CLUE: Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
The main objective is to identify the role of coagulation in the development and progression of chronic liver diseases and their complications.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| controls without liver disease blood collection on the day of inclusion |
Other: biomarker assay
blood sample on the day of inclusion
Other Names:
|
| patients with chronic liver disease without cirrhosis blood collection on the day of inclusion |
Other: biomarker assay
blood sample on the day of inclusion
Other Names:
|
| patients with chronic liver disease with compensated cirrhosis blood collection on the day of inclusion |
Other: biomarker assay
blood sample on the day of inclusion
Other Names:
|
| patients with chronic liver disease with stable decompensated cirrhosis blood collection on the day of inclusion |
Other: biomarker assay
blood sample on the day of inclusion
Other Names:
|
| patients with chronic liver disease with decompensated cirrhosis in the acute phase blood collection on the day of inclusion |
Other: biomarker assay
blood sample on the day of inclusion
Other Names:
|
| patients with chronic liver disease with decompensated cirrhosis and organ failure blood collection on the day of inclusion |
Other: biomarker assay
blood sample on the day of inclusion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Activated partial thromboplastin time abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of activated partial thromboplastin time for each patient at inclusion
- Factor II abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of factor II for each patient at inclusion
- Factor V abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of factor V for each patient at inclusion
- Factor VII abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of factor VII for each patient at inclusion
- Factor VIII abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of factor VIII for each patient at inclusion
- Factor IX abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of factor IX for each patient at inclusion
- Factor X abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of factor X for each patient at inclusion
- Factor XI abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of factor XI for each patient at inclusion
- Fibrinogen abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of fibrinogen for each patient at inclusion
- D-dimer abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
mesure of D-dimer for each patient at inclusion
- Protein C abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of protein C for each patient at inclusion
- protein S abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
mesure of protein S for each patient at inclusion
- Willebrand factor abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of plasma Willebrand factor for each patient at inclusion
- Thrombin generation test abnormalities in patients with chronic liver disease at different stages and controls without liver disease [at 10 years]
Mesure of thrombin generation test for each patient at inclusion
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients with chronic liver disease:
Patients over 18 years of age Patients affiliated with a social security plan or entitled to receive benefits Patients with chronic liver disease or cirrhosis whose diagnosis is based on one or more of the following
-
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)
Controls without liver disease Patients 18 years of age with no known liver disease Patients who have had blood drawn in the hospital prior to surgery (pre-operative work-up as part of the care process).
Exclusion Criteria:
Common non-inclusion criteria for patients with chronic liver disease and controls without liver disease will be as follows:
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Pregnant or lactating women
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Protected populations: persons under guardianship, under curatorship or safeguard of justice
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Patient under AME
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Patient who has not signed a consent form
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Recent surgery before the blood test (< 2 weeks)
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Transfusion of blood products (packed red blood cells, platelet concentrates, fresh frozen plasma, etc.) recently (< 2 weeks)
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Use of medication that interferes with hemostasis
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Active extra-hepatic cancer or cancer less than 5 years old
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Organ transplantation (liver, kidney, lung, heart)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Pierre Emmanuel Rautou, APHP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP220750
- 2022-A01421-42