Von Willebrand Factor to Predict Postoperative Outcome

NCT ID: NCT02118545

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Dysfunction Morbidity Mortality Hospitalisation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Patrick Starlinger

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patrick Starlinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Thomas Gruenberger, MD

Role: STUDY_CHAIR

Rudolf Foundation Clinic

Stefan Stättner, MD

Role: STUDY_CHAIR

Paracelsus Medical University

Guido Beldi, MD

Role: STUDY_CHAIR

University of Bern

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University Vienna

Vienna, Vienna, Austria

Site Status

Paracelsus Medical University

Salzburg, , Austria

Site Status

Rudolf Foundation Clinic

Vienna, , Austria

Site Status

University Hospital Bern

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29140542 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Vie-Sal-Ber

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3D Liver Volumetry
NCT07297615 NOT_YET_RECRUITING NA