Status:
COMPLETED
Microvesicles and Monocytes to Predict Mortality of Patients with Cirrhosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cirrhosis
Eligibility:
All Genders
18-90 years
Brief Summary
Chronic liver diseases related to viral hepatitis, metabolic syndrome or excessive alcohol consumption can evolve towards cirrhosis. Cirrhosis is responsible for 170 000 deaths per year in Europe. Ini...
Detailed Description
Natural history of cirrhosis Cirrhosis is the end stage form of chronic liver disease. It is estimated that 200,000 to 500,000 people in France have cirrhosis. Cirrhosis is responsible for more than ...
Eligibility Criteria
Inclusion
- Age between 18 and 90 years
- Child-Pugh B or Child-Pugh C cirrhosis diagnosed on the basis of one or several of the following elements :
- Liver Biopsy
- Liver stiffness\>15kPa measured by Fibroscan
- Combination of clinical, laboratory and imaging criteria characteristic of cirrhosis (association of signs of portal hypertension, liver failure and abnormal liver morphology in a patient with at least one cause of cirrhosis)
Exclusion
- Acute renal failure (increase in serum creatinin level by more than 1.5 times the baseline value or by more than 26 μmol/l from the baseline value) within 15 days before inclusion
- Bacterial infection proven or highly suspected on the basis of clinical-laboratory features within 15 days of inclusion
- Digestive bleeding within 15 days before inclusion
- Alcoholic hepatitis in the previous month
- History of porto-systemic shunt or liver transplant
- Primary sclerosing cholangitis
- Primary biliary cirrhosis
- Budd-Chiari Syndrome
- Hepatocellular carcinoma outside the Milan criteria contraindicating transplantation
- Active extrahepatic neoplasia
- HIV or known immune deficiency or immunosuppressive treatment
- Pregnant or breastfeeding woman
- Protected populations: persons under guardianship or curatorship
- Patient not affiliated to social security
- Patient who did not signed consent
- Ongoing participation in an intervention research whose protocol could, according to the literature, modify the release of hepatocyte microvesicles or the IFN score
Key Trial Info
Start Date :
June 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT03837444
Start Date
June 12 2019
End Date
February 29 2024
Last Update
December 20 2024
Active Locations (5)
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1
Avicenne Hospital
Bobigny, France
2
Beaujon hospital
Clichy, France
3
La Pitié Salpêtrière hospital
Paris, France
4
De La Fontaine hospital
Saint-Denis, France