Clinical Trials Directory

Trials / Completed

CompletedNCT03342170

Influence of ABO Blood Group on the Risk of Complications in Alcoholic or Viral C Cirrhosis?

Influence of ABO Blood Group on the Risk of Complications in Alcoholic or Viral C Cirrhosis? Analysis From Two French Prospectives National Cohorts CIRRAL and CIRVIR of Patients With Alcoholic or Viral Cirrhosis Child Pugh A

Status
Completed
Phase
Study type
Observational
Enrollment
1,500 (actual)
Sponsor
University Hospital, Caen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
GENETICG20210A prothrombin gene mutation and Factor 5 Leiden mutationblood sample

Timeline

Start date
2019-01-01
Primary completion
2019-12-31
Completion
2020-01-22
First posted
2017-11-14
Last updated
2020-01-27

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03342170. Inclusion in this directory is not an endorsement.