ITMO public health
Last update : 09/07/2020 | Version : 1 | ID : 141
| General | |
| Identification | |
| Detailed name | Prevention of venous thromboembolic events with Arixtra 2.5mg for medical ill patients in hospital |
| Sign or acronym | ARCHIMED HOPITAL |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 906317 |
| General Aspects | |
| Medical area |
Hematology |
| Health determinants |
Medicine |
| Keywords | 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 | 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 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. |
All public and private hospitals that purchase ARIXTRA® 2.5 mg in metropolitan France will be solicited to participate in this study (source: database from the GlaxoSmithKline laboratory).
Investigators will be the pharmacists of the hospitals that have accepted to participate in the study. Using the registry kept, the pharmacist will include the first 10 patients responding to the following criteria: • Patient of at least 18 years of age, • hospitalized in one of the establishment's care departments (excluding surgery departments), for whom a treatment via ARIXTRA® 2.5 mg is initiated with thromboprophylaxis |
| Database objective | |
| Main objective | The main objective of this study is to evaluate the average duration of treatment via ARIXTRA® 2.5 mg at the hospital within the framework of the thromboprophylaxis indication |
| Inclusion criteria |
Using the registry kept, the pharmacist will include the first 10 patients responding to the following criteria:
• Patient of at least 18 years of age, • hospitalized in one of the establishment's care departments (excluding surgery departments), • 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) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 680 |
| 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 event/morbidity Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Data collection method | During the first month following the set up of the study in the center, the pharmacist will log in a registry all of the prescription requests for ARIXTRA® 2.5 mg in thromboprophylaxis carried out by his establishment's care departments (excluding surgery departments). The pharmacist will identify the patients that should be included in the study according to the defined eligibility criteria. He will complete a specific inclusion questionnaire for the first 10 patients that meet the eligibility criteria. The pharmacist will complete for each patient included a follow-up questionnaire when released from the hospital. |
| 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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