ARIANE - Arixtra and platelet monitoring (Study of the actual usage of Arixtra® 2, 5 mg in general practice ARCHIVE

Head :
Leclerc-Zwirn Christel, Laboratoire GSK

Last update : 01/01/2019 | Version : 1 | ID : 143

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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 Arixtra and platelet monitoring (Study of the actual usage of Arixtra® 2, 5 mg in general practice
Sign or acronym ARIANE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL : 907260
General Aspects
Medical area General practice
Others (details) Thrombosis
Keywords platelet monitoring, pharmaco-epidemiology, observational, thromboprophylaxis
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) Not-repeated cross-sectional studies (except case control studies)
Database recruitment is carried out by an intermediary A selection of health care professionals
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. Investigators will be selected via random drawing using a complete sampling frame of the general practitioners exercising in metropolitan France (source: CEGEDIM file. During the entire period of inclusion, the investigating doctor will keep a registry of the eligible patients receiving ARIXTRA® 2.5 mg or an LMWH in thromboprophylaxis. The registry will make it possible to ensure representativeness of patients for whom the doctor will complete the medical questionnaires
Database objective
Main objective Evaluate and compare in general practice the level of prescription for platelet monitoring of patients receiving Arixtra® 2.5 mg (fondaparinux sodium) or an LMWH (low-molecular-weight heparin) in venous thromboprophylaxis.
Inclusion criteria • Patient of at least 18 years of age
• Bedridden patient or with reduced mobility
Patient for whom a treatment via ARIXTRA® 2.5 mg or an LMWH is initiated within the framework of venous 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) 2008
Date of last collection (YYYY or MM/YYYY) 2009
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals 910
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 care consumption and services
Care consumption (detail) Medicines consumption
Procedures
Data collection method Registry, medical questionnaire
Participant monitoring No
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Accepted for publication in "La Presse médicale"
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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