Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis. (AH2023)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Alcoholic Hepatitis

Treatments: Diagnostic Test: prothrombin time

Study type: Observational

Funder types: Other

Identifiers

NCT05883891

5840 (Other Identifier)

Details and patient eligibility

About

Alcoholic hepatitis (AH) is the most severe form of acute alcohol-related liver disease. Maddrey's discriminant function (mDF) >32 defines the severe form of AH, which is associated with a high mortality. Corticosteroid therapy (CS) represents the main medical treatment that may reduce short-term mortality. Lille score at day 7 assesses the therapeutic response to steroid therapy. At present, no parameters able to predict the response to steroid therapy have been highlighted. The mDF depends mainly on prothrombin time (PT). Aim of the present study was to evaluate if the PT value could predict the response to CS in severe AH (sAH).

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of first episode of severe alcoholic hepatitis with Maddrey's function score of 32 or higher, and the absence of contraindication to CS therapy (non-controlled infections/sepsis, hepatic encephalopathy, recent acute gastrointestinal bleeding, severe kidney dysfunction). The diagnosis of AH was based on the criteria of the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded Alcoholic Hepatitis Consortia (Crabb DW, 2016). In particular, were enrolled in the study patients with: heavy alcohol use for >6 months, with an average consumption of more than 3 drinks (∼40 g) per day for women and 4 drinks (∼50-60 g) per day for men and with <30 days of abstinence before the onset of jaundice; AST/ALT ratio > 1.5 with an AST level > 45 IU/L (1.5 times upper limit of normal) and < 400 IU/L; serum bilirubin >3 mg/dL.

Exclusion criteria

• acute or chronic viral hepatitis,
• nonalcoholic steatohepatitis,
• cocaine use,
• drug-induced liver injury,
• fulminant Wilsons disease,
• hepatocellular carcinoma,
• portal vein thrombosis,
• biliary obstruction,
• severe autoimmune liver disease,
• neoplasms,
• severe comorbidities.

Trial design

52 participants in 1 patient group

severe alcoholic hepatitis

Description:

Patients admitted with a clinical diagnosis of severe alcoholic hepatitis eligible to corticosteroid treatment. Prothrombin time at diagnosis was registered to evaluate wether it correlated with Lille score at day 7 and therefore response to standard medical treatment.

Treatment:

Diagnostic Test: prothrombin time