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

NCT03342170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2020-01-27

No results posted yet for this study

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

  • Alcoholic or Viral C Compensated Cirrhosis

Interventions

GENETIC

G20210A prothrombin gene mutation and Factor 5 Leiden mutation

blood sample

Sponsors & Collaborators

  • Thong DAO

    collaborator UNKNOWN

  • Annie BOREL-DERLON

    collaborator UNKNOWN

  • Nathalie GANNE-CARRIE

    collaborator UNKNOWN

  • Pierre NAHON

    collaborator UNKNOWN

  • Sylvie CHEVRET

    collaborator UNKNOWN

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Isabelle OLLIVIER, MD · University Hospital, Caen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-12-31
Completion
2020-01-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03342170 on ClinicalTrials.gov