Vienna Vascular Liver Disease Study | NCT03541057

Studies
Vienna Vascular Liver Disease Study

NCT03541057

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Jan 3, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2017Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

May 6, 2018

First Submission Date that Met QC Criteria

May 17, 2018

First Posted Date

May 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2023

Last Update Posted Date

Jan 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Reiberger, Assoc.-Prof. Priv.-Doz. Dr., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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
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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Reiberger, MD	Contact	0043140400	47410	thomas.reiberger@meduniwien.ac.at
Bernhard Scheiner, MD	Contact	0043140400	47410	bernhard.scheiner@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39807082	Derived	Balcar L, Dominik N, Mozayani B, Semmler G, Halilbasic E, Mandorfer M, Reiberger T, Trauner M, Scheiner B, Stattermayer AF. Elevated Hepatic Copper Content in Porto-Sinusoidal Vascular Disorder (PSVD): Leading Down a Wrong Track. Liver Int. 2025 Feb;45(2):e16175. doi: 10.1111/liv.16175.

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D020246	Venous Thrombosis
D013927	Thrombosis