Value of Von Willebrand Factor in Portal Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Arnulf Ferlitsch, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01358123
First received: May 18, 2011
Last updated: October 23, 2013
Last verified: October 2013
  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 Medical University of Vienna:

Primary Outcome Measures:
  • von Willebrand Factor Ag Level [ Time Frame: at first visit (HVPG Measurement) (day 1) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Survival of Patients after index measurement of von Willebrand Factor and HVPG


Estimated Enrollment: 300
Study Start Date: September 2006
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Arnulf Ferlitsch, MD, Associate Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01358123     History of Changes
Other Study ID Numbers: vwfcirr
Study First Received: May 18, 2011
Last Updated: October 23, 2013
Health Authority: Austria: Ethikkommission

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

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

ClinicalTrials.gov processed this record on August 25, 2014