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Value of Von Willebrand Factor in Portal Hypertension

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Arnulf Ferlitsch, MD, Medical University of Vienna.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Arnulf Ferlitsch, MD, Medical University of Vienna Identifier:
First received: May 18, 2011
Last updated: September 24, 2015
Last verified: September 2015
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.

Liver Cirrhosis Portal Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Von Willebrand Factor As Non-Invasive Predictor Of Clinically Significant Portal Hypertension And Mortality In Patients With Liver Cirrhosis

Resource links provided by NLM:

Further study details as provided by Arnulf Ferlitsch, MD, Medical University of Vienna:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Overall Mortality [ Time Frame: 3 Months ]
    Survival of Patients after index measurement of von Willebrand Factor and HVPG

Estimated Enrollment: 300
Study Start Date: September 2006
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 98 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

  • Liver cirrhosis

Exclusion Criteria:

  • no HVPG measurement
  Contacts and Locations
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Please refer to this study by its identifier: NCT01358123

Contact: Arnulf Ferlitsch, MD +43140400

Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Arnulf Ferlitsch    +436765666536   
Principal Investigator: Arnulf Ferlitsch, MD         
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna
  More Information

Responsible Party: Arnulf Ferlitsch, MD, Associate Professor, Medical University of Vienna Identifier: NCT01358123     History of Changes
Other Study ID Numbers: vwfcirr
Study First Received: May 18, 2011
Last Updated: September 24, 2015

Keywords provided by Arnulf Ferlitsch, MD, Medical University of Vienna:
liver cirrhosis
portal hypertension
von willebrand factor
hepatic venous pressure gradient

Additional relevant MeSH terms:
Liver Cirrhosis
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases processed this record on September 19, 2017