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NCT Number: NCT05865691

Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease

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.

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Key information

Conditions

Chronic Liver Diseases Cardiovascular Diseases Coagulation Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beaujon Hospital

Clichy, France

Location status: Recruiting

Location contact

Pierre emmanuel Rautou

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biomarker assay

Other

blood sample on the day of inclusion

Other names: blood sample

Primary outcomes

  1. Activated partial thromboplastin time abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of activated partial thromboplastin time for each patient at inclusion

  2. Factor II abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of factor II for each patient at inclusion

  3. Factor V abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of factor V for each patient at inclusion

  4. Factor VII abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of factor VII for each patient at inclusion

  5. Factor VIII abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of factor VIII for each patient at inclusion

  6. Factor IX abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of factor IX for each patient at inclusion

  7. Factor X abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of factor X for each patient at inclusion

  8. Factor XI abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of factor XI for each patient at inclusion

  9. Fibrinogen abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of fibrinogen for each patient at inclusion

  10. D-dimer abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    mesure of D-dimer for each patient at inclusion

  11. Protein C abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of protein C for each patient at inclusion

  12. protein S abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    mesure of protein S for each patient at inclusion

  13. Willebrand factor abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of plasma Willebrand factor for each patient at inclusion

  14. Thrombin generation test abnormalities in patients with chronic liver disease at different stages and controls without liver disease

    Time frame: at 10 years

    Mesure of thrombin generation test for each patient at inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Alix Riescher-Tuczkiewicz

CONTACT

[email protected]

140875283

Pierre Emmanuel Rautou

CONTACT

[email protected]

140875283 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CLUE

Important dates

Study start
2023
Primary completion
2035
Study completion
2035
First posted
May 19, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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