Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot2: STU1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions
| Page standards status: Informative |
<ResearchStudy xmlns="http://hl7.org/fhir">
<id value="346485"/>
<meta>
<versionId value="4"/>
<lastUpdated value="2025-03-07T13:36:24.212Z"/>
<profile
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/ctis-record"/>
</meta>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
</text>
<contained>
<Organization>
<id value="organization-554686"/>
<name value="Assistance Publique Hopitaux De Paris"/>
<description value="Hospital/Clinic/Other health care facility"/>
</Organization>
</contained>
<contained>
<PractitionerRole>
<id value="contact-190857"/>
<organization>
<reference value="#organization-554686"/>
<type value="Organization"/>
<display value="Assistance Publique Hopitaux De Paris"/>
</organization>
<display value="Dr El Karoui Khalil khalil.el-karoui@aphp.fr"/>
<contact>
<name>
<text value="Dr El Karoui Khalil"/>
</name>
<telecom>
<system value="email"/>
<value value="khalil.el-karoui@aphp.fr"/>
</telecom>
<telecom>
<system value="phone"/>
<value value="+33156016317"/>
</telecom>
</contact>
</PractitionerRole>
</contained>
<contained>
<PractitionerRole>
<id value="contact-190858"/>
<organization>
<reference value="#organization-554686"/>
<type value="Organization"/>
<display value="Assistance Publique Hopitaux De Paris"/>
</organization>
<display value="Dr El Karoui Khalil khalil.el-karoui@aphp.fr"/>
<contact>
<name>
<text value="Dr El Karoui Khalil"/>
</name>
<telecom>
<system value="email"/>
<value value="khalil.el-karoui@aphp.fr"/>
</telecom>
<telecom>
<system value="phone"/>
<value value="+33156016317"/>
</telecom>
</contact>
</PractitionerRole>
</contained>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-author">
<valueContactDetail>
<name value="Computable Publishing®: CTIS-to-FEvIR Converter"/>
</valueContactDetail>
</extension>
<extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to">
<extension url="type">
<valueCode value="transforms"/>
</extension>
<extension url="targetUri">
<valueUri
value="https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-516402-32-00"/>
</extension>
</extension>
<extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to">
<extension url="type">
<valueCode value="transformed-with"/>
</extension>
<extension url="targetUri">
<valueUri value="https://fevir.net"/>
</extension>
</extension>
<url value="https://fevir.net/resources/ResearchStudy/346485"/>
<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="urn:ietf:rfc:3986"/>
<value value="https://fevir.net/FOI/346485"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<identifier>
<use value="official"/>
<system value="https://euclinicaltrials.eu/ctis"/>
<value value="2024-516402-32-00"/>
</identifier>
<name value="CTIS_2024_516402_32_00_FHIR_Transform"/>
<title
value="Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU)"/>
<label>
<type>
<coding>
<system value="http://hl7.org/fhir/title-type"/>
<code value="primary"/>
<display value="Primary title"/>
</coding>
<text value="Public title"/>
</type>
<value
value="Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial (HYPERSHU)"/>
</label>
<label>
<type>
<coding>
<system value="http://hl7.org/fhir/title-type"/>
<code value="short-title"/>
<display value="Short title"/>
</coding>
</type>
<value value="APHP211039"/>
</label>
<label>
<type>
<coding>
<system value="http://hl7.org/fhir/title-type"/>
<code value="language"/>
<display value="Different language"/>
</coding>
<text value="French"/>
</type>
<value
value="Eculizumab dans le syndrome hémolytique et urémique associé à l'urgence hypertensive: essai contrôlé multicentrique randomisé (HYPERSHU)"/>
</label>
<label>
<type>
<coding>
<system value="http://hl7.org/fhir/title-type"/>
<code value="language"/>
<display value="Different language"/>
</coding>
<text value="French of public title"/>
</type>
<value
value="Eculizumab dans le syndrome hémolytique et urémique associé à l'urgence hypertensive: essai contrôlé multicentrique randomisé (HYPERSHU)"/>
</label>
<status value="active"/>
<condition>
<text
value="Adult patients with aHUS associated with HE and severe kidney involvement (needing dialysis or serum creatinine ≥ 354μM)"/>
</condition>
<condition>
<coding>
<system value="https://www.meddra.org"/>
<version value="20.1"/>
<code value="10079840"/>
<display value="Atypical haemolytic uraemic syndrome"/>
</coding>
</condition>
<description value="Example of CTISRecord Profile"/>
<period>
<start value="2024-02-13"/>
<end value="2027-02-13"/>
</period>
<note>
<text
value="The target number for this trial (66) was not found in the EU CTIS record but it was found in the corresponding ClinicalTrials.gov record (NCT05726916)."/>
</note>
<associatedParty>
<name value="Dr El Karoui Khalil"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="general-contact"/>
<display value="general-contact"/>
</coding>
<text value="public contact"/>
</role>
<party>
<reference value="#contact-190857"/>
<type value="PractitionerRole"/>
<display value="Dr El Karoui Khalil khalil.el-karoui@aphp.fr"/>
</party>
</associatedParty>
<associatedParty>
<name value="Dr El Karoui Khalil"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="general-contact"/>
<display value="general-contact"/>
</coding>
<text value="scientific contact"/>
</role>
<party>
<reference value="#contact-190858"/>
<type value="PractitionerRole"/>
<display value="Dr El Karoui Khalil khalil.el-karoui@aphp.fr"/>
</party>
</associatedParty>
<progressStatus>
<state>
<coding>
<system value="http://hl7.org/fhir/research-study-status"/>
<code value="overall-study"/>
<display value="Overall study"/>
</coding>
</state>
<actual value="false"/>
<period>
<start value="2024-02-13"/>
<end value="2027-02-13"/>
</period>
</progressStatus>
<recruitment>
<targetNumber value="66"/>
<eligibility>🔗
<reference value="Group/346486"/>
<type value="Group"/>
<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>
<display value="CTIS2024-516402-32-00 Eligibility Criteria"/>
</eligibility>
</recruitment>
<objective>
<name
value="To demonstrate the efficacy of early Eculizumab administration added on standard of care BP control on dialysis-dependence at month 6 in HEaHUS patients with severely impaired initial renal function."/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the role of complement biomarkers in predicting therapeutic response"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the frequency of complement genetic rare variants in this population"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the efficacy of early eculizumab administration added on standard of care BP control on 3-month (W13) and 12 months renal replacement therapy risk"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the frequency of severe infections in both groups"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the time to resolution of hemolysis and acute dialysis"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To evaluate the frequency of histological lesions and their prognosis (if kidney biopsy is performed)"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name value="To evaluate the medico-economic impact of Eculizumab"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Objective of the first ancillary study: A first ancillary study will include a pangenomic analysis aimed at identifying new genetic variants associated with HE-aHUS. This ancillary study will be based on the residual genetic samples already scheduled in the biocollection. This ancillary study will be coordinated by Pr L. Mesnard (Nephrology Department, Tenon Hospital, Paris) and performed according to an already available funding"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Objective of any other potential ancillary study: biological collection For any other ancillary study: residual samples will be stored for a biological collection to identify new potential genetic and pathophysiological determinants of HE-aHUS (Department of Immunobiology, HEGP, Dr Frémeaux-Bacchi)."/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure">
<extension url="name">
<valueString
value="Response to therapy, defined by the absence of any of the following events: i) at 6-month follow-up: persistent renal replacement therapy, eGFR<15ml/mn/1,73m2, or patient death; ii) at W2 : persistent hemolysis despite well conducted antihypertensive therapy. Any Eculizumab rescue in the control group will be considered as a failure."/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>🔗
<reference value="EvidenceVariable/346487"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Primary Outcome 1"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Primary Outcome 1"/>
</valueReference>
</extension>
</extension>
<name value="Primary Endpoints"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
</objective>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure">
<extension url="name">
<valueString
value="Prognosis role of repeat complement biomarkers (W1, W4, W13)"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>🔗
<reference value="EvidenceVariable/346488"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 1"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 1"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure">
<extension url="name">
<valueString value="Frequency of Complement genetic rare variants"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>🔗
<reference value="EvidenceVariable/346489"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 2"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 2"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure">
<extension url="name">
<valueString
value="Renal replacement therapy rates at months 3 and 12 follow-up"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>🔗
<reference value="EvidenceVariable/346490"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 3"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 3"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure">
<extension url="name">
<valueString
value="Frequency of severe infections (defined by the need for hospitalization)"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>🔗
<reference value="EvidenceVariable/346491"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 4"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 4"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure">
<extension url="name">
<valueString value="Time to resolution of haemolysis"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>🔗
<reference value="EvidenceVariable/346492"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 5"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 5"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure">
<extension url="name">
<valueString value="Time to resolution of renal replacement therapy"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>🔗
<reference value="EvidenceVariable/346493"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 6"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 6"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure">
<extension url="name">
<valueString
value="Frequency and prognostic role of kidney lesions (glomerular and arteriolar microthromboses), glomerulosclerosis and kidney fibrosis if kidney biopsy is performed"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>🔗
<reference value="EvidenceVariable/346494"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 7"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 7"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-outcome-measure">
<extension url="name">
<valueString
value="Costs relating to renal replacement therapy (or lack of), Eculizumab and other antihypertensive treatments, hospitalizations"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>🔗
<reference value="EvidenceVariable/346495"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="CTIS2024-516402-32-00 Secondary Outcome 8"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="CTIS2024-516402-32-00 Secondary Outcome 8"/>
</valueReference>
</extension>
</extension>
<name value="Secondary Endpoints"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
</objective>
</ResearchStudy>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot2. Generated 2025-03-28
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