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Registre prospectif des patients pris en charge pour un évènement thromboembolique (étude internationale multicentrique)

France, Argentine, Belize...and 4 more, 2006 - 3000
Reference ID
FRESH-PEF60139-fr
Producer(s)
Laurent;BERTOLETTI
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Apr 29, 2026
Last modified
Jun 23, 2026
Page views
18
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF60139-fr

    Title

    Registre prospectif des patients pris en charge pour un évènement thromboembolique (étude internationale multicentrique)

    Abbreviation or Acronym

    RIETE

    Country
    Name Country code
    France fr
    Argentine ar
    Belize bz
    Chili cl
    Grèce gr
    Italie it
    Espagne es
    Abstract

    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.

    Kind of Data

    ['Données cliniques','Données biologiques','Données de santé rapportées par les participants de l'étude']

    Unit of Analysis

    Individus

    Scope

    Topics
    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
    Keywords
    prevention. tolérance aux traitements antiplatelet treatment

    Coverage

    Universe

    {
    "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": ""
    }

    Producers and sponsors

    Primary investigators
    Name
    Laurent;BERTOLETTI
    Producers
    Name Role
    CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE sponsor
    Funding Agency/Sponsor
    Name
    UNIVERSITE JEAN MONNET (EPSCP)
    Other Identifications/Acknowledgments
    Name
    ;
    réseau mondial RIETE, réseau Français INNOVTE, réseau mondial INVENT-VTE

    Study authorization

    Agency
    Agency name
    CNIL

    Sampling

    Sample frame

    Unit Type

    ['Via des structures (services ou établissements de santé, écoles, entreprises…)']

    Sampling Procedure

    ['{"concept":{"vocab":"CESSDA","vocabURI":"Other"},"value":"Autre"}']

    Survey instrument

    Questionnaires

    Accès restreint sur projet spécifique

    Methodology notes

    Etude observationnelle

    Data collection

    Dates of Data Collection
    Start End
    2006-01-01 3000-01-01
    Frequency of Data Collection

    adaptée

    Mode of data collection
    • {"concept":{"vocab":"CESSDA","vocabURI":"Interview"},"value":"Entretien avec le participant (dont clinique)"}

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Evénements de santé/morbidité Evénements de santé/mortalité Consommation de soins/services de santé
    Study activities
    Type
    secondary evaluation

    Quality standards

    Other quality statement

    ['- 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']

    Data Access

    Access authority
    Name Email
    Contact;RGPD contact.rgpd@chu-etienne.fr
    Availability Status

    {"extLink":{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"},"value":"Accès réservé"}

    Restrictions

    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

    Contacts

    Contacts
    Name Email
    Laurent;BERTOLETTI laurent.bertoletti@chu-st-etienne.fr

    Metadata production

    DDI Document ID

    FRESH-PEF60139-fr

    Producers
    Name
    Admin Fresh
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