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<docDscr>
  <citation>
    <titlStmt>
      <titl>Development of Multimodal Resonance Imaging for Outcome Prediction in Coma Patients</titl>
      <IDNo>FRESH-PEF60185-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="" role=""></producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Development of Multimodal Resonance Imaging for Outcome Prediction in Coma Patients            </titl>
      <altTitl>
                    IRM-COMA                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60185-en            </IDNo>
      <IDNo agency="PEF">
                    60185                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60185                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Louis PUYBASSET                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)">
        <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
        <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" email="louis.puybasset@aphp.fr">
                    Louis;PUYBASSET
                                            <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Coma</keyword>
    </subject>
    <abstract contentType="purpose">To develop a composite score able to predict the awakening of coma patients following a severe cranial trauma. This composite score will be built from the results of the multimodal MRI (quantified indicator) in combination with clinical covariables e.g. age of the patient, the mechanism of the accident (high versus low speed), initial Glasgow score, clinical examination data at time of MRI and comorbidities. The composite score will aim to predict the outcome of patients at 1 year, evaluated by one of the following three categories: favourable outcome (GOS 3+, 4, and 5) and unfavourable outcome (GOS 1, 2, and 3-). The GOS 3- score has been defined as severe disability with minimally conscious state and GOS 3+ score as severe disability excluding cognitive sequelae. - To evaluate the relevance of the composite score to predict the clinical outcome at 1 year assessed by the Rankin score, GOS and the disability rating scale (DRS). - To analyse intra and inter-observer reproducibility study of the analysis of the various sequences.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2006-01-01"/>
      <collDate event="end" date="2011-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <nation abbr="be">
                    Belgium
                                            <concept vocab="ISO" vocabURI="be"/>
                                    </nation>
      <nation abbr="ch">
                    Switzerland
                                            <concept vocab="ISO" vocabURI="ch"/>
                                    </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 clusion="I">1, Adults covered by a social security scheme. 2. Hospitalised in intensive care and requiring artificial ventilation following a severe cranial trauma, an ischaemic or haemorrhagic cerebrovascular accident or a cerebral anoxia. 3. Not answering simple orders at least 7 days after ictus. 4. Receiving an amount of sedatives and not being able to explain the coma. 5. Having a standardised intracranial pressure (≤ 15 mm Hg) and in absence of severe haemodynamic or respiratory failure so that the MRI does not represent any additional danger. - severe haemodynamic failure is defined as a circulatory condition requiring administration of high-dose catecholamines (noradrenaline &gt; 3 mg/h and/or dobutamine &gt; 10 µg/kg/min); - Severe respiratory failure is defined as the use of FiO2 &gt; 60% combined with positive expiratory pressure &gt; 10 cm H2O.                    </universe>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</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>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <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">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>- 250: traumatisés crâniens - 150: autres causes de coma (accident vasculaire cérébral ischémique ou hémorragique)</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>To be decided if data may be used by academic teams Data may not be used by industrial teams</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
