Integrative Epidemiology of Prognosis in Patients With Acute Alcoholic Hepatitis at AP-HP
NCT ID: NCT07262515
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1400 participants
OBSERVATIONAL
2024-07-19
2025-12-31
Brief Summary
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The purpose of this study is to improve the prediction of patient outcomes after a diagnosis of acute alcoholic hepatitis. By integrating clinical, biological, and histological information collected from the AP-HP data warehouse, the investigators aim to identify more reliable prognostic markers. This could help physicians better tailor treatments and improve survival of patients affected by this condition.
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Detailed Description
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This retrospective, multicenter observational study conducted at AP-HP hospitals will analyze a large cohort of patients diagnosed with AAH since 2017. Data extracted from the AP-HP Clinical Data Warehouse (EDS) will include demographics, comorbidities, biological markers (liver and renal function tests, coagulation parameters, lactate), histological findings (necrosis, fibrosis, neutrophil infiltration, bilirubinostasis), microbiology results, prescribed medications, and outcomes such as infections, need for liver transplantation, and mortality.
The primary outcome is overall survival after diagnosis. Secondary outcomes include the impact of intermediate factors such as bacterial or fungal infections, alcohol withdrawal, organ failure, and transplantation on prognosis. Statistical analyses will combine classical survival models (Cox regression, Accelerated Failure Time models) and modern machine learning approaches (random forest, gradient boosting).
The goal is to develop integrative prognostic models that provide a more accurate and personalized assessment of prognosis in AAH, ultimately guiding clinical decision-making and improving patient management.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients with acute alcoholic hepatitis
All adult patients diagnosed with acute alcoholic hepatitis at AP-HP hospitals, identified using ICD-10 codes (K701), pathology reports, and clinical data.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute alcoholic hepatitis (ICD10 K701 or occurrence of the terms "HAA" (French translation of "AAH" or "hépatite alcoolique aiguë" (French translation of "acute alcoholic hepatitis") in a pathology report, followed by manual verification
Exclusion Criteria
18 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Ministry of Health, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Vincent MALLET
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Necker Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DAT23012
Identifier Type: -
Identifier Source: org_study_id
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