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

C

Caen University Hospital

Status

Completed

Conditions

Alcoholic or Viral C Compensated Cirrhosis

Treatments

Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation

Study type

Observational

Funder types

Other

Identifiers

NCT03342170
ABOCIRRALVIR

Details and patient eligibility

About

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.

Enrollment

1,500 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with either alcoholic or viral C cirrhosis included in national cohorts CIRRAL and CIRVIR

Exclusion criteria

  • Those of CIRRAL and CIRVIR with None Tumoral Portal Thrombosis prior history

Trial design

1,500 participants in 2 patient groups

CIRRAL
Description:
alcoholic cirrhosis
Treatment:
Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation
CIRVIR
Description:
Viral cirrhosis
Treatment:
Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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