VALID: Vienna Vascular Liver Disease Study

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT03541057

Collaborator

(none)

150

Enrollment

Location

59.6

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 12, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Last Update Posted:

Nov 3, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2020