Understanding the Role of Coagulation and Inflammation in Chronic Liver Disease
Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease
This study is trying to understand how blood clotting and inflammation affect people with chronic liver disease to help improve their treatment and care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Clichy) |
| Trial ID | NCT05865691 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the roles of coagulation, inflammation, and vascular changes in the onset and progression of chronic liver diseases. By analyzing patients with chronic liver disease and comparing them to healthy controls, the study seeks to identify key biomarkers and mechanisms that contribute to these conditions. The findings could enhance patient management and inform healthcare strategies for chronic liver diseases, which significantly impact quality of life and economic resources. The study will utilize biomarker assays to gather relevant data.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with diagnosed chronic liver disease or cirrhosis, as well as healthy controls without liver disease.
Not a fit: Patients with acute liver conditions or those who do not meet the inclusion criteria for chronic liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with chronic liver diseases, enhancing their quality of life.
How similar studies have performed: Other studies have explored similar factors in chronic liver diseases, but the specific focus on coagulation and inflammation in this context may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Clichy
- Beaujon Hospital — Clichy, France (Recruiting)
Study contacts
- Principal investigator: Pierre Emmanuel Rautou — Aphp
- Study coordinator: Pierre Emmanuel Rautou
- Email: pierre-emmanuel.rautou@aphp.fr
- Phone: 140875283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.