Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
Chronic liver diseases represent a major public health problem and are responsible for more than 150,000 deaths in Europe each year. These diseases are accompanied by symptoms that profoundly alter the quality of life and mainly affect people of working age, leading to a major economic impact.
Coagulation disorders, inflammation and vascular alterations are associated with chronic liver diseases but their role in the onset and/or progression of liver diseases is still not fully understood.
A better understanding of chronic liver diseases and in particular of the factors that play a role in the onset and progression of these diseases would improve patient management and therefore have a positive impact on individuals, but also on the healthcare system and the economy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Liver biopsy showing chronic liver disease or cirrhosis
Liver elastography by Fibroscan® assessing the elasticity of the liver at more than 10 kpa
Combination of clinical, biological and imaging criteria characteristic of chronic liver disease (signs of portal hypertension, liver failure and liver dysmorphia in a patient with at least one risk factor for chronic liver disease)
Disqualifiers
Pregnant or lactating women
Protected populations: persons under guardianship, under curatorship or safeguard of justice
Patient under AME
Patient who has not signed a consent form
Trial population
Patients over 18 years of age with chronic liver disease Controls without liver disease will be individuals over 18 years of age without liver disease
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
biomarker assay
Other interventionblood sample on the day of inclusion
Treatment groups
360 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: controls without liver disease1 intervention
Group B: patients with chronic liver disease without cirrhosis1 intervention
Group C: patients with chronic liver disease with compensated cirrhosis1 intervention
Group D: patients with chronic liver disease with stable decompensated cirrhosis1 intervention
Group E: patients with chronic liver disease with decompensated cirrhosis in the acute phase1 intervention
Group F: patients with chronic liver disease with decompensated cirrhosis and organ failure1 intervention
Trial outcomes
Primary outcomes
1
Activated partial thromboplastin time abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of activated partial thromboplastin time for each patient at inclusion
Time frame
at 10 years2
Factor II abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor II for each patient at inclusion
Time frame
at 10 years3
Factor V abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor V for each patient at inclusion
Time frame
at 10 years4
Factor VII abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor VII for each patient at inclusion
Time frame
at 10 yearsSponsors and contacts
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Source ClinicalTrials.gov