ARCHIMED HOPITAL - Prevention of venous thromboembolic events with Arixtra 2.5mg for medical ill patients in hospital

Head :
Leclerc-Zwirn Christel, Laboratoire GSK

Last update : 09/07/2020 | Version : 1 | ID : 141

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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 Prevention of venous thromboembolic events with Arixtra 2.5mg for medical ill patients in hospital
Sign or acronym ARCHIMED HOPITAL
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL : 906317
General Aspects
Medical area Hematology
Health determinants Medicine
Keywords pharmaco-epidemiology, thromboprophylaxis, fondaparinux, arixtra
Scientific investigator(s) (Contact)
Name of the director Leclerc-Zwirn
Surname Christel
Phone +33 (0)1 39 17 86 96
Email christel.c.leclerc-zwirn@gsk.com
Unit Laboratoire GSK
Collaborations
Funding
Funding status Private
Details GSK laboratory
Governance of the database
Sponsor(s) or organisation(s) responsible LABORATOIRE GSK
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
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. All public and private hospitals that purchase ARIXTRA® 2.5 mg in metropolitan France will be solicited to participate in this study (source: database from the GlaxoSmithKline laboratory).
Investigators will be the pharmacists of the hospitals that have accepted to participate in the study. Using the registry kept, the pharmacist will include the first 10 patients responding to the following criteria:
• Patient of at least 18 years of age,
• hospitalized in one of the establishment's care departments (excluding surgery departments),
for whom a treatment via ARIXTRA® 2.5 mg is initiated with thromboprophylaxis
Database objective
Main objective The main objective of this study is to evaluate the average duration of treatment via ARIXTRA® 2.5 mg at the hospital within the framework of the thromboprophylaxis indication
Inclusion criteria Using the registry kept, the pharmacist will include the first 10 patients responding to the following criteria:
• Patient of at least 18 years of age,
• hospitalized in one of the establishment's care departments (excluding surgery departments),
• for whom a treatment via ARIXTRA® 2.5 mg is initiated with thromboprophylaxis
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 National
Detail of the geography area France
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 680
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Medical registration
Declarative data (detail) Face to face interview
Presence of a biobank No
Health parameters studied Health event/morbidity
Health care consumption and services
Care consumption (detail) Hospitalization
Medicines consumption
Procedures
Data collection method During the first month following the set up of the study in the center, the pharmacist will log in a registry all of the prescription requests for ARIXTRA® 2.5 mg in thromboprophylaxis carried out by his establishment's care departments (excluding surgery departments). The pharmacist will identify the patients that should be included in the study according to the defined eligibility criteria. He will complete a specific inclusion questionnaire for the first 10 patients that meet the eligibility criteria. The pharmacist will complete for each patient included a follow-up questionnaire when released from the hospital.
Participant monitoring Yes
Details on monitoring of participants The data that will be collected in the follow-up questionnaire are: • Premature interruption of the treatment,• total duration of the administration of the treatment, • prescriptions for prophylactic purposes after the treatment
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Publications in progress
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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