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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coagulation; Chronic Liver Diseases
• Intervention / Treatment: Other: biomarker assay

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 Type: Observational
• Enrollment (Anticipated): 360

Contacts and Locations

• Study Contact: Name: Pierre Emmanuel RAUTOU; Phone Number: +33 140875283; Email: pierre-emmanuel.rautou@aphp.fr
• Study Contact Backup: Name: Alix Riescher-Tuczkiewicz; Phone Number: 140875283; Email: alix.riescher-tuczkiewicz@inserm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	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: blood sample
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: blood sample
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: blood sample
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: blood sample
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: blood sample
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: blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 10 years
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	at 10 years
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	at 10 years
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	at 10 years
Factor VIII abnormalities in patients with chronic liver disease at different stages and controls without liver disease	Mesure of factor VIII for each patient at inclusion	at 10 years
Factor IX abnormalities in patients with chronic liver disease at different stages and controls without liver disease	Mesure of factor IX for each patient at inclusion	at 10 years
Factor X abnormalities in patients with chronic liver disease at different stages and controls without liver disease	Mesure of factor X for each patient at inclusion	at 10 years
Factor XI abnormalities in patients with chronic liver disease at different stages and controls without liver disease	Mesure of factor XI for each patient at inclusion	at 10 years
Fibrinogen abnormalities in patients with chronic liver disease at different stages and controls without liver disease	Mesure of fibrinogen for each patient at inclusion	at 10 years
D-dimer abnormalities in patients with chronic liver disease at different stages and controls without liver disease	mesure of D-dimer for each patient at inclusion	at 10 years
Protein C abnormalities in patients with chronic liver disease at different stages and controls without liver disease	Mesure of protein C for each patient at inclusion	at 10 years
protein S abnormalities in patients with chronic liver disease at different stages and controls without liver disease	mesure of protein S for each patient at inclusion	at 10 years
Willebrand factor abnormalities in patients with chronic liver disease at different stages and controls without liver disease	Mesure of plasma Willebrand factor for each patient at inclusion	at 10 years
Thrombin generation test abnormalities in patients with chronic liver disease at different stages and controls without liver disease	Mesure of thrombin generation test for each patient at inclusion	at 10 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Pierre Emmanuel Rautou, APHP

Study record dates

Study Major Dates

• Study Start (Anticipated): May 9, 2023
• Primary Completion (Anticipated): July 31, 2035
• Study Completion (Anticipated): December 31, 2035

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Inflammation
• Other Study ID Numbers: APHP220750; 2022-A01421-42 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No