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Chronic Liver DiseaseNCT02618798

Hepatic Venous Pressure Gradient and Platelet Activation in Chronic Liver Disease

An observational study of Chronic Liver Disease, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Thrombosis may be crucial in driving the progression of fibrosis in chronic liver disease (CLD). The potential role of platelets and platelet activation in this process is unclear. Platelets participate in inflammation by secretion of pro-inflammatory mediators which may advance hepatic fibrosis. Read more about this study

Who is it for?
Ages 19 to 90 years
Conditions the study is for
Chronic Liver Disease
How many people
100 participants
Where
1 siteAustria
Study dates
Jan 2014to Jan 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 19 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients suffering from chronic liver disease scheduled for routine measurement of the hepatic venous pressure gradient (HVPG).

Who may be able to join

  • Confirmed chronic liver disease (CLD), alcoholic, viral, cholestatic.
  • CHILD-PUGH Stage A, B, C, and non-cirrhotics
  • Planned routine measurement of HVPG.
  • Age: 19 years or older

Who cannot join

  • Impaired kidney function (Creatinine > 1.3mg/dl)
  • Platelet count < 50,000/µl
  • Participation in a clinical trial in the 3 weeks preceding the study
  • IFN-therapy within 6 months of inclusion into the study.
  • Use of anti-thrombotic or anticoagualant medication
  • Pregnancy
Show all 9Show fewer
  • Intra or extra-hepatic malignancy
  • Haemostatic diseases other than cirrhosis
  • Current abuse of alcohol (Abstinence from alcohol for at least 6 weeks preceding the study is required)

Trial locations and contacts

1 site in 1 country.

Gisela Scharbert, M.D. contact

gisela.scharbert@meduniwien.ac.at

Austria1 site, 1 recruiting
  • Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna

    Vienna, State of Vienna, 1090

    Gisela Scharbert, MD, 0043140400 ext. 4137, gisela.scharbert@meduniwien.ac.at

    Sibylle Pramhas, MD, 0043140400 ext. 4144, sibylle.pramhas@meduniwien.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: Association of Hepatic Venous Pressure Gradient With Platelet Activation in Chronic Liver Disease

Background: Thrombosis may be crucial in driving the progression of fibrosis in chronic liver disease (CLD). The potential role of platelets and platelet activation in this process is unclear. Platelets participate in inflammation by secretion of pro-inflammatory mediators which may advance hepatic fibrosis. Hepatitis B virus transgenic mice, developed significantly smaller necroinflammatory foci and their serum ALT levels were 80% lower, if they were pre-treated with anti-platelet antibodies. Sinusoidal aggregation of activated platelets also occurs in chronic hepatitis C in humans. It may contribute to thrombocytopenia observed in CLD. Platelet activation is generally believed to be compromised in CLD. However, there is data suggesting that CLD may even be associated with an enhancement of platelet activation. Measurement of hepatic venous pressure gradient (HVPG) constitutes the most common method for estimation of portal venous pressure. HVPG is significantly correlated with histological indices of CLD progression.

Study hypotheses:

Read more
  1. HVPG as a marker for advancement of hepatic fibrosis and progression of CLD is associated with an increase in platelet activation.
  2. Platelet activation and function is not generally compromised in CLD. Comparison of platelet function in CLD to a control group of healthy volunteers is intended to clarify whether CLD leads to a manifest platelet dysfunction

Methods: Study design is observational. 100 patients with CLD of various origins (viral, alcoholic, cholestatic) scheduled for routine HVPG measurement will be enrolled. 30 healthy volunteers will donate blood as a control group. Platelet function and activation will be evaluated by multiple electrode aggregometry (primary outcome variable area under the curve (AUC). Plasma levels of P-selectin (ELISA), PFA (Platelet Function Analyzer) 100™ parameters (EPI-CT and ADP-CT), percentage of P-selectin, GPIIb/IIIa, thrombin receptor positive platelets after stimulation (flow-cytometry) will constitute secondary outcome parameters. Plasmatic coagulation will be evaluated by rotational thrombelastometry (ROTEM). Platelet count and routine coagulation parameters will be monitored. HVPG measurement by hepatic vein catheterization and patient blood sampling will be carried out via the internal jugular vein. Blood sampling in volunteers will be performed via the antecubital vein

Study Rationale: If higher levels of platelet activation are associated with increased HVPGs, this would provide an insight into the pathogenesis of CLD. It would also point toward a possible benefit of anti-platelet therapy in CLD. Verification of platelet dysfunction in CLD is relevant to clinical practice in anaesthesiology and intensive care as procedures are often postponed in CLD-patients for fear of bleeding complications. CLD patients may also receive prophylactic platelet concentrates prior to interventions which is costly, fraught with risk of bacterial infection and may be unnecessary in the absence of platelet dysfunction.

Keywords
chronic liver disease, CLD, platelet function

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Multiple electrode aggregometry (MEA) parameter area under the curve (AUC)

    Measured: Single measurement within study duration of two years

Secondary outcomes (10)
  1. MEA parameters velocity (AU/min)

    Measured: Single measurement within study duration of two years

  2. Aggregation (AU)

    Measured: Single measurement within study duration of two years

  3. Percentage (%) of P-selectin positive platelets

    FACS

    Measured: Single measurement within study duration of two years

  4. Percentage (%) GPIIa/IIIb receptor positive platelets

    FACS

    Measured: Single measurement within study duration of two years

  5. Percentage (%) thrombin receptor positive platelets

    FACS

    Measured: Single measurement within study duration of two years

  6. P-selectin plasma level

    Measured: Single measurement within study duration of two years

  7. Serotonin plasma level

    Measured: Single measurement within study duration of two years

  8. Rotational thrombelastometry parameter: CT (coagulation time) (seconds)

    Measured: Single measurement within study duration of two years

  9. Rotational thrombelastometry parameter: CFT (clot formation time) (seconds)

    Measured: Single measurement within study duration of two years

  10. Rotational thrombelastometry parameter: MCF (maximum clot firmness) (mm)

    Measured: Single measurement within study duration of two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2016 (estimated)
  4. Study completionJan 2016 (estimated)

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02618798
Sponsor's protocol ID
HVPG_Platelets_Version_4.0
Status last verified
Nov 2015
First submitted
23 Nov 2015
Last updated
1 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Liver Disease, run by Medical University of Vienna at 1 site in Austria.

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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sibylle Pramhas, M.D. (+43140400 ext. 41000, sibylle.pramhas@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multiple electrode aggregometry (MEA) parameter area under the curve (AUC) (time frame: Single measurement within study duration of two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 Dec 2015.

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