Vienna Vascular Liver Disease Study

Vienna Vascular Liver Disease Study: Characterization of Patients With Vascular Liver Disease - a Registry With Biobank

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03541057

Acronym

VALID

Enrollment

200

Registered

2018-05-30

Start date

2017-12-12

Completion date

2024-12-31

Last updated

2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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) and Porto-sinusoidal vascular disorder * 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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 * 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

Exclusion criteria

\- withdrawal of written informed consent

Design outcomes

Primary

Measure	Time frame	Description
Hepatic Decompensation	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

Measure	Time frame	Description
Liver-related death	Up to 10 years (=Study Period)	Death from a liver-related cause
Coagulation status	Up to 10 years (=Study Period)	Coagulation status of the Patient as assessed by advanced coagulation tests (including TEG-ROTEM and TGA)

Countries

Austria

Contacts

Primary ContactThomas Reiberger, MD

thomas.reiberger@meduniwien.ac.at0043140400

Backup ContactBernhard Scheiner, MD

bernhard.scheiner@meduniwien.ac.at0043140400

Outcome results