MICAH study

Multi-centre Cohort Study in Alcoholic Hepatitis (MICAH)

Aim

To recruit patients with Alcoholic Hepatitis (AH), irrespective of severity, to evaluate performance of the prognostic scoring systems and diagnostic and prognostic biomarkers. In order to evaluate diagnostic biomarkers, we will also recruit control patients with acute decompensation of cirrhosis (AD). 

Objectives

Primary (biomarker)

To identify serum biomarkers of AH that distinguish it from AD in order to reduce the need for liver biopsy

Secondary (biomarker)

To provide a platform for the evaluation of biomarkers which allow stratification of patients into different risk groups based on susceptibility to infection, acute kidney injury (AKI) or mortality. 

Mechanistic 

• To explore the immunological basis to the increased susceptibility to infection observed in alcoholic hepatitis (sample collection) 
• To explore the mechanisms underlying the persistence of hepatic inflammation after cessation of alcohol use (sample collection) 
• To explore the mechanisms underlying the impairment of hepatic regeneration in patients with alcoholic hepatitis (sample collection) 

Design

Prospective, multi-centre cohort study with nested case-control studies for:

• Mortality
• Infection  
• AKI  

Study duration

24 months with additional one year, five years and ten years remote follow-up via NHS Digital (England), NHS Welsh Informatics Service (Wales), and Information Services Division (Scotland).

Sample size

Approximately of 1300 patients:

• 800 patients with alcoholic hepatitis including non-severe patients irrespective of discriminant function
• 500 patients with acute decompensation of cirrhosis without features of alcoholic hepatitis histologically +/- clinically (AD)

Study sites

Approximately 40 centres in the United Kingdom. Accrual rate will be approximately two patients every four weeks at each site.