ITMO public health
Last update : 01/01/2019 | Version : 1 | ID : 144
| 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 |
| 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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