FRESH-PEF60139-fr
Registre prospectif des patients pris en charge pour un évènement thromboembolique (étude internationale multicentrique)
RIETE
| Name | Country code |
|---|---|
| France | fr |
| Argentine | ar |
| Belize | bz |
| Chili | cl |
| Grèce | gr |
| Italie | it |
| Espagne | es |
The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism
Objectives
The main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events.
As an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications.
Patient entry criteria
Participating hospitals enroll all patients that meet predefined eligibility criteria. Patients are included if they have acute deep-vein thrombosis (DVT), pulmonary embolism (PE) and/or superficial venous thrombosis (SVT), confirmed by objective tests (i.e. contrast venography, ultrasonography, impedance plethysmography or magnetic resonance, for suspected DVT; pulmonary angiography, lung scintigraphy or helical computed tomography scan, for suspected PE; ultrasonography for suspected SVT). Patients are excluded if they are currently participating in a therapeutic clinical trial or if they will not be available for a 3-month follow-up.
Study parameters and endpoints
The primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.
Use of the RIETE study database
Although not intended to influence the routine management of patients participating in the registry, collated data from RIETE are available on the registry's website (www.riete.org) for use by physicians participating, and others in the field. An underlying or coexisting medical condition is selected from a drop-down list and data from the RIETE database are displayed, showing treatments, doses and outcomes of patients with similar clinical profiles. The user can thus compare different therapies and decide which is the most appropriate for their patient, based on previous "real-world" outcomes.
['Données cliniques','Données biologiques','Données de santé rapportées par les participants de l'étude']
Individus
| Topic | Vocabulary |
|---|---|
| Cardiologie et médecine vasculaire | health theme |
| Hématologie | health theme |
| Médecine d’urgence | health theme |
| Médecine interne | health theme |
| Pneumologie | health theme |
| Thromboembolie veineuse | cim-11 |
| Déterminants liés au système de santé | health determinant |
| Déterminants liés au système de santé : Consommation des soins | health determinant |
{
"level_sex_clusion_I": [
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D005260"
},
"value": "Féminin"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D008297"
},
"value": "Masculin"
}
],
"level_age_clusion_I": [
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D055815"
},
"value": "Adulte (19 à 24 ans)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D000328"
},
"value": "Adulte (25 à 44 ans)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D008875"
},
"value": "Adulte (45 à 64 ans)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D000368"
},
"value": "Personne âgée (65 à 79 ans)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D000369"
},
"value": "Grand âge (80 ans et plus)"
}
],
"level_type_clusion_I": "Patients",
"level_type_clusion_other": "",
"clusion_I": " patient vu à l’hôpital pour une thrombose veineuse profonde (TVP) symptomatique des membres supérieurs ou inférieurs et\/ou une embolie pulmonaire (EP) symptomatique, confirmées par des examens objectifs (i.e phlébographie, doppler veineux, pléthysmographie, IRM pour suspicion de TVP, angiographie pulmonaire, scintigraphie pulmonaire ventilation\/perfusion ou scanner spirale pour suspicion d’EP) ; - patient non inclus dans un essai clinique thérapeutique ; - patient dont le suivi à trois mois est possible",
"clusion_E": ""
}
| Name |
|---|
| Laurent;BERTOLETTI |
| Name | Role |
|---|---|
| CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE | sponsor |
| Name |
|---|
| UNIVERSITE JEAN MONNET (EPSCP) |
| Name |
|---|
| ; |
| réseau mondial RIETE, réseau Français INNOVTE, réseau mondial INVENT-VTE |
| Agency name |
|---|
| CNIL |
['Via des structures (services ou établissements de santé, écoles, entreprises…)']
['{"concept":{"vocab":"CESSDA","vocabURI":"Other"},"value":"Autre"}']
Accès restreint sur projet spécifique
Etude observationnelle
| Start | End |
|---|---|
| 2006-01-01 | 3000-01-01 |
adaptée
['- Présence d'une requête de cohérence après la saisie des données informatiques.- Gestion des données manquantes par retour au dossier source et/ou par retour vers le patient ou vers un tiers- Enquêtes auprès des mairies pour les décès - Relance des médecins pour réaliser les visites de suivi- Réalisation d'audit qualité interne selon les inclusions- Les patients sont informés de l'utilisation de leur données par orale']
| Name | |
|---|---|
| Contact;RGPD | contact.rgpd@chu-etienne.fr |
{"extLink":{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"},"value":"Accès réservé"}
Utilisation possible des données par des équipes académiques avec accès de façon contractuelles selon les règles de publication établies par le comité scientifique de RIETE Utilisation impossible des données par des industriels
| Name | |
|---|---|
| Laurent;BERTOLETTI | laurent.bertoletti@chu-st-etienne.fr |
FRESH-PEF60139-fr
| Name |
|---|
| Admin Fresh |