Cirrhosis
Conditions
Keywords
cirrhosis, hypercoagulability, thrombin generation assay, soluble Endothelial Protein C Receptor
Brief summary
Cirrhosis is a condition in which the liver does not function properly due to long-term damage. This damage is characterized by the replacement of normal liver tissue by scar tissue. The liver carries out several necessary functions, including synthesis of proteins participating in blood coagulation process. Some of these proteins contribute to coagulation and others make blood more fluid. In healthy people there is a balance between the two. In cirrhotic patient, there is an imbalance inducing hypercoagulation (hypercoagulability state). Cirrhotic patients are so known to be at risk of vein thrombosis (for example portal vein thrombosis: clot in hepatic vein). Mechanisms leading to this imbalance are unclear. Studies need to be completed to improve patient's management. The EPCRs (Endothelial Protein C Receptor soluble) takes part in blood coagulation process. Previous studies have shown that blood levels of EPCRs are increased in patients with cirrhosis. The primary purpose of the study is to evaluate if the EPCRs could play a role in cirrhosis-associated hypercoagulability state.
Detailed description
Three groups will be constitued: one with cirrhotic patients, one with healthy volunteers, and one with patients with hepatocellular carcinoma, a form of liver cancer (previous studies have also shown that blood levels of EPCRs are increased in these patients). All participants will undergo a unique visit at hospital. An informed consent will be obtained before any related study procedures\*. \* procedures: physical examination (including height, weight, waist measurement), vital signs (blood pressure, heart rate, temperature), medical history, concomitant medication, blood sample.
Interventions
BIOLOGICALThrombin generation assay (in vitro)
One blood sample.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Exploratory, cross-sectional, case-control pathophysiology study, based on ex vivo treatment of blood samples.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients with cirrhosis Inclusion criteria : * Male, age 18 or older * Cirrhosis, defined by: prothombin time ≤ 70% +/- liver dysmorphism +/- Fibroscan \> 12.5 kPa +/- histology +/- portal hypertension associated with hepatocellular insufficiency * Cirrhosis associated with hepatitis B or C, or alcoholic liver disease, or non alcoholic steato hepatitis * Measurable portal flow by ultrasound doppler * Child Pugh score A,B or C, without acute infection or acute bleeding * Signed written informed consent * Affiliation to french social security system
Exclusion criteria
: * Known history of vein thrombosis * Known family history (in first-degree relative) of spontaneous thrombosis * Partial or complete portal system vein thrombosis * Uncontrolled infection after 7-day course of antibiotics * Anticoagulant intake * Hepatocellular carcinoma * Protected or deprived of liberty adult * Any medical or surgical history that could interfere with the study, as judged by the investigator * Blood transfusion within 7 days * Participation in a clinical trial for drug Healthy volunteers Inclusion criteria : * Male, age 18 or older * Body Mass Index between 18 and 30 kg/m2 * Normal physical examination * Willing and able to comply with requirements of the study * Agree to be registered in the french national registry for healthy volunteers * Signed written informed consent * Affiliation to french social security system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin. | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Thrombin generation assay parameters : peak height | 24 months |
| Thrombin generation assay parameters : lag time | 24 months |
| Thrombin generation assay parameters : time to peak | 24 months |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed