Hepatic Venous Pressure Gradient and Platelet Activation in Chronic Liver Disease

NCT02618798 | Unknown

• 1 other identifier: HVPG_Platelets_Version_4.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.HVPG as a marker for advancement of hepatic fibrosis and progression of CLD is associated with an increase in platelet activation.
2. 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

Conditions

Chronic Liver Disease

Keywords

chronic liver disease; CLD; platelet function

Outcome Measures

Primary Outcomes (1)

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

  Single measurement within study duration of two years

Secondary Outcomes (10)

• MEA parameters velocity (AU/min)

  Single measurement within study duration of two years

• Aggregation (AU)

  Single measurement within study duration of two years

• Percentage (%) of P-selectin positive platelets

  Single measurement within study duration of two years

• Percentage (%) GPIIa/IIIb receptor positive platelets

  Single measurement within study duration of two years

• Percentage (%) thrombin receptor positive platelets

  Single measurement within study duration of two years

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Impaired kidney function (Creatinine \> 1.3mg/dl)
• Platelet count \< 50,000/µl
• Participation in a clinical trial in the 3 weeks preceding the study
• Use of anti-thrombotic or anticoagualant medication
• Pregnancy
• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma Platelet pellet

Central Study Contacts

Sibylle Pramhas, M.D.

CONTACT

+43140400; sibylle.pramhas@meduniwien.ac.at

Gisela Scharbert, M.D.

CONTACT

gisela.scharbert@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 1, 2015

Record last verified: 2015-11

Locations

AU (1)