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Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease

Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05865691
Acronym
CLUE
Enrollment
360
Registered
2023-05-19
Start date
2023-09-07
Completion date
2035-12-31
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Diseases, Coagulation

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.

Interventions

blood sample on the day of inclusion

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Activated partial thromboplastin time abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of activated partial thromboplastin time for each patient at inclusion
Factor II abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of factor II for each patient at inclusion
Factor V abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of factor V for each patient at inclusion
Factor VII abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of factor VII for each patient at inclusion
Factor VIII abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of factor VIII for each patient at inclusion
Factor IX abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of factor IX for each patient at inclusion
Factor X abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of factor X for each patient at inclusion
Factor XI abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of factor XI for each patient at inclusion
Fibrinogen abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of fibrinogen for each patient at inclusion
D-dimer abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsmesure of D-dimer for each patient at inclusion
Protein C abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of protein C for each patient at inclusion
protein S abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsmesure of protein S for each patient at inclusion
Willebrand factor abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of plasma Willebrand factor for each patient at inclusion
Thrombin generation test abnormalities in patients with chronic liver disease at different stages and controls without liver diseaseat 10 yearsMesure of thrombin generation test for each patient at inclusion

Countries

France

Contacts

Primary ContactPierre Emmanuel Rautou
pierre-emmanuel.rautou@aphp.fr140875283
Backup ContactAlix Riescher-Tuczkiewicz
alix.riescher-tuczkiewicz@inserm.fr140875283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026