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

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

Sponsoren

Hauptsponsor: University Hospital, Caen

Mitarbeiter: Thong DAO
Annie BOREL-DERLON
Nathalie GANNE-CARRIE
Pierre NAHON
Sylvie CHEVRET

Quelle University Hospital, Caen
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum January 1, 2019
Fertigstellungstermin January 22, 2020
Primäres Abschlussdatum December 31, 2019
Studientyp Observational [Patient Registry]
Primärer Ausgang
Messen Zeitfenster
cumulated incidence of complications at 3 years from inclusion to 3 years
Einschreibung 1500
Bedingung
Intervention

Interventionsart: Genetic

Interventionsname: G20210A prothrombin gene mutation and Factor 5 Leiden mutation

Beschreibung: blood sample

Teilnahmeberechtigung

Probenahmeverfahren: Non-Probability Sample

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Isabelle OLLIVIER, MD Principal Investigator University Hospital, Caen
Ort
Einrichtung: CHU de CAEN
Standort Länder

France

Überprüfungsdatum

August 2019

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Armgruppe

Etikette: CIRRAL

Beschreibung: alcoholic cirrhosis

Etikette: CIRVIR

Beschreibung: Viral cirrhosis

Akronym ABOCIRRALVIR
Studiendesign Info

Beobachtungsmodell: Cohort

Zeitperspektive: Prospective

Quelle: ClinicalTrials.gov