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Among explanations, bleeding definition could vary and classification bias exists related to the lack of medical evaluation. To quantify the risk of major haemorrhagic event and event\u2010free survival associated with antithrombotic drugs (vitamin K antagonist [<jats:styled-content style=\"fixed-case\">VKA<\/jats:styled-content>], non\u2010<jats:styled-content style=\"fixed-case\">VKA<\/jats:styled-content> anticoagulant [<jats:styled-content style=\"fixed-case\">NOAC<\/jats:styled-content>], antiplatelet agent, parenteral anticoagulant) in 2012\u20132015, we linked the French nationwide Health Insurance database (<jats:styled-content style=\"fixed-case\">SNIIRAM<\/jats:styled-content>) with a local \u2018emergency database\u2019 (clinical and biological data collected in clinical records). In the <jats:styled-content style=\"fixed-case\">VKA<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">NOAC<\/jats:styled-content> comparison, a Cox regression analysis will be used to estimate the hazard ratio of major haemorrhagic event adjusted on gender, modified <jats:styled-content style=\"fixed-case\">HAS<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">BLED<\/jats:styled-content> score and comorbidities. A distinction on the type of major haemorrhagic event (intracranial, gastrointestinal and other haemorrhagic events) was made. We present here the study protocol and the database linkage results. Using six linkage keys, among 3\u00a0837\u00a0557 hospital visits identified in <jats:styled-content style=\"fixed-case\">SNIIRAM<\/jats:styled-content>, 5264 have been matched with a major haemorrhagic event identified in the \u2018emergency database\u2019, thus clinically confirmed. The 1090 unmatched haemorrhagic events could be explained by the fact that patients were not extracted in the <jats:styled-content style=\"fixed-case\">SNIIRAM<\/jats:styled-content> database (patients living in accommodation establishment with internal use of pharmacy, military people with specific insurance\u2026). We showed the value of <jats:styled-content style=\"fixed-case\">SNIIRAM<\/jats:styled-content> enrichment with a clinical database, a necessary step to categorize haemorrhagic events by a clinically relevant definition and medical validation; it will allow to estimate more accuracy each type of haemorrhagic event.<\/jats:p>","DOI":"10.1111\/fcp.12444","type":"journal-article","created":{"date-parts":[[2018,12,10]],"date-time":"2018-12-10T16:18:37Z","timestamp":1544458717000},"page":"443-462","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Major bleeding with antithrombotic agents: a 2012\u20132015 study using the French nationwide Health Insurance database linked to emergency department records within five areas \u2013 rationale and design of <scp>SACHA<\/scp> study"],"prefix":"10.1111","volume":"33","author":[{"given":"Jacques","family":"Bouget","sequence":"first","affiliation":[{"name":"Univ Rennes REPERES 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