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<docDscr>
  <citation>
    <titlStmt>
      <titl>Perspective cohort of patients managed for a venous thromboembolic event (multi-center international study)</titl>
      <IDNo>FRESH-PEF60139-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="" role="">Admin Fresh</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Perspective cohort of patients managed for a venous thromboembolic event (multi-center international study)            </titl>
      <altTitl>
                    RIETE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60139-en            </IDNo>
      <IDNo agency="PEF">
                    60139                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60139                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Laurent BERTOLETTI                                                <ExtLink title="ORCID" URI="null" role="pi id"/>
                                                                                                                    <ExtLink title="IdRef" URI="null" role="pi id"/>
                                                                                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE">
        <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
        <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
        <ExtLink title="RNSR" URI="null" role="labo id"/>
      </AuthEnty>
      <othId affiliation="" type="contributor">
        <ExtLink title="ORCID" URI="" role="team member id"/>
        <ExtLink title="IdRef" URI="" role="team member id"/>
      </othId>
      <othId affiliation="" type="affiliation">
        <ExtLink title="RNSR" URI="" role="labo id"/>
      </othId>
      <othId affiliation="RIETE global network, INNOVTE French network, INVENT-VTE global network" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            UNIVERSITE JEAN MONNET (EPSCP)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE" email="laurent.bertoletti@chu-st-etienne.fr">
                    Laurent;BERTOLETTI
                                            <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
                                            <ExtLink title="RNSR" URI="" role="labo id"/>
                                    </contact>
      <depDate date="2026-08-15"/>
      <distDate date="2026-08-15"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <studyAuthorization>
    <authorizingAgency>CNIL                </authorizingAgency>
  </studyAuthorization>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Prevention</keyword>
      <topcClas vocab="health theme">
                        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"/>
                                                            <ExtLink title="MeSH" URI="D002309"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Emergency medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5e1591e2-d02b-436c-8216-6b8912eee467"/>
                                                            <ExtLink title="MeSH" URI="D004635"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Hematology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/9239f328-78c9-40a5-a0b9-8e66fd9b6245"/>
                                                            <ExtLink title="MeSH" URI="D006402"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        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"/>
                                                            <ExtLink title="MeSH" URI="D007388"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Pulmonary medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/f6e18c52-6087-4662-904c-5c4b8174e40e"/>
                                                            <ExtLink title="MeSH" URI="D015272"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Venous thromboembolism                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
    </subject>
    <abstract contentType="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>
    <abstract contentType="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

Objectives
The 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.
Another objective of RIETE is to develop predictive scores that help physicians better identify patients at high risk of developing some of these complications.
Patient eligibility criteria
Participating 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.

Study parameters and endpoints
The 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.

Use of the RIETE study database
Although not intended to influence the routine management of patients participating in the registry, data compiled from RIETE are available on the registry’s 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.</abstract>
    <sumDscr>
      <collDate event="start" date="2006-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <nation abbr="ar">
                    Argentina
                                            <concept vocab="ISO" vocabURI="ar"/>
                                    </nation>
      <nation abbr="bz">
                    Belize
                                            <concept vocab="ISO" vocabURI="bz"/>
                                    </nation>
      <nation abbr="cl">
                    Chile
                                            <concept vocab="ISO" vocabURI="cl"/>
                                    </nation>
      <nation abbr="gr">
                    Greece
                                            <concept vocab="ISO" vocabURI="gr"/>
                                    </nation>
      <nation abbr="il">
                    Israel
                                            <concept vocab="ISO" vocabURI="il"/>
                                    </nation>
      <nation abbr="it">
                    Italy
                                            <concept vocab="ISO" vocabURI="it"/>
                                    </nation>
      <nation abbr="es">
                    Spain
                                            <concept vocab="ISO" vocabURI="es"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individus            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="D005260"/>
                                                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="D008297"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="D000369"/>
                                                    </universe>
      <universe 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                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>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.</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services</description>
    </developmentActivity>
    <developmentActivity type="secondary evaluation">
                                    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <frequenc>suitable</frequenc>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&gt;= 20000 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
      <sources>
        <sources>
          <sourceCitation>
                                    
                                    
                                                                    </sourceCitation>
        </sources>
      </sources>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <notes subject="follow-up">
                        Monitoring by participant visit to the investigation center                    </notes>
    <anlyInfo>
      <respRate>130 000 - avril 2026</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                            <ExtLink title="COAR" URI="http://purl.org/coar/access_right/c_16ec"/>
                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>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.</restrctn>
      <contact email="contact.rgpd@chu-etienne.fr">Contact;RGPD</contact>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
