Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).
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|ClinicalTrials.gov Identifier: NCT04142723|
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment|
|Hepatitis, Alcoholic||Biological: blood withdraw|
This study is sponsored and organized by the "group Latin American of interest special in the study of the disease hepatic Alcohol" (ALEH-GLEHA), belonging to the Latin American Association for the study of the hepatic illnesses (ALEH), which is an association non-profit that has nearly 1,000 members from most of the countries of Latin America.
All patients admitted to the hospital with suspected alcoholic hepatitis will be evaluated to see if they can be included in the study. Patients will be enrolled according with the inclusion and exclusion criteria.
The investigators will take a blood sample to be analyzed as part of the necessary data record, for the study of genes and identification of proteins involved in the development, evolution and prognosis of alcoholic hepatitis.
If the medical doctor had instructed to perform a liver biopsy, voluntarily the investigators will ask to participants donate a small share of the surplus of histological sample To achieve this, it is necessary to generate a data bank of clinical information and biological samples (blood, urine, bile, stools, salivary sample or tissue samples) that allows studying the various factors involved in the development and prognosis of this disease in the countries of the Americas.
The investigators will make a clinical follow-up for a year, consisting of phone calls to complete a questionnaire about participant's health. These calls will be made in month 1, 3, 6 and 12 subsequent to participant's hospital discharge.
The data collected are identified by a code and only the study physicians can correlate the data with the participants and medical history, so the participant's identity will not be shared.
There is no financial compensation associated with the study
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||4 Years|
|Official Title:||Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||June 20, 2022|
|Estimated Study Completion Date :||June 20, 2022|
- Biological: blood withdraw
venous blood sampling
- Number of subjects hospitalized with alcoholic hepatitis who die at 30, 60 and 90 days. [ Time Frame: 90 days ]
To determine the clinical characteristics, complications and in-hospital mortality of patients who are hospitalized for alcoholic hepatitis in different establishments in America.
To achieve this, it is necessary to generate a data bank of clinical information and biological samples (blood, urine, bile, stools, salivary sample or tissue samples) that allows studying the various factors involved in the development and prognosis of this disease in the countries of the Americas. This will help us to know aspects of the highest prevalence and mortality from alcoholic hepatitis in Latin Americans in comparison to other regions of the world and useful information in the prevention and early diagnosis of this disease.
- Number of subjects hospitalized with alcoholic hepatitis who develop complications (infection, gastrointestinal bleeding, renal failure, etc.) [ Time Frame: 4 years ]Inquire about the incidence of infections and prevalence of infections resistant to antibiotics in patients hospitalized for alcoholic hepatitis.
- Number of subjects with alcoholic hepatitis who are cataloged as responders by Lille score. [ Time Frame: 4 years ]with the data bank researches will be able to track patients through health questionnaires
- Mean Model of End-Stage Liver Disease (MELD) score at day 0, 30, 60 and 90. [ Time Frame: 4 years ]with the data bank researches will be able to track patients through health questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142723
|Contact: Juan pablo p arab, MD||56223543845 ext email@example.com|
|Contact: Juan Pablo P Roblero, MD||56223543845 ext firstname.lastname@example.org|
|Principal Investigator:||juan pablo p arab, md||Pontificia Universidad Catolica de Chile|