Liver DysfunctionNCT02118545
Von Willebrand Factor to Predict Postoperative Outcome
An observational study of Liver Dysfunction and Morbidity, run by Medical University of Vienna at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Dysfunction, Morbidity, Mortality
- How many people
- 133 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients undergoing liver resection
- only patients with either hepatocellular carcinoma, cholangiocellular carcinoma or colorectal cancer liver metastasis will be included
Who cannot join
- inherited coagulopathy
- age > 85
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Austria3 sites
Paracelsus Medical University
Salzburg
Medical University Vienna
Vienna, State of Vienna, 1090
Rudolf Foundation Clinic
Vienna
About this study
Official title: 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.
- Conditions
- Liver Dysfunction, Morbidity, Mortality, Hospitalisation
- Keywords
- vWF, Liver Resection, Liver Dysfunction, Liver Regeneration, Postoperative Outcome
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Postoperative Liver Dysfunction
Preoperative vWF-Ag Predicts Postoperative Liver Dysfunction after Liver Resection
Measured: 90 postoperative days
Secondary outcomes (3)
Number of Participants with Postoperative Morbidity
Preoperative vWF-Ag Predicts Postoperative Morbidity after Liver Resection
Measured: 90 postoperative days
Number of Participants with Postoperative Mortality
Preoperative vWF-Ag Predicts Postoperative Mortality after Liver Resection
Measured: 90 postoperative days
Days of Postoperative Hospitalisation
Preoperative vWF-Ag Predicts Postoperative Hospitalisation after Liver Resection
Measured: 90 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DysfunctionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Starlinger, Medical University of Vienna
- Investigators
- Patrick Starlinger, MD, PhD, Principal investigator, Medical University of ViennaThomas Gruenberger, MD, Study chair, Rudolf Foundation ClinicStefan Stättner, MD, Study chair, Paracelsus Medical UniversityGuido Beldi, MD, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118545
- Sponsor's protocol ID
- Vie-Sal-Ber
- Status last verified
- Sep 2015
- First submitted
- 15 Apr 2014
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29140542
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Von Willebrand Factor to Predict Postoperative Liver Dysfunction and Morbidity After Liver Resection
- ClinicalTrials.gov ID
- NCT02118545
- Acronym / sponsor ID
- Vie-Sal-Ber
- Conditions
- Liver Dysfunction, Morbidity, Mortality, Hospitalisation
- Keywords
- vWF, Liver Resection, Liver Dysfunction, Liver Regeneration, Postoperative Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2016 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- patients undergoing liver resection
- only patients with either hepatocellular carcinoma, cholangiocellular carcinoma or colorectal cancer liver metastasis will be included
Key exclusion criteria (2 listed)
- inherited coagulopathy
- age > 85
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Postoperative Liver Dysfunction
Time frame: 90 postoperative days
Preoperative vWF-Ag Predicts Postoperative Liver Dysfunction after Liver Resection
3 secondary outcomes
Number of Participants with Postoperative Morbidity
Time frame: 90 postoperative days
Number of Participants with Postoperative Mortality
Time frame: 90 postoperative days
Days of Postoperative Hospitalisation
Time frame: 90 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Derived from this study: PubMed 29140542Starlinger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Starlinger, MD, PhD principal investigator
Medical University of Vienna
Thomas Gruenberger, MD study chair
Rudolf Foundation Clinic
Stefan Stättner, MD study chair
Paracelsus Medical University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Dysfunction and Morbidity, run by Medical University of Vienna at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Postoperative Liver Dysfunction (time frame: 90 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016; AzTrials last refreshed its copy on 30 Oct 2026.