Clinical trial NCT02118545: Von Willebrand Factor to Predict Postoperative Outcome
Official title: Preoperative Von Willebrand Factor to Predict Postoperative Liver Dysfunction and Morbidity After Liver Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Dysfunction
Morbidity
Mortality
Hospitalisation
Keywords: vWF
Liver Resection
Liver Dysfunction
Liver Regeneration
Postoperative Outcome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Postoperative Liver Dysfunction
timeFrame: 90 postoperative days
Secondary outcomes:
measure: Number of Participants with Postoperative Morbidity
timeFrame: 90 postoperative days
measure: Number of Participants with Postoperative Mortality
timeFrame: 90 postoperative days
measure: Days of Postoperative Hospitalisation
timeFrame: 90 postoperative days
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Paracelsus Medical University
city: Vienna
country: Austria
facility: Medical University Vienna
city: Vienna
country: Austria
facility: Rudolf Foundation Clinic
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Medical University Vienna
name: Patrick Starlinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rudolf Foundation Clinic
name: Thomas Gruenberger, MD
role: STUDY_CHAIR
affiliation: Paracelsus Medical University
name: Stefan Stättner, MD
role: STUDY_CHAIR
affiliation: University of Bern
name: Guido Beldi, MD
role: STUDY_CHAIR
References:
citation: 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.