Last update : 01/01/2020 | Version : 1 | ID : 142
General | |
Identification | |
Detailed name | Prevention of venous thromboembolic events with Arixtra 2.5mg for medical ill patients in general practice |
Sign or acronym | ARCHIMED VILLE |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 906318 |
General Aspects | |
Medical area |
General practice |
Others (details) | venous thromboembolic events |
Keywords | pharmaco-epidemiology, thrombosis, 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 | 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 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. He will complete a specific inclusion questionnaire for the first 3 patients that meet the eligibility criteria. |
Database objective | |
Main objective | Evaluate the average duration of treatment via ARIXTRA® 2.5 mg with thromboprophylaxis in ambulatory general practice |
Inclusion criteria |
Patient of at least 18 years of age, -bedridden or with reduced mobility, -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) | 2007 |
Date of last collection (YYYY or MM/YYYY) | 2010 |
Size of the database | |
Size of the database (number of individuals) |
[500-1000[ individuals |
Details of the number of individuals | 834 |
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 | Throughout the entire duration of the study, the doctor will log the prescriptions of ARIXTRA® 2,.5 mg for thromboprophylaxis in a registry. This registry will make it possible to evaluate prescription volume and the representativeness of the patients effectively included in the study. The doctor will complete for each patient included a follow-up questionnaire at the end of treatment. |
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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