Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease

NCT05865691 | Recruiting

• 2 other identifiers: APHP2207502022-A01421-42
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Diseases; Coagulation

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (6)

controls without liver disease

blood collection on the day of inclusion

Other: biomarker assay

patients with chronic liver disease without cirrhosis

blood collection on the day of inclusion

Other: biomarker assay

patients with chronic liver disease with compensated cirrhosis

blood collection on the day of inclusion

Other: biomarker assay

patients with chronic liver disease with stable decompensated cirrhosis

blood collection on the day of inclusion

Other: biomarker assay

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

blood collection on the day of inclusion

Other: biomarker assay

patients with chronic liver disease with decompensated cirrhosis and organ failure

blood collection on the day of inclusion

Other: biomarker assay

Interventions

biomarker assay OTHER

blood sample on the day of inclusion

Also known as: blood sample

controls without liver disease; patients with chronic liver disease with compensated cirrhosis; patients with chronic liver disease with decompensated cirrhosis and organ failure; patients with chronic liver disease with decompensated cirrhosis in the acute phase; patients with chronic liver disease with stable decompensated cirrhosis; patients with chronic liver disease without cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Beaujon Hospital

Clichy, France

RECRUITING

MeSH Terms

Conditions

Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre Emmanuel Rautou

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Emmanuel Rautou

CONTACT

140875283; pierre-emmanuel.rautou@aphp.fr

Alix Riescher-Tuczkiewicz

CONTACT

140875283; alix.riescher-tuczkiewicz@inserm.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 19, 2023
• Study Start: September 7, 2023
• Primary Completion (Estimated): October 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

FR (1)