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Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05883891
Acronym
AH2023
Enrollment
52
Registered
2023-06-01
Start date
2017-06-01
Completion date
2022-11-30
Last updated
2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis

Keywords

early liver transplantation, alcohol, cirrhosis, corticosteroid therapy, Maddrey's discriminant function, Lille score, prothrombin time, Alcohol Use Disorder, steroid response

Brief summary

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).

Interventions

DIAGNOSTIC_TESTprothrombin time

Prothrombin time at value at diagnosis was used to assess the presence of a correlation with Lille score at day 7 and therefore wether it could predict response to medical treatment.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
response to steroid treatmentseven daysresponse to standard medical treatment assessed with Lille scoremat day 7

Secondary

MeasureTime frameDescription
death28 daysdeath occurring during hospitalization from any cause
early liver transplantation7 daysearly transplantation in case of failure of medical treatment
infection28 daysoccurrence of opportunistic infections following steroid treatment

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026