{"doc_desc":{"title":"Cohorte de patients dans le coma : mise au point d\u2019un outil de pr\u00e9diction neurologique de r\u00e9veil par IRM multimodale","idno":"FRESH-PEF60185-fr","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60185-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60185"},{"agency":"FReSH","code":"FRESH-PEF60185"}]},"title":"Cohorte de patients dans le coma : mise au point d\u2019un outil de pr\u00e9diction neurologique de r\u00e9veil par IRM multimodale","alternate_title":"IRM-COMA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Louis;PUYBASSET","PILabo":"","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-6849-1825","role":"pi id"},{"title":"IdRef","uri":"086982273","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"louis.puybasset@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]}]},"distribution_statement":{"contact":[{"name":"Louis;PUYBASSET","email":"louis.puybasset@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Coma"},{"keyword":"score composite"},{"keyword":"\u00e9veil"},{"keyword":"traumatisme cr\u00e2nien s\u00e9v\u00e8re"},{"keyword":"IRM multimodale"},{"keyword":"covariables"},{"keyword":"m\u00e9canisme de l\u2019accident"},{"keyword":"Glasgow"},{"keyword":"co-morbidit\u00e9s"},{"keyword":"\u00e9volution favorable"},{"keyword":"d\u00e9favorable"},{"keyword":"score GOS"},{"keyword":"handicap s\u00e9v\u00e8re"},{"keyword":"s\u00e9quelles cognitives."}],"topics":[],"purpose":"Mettre au point un score composite permettant de pr\u00e9dire l\u2019\u00e9veil des patients dans le coma suite \u00e0 un traumatisme cr\u00e2nien s\u00e9v\u00e8re. Ce score composite sera construit \u00e0 partir des r\u00e9sultats de l\u2019IRM multimodale (indicateur chiffr\u00e9) en combinaison avec des covariables telles que l\u2019\u00e2ge du patient, le m\u00e9canisme de l\u2019accident (haute VS. basse vitesse), le score de Glasgow initial, les donn\u00e9es de l\u2019examen clinique au moment de l\u2019IRM et les co-morbidit\u00e9s. Le score composite qui en r\u00e9sultera aura pour objectif de pr\u00e9dire au mieux la probabilit\u00e9 d\u2019\u00eatre \u00e0 un 1 an dans l\u2019une des deux trois cat\u00e9gories suivantes : \u00e9volution favorable (GOS 3+, 4 et 5) et d\u00e9favorable (GOS 1,2 et 3-). Le score GOS 3- a \u00e9t\u00e9 d\u00e9fini comme handicap s\u00e9v\u00e8re avec un \u00e9tat hypo-relationnel et le score GOS 3+ comme handicap s\u00e9v\u00e8re \u00e0 l\u2019exception de s\u00e9quelles cognitives. Objectif secondaire : - \u00c9valuer la pertinence du score composite pour pr\u00e9dire l\u2019\u00e9volution clinique \u00e0 1 an par le rankin, le GOS \u00e9tendu, le disability rating scale (DRS). - Analyser de la reproductibilit\u00e9 intra et inter-observateur de l\u2019analyse des diff\u00e9rentes s\u00e9quences.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Belgique","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}},{"name":"Suisse","abbreviation":"ch","extLink":{"vocab":"ISO","vocabURI":"ch"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"1. Adulte affili\u00e9 au r\u00e9gime de s\u00e9curit\u00e9 sociale. 2. Hospitalis\u00e9 en r\u00e9animation et n\u00e9cessitant la ventilation artificielle suite \u00e0 un trauma cr\u00e2nien ou un accident vasculaire c\u00e9r\u00e9bral isch\u00e9mique ou h\u00e9morragique ou une anoxie c\u00e9r\u00e9brale. 3. Ne r\u00e9pondant pas aux ordres simples 7 jours apr\u00e8s l\u2019ictus. 4. Recevant une dose de s\u00e9datifs ne pouvant expliquer le coma. 5. Ayant une pression intra-cr\u00e2nienne normalis\u00e9e (< 15 mmhg) et l\u2019absence de d\u00e9faillance h\u00e9modynamique ou respiratoire s\u00e9v\u00e8re de telle sorte que le l\u2019IRM ne repr\u00e9sente aucun danger. - la d\u00e9faillance h\u00e9modynamique s\u00e9v\u00e8re est d\u00e9finie comme un \u00e9tat circulatoire requ\u00e9rant une administration de cat\u00e9cholamines \u00e0 fortes doses (noradr\u00e9naline > 3 mg\\\/h et\\\/ou dobutamine > 10 \u00b5g\\\/kg\\\/min); - la d\u00e9faillance respiratoire s\u00e9v\u00e8re est d\u00e9finie comme le recours \u00e0 une fio2 > 60 % combin\u00e9e \u00e0 une pression expiratoire positive sup\u00e9rieure \u00e0 10 CMH2O.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['- Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques- Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi- Monitoring - Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es par \u00e9crit']"}},"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"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"- 250: traumatis\u00e9s cr\u00e2niens- 150: autres causes de coma (accident vasculaire c\u00e9r\u00e9bral isch\u00e9mique ou h\u00e9morragique)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation des donn\u00e9es par des \u00e9quipes acad\u00e9miques \u00e0 d\u00e9terminer Utilisation impossible des donn\u00e9es par des industriels","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"07-08-2014","isContributorPI":"Non","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23135261"},{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-IRM-COMA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Entretiens : saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France, Belgique, SuisseLyon, Lille, Paris, Nancy, Marseille, Montpellier, Grenoble, Rouen, Bordeaux, Li\u00e8ge et Gen\u00e8ve."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}