Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое biomarker assay
  blood sample on the day of inclusion

Первичные конечные точки

• Activated partial thromboplastin time abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]
• Factor II abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]
• Factor V abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]
• Factor VII abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]
• Factor VIII abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]
• Factor IX abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]
• Factor X abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]
• Factor XI abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]
• Fibrinogen abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]
• D-dimer abnormalities in patients with chronic liver disease at different stages and controls without liver disease [Срок оценки: at 10 years]

Критерии участия

Критерии включения

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).

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• Beaujon Hospital — Clichy

Идентификаторы

NCT: NCT05865691 · APHP220750 · 2022-A01421-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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