Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease (CLUE)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Chronic Liver Diseases; Coagulation

Treatments: Other: biomarker assay

Study type: Observational

Funder types: Other

Identifiers

NCT05865691

APHP220750

2022-A01421-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

360 participants in 6 patient groups

controls without liver disease

Description:

blood collection on the day of inclusion

Treatment:

Other: biomarker assay

patients with chronic liver disease without cirrhosis

Description:

blood collection on the day of inclusion

Treatment:

Other: biomarker assay

patients with chronic liver disease with compensated cirrhosis

Description:

blood collection on the day of inclusion

Treatment:

Other: biomarker assay

patients with chronic liver disease with stable decompensated cirrhosis

Description:

blood collection on the day of inclusion

Treatment:

Other: biomarker assay

patients with chronic liver disease with decompensated cirrhosis in the acute phase

Description:

blood collection on the day of inclusion

Treatment:

Other: biomarker assay

patients with chronic liver disease with decompensated cirrhosis and organ failure

Description:

blood collection on the day of inclusion

Treatment:

Other: biomarker assay