Value of Von Willebrand Factor in Portal Hypertension

September 24, 2015 updated by: Arnulf Ferlitsch, MD, Medical University of Vienna

Von Willebrand Factor As Non-Invasive Predictor Of Clinically Significant Portal Hypertension And Mortality In Patients With Liver Cirrhosis

In patients with liver cirrhosis elevated levels of von Willebrand factor antigen (vWF-Ag) are found frequently but the clinical significance is unclear. vWF-Ag plays an important role in primary haemostasis and development of thrombotic vascular obliteration is discussed as a possible mechanism leading to portal hypertension. Invasive measurement of hepatic venous pressure gradient (HVPG) is the current gold standard for the diagnosis of portal hypertension. The investigators hypothesize that vWF-Ag levels in plasma may correlate with portal pressure and predict clinically significant portal hypertension (CSPH, HVPG >=10mmHg) and its complications.

Study Overview

Status

Unknown

Conditions

Detailed Description

Patients with alcoholic, viral (chronic hepatitis C), and cryptogenic liver cirrhosis are included. Portal hemodynamics are assessed by HVPG measurement, vWF-Ag levels were measured by ELISA. Results will be compared. 3 and 6 months mortality will be recorded.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Principal Investigator:
          • Arnulf Ferlitsch, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with liver cirrhosis of all etioloiges, routinely scheduled for routine HVPG measurement will systematically be included during the study period

Description

Inclusion Criteria:

  • Liver cirrhosis

Exclusion Criteria:

  • no HVPG measurement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
von Willebrand Factor Ag Level
Time Frame: at first visit (HVPG Measurement) (day 1)
von Willebrand Factor Antigen Levels are measured via ELISA and compared /corrlated to Hepatic Venous Pressure Gradient (HVPG). von Willebrand Factor Antigen levels are drawn and analyzed at the day of HVPG measurement. No follow up measurements will be performed, survival will be measured as secondary outcome parameter
at first visit (HVPG Measurement) (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Mortality
Time Frame: 3 Months
Survival of Patients after index measurement of von Willebrand Factor and HVPG
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Arnulf Ferlitsch, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vwfcirr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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