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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358123
First Posted: May 23, 2011
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arnulf Ferlitsch, MD, Medical University of Vienna
  Purpose
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.

Condition
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.
  Eligibility

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Liver cirrhosis

Exclusion Criteria:

  • no HVPG measurement
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358123


Contacts
Contact: Arnulf Ferlitsch, MD +43140400 arnulf.ferlitsch@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Arnulf Ferlitsch    +436765666536    arnulf.ferlitsch@meduniwien.ac.at   
Principal Investigator: Arnulf Ferlitsch, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna
  More Information

Responsible Party: Arnulf Ferlitsch, MD, Associate Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01358123     History of Changes
Other Study ID Numbers: vwfcirr
First Submitted: May 18, 2011
First Posted: May 23, 2011
Last Update Posted: September 25, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Hypertension
Fibrosis
Liver Cirrhosis
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases