Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease
NCT ID: NCT05865691
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
360 participants
OBSERVATIONAL
2023-09-07
2035-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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controls without liver disease
blood collection on the day of inclusion
biomarker assay
blood sample on the day of inclusion
patients with chronic liver disease without cirrhosis
blood collection on the day of inclusion
biomarker assay
blood sample on the day of inclusion
patients with chronic liver disease with compensated cirrhosis
blood collection on the day of inclusion
biomarker assay
blood sample on the day of inclusion
patients with chronic liver disease with stable decompensated cirrhosis
blood collection on the day of inclusion
biomarker assay
blood sample on the day of inclusion
patients with chronic liver disease with decompensated cirrhosis in the acute phase
blood collection on the day of inclusion
biomarker assay
blood sample on the day of inclusion
patients with chronic liver disease with decompensated cirrhosis and organ failure
blood collection on the day of inclusion
biomarker assay
blood sample on the day of inclusion
Interventions
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biomarker assay
blood sample on the day of inclusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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).
* 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
* Recent surgery before the blood test (\< 2 weeks)
* Transfusion of blood products (packed red blood cells, platelet concentrates, fresh frozen plasma, etc.) recently (\< 2 weeks)
* Use of medication that interferes with hemostasis
* Active extra-hepatic cancer or cancer less than 5 years old
* Organ transplantation (liver, kidney, lung, heart)
18 Years
ALL
No
Sponsors
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Assistance Publique - HĂ´pitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Pierre Emmanuel Rautou
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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Beaujon Hospital
Clichy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A01421-42
Identifier Type: OTHER
Identifier Source: secondary_id
APHP220750
Identifier Type: -
Identifier Source: org_study_id
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