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CompletedNCT03342170ABOCIRRALVIRUpdated Jan 27, 2020

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

An observational study in Alcoholic or Viral C Compensated Cirrhosis, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by University Hospital, Caen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Alcoholic or Viral C Compensated Cirrhosis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Those of CIRRAL and CIRVIR with None Tumoral Portal Thrombosis prior history
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (actual)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • CIRRAL

    alcoholic cirrhosis

    Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation

  • CIRVIR

    Viral cirrhosis

    Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation

Interventions

  • GeneticG20210A prothrombin gene mutation and Factor 5 Leiden mutation

    blood sample

05

What researchers measure

Primary outcomes

  1. cumulated incidence of complications at 3 years

    patient follow up during 3 years

    Time frame: from inclusion to 3 years

06

Study locations

1 site
  • CHU de CAEN
    Caen, 14033, France
07

References and documents

Publications

  • Ollivier-Hourmand I, Repesse Y, Nahon P, Chaffaut C, Dao T, Nguyen TTN, Marcellin P, Roulot D, De Ledinghen V, Pol S, Guyader D, Archambeaud I, Zoulim F, Oberti F, Tran A, Bronowicki JP, D'Alteroche L, Ouzan D, Peron JM, Zarski JP, Bourliere M, Larrey D, Louvet A, Cales P, Abergel A, Mathurin P, Mallat A, Blanc JF, Nguyen-Khac E, Riachi G, Alric L, Serfaty L, Antonini T, Moreno C, Attali P, Thabut D, Pilette C, Grange JD, Silvain C, Carbonell N, Bernard-Chabert B, Goria O, Wartelle C, Moirand R, Christidis C, Perlemuter G, Ozenne V, Henrion J, Hillaire S, Di Martino V, Amiot X, Sutton A, Barget N, Chevret S, Ganne-Carrie N; ANRS CO12 CIRVIR, CIRRAL groups. ABO blood group does not influence Child-Pugh A cirrhosis outcome: An observational study from CIRRAL and ANRS CO12 CIRVIR cohorts. Liver Int. 2022 Jun;42(6):1386-1400. doi: 10.1111/liv.15159. Epub 2022 Jan 17. PubMed 35025128 ↗
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Registry details

Key details

Study ID
NCT03342170
Lead sponsor
University Hospital, Caen
Collaborators
Thong DAO, Annie BOREL-DERLON, Nathalie GANNE-CARRIE, Pierre NAHON, Sylvie CHEVRET
Responsible party
Sponsor
First posted
Nov 14, 2017
Start date
Jan 1, 2019
Primary completion
Dec 31, 2019
Completion
Jan 22, 2020
Last update
Jan 27, 2020

Study contacts

Isabelle OLLIVIER, MD
principal investigator · University Hospital, Caen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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