An observational study in Alcoholic or Viral C Compensated Cirrhosis, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by University Hospital, Caen · Observational
The non-O blood group is a risk factor of deep vein thrombosis and recurrence of thromboembolic events, especially when associated with Factor 5 Leiden or prothrombin G20210A mutations. A recent study suggests that non-O blood group may promote portal vein thrombosis in non cirrhotic patients.
In addition, in general population and chronic hepatitis C, non-O blood group combined with one or the other of the above genetic abnormalities is associated with an increased risk of liver fibrosis and accelerated fibrogenesis. The suspected mechanism could be an increased procoagulant factor VIII and an increased Willebrand plasma level, due to a low ADAMTS 13 activity, the result of which is an hypercoagulable state and a microthrombotic process.
In cirrhotic patients procoagulant factors and ADAMTS 13 which are respectively increased and decreased, have be shown to be prognostic markers of hepatocellular function and portal hypertension. It has been hypothesized that the hypercoagulable state and the microthrombotic process could contribute to the worsening of the disease and enoxaparin has been shown to positively modify the prognosis of cirrhosis.
The role of non-O blood group in decompensation of cirrhosis and occurrence of complications including non-tumor portal vein thrombosis has never been studied. The investigators plan a longitudinal observational study to determine the incidence of complications in alcoholic and viral cirrhosis in case of non-O blood group compared to O blood group. The aim of this study is to determine whether ABO blood group may promote complications in alcoholic or viral cirrhosis. This is an ancillary study of two national cohorts assessing natural history and hepatocellular carcinoma risk factors in alcoholic (CIRRAL) and viral (CIRVIR) cirrhosis.
cohorts of cirrhotics patients Child Pugh A followed prospectively to study the natural history of cirrhosis and HCC risk
Exclusion Criteria:
alcoholic cirrhosis
Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation
Viral cirrhosis
Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation
blood sample
cumulated incidence of complications at 3 years
patient follow up during 3 years
Time frame: from inclusion to 3 years
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Caen