{"doc_desc":{"title":"Registre prospectif des patients pris en charge pour un \u00e9v\u00e8nement thromboembolique (\u00e9tude internationale multicentrique)","idno":"FRESH-PEF60139-fr","producers":[{"name":"Admin Fresh","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60139-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60139"},{"agency":"FReSH","code":"FRESH-PEF60139"}],"metadata_yes":[{"code":"FReSH","agency":"FReSH"}]},"title":"Registre prospectif des patients pris en charge pour un \u00e9v\u00e8nement thromboembolique (\u00e9tude internationale multicentrique)","alternate_title":"RIETE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Laurent;BERTOLETTI","firstname":"Laurent","lastname":"BERTOLETTI","type":"investigator","extlink":[{"title":"ORCID","uri":"","role":"pi id"},{"title":"IdRef","uri":"","role":"pi id"},{"title":"ROR","uri":"https:\/\/ror.org\/04pn6vp43","role":"organisation id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}],"email":"laurent.bertoletti@chu-st-etienne.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","PILabo":"CHU Saint-Etienne \/ INSERM CENTRE D\u2019INVESTIGATION CLINIQUE \u2013 EPIDEMIOLOGIE CLINIQUE (CIE3) - UMR 1059 SAINBIOSE -CHU DE SAINT ETIENNE","isContact":true}],"oth_id":[{"name":";","firstname":"","lastname":"","type":"contributor","isContact":"","extlink":[{"title":"ORCID","uri":"","role":"team member id"},{"title":"IdRef","uri":"","role":"team member id"}]},{"name":"","type":"affiliation","teamMemberLabo":"","extlink":[{"title":"RNSR","uri":"","role":"labo id"}]},{"name":"r\u00e9seau mondial RIETE, r\u00e9seau Fran\u00e7ais INNOVTE, r\u00e9seau mondial INVENT-VTE","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","role":"sponsor","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04pn6vp43","role":"sponsor id"},{"title":"SIREN","uri":"264200304","role":"sponsor id"}]}],"funding_agencies":[{"name":"UNIVERSITE JEAN MONNET (EPSCP)","extlink":[{"title":"SIREN","uri":"938501681"},{"title":"ROR","uri":"https:\/\/ror.org\/030bahv93"}]}]},"distribution_statement":{"contact":[{"name":"Laurent;BERTOLETTI","lastname":"BERTOLETTI","firstname":"Laurent","type":"contact","email":"laurent.bertoletti@chu-st-etienne.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","contactPointLabo":"CHU Saint-Etienne \/ INSERM CENTRE D\u2019INVESTIGATION CLINIQUE \u2013 EPIDEMIOLOGIE CLINIQUE (CIE3) - UMR 1059 SAINBIOSE -CHU DE SAINT ETIENNE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04pn6vp43","role":"organisation id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}]}]},"study_info":{"keywords":[{"keyword":"prevention."},{"keyword":"tol\u00e9rance aux traitements"},{"keyword":"antiplatelet treatment"}],"topics":[{"topic":"Cardiologie et m\u00e9decine vasculaire","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39 | http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"D002309"}],"vocab":"health theme"},{"topic":"H\u00e9matologie","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"D006402"}],"vocab":"health theme"},{"topic":"M\u00e9decine d\u2019urgence","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5e1591e2-d02b-436c-8216-6b8912eee467"},{"title":"MeSH","uri":"D004635"}],"vocab":"health theme"},{"topic":"M\u00e9decine interne","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/0d45044a-74d5-4bd7-b920-b92af3388576 | http:\/\/data.europa.eu\/8mn\/euroscivoc\/f0844378-9f30-4873-b19b-5bff8c184a36"},{"title":"MeSH","uri":"D007388"}],"vocab":"health theme"},{"topic":"Pneumologie","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"D015272"}],"vocab":"health theme"},{"topic":"Thromboembolie veineuse","vocab":"cim-11","extLink":[{"title":"CIM-11","uri":"http:\/\/id.who.int\/icd\/entity\/1197943614"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"}],"purpose":"Documenter l\u2019\u00e9pid\u00e9miologie de la maladie veineuse thromboembolique, tant sur les caract\u00e9ristiques d\u00e9mographiques et cliniques des patients que sur la prise en charge et le pronostic \u00e0 3 mois (incidence des r\u00e9cidives d\u2019\u00e9v\u00e9nements thromboemboliques (TVP et EP) symptomatiques, fatals ou non, incidence des h\u00e9morragies, d\u00e9c\u00e8s, complications)","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\r\n\r\nObjectives\r\nThe 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.\r\nAs 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.\r\nPatient entry criteria\r\nParticipating 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.\r\n\r\nStudy parameters and endpoints\r\nThe 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.\r\n\r\nUse of the RIETE study database\r\nAlthough 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.","coll_dates":[{"start":"2006-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Argentine","abbreviation":"ar","extLink":{"vocab":"ISO","vocabURI":"ar"}},{"name":"Belize","abbreviation":"bz","extLink":{"vocab":"ISO","vocabURI":"bz"}},{"name":"Chili","abbreviation":"cl","extLink":{"vocab":"ISO","vocabURI":"cl"}},{"name":"Gr\u00e8ce","abbreviation":"gr","extLink":{"vocab":"ISO","vocabURI":"gr"}},{"name":"Italie","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Espagne","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D005260\"\n            },\n            \"value\": \"F\u00e9minin\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008297\"\n            },\n            \"value\": \"Masculin\"\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D055815\"\n            },\n            \"value\": \"Adulte (19 \u00e0 24 ans)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000328\"\n            },\n            \"value\": \"Adulte (25 \u00e0 44 ans)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008875\"\n            },\n            \"value\": \"Adulte (45 \u00e0 64 ans)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000368\"\n            },\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000369\"\n            },\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\"\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" patient vu \u00e0 l\u2019h\u00f4pital pour une thrombose veineuse profonde (TVP) symptomatique des membres sup\u00e9rieurs ou inf\u00e9rieurs et\\\/ou une embolie pulmonaire (EP) symptomatique, confirm\u00e9es par des examens objectifs (i.e phl\u00e9bographie, doppler veineux, pl\u00e9thysmographie, IRM pour suspicion de TVP, angiographie pulmonaire, scintigraphie pulmonaire ventilation\\\/perfusion ou scanner spirale pour suspicion d\u2019EP) ; - patient non inclus dans un essai clinique th\u00e9rapeutique ; - patient dont le suivi \u00e0 trois mois est possible\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques','Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['- Pr\u00e9sence d'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques.- Gestion des donn\u00e9es manquantes par retour au dossier source et\/ou par retour vers le patient ou vers un tiers- Enqu\u00eates aupr\u00e8s des mairies pour les d\u00e9c\u00e8s - Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi- R\u00e9alisation d'audit qualit\u00e9 interne selon les inclusions- Les patients sont inform\u00e9s de l'utilisation de leur donn\u00e9es par orale']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9"},{"activity_type":"secondary evaluation","activity_description":""}]},"method":{"data_collection":{"time_method":"","frequency":"adapt\u00e9e","sampling_procedure":"['{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Other\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Interview\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":[]}],"target_sample_size":">= 20000 individus","response_rate":"130 000 - avril 2026"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]},{"subject":"follow-up","values":["Suivi par visite du participant au centre investigateur"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"extLink\":{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"},\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\"}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques avec acc\u00e8s de fa\u00e7on contractuelles selon les r\u00e8gles de publication \u00e9tablies par le comit\u00e9 scientifique de RIETE Utilisation impossible des donn\u00e9es par des industriels","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":"Contact;RGPD","firstname":"Contact","lastname":"RGPD","email":"contact.rgpd@chu-etienne.fr"}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":false,"versionLang":"fr","originLang":"fr","lastUpdatedAuto":"23-06-2026","lastUpdatedManual":"23-06-2026","autoTranslation":false,"status":"Envoy\u00e9e pour publication","respValidation":"","isHealthTheme":true,"isContributorPI":false,"addTeamMember":"","primaryInvestigator":{"isPIContact":true,"piMail":"laurent.bertoletti@chu-st-etienne.fr","piAffiliation":{"piLabo":"CHU Saint-Etienne \/ INSERM CENTRE D\u2019INVESTIGATION CLINIQUE \u2013 EPIDEMIOLOGIE CLINIQUE (CIE3) - UMR 1059 SAINBIOSE -CHU DE SAINT ETIENNE"}},"relatedDocument":[{"type":"Publication issue de l'\u00e9tude et pr\u00e9sentant les r\u00e9sultats de la recherche (articles, posters, rapports, ouvrages ou chapitres...)","title":"List of publications in HAL","link":"http:\/\/www.hal.inserm.fr\/RIETE"}],"contactPointLabo":"CHU Saint-Etienne \/ INSERM CENTRE D\u2019INVESTIGATION CLINIQUE \u2013 EPIDEMIOLOGIE CLINIQUE (CIE3) - UMR 1059 SAINBIOSE -CHU DE SAINT ETIENNE","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":false},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":false,"allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[{"name":"thrombose","type":"","typeOther":""}],"cohortLongitudinal":{"recrutementTiming":[]},"otherResearchType":{"otherResearchTypeDetails":""},"inclusionGroups":[],"nrInclusionGroups":false,"collectionProcess":{"collectionModeDetails":"Entretiens : saisie directe; Examens cliniques : saisie manuscrite; Examens biologiques : Saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategy":[],"samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Espagne, Italie, Argentine, Isra\u00ebl, Chili, Gr\u00e8ce, Royaume-Uni, Br\u00e9sil, France"},"dataTypes":{"clinicalDataDetails":"Examen clinique au cours du suivi tous les 3 mois : traitement anticoagulant, filtre cave, complications (r\u00e9cidives thromboemboliques, h\u00e9morragies majeures ou cliniquement pertinentes, d\u00e9c\u00e8s, complications osseuse ou cutan\u00e9es, thrombop\u00e9nies)","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":"","paraclinicalDataOther":"","otherLiquidsDetails":""},"variableDictionnary":{"variableDictionnaryAvailable":true,"variableDictionnaryLink":"site"},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}