ITMO public health
Last update : 01/01/2019 | Version : 1 | ID : 143
| 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 |
| 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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