Von Willebrand Factor to Predict Postoperative Outcome

NCT02118545 | Completed

• 1 other identifier: Vie-Sal-Ber
• Study Type: observational
• Target: 133
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Liver Dysfunction; Morbidity; Mortality; Hospitalisation

Keywords

vWF; Liver Resection; Liver Dysfunction; Liver Regeneration; Postoperative Outcome

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Postoperative Liver Dysfunction

  Preoperative vWF-Ag Predicts Postoperative Liver Dysfunction after Liver Resection

  90 postoperative days

Secondary Outcomes (3)

• Number of Participants with Postoperative Morbidity

  90 postoperative days

• Number of Participants with Postoperative Mortality

  90 postoperative days

• Days of Postoperative Hospitalisation

  90 postoperative days

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• inherited coagulopathy
• age \> 85

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (4)

Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

Paracelsus Medical University

Salzburg, Austria

Location

Rudolf Foundation Clinic

Vienna, Austria

Location

University Hospital Bern

Bern, Switzerland

Location

Related Publications (1)

• Starlinger P, Pereyra D, Haegele S, Braeuer P, Oehlberger L, Primavesi F, Kohler A, Offensperger F, Reiberger T, Ferlitsch A, Messner B, Beldi G, Staettner S, Brostjan C, Gruenberger T. Perioperative von Willebrand factor dynamics are associated with liver regeneration and predict outcome after liver resection. Hepatology. 2018 Apr;67(4):1516-1530. doi: 10.1002/hep.29651. Epub 2018 Feb 27.

  PMID: 29140542 DERIVED

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Patrick Starlinger, MD, PhD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

• Thomas Gruenberger, MD

  Rudolf Foundation Clinic

  STUDY CHAIR

• Stefan Stättner, MD

  Paracelsus Medical University

  STUDY CHAIR

• Guido Beldi, MD

  University of Bern

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Last Updated: March 8, 2016

Record last verified: 2015-09

Locations

AU (3); CH (1)