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

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

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.

Study Overview

• Status: Completed
• Conditions: Alcoholic or Viral C Compensated Cirrhosis
• Intervention / Treatment: Genetic: G20210A prothrombin gene mutation and Factor 5 Leiden mutation

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CHU de Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulated incidence of complications at 3 years	patient follow up during 3 years	from inclusion to 3 years

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Thong DAO; Annie BOREL-DERLON; Nathalie GANNE-CARRIE; Pierre NAHON; Sylvie Chevret
• Investigators: Principal Investigator: Isabelle OLLIVIER, MD, University Hospital, Caen

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: ABOCIRRALVIR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No