{"doc_desc":{"title":"Perspective cohort of patients managed for a venous thromboembolic event (multi-center international study)","idno":"FRESH-PEF60139-en","producers":[{"name":"Admin Fresh","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60139-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60139"},{"agency":"FReSH","code":"FRESH-PEF60139"}],"metadata_yes":[{"code":"FReSH","agency":"FReSH"}]},"title":"Perspective cohort of patients managed for a venous thromboembolic event (multi-center international study)","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":"RIETE global network, INNOVTE French network, INVENT-VTE global network","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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"}],"topics":[{"topic":"Cardiology and vascular medicine","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":"Emergency medicine","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5e1591e2-d02b-436c-8216-6b8912eee467"},{"title":"MeSH","uri":"D004635"}],"vocab":"health theme"},{"topic":"Hematology","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"D006402"}],"vocab":"health theme"},{"topic":"Internal medicine","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":"Pulmonary medicine","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"D015272"}],"vocab":"health theme"},{"topic":"Venous thromboembolism","vocab":"cim-11","extLink":[{"title":"CIM-11","uri":"http:\/\/id.who.int\/icd\/entity\/1197943614"}]},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"}],"purpose":"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","abstract":"The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary project launched in March 2001 that aims to establish a comprehensive registry of consecutive patients with venous thromboembolism\r\n\r\nObjectives\r\nThe main objective is to provide information online to help physicians improve their understanding of the natural history of thromboembolic disease, particularly in those patient subgroups that are typically not included in randomized clinical trials (pregnant women, elderly patients, patients with metastatic cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, patients with extreme body weight, etc.), with the aim of reducing mortality, the frequency of thromboembolic recurrences, as well as bleeding complications and arterial events.\r\nAnother objective of RIETE is to develop predictive scores that help physicians better identify patients at high risk of developing some of these complications.\r\nPatient eligibility criteria\r\nParticipating hospitals enroll all patients who meet predefined eligibility criteria. Patients are included if they have acute deep vein thrombosis (DVT), pulmonary embolism (PE), and\/or superficial vein thrombosis (SVT), confirmed by objective tests (i.e., contrast venography, ultrasonography, impedance plethysmography, or magnetic resonance imaging 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 data recorded by the registry include details of each patient's clinical status, including any coexisting or underlying conditions, as well as the type, dose, duration, and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints include 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, data compiled from RIETE are available on the registry\u2019s website (www.riete.org) for use by participating physicians 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 for 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":"Argentina","abbreviation":"ar","extLink":{"vocab":"ISO","vocabURI":"ar"}},{"name":"Belize","abbreviation":"bz","extLink":{"vocab":"ISO","vocabURI":"bz"}},{"name":"Chile","abbreviation":"cl","extLink":{"vocab":"ISO","vocabURI":"cl"}},{"name":"Greece","abbreviation":"gr","extLink":{"vocab":"ISO","vocabURI":"gr"}},{"name":"Israel","abbreviation":"il","extLink":{"vocab":"ISO","vocabURI":"il"}},{"name":"Italy","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Spain","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\": \"Female\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008297\"\n            },\n            \"value\": \"Male\"\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D055815\"\n            },\n            \"value\": \"Young Adult (19 to 24 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000328\"\n            },\n            \"value\": \"Adult (25 to 44 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008875\"\n            },\n            \"value\": \"Middle Aged (45 to 64 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000368\"\n            },\n            \"value\": \"Aged (65 to 79 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000369\"\n            },\n            \"value\": \"Aged, 80 and over (80 years and more)\"\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"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\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['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.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"},{"activity_type":"secondary evaluation","activity_description":""}]},"method":{"data_collection":{"time_method":"","frequency":"suitable","sampling_procedure":"['{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Other\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Interview\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":[]}],"target_sample_size":">= 20000 individuals","response_rate":"130 000 - avril 2026"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]},{"subject":"follow-up","values":["Monitoring by participant visit to the investigation center"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"extLink\":{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"},\"value\":\"Restricted access\"}"},"dataset_use":{"restrictions":"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.","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":"en","originLang":"en","lastUpdatedAuto":"23-06-2026","lastUpdatedManual":"23-06-2026","autoTranslation":false,"status":"Awaiting validation","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 resulting from the study and presenting research findings (articles, posters, reports, books or chapters, etc.)","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":"thrombosis","type":"","typeOther":""}],"cohortLongitudinal":{"recrutementTiming":[]},"otherResearchType":{"otherResearchTypeDetails":""},"inclusionGroups":[],"nrInclusionGroups":false,"collectionProcess":{"collectionModeDetails":"Interviews: direct data entry Clinical examinations: hand-written entry Biological examinations: direct data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategy":[],"samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Spain, Italy, Argentina, Israel, Chili, Greece, United Kingdom, Brazil, France"},"dataTypes":{"clinicalDataDetails":"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)","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":"","paraclinicalDataOther":"","otherLiquidsDetails":""},"variableDictionnary":{"variableDictionnaryAvailable":true,"variableDictionnaryLink":"website"},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}