ARISTOTE - Use of Fondaparinux in current clinical practice for thromboprophylaxis following major orthopedic surgery in France ARCHIVE

Head :
Leclerc-Zwirn Christel, Laboratoire GSK

Last update : 01/01/2019 | Version : 1 | ID : 144

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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 Use of Fondaparinux in current clinical practice for thromboprophylaxis following major orthopedic surgery in France
Sign or acronym ARISTOTE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL n°05-1277
General Aspects
Medical area Endocrinology and metabolism
Traumatology
Others (details) venous thromboembolic events (VTE), major bleeding
Keywords orthopedic surgery, 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 Laboratoire GSK
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. The selection of orthopedic surgery departments will be made using the complete list of public or private establishments
equipped with a care offering in orthopedic surgery and purchasers of ARIXTRA® 2.5 mg
in metropolitan France (ARIXTRA® sales file). In order to ensure the inclusion of a sufficient number
of eligible patients by respecting a certain representativeness of the sample, all of the centers will be
solicited to participate in the study regardless of their purchase volume of the product.

Inclusion: every patient that can potentially be included, i.e. any patient admitted for orthopedic surgery and for whom a prescription of ARIXTRA® 2.5 mg was dispensed in the follow-up from an orthopedic surgical intervention
Database objective
Main objective • Describe the actual conditions of use of ARIXTRA® 2.5 mg in routine practice after an orthopedic surgical intervention.
• Observe the frequency of occurrence of VTEs during the 6 weeks following the initiation of the treatment via ARIXTRA® 2.5 mg.
• Observe the frequency of occurrence of major bleeding during the 6 weeks following the initiation of the treatment via ARIXTRA® 2.5 mg.
Inclusion criteria • Patients of at least 18 years of age.
• Patients hospitalized in orthopedic surgery and for whom a treatment via ARIXTRA® 2.5 mg is initiated.
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) 2006
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 608
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Face to face interview
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 Collection during the hospitalization of patients in 2 steps: at the inclusion and at the time when released from the department. Collection of data concerning the occurrence of complications (VTE and/or major bleeding) after being released from the department. Data collection will be carried out by the investigating physicians approximately 6 weeks after treatment initiation, at the time of a follow-up consultation in orthopedic surgery or otherwise, a telephone interview. In parallel, during the entire period of inclusion, the investigating physicians will list all patients eligible for the study in a register. Moreover, a collection of data will be carried out specifically with the hospital pharmacy of each participating center
Participant monitoring Yes
Details on monitoring of participants 6 weeks of follow-up
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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