ITMO public health
Last update : 07/09/2015 | Version : 3 | ID : 60139
| General | |
| Identification | |
| Detailed name | Perspective cohort of patients hospitalized for a thromboeolic event (multi-center international study) |
| Sign or acronym | RIETE |
| General Aspects | |
| Medical area |
Cardiology General practice |
| Health determinants |
Healthcare system and access to health care services Iatrogenic Medicine |
| Keywords | Prevention |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bertoletti |
| Surname | Laurent |
| Address | Service de Médecine Vasculaire et Thérapeutique, Hôpital Nord, CHU de St-Etienne, 42055 SAINT ETIENNE CEDEX 2 |
| laurent.bertoletti@chu-st-etienne.fr | |
| Unit | CENTRE D’INVESTIGATION CLINIQUE – EPIDEMIOLOGIE CLINIQUE (CIE3) GROUPE DE RECHERCHE SUR LA THROMBOSE (EA 3065) CHU DE SAINT ETIENNEE |
| Organization | CHU Saint-Etienne |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | service's academic university |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU DE SAINT-ETIENNE |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective. Organizations actives in the constitution of the cohort: CHU, CHG. End of inclusions:01/12/2010 |
| Database objective | |
| Main objective | Document the epidemiology of the venous thromboembolic disease, demographic and clinical characteristics of patients, as well as caring and 3 months prognosis (incidence of recurrence of symptomatic thromboembolic events (TVP and EP), fatal or not, incidence of hemorrhages, death, complications. Secondary objective : TVP ET |
| Inclusion criteria | Patient visited at the hospital for a symptomatic deep venous thrombosis (TVP) of the upper or lower limbs, and/or a symptomatic pulmonary embolism (EP), confirmed by objective examination (i.e phlebography, venous doppler, plethysmography, MRI on suspicion of TVP, pulmonary angiography, pulmonary scintygraphy ventilation/perfusion or spiral scan for EP suspicion); patient not included in a therapeutically clinical trial; patient allowing a 3 months follow-up |
| 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 |
International |
| Detail of the geography area | Spain, Italy, Argentina, Israel, Chili, Greece, United Kingdom, Brazil, France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2006 |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | 57 000 in June 2015 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination every 3 months during the follow-up: anticoagulant treatment, vena cava filter, complications (recurrence of thromboeolic events, major or clinically pertinent hemorrhages, death, bone or cutaneous complications, thrombocytopenia) |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Clinical examination every 3 months during the follow-up: anticoagulant treatment, vena cava filter, complications (recurrence of thromboeolic events, major or clinically pertinent hemorrhages, death, bone or cutaneous complications, thrombocytopenia) |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Interviews: direct data entry Clinical examinations: hand-written entry Biological examinations: direct data entry |
| Quality procedure(s) used | Coherence request after computer data entry. Missing data asked back to the original file and/or back to the patient or a third. Surveys about death among city halls. Doctor remainders for follow-up visits. Intern quality audit. Patients are orallyinformed about the use of their data. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Duration: 3 months |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Pathology register |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/RIETE |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=riete+AND+Venous+thromboembolism |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Possible data utilization by academic teams with contractual access conditions according to publishing rules established by the RIETE scientific committee.
Data utilization not available for industry sectors. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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