Vienna Vascular Liver Disease Study

NCT03541057 | Unknown

• 1 other identifier: VALID 1928/2017
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Liver Disease; Portal Vein Thrombosis; Budd-Chiari Syndrome; Non-Cirrhotic Portal Hypertension; Rendu Osler Weber; Cardiac Cirrhosis; Porto-sinusoidal Vascular Disorder

Outcome Measures

Primary Outcomes (1)

• Hepatic Decompensation

  Any first hepatic decompensation: variceal bleeding, new onset of ascites, new onset of hepatic encephalopathy, new onset of jaundice

  Up to 10 years (=Study Period)

Secondary Outcomes (2)

• Liver-related death

  Up to 10 years (=Study Period)

• Coagulation status

  Up to 10 years (=Study Period)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• PSVD: porto-sinusoidal vascular disorder
• 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

You may not qualify if:

• \- withdrawal of written informed consent

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, stool, urine, liver tissue, tissue from the lower / upper gastrointestinal tract (biopsy)

MeSH Terms

Conditions

Budd-Chiari Syndrome

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Thomas Reiberger, MD

CONTACT

0043140400; thomas.reiberger@meduniwien.ac.at

Bernhard Scheiner, MD

CONTACT

0043140400; bernhard.scheiner@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.-Prof. Priv.-Doz. Dr.

Study Record Dates

• First Submitted: May 6, 2018
• First Posted: May 30, 2018
• Study Start: December 12, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

AU (1)