vascular Liver Disease Study: Characterization of Patients With Vascular Liver Disease - a Registry With Biobank
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022





Primary Outcome Measures :
  1. Hepatic Decompensation [ Time Frame: Up to 10 years (=Study Period) ]
    Any first hepatic decompensation: variceal bleeding, new onset of ascites, new onset of hepatic encephalopathy, new onset of jaundice


Secondary Outcome Measures :
  1. Liver-related death [ Time Frame: Up to 10 years (=Study Period) ]
    Death from a liver-related cause

  2. Coagulation status [ Time Frame: Up to 10 years (=Study Period) ]
    Coagulation status of the Patient as assessed by advanced coagulation tests (including TEG-ROTEM and TGA)


Biospecimen Retention:   Samples Without DNA
Blood, stool, urine, liver tissue, tissue from the lower / upper gastrointestinal tract (biopsy)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients with a vascular liver disease (as specified above) presenting at the outpatient department / inpatient ward of the Medical University of Vienna.
Criteria

Inclusion Criteria:

  • Diagnosis of a vascular liver disease by imaging (sonography, CT, MRI), transient elastography or liver histology
  • PVT: Portal vein thrombosis
  • NCPH: non-cirrhotic Portal Hypertension
  • BCS: Budd-Chiari-Syndrome
  • SOS: sinusoidal occlusive disease
  • HHT: hereditary hemorrhagic teleangiectasia
  • CIRCAD: cirrhosis cardiaque
  • Age >18 years and <100 years
  • Written informed consent obtained

Exclusion Criteria:

- withdrawal of written informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541057


Contacts
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Contact: Thomas Reiberger, MD 0043140400 ext 47410 thomas.reiberger@meduniwien.ac.at
Contact: Bernhard Scheiner, MD 0043140400 ext 47410 bernhard.scheiner@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Thomas Reiberger, MD    0043140400 ext 47410    thomas.reiberger@meduniwien.ac.at   
Contact: Bernhard Scheiner, MD    0043140400 ext 47410    bernhard.scheiner@meduniwien.ac.at   
Principal Investigator: Thomas Reiberger, MD         
Sub-Investigator: Bernhard Scheiner, MD         
Sub-Investigator: Mattias Mandorfer, MD         
Sub-Investigator: Philipp Schwabl, MD         
Sub-Investigator: Theresa Bucsics, MD         
Sub-Investigator: Katharina Lampichler, MD         
Sub-Investigator: Matthias Pinter, MD         
Sponsors and Collaborators
Medical University of Vienna

Additional Information:

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Responsible Party: Thomas Reiberger, Assoc.-Prof. Priv.-Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03541057    
Other Study ID Numbers: VALID 1928/2017
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Hypertension, Portal
Budd-Chiari Syndrome
Thrombosis
Vascular Diseases
Cardiovascular Diseases
Digestive System Diseases
Embolism and Thrombosis
Venous Thrombosis