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

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ClinicalTrials.gov Identifier: NCT03342170
Recruitment Status : Not yet recruiting
First Posted : November 14, 2017
Last Update Posted : November 20, 2017
Sponsor:
Collaborators:
Thong DAO
Annie BOREL-DERLON
Nathalie GANNE-CARRIE
Pierre NAHON
Sylvie CHEVRET
Information provided by (Responsible Party):
University Hospital, Caen

Brief 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.


Condition or disease Intervention/treatment
Alcoholic or Viral C Compensated Cirrhosis Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official 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
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
CIRRAL
alcoholic cirrhosis
Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation
blood sample

CIRVIR
Viral cirrhosis
Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation
blood sample




Primary Outcome Measures :
  1. cumulated incidence of complications at 3 years [ Time Frame: from inclusion to 3 years ]
    patient follow up during 3 years


Biospecimen Retention:   Samples With DNA
G20210A prothrombin gene mutation Factor 5 Leiden mutation


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cohorts of cirrhotics patients Child Pugh A followed prospectively to study the natural history of cirrhosis and HCC risk
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342170


Contacts
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Contact: Guillaume DELAVAL +33 2 31 06 54 32 delaval-g@chu-caen.fr

Sponsors and Collaborators
University Hospital, Caen
Thong DAO
Annie BOREL-DERLON
Nathalie GANNE-CARRIE
Pierre NAHON
Sylvie CHEVRET
Investigators
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Principal Investigator: Isabelle OLLIVIER, MD University Hospital, Caen

Additional Information:

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03342170     History of Changes
Other Study ID Numbers: ABOCIRRALVIR
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Thrombin
Hemostatics
Coagulants