<?xml version="1.0" encoding="UTF-8"?>
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<docDscr>
  <citation>
    <titlStmt>
      <titl>Study of Acute Liver Transplant</titl>
      <IDNo>FRESH-PEF2948-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNIVERSITE DE BORDEAUX" role="">Cécile DROZ-PERROTEAU</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Study of Acute Liver Transplant            </titl>
      <altTitl>
                    SALT-I                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF2948-en            </IDNo>
      <IDNo agency="PEF">
                    2948                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF2948                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Sinem EZGI GULMEZ                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
        <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Nicholas MOORE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
        <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            Helsinn (Switzerland)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="UNIVERSITE DE BORDEAUX" email="sigulmez@ku.edu.tr">
                    Sinem;EZGI GULMEZ
                                            <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE DE BORDEAUX" email="nicholas.moore@u-bordeaux.fr">
                    Nicholas;MOORE
                                            <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Nimesulide</keyword>
      <keyword vocab="" vocabURI="">
                    non-steroidal anti-inflammatory drugs (NSAIDs)</keyword>
      <keyword vocab="" vocabURI="">
                    drug intoxication</keyword>
      <keyword vocab="" vocabURI="">
                    retrospective</keyword>
      <keyword vocab="" vocabURI="">
                    case-population</keyword>
      <keyword vocab="" vocabURI="">
                    liver transplantation</keyword>
      <keyword vocab="" vocabURI="">
                    Europe</keyword>
      <keyword vocab="" vocabURI="">
                    Pharmacoepidemiology</keyword>
      <keyword vocab="" vocabURI="">
                    Department of Pharmacology</keyword>
      <keyword vocab="" vocabURI="">
                    Bordeaux</keyword>
      <topcClas vocab="health theme">
                        Hepatology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/27c456a1-051a-42f6-b52a-3beff0487da7"/>
                                                </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants: Other                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Acute liver failure, Nimesulide, non-steroidal anti-inflammatory drugs (NSAIDs), liver transplantation, drug intoxication, retrospective, case-population, Europe, Pharmacoepidemiology, Department of Pharmacology, Bordeaux</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <collDate event="end" date="2011-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <nation abbr="it">
                    Italy
                                            <concept vocab="ISO" vocabURI="it"/>
                                    </nation>
      <nation abbr="pt">
                    Portugal
                                            <concept vocab="ISO" vocabURI="pt"/>
                                    </nation>
      <nation abbr="gb">
                    United Kingdom
                                            <concept vocab="ISO" vocabURI="gb"/>
                                    </nation>
      <nation abbr="nl">
                    Netherlands
                                            <concept vocab="ISO" vocabURI="nl"/>
                                    </nation>
      <nation abbr="gr">
                    Greece
                                            <concept vocab="ISO" vocabURI="gr"/>
                                    </nation>
      <nation abbr="ie">
                    Ireland
                                            <concept vocab="ISO" vocabURI="ie"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Patient who was at least 18 years old at the time of registration on transplant list; Patient with acute liver failure placed on liver transplantation list and exposed to NSAIDs during the 30 days before the 1st signs or symptoms of liver disease, whether or not transplantation was performed; Patient resident of the participating country;                    </universe>
      <universe clusion="E">elective liver transplants for chronic diseases such as cirrhosis, chronic hepatitis or cancer.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <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>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Case-control study                    </notes>
    <anlyInfo>
      <respRate>500</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
    <notes>Ownership of study data is the subject of an agreement between the University Bordeaux Segalen and the funder.</notes>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
