Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease

NCT ID: NCT05865691

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-07

Study Completion Date

2035-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Liver Diseases Coagulation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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controls without liver disease

blood collection on the day of inclusion

biomarker assay

Intervention Type OTHER

blood sample on the day of inclusion

patients with chronic liver disease without cirrhosis

blood collection on the day of inclusion

biomarker assay

Intervention Type OTHER

blood sample on the day of inclusion

patients with chronic liver disease with compensated cirrhosis

blood collection on the day of inclusion

biomarker assay

Intervention Type OTHER

blood sample on the day of inclusion

patients with chronic liver disease with stable decompensated cirrhosis

blood collection on the day of inclusion

biomarker assay

Intervention Type OTHER

blood sample on the day of inclusion

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

blood collection on the day of inclusion

biomarker assay

Intervention Type OTHER

blood sample on the day of inclusion

patients with chronic liver disease with decompensated cirrhosis and organ failure

blood collection on the day of inclusion

biomarker assay

Intervention Type OTHER

blood sample on the day of inclusion

Interventions

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biomarker assay

blood sample on the day of inclusion

Intervention Type OTHER

Other Intervention Names

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blood sample

Eligibility Criteria

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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).


* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - HĂ´pitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Emmanuel Rautou

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Beaujon Hospital

Clichy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Emmanuel Rautou

Role: CONTACT

140875283 ext. +33

Alix Riescher-Tuczkiewicz

Role: CONTACT

140875283

Facility Contacts

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Pierre emmanuel Rautou

Role: primary

Other Identifiers

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2022-A01421-42

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220750

Identifier Type: -

Identifier Source: org_study_id

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