Von Willebrand Factor to Predict Postoperative Outcome

March 7, 2016 updated by: Patrick Starlinger, Medical University of Vienna

Preoperative Von Willebrand Factor to Predict Postoperative Liver Dysfunction and Morbidity After Liver Resection

vWF is stored in weibel-palade-bodies of endothelial cells as well as alpha-granula of platelets and is released upon their activation. Endothelial cell dysfunction as well as platelet activation often occur in liver disease and portal hypertension, which may lead to an increase in circulating vWF levels. Indeed, multiple studies have reported that liver disease is associated with increased circulating vWF- antigen (vWF-Ag). Furthermore, increased circulating vWF -Ag Levels have been shown to be associated with increased mortality rates in patients with chronic liver disease. Within a prospective evaluation cohort, the investigators were able to document that patients with increased vWF-Ag levels prior to liver resection suffered from an increased incidence of postoperative liver dysfunction and morbidity. Within this prospective multicenter validation study, the investigators now aim to prospectively validate that circulating vWF-Ag prior to liver resection is a valuable marker to predict postoperative clinical outcome.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

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

Study Locations

  • Austria
      • Salzburg, Austria
        • Paracelsus Medical University
      • Vienna, Austria, 1090
        • Medical University Vienna
      • Vienna, Austria
        • Rudolf Foundation Clinic
  • Switzerland
      • Bern, Switzerland
        • University Hospital Bern

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 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing liver resections for either hepatocellular carcinoma, cholangiocellular carcinoma or colorectal cancer liver metastasis. vWF-Ag will be evaluated prior to liver resection

Description

Inclusion Criteria:

  • patients undergoing liver resection
  • only patients with either hepatocellular carcinoma, cholangiocellular carcinoma or colorectal cancer liver metastasis will be included

Exclusion Criteria:

  • inherited coagulopathy
  • age > 85

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

Cohorts and Interventions

Group / Cohort
vWF and postoperative Outcome
An independent prospective validation cohorts will be obtained from 4 different Institutions: 2 in Vienna , 1 in Salzburg and 1 in Bern

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Postoperative Liver Dysfunction
Time Frame: 90 postoperative days
Preoperative vWF-Ag Predicts Postoperative Liver Dysfunction after Liver Resection
90 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Postoperative Morbidity
Time Frame: 90 postoperative days
Preoperative vWF-Ag Predicts Postoperative Morbidity after Liver Resection
90 postoperative days
Number of Participants with Postoperative Mortality
Time Frame: 90 postoperative days
Preoperative vWF-Ag Predicts Postoperative Mortality after Liver Resection
90 postoperative days
Days of Postoperative Hospitalisation
Time Frame: 90 postoperative days
Preoperative vWF-Ag Predicts Postoperative Hospitalisation after Liver Resection
90 postoperative days

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Patrick Starlinger, MD, PhD, Medical University Vienna
  • Study Chair: Thomas Gruenberger, MD, Rudolf Foundation Clinic
  • Study Chair: Stefan Stättner, MD, Paracelsus Medical University
  • Study Chair: Guido Beldi, MD, University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2014

Primary Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (ESTIMATE)

April 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vie-Sal-Ber

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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