Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease

Coagulation Clinical Trial

— CLUE  

Official title:

Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05865691
• Other study ID #: APHP220750
• Secondary ID: 2022-A01421-42
• Status: Not yet recruiting
• Start date: May 9, 2023
• Est. completion date: December 31, 2035

Study information

• Verified date: May 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Pierre Emmanuel Rautou
• Phone: 140875283
• Email: pierre-emmanuel.rautou[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 31, 2035
• Est. primary completion date: July 31, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Liver Diseases
• Coagulation
• Inflammation
• Liver Diseases

Intervention

Other:
• biomarker assay
blood sample on the day of inclusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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