Alcoholic or Viral C Compensated Cirrhosis Clinical Trial
— ABOCIRRALVIROfficial title:
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
| Verified date | August 2019 |
| Source | University Hospital, Caen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 1500 |
| Est. completion date | January 22, 2020 |
| Est. primary completion date | December 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de CAEN | Caen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen | Annie BOREL-DERLON, Nathalie GANNE-CARRIE, Pierre NAHON, Sylvie CHEVRET, Thong DAO |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | cumulated incidence of complications at 3 years | patient follow up during 3 years | from inclusion to 3 years |