Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: CTIS2024-516402-32-00 Eligibility Criteria

Page standards status: Informative

Raw xml | Download


<Group xmlns="http://hl7.org/fhir">
  <id value="346486"/>
  <meta>
    <versionId value="5"/>
    <lastUpdated value="2026-01-26T16:43:36.602Z"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
  <table class="narrative-table">
    <tbody>
<tr>


<th colspan="2" scope="row" class="row-header"><a name="metadata"> </a>Metadata</th>


</tr>

<tr>


<th scope="row" class="row-header">Title</th>



<td class="content-container">CTIS2024-516402-32-00 Eligibility Criteria</td>


</tr>













  
<tr>


<th scope="row" class="row-header">Identifier</th>



<td class="content-container">346486</td>


</tr>





























<tr>


<th scope="row" class="row-header">Steward (Publisher)</th>



<td class="content-container">Computable Publishing LLC</td>


</tr>











<tr>


<th scope="row" class="row-header">Description</th>



<td class="content-container"><div><p>This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
</div></td>


</tr>



<tr>


<th scope="row" class="row-header">Copyright</th>



<td class="content-container"><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div></td>


</tr>




































































































































































































































































































































<tr>
  <th colspan="2" scope="row" class="row-header">Generated using version 0.5.6 of the sample-content-ig Liquid templates</th>
</tr>

    </tbody>
  </table>
</div>
  </text>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-author">
    <valueContactDetail>
      <name value="Brian S. Alper, MD, MSPH"/>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as">
    <valueMarkdown
                   value="CTIS2024-516402-32-00 Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 346486. Revised 2026-01-26. Available at: https://fevir.net/resources/Group/346486. Computable resource at: https://fevir.net/resources/Group/346486#json."/>
  </extension>
  <url value="https://fevir.net/resources/Group/346486"/>
  <identifier>
    <type>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
        <code value="ACSN"/>
        <display value="Accession ID"/>
      </coding>
      <text value="FEvIR Object Identifier"/>
    </type>
    <system value="https://fevir.net/FOI"/>
    <value value="346486"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <identifier>
    <type>
      <text value="FEvIR Linking Identifier"/>
    </type>
    <system value="https://fevir.net/FLI"/>
    <value value="CTIS2024-516402-32-00 Eligibility Criteria"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <name value="CTIS2024_516402_32_00_Eligibility_Criteria"/>
  <title value="CTIS2024-516402-32-00 Eligibility Criteria"/>
  <status value="active"/>
  <publisher value="Computable Publishing LLC"/>
  <contact>
    <telecom>
      <system value="email"/>
      <value value="support@computablepublishing.com"/>
    </telecom>
  </contact>
  <description
               value="This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide."/>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <membership value="conceptual"/>
  <combinationMethod value="all-of"/>
  <characteristic id="Inclusion-1">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text value="Age ≥ 18 years"/>
    </valueCodeableConcept>
    <exclude value="false"/>
  </characteristic>
  <characteristic id="Inclusion-2">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Hospitalization forHE-aHUS within prior 10 days: o Presume acute renal failure (renal replacement therapy or serum creatinine ≥ 354μM). o Mechanical hemolysis including: anemia, thrombopenia, and: low haptoglobin (1,5UNL), or presence of schistocytes o Severe hypertension with systolic blood pressure &gt;180mmHg and/or diastolic blood pressure&gt;110mmHg o Target organ damage, including neurological involvement (notably hypertensive encephalopathy, headache, confusion, nausea, posterior reversible encephalopathy syndrome), or cardiovascular involvement (notably acute left ventricular failure, acute pulmonary edema, acute cardiac ischemia, chest pain, dyspnea, palpitations), or ophtalmological involvement (notably ischemic retinopathy or blurred vision)"/>
    </valueCodeableConcept>
    <exclude value="false"/>
  </characteristic>
  <characteristic id="Inclusion-3">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="For women of childbearing potential: Effective contraception during the study and for at least 5 months after the last dose of treatment with eculizumab"/>
    </valueCodeableConcept>
    <exclude value="false"/>
  </characteristic>
  <characteristic id="Inclusion-4">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text value="Subject affiliated to a social security regimen"/>
    </valueCodeableConcept>
    <exclude value="false"/>
  </characteristic>
  <characteristic id="Inclusion-5">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text value="Subject having signed written informed consent"/>
    </valueCodeableConcept>
    <exclude value="false"/>
  </characteristic>
  <characteristic id="Exclusion-1">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Atrophic kidneys with maximum length&lt;8cm on recent (&lt;1 month) renal ultrasound, CT scan, or renal MRI"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-10">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Contra-indication to eculizumab or renin angiotensin system blockers"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-11">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text value="Solid organ or haematopoietic transplant"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-12">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="History (&lt;1year) of active cancer or exposition to drugs associated with aHUS (&lt; 3 months)"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-13">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Severe cognitive or psychiatric disorders, patients unable to give an informed consent"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-14">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text value="PCR SARS-CoV2 positive"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-15">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Pregnant or breastfeeding woman or ineffective contraception"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-16">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Persons deprived of their liberty by judicial or administrative decision"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-17">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Persons under legal protection (guardianship, curatorship)"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-18">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-2">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="High clinical suspicion of Complement-mediated aHUS (including familial history of aHUS)"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-3">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="High clinical suspicion of typical HUS (including Shiga Toxin-producing E. Coli infection) or Thrombotic thrombocytopenic purpura"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-4">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="High clinical suspicion of secondary HUS related to autoimmune disease (including lupus, scleroderma, antiphospholipid syndrome, ANCA vasculitis), or C3 glomerulopathy."/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-5">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="High clinical suspicion of recent hemorrhagic or ischemic stroke"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-6">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="ADAMTS 13&lt;10%, HIV or HCV infection, positivity of 2 markers among: anticardiolipin IgG/antiBeta2 GP1 IgG/lupus anticoagulant, positivity of ANCA (ELISA PR3 or MPO)"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-7">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text value="Active infection"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-8">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Subjects with unresolved Neisseria meningitidis infection"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
  <characteristic id="Exclusion-9">
    <code>
      <text value="Eligibility Criterion"/>
    </code>
    <valueCodeableConcept>
      <text
            value="Subjects refusing Neisseria meningitidis vaccination or refusing antibioprophylaxis with oracillin (In case of penicillin allergy, antibioprophylaxis with macrolide couldbeproposed according to ANSM recommendations (azithromycin or roxithromycin))"/>
    </valueCodeableConcept>
    <exclude value="true"/>
  </characteristic>
</Group>