Clinical trial NCT05865691: Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease
Official title: Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Liver Diseases
Coagulation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

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.

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.

Eligibility 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:

* 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)

Primary outcomes:
measure: Activated partial thromboplastin time abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Factor II abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Factor V abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Factor VII abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Factor VIII abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Factor IX abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Factor X abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Factor XI abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Fibrinogen abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: D-dimer abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Protein C abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: protein S abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Willebrand factor abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
measure: Thrombin generation test abnormalities in patients with chronic liver disease at different stages and controls without liver disease
timeFrame: at 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Clichy
country: France
facility: Beaujon Hospital
Study officials:
affiliation: APHP
name: Pierre Emmanuel Rautou
role: PRINCIPAL_INVESTIGATOR
References: