SALT-I - Study of Acute Liver Transplant ARCHIVE

Head :
Gülmez Sinem Ezgi, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen

Last update : 10/27/2017 | Version : 2 | ID : 2948

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Study of Acute Liver Transplant
Sign or acronym SALT-I
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CCTIRS 08.323, CNIL 908293
General Aspects
Medical area Gastroenterology et hepatology
Health determinants Iatrogenic
Intoxication
Keywords Nimesulide, non-steroidal anti-inflammatory drugs (NSAIDs), drug intoxication, retrospective, case-population, liver transplantation, Europe, Pharmacoepidemiology, Department of Pharmacology, Bordeaux
Scientific investigator(s) (Contact)
Name of the director Gülmez
Surname Sinem Ezgi
Address Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX
Phone + 33 (0)5 57 57 46 75
Email sinemezgi.gulmez@u-bordeaux2.fr
Unit Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Organization Université Bordeaux
Name of the director Moore
Surname Nicholas
Address Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX
Phone + 33(0)5 57 57 46 75
Email nicholas.moore@pharmaco.u-bordeaux2.fr
Unit Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Organization Université Bordeaux
Collaborations
Funding
Funding status Private
Details Laboratoire Helsinn Healthcare
Governance of the database
Sponsor(s) or organisation(s) responsible INSERM
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Case control study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. The study was conducted among liver transplant centres in France, Italy, Portugal, Great Britain, the Netherlands, Greece and Ireland. All patients included in the liver transplantation lists between 1 January 2005 and 31 December 2007 were identified by the centres.
Database objective
Main objective Acute liver failure, Nimesulide, non-steroidal anti-inflammatory drugs (NSAIDs), liver transplantation, drug intoxication, retrospective, case-population, Europe, Pharmacoepidemiology, Department of Pharmacology, Bordeaux
Inclusion criteria Patient who was at least 18 years old at the time of registration on transplant list; Patient with acute liver failure placed on liver transplantation list and exposed to NSAIDs during the 30 days before the 1st signs or symptoms of liver disease, whether or not transplantation was performed; Patient resident of the participating country; Excluding elective liver transplants for chronic diseases such as cirrhosis, chronic hepatitis or cancer.
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Male
Woman
Geography area International
Detail of the geography area Transplant centres in France, Italy, Portugal, Great Britain, the Netherlands, Greece, Ireland
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2009
Date of last collection (YYYY or MM/YYYY) 2011
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals 500
Data
Database activity Data collection completed
Type of data collected Clinical data
Administrative data
Clinical data (detail) Direct physical measures
Administrative data (detail) Month and year of birth, city and country of residence, affiliation to social security system
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Care consumption (detail) Medicines consumption
Procedures
Data collection method The data collection is performed by a clinical research assistant from medical records via an electronic or paper questionnaire. Some of the data was complemented by the CRISTAL database for France (information system of the Biomedicine Agency), the UKTR database for Ireland and England, and LTX-NL for the Netherlands. The Validation Committee shall determine the date of index events and the first signs or symptoms of liver disease at the origin of acute liver failure and assess causality in these cases exposed to NSAIDs.
Participant monitoring No
Links to administrative sources Yes
Linked administrative sources (detail) CRISTAL databases (France - Biomedicine Agency), UKTR (Ireland and England), LTX-NL (the Netherlands)
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) A final study report was submitted to the funder and the CHMP. The final study report and scientific communications (posters, papers, ...) are validated by the study Scientific Committee. Ownership of study data is the subject of an agreement between the University Bordeaux Segalen and the funder. Terms for third-party access to the database are to be defined
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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