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Completed

NCT Number: NCT05883891

Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

prothrombin time

Diagnostic Test

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.

Primary outcomes

  1. response to steroid treatment

    Time frame: seven days

    response to standard medical treatment assessed with Lille scoremat day 7

Secondary outcomes

  1. death

    Time frame: 28 days

    death occurring during hospitalization from any cause

  2. early liver transplantation

    Time frame: 7 days

    early transplantation in case of failure of medical treatment

  3. infection

    Time frame: 28 days

    occurrence of opportunistic infections following steroid treatment

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: AH2023

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2023
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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