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.
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
Austria1 site, 1 recruiting
- 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
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
- HVPG as a marker for advancement of hepatic fibrosis and progression of CLD is associated with an increase in platelet activation.
- 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.
- Conditions
- Chronic Liver Disease
- Keywords
- chronic liver disease, CLD, platelet function
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple electrode aggregometry (MEA) parameter area under the curve (AUC)
Measured: Single measurement within study duration of two years
Secondary outcomes (10)
MEA parameters velocity (AU/min)
Measured: Single measurement within study duration of two years
Aggregation (AU)
Measured: Single measurement within study duration of two years
Percentage (%) of P-selectin positive platelets
FACS
Measured: Single measurement within study duration of two years
Percentage (%) GPIIa/IIIb receptor positive platelets
FACS
Measured: Single measurement within study duration of two years
Percentage (%) thrombin receptor positive platelets
FACS
Measured: Single measurement within study duration of two years
P-selectin plasma level
Measured: Single measurement within study duration of two years
Serotonin plasma level
Measured: Single measurement within study duration of two years
Rotational thrombelastometry parameter: CT (coagulation time) (seconds)
Measured: Single measurement within study duration of two years
Rotational thrombelastometry parameter: CFT (clot formation time) (seconds)
Measured: Single measurement within study duration of two years
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.
- First posted1 Dec 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibylle Pramhas, Medical University of Vienna
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Hepatic Venous Pressure Gradient With Platelet Activation in Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT02618798
- Acronym / sponsor ID
- HVPG_Platelets_Version_4.0
- Conditions
- Chronic Liver Disease
- Keywords
- chronic liver disease, CLD, platelet function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 1 Dec 2015 (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.
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:
- HVPG as a marker for advancement of hepatic fibrosis and progression of CLD is associated with an increase in platelet activation.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from chronic liver disease scheduled for routine measurement of the hepatic venous pressure gradient (HVPG).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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
Multiple electrode aggregometry (MEA) parameter area under the curve (AUC)
Time frame: Single measurement within study duration of two years
10 secondary outcomes
MEA parameters velocity (AU/min)
Time frame: Single measurement within study duration of two years
Aggregation (AU)
Time frame: Single measurement within study duration of two years
Percentage (%) of P-selectin positive platelets
Time frame: Single measurement within study duration of two years
Percentage (%) GPIIa/IIIb receptor positive platelets
Time frame: Single measurement within study duration of two years
Percentage (%) thrombin receptor positive platelets
Time frame: Single measurement within study duration of two years
P-selectin plasma level
Time frame: Single measurement within study duration of two years
Serotonin plasma level
Time frame: Single measurement within study duration of two years
Rotational thrombelastometry parameter: CT (coagulation time) (seconds)
Time frame: Single measurement within study duration of two years
Rotational thrombelastometry parameter: CFT (clot formation time) (seconds)
Time frame: Single measurement within study duration of two years
Rotational thrombelastometry parameter: MCF (maximum clot firmness) (mm)
Time frame: Single measurement within study duration of two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2015.
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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.
Gisela Scharbert, M.D. contact
1 site in 1 country: see every site and its status.
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.