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Source1

{
  "resourceType": "Group",
  "id": "346486",
  "meta": {
    "versionId": "5",
    "lastUpdated": "2026-01-26T16:43:36.602Z"
  },
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-author",
      "valueContactDetail": {
        "name": "Brian S. Alper, MD, MSPH"
      }
    },
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as",
      "valueMarkdown": "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."
    }
  ],
  "url": "https://fevir.net/resources/Group/346486",
  "identifier": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code": "ACSN",
            "display": "Accession ID"
          }
        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "346486",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "type": {
        "text": "FEvIR Linking Identifier"
      },
      "system": "https://fevir.net/FLI",
      "value": "CTIS2024-516402-32-00 Eligibility Criteria",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "name": "CTIS2024_516402_32_00_Eligibility_Criteria",
  "title": "CTIS2024-516402-32-00 Eligibility Criteria",
  "status": "active",
  "publisher": "Computable Publishing LLC",
  "contact": [
    {
      "telecom": [
        {
          "system": "email",
          "value": "support@computablepublishing.com"
        }
      ]
    }
  ],
  "description": "This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.",
  "copyright": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "membership": "conceptual",
  "combinationMethod": "all-of",
  "characteristic": [
    {
      "id": "Inclusion-1",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Age ≥ 18 years",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Âge ≥ 18 ans"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": false
    },
    {
      "id": "Inclusion-2",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "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 >180mmHg and/or diastolic blood pressure>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)",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Hospitalisation pour un SHUa-HE dans les 10 jours précédents :\no Présomption d'insuffisance rénale aiguë (traitement de substitution rénale ou taux de créatinine sérique ≥  354µM \no Hémolyse mécanique comprenant : anémie, thrombopénie, et : haptoglobine basse (1,5UNL), ou présence de schisocytes\no Hypertension sévère avec une pression artérielle systolique >180mmHg et/ou une pression artérielle diastolique>110mmHg\no Atteinte des organes cibles, y compris atteinte neurologique (notamment encéphalopathie hypertensive, céphalées, confusion, nausées, syndrome d'encéphalopathie réversible postérieure), ou atteinte cardiovasculaire (notamment insuffisance ventriculaire gauche aiguë, œdème pulmonaire aigu, ischémie cardiaque aiguë, douleurs thoraciques, dyspnée, palpitations), ou atteinte ophtalmologique (notamment rétinopathie ischémique ou vision trouble)."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": false
    },
    {
      "id": "Inclusion-3",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "For women of childbearing potential: Effective contraception during the study and for at least 5 months after the last dose of treatment with eculizumab",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Pour les femmes en mesure de procréer : Contraception efficace durant la recherche et au moins jusqu’à 5 mois après la dernière administration d’éculizumab"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": false
    },
    {
      "id": "Inclusion-4",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Subject affiliated to a social security regimen",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Sujet affilié à un régime de sécurité sociale"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": false
    },
    {
      "id": "Inclusion-5",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Subject having signed written informed consent",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Sujet ayant signé un consentement éclairé écrit"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": false
    },
    {
      "id": "Exclusion-1",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Atrophic kidneys with maximum length<8cm on recent (<1 month) renal ultrasound, CT scan, or renal MRI",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Reins atrophiés dont la longueur maximale est inférieure à 8 cm sur une échographie rénale, une tomodensitométrie ou une IRM rénale récente (<1 mois)"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-10",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Contra-indication to eculizumab or renin angiotensin system blockers",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Contre-indication à l'éculizumab ou aux bloqueurs du système rénine angiotensine."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-11",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Solid organ or haematopoietic transplant",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Greffe d'organe solide ou hématopoïétique"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-12",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "History (<1year) of active cancer or exposition to drugs associated with aHUS (< 3 months)",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Antécédents (<1 an) de cancer actif ou d'exposition à des médicaments associés au SHUa (< 3 mois)"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-13",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Severe cognitive or psychiatric disorders, patients unable to give an informed consent",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Troubles cognitifs ou psychiatriques graves, patients incapables de donner un consentement éclairé."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-14",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "PCR SARS-CoV2 positive",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "PCR SARS-CoV2 positive"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-15",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Pregnant or breastfeeding woman or ineffective contraception",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Femme enceinte ou allaitante ou contraception inefficace"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-16",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Persons deprived of their liberty by judicial or administrative decision",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Personnes privées de leur liberté par décision judiciaire ou administrative"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-17",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Persons under legal protection (guardianship, curatorship)",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Personnes sous protection juridique (tutelle, curatelle)"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-18",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Participation à une autre étude interventionnelle impliquant la personne humaine ou être dans la période d'exclusion à la fin d'une précédente étude impliquant la personne humaine."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-2",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "High clinical suspicion of Complement-mediated aHUS (including familial history of aHUS)",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Forte suspicion clinique de SHUa médié par le complément (y compris antécédents familiaux de SHUa)."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-3",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "High clinical suspicion of typical HUS (including Shiga Toxin-producing E. Coli infection) or Thrombotic thrombocytopenic purpura",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Forte suspicion clinique de SHU typique (y compris une infection à E. Coli producteur deshigatoxine) ou de purpura thrombocytopénique thrombotique."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-4",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "High clinical suspicion of secondary HUS related to autoimmune disease (including lupus, scleroderma, antiphospholipid syndrome, ANCA vasculitis), or C3 glomerulopathy.",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Forte suspicion clinique de SHU secondaire lié à une maladie auto-immune (y compris lupus, sclérodermie, syndrome des antiphospholipides, vascularite à ANCA), ou une glomérulopathie à C3."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-5",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "High clinical suspicion of recent hemorrhagic or ischemic stroke",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Forte suspicion clinique d'un accident vasculaire cérébral hémorragique ou ischémique récent."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-6",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "ADAMTS 13<10%, HIV or HCV infection, positivity of 2 markers among: anticardiolipin IgG/antiBeta2 GP1 IgG/lupus anticoagulant, positivity of ANCA (ELISA PR3 or MPO)",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "ADAMTS 13<10%, infection par le VIH ou le VHC, positivité de 2 marqueurs parmi : IgG anticardiolipine/ IgG antiBeta2 GP1/ anticoagulant lupique, positivité des ANCA (ELISA PR3 ou MPO)."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-7",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Active infection",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Infection active"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-8",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "Subjects with unresolved Neisseria meningitidis infection",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Patients avec une infection à Neisseria meningitidis non résolue"
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    },
    {
      "id": "Exclusion-9",
      "code": {
        "text": "Eligibility Criterion"
      },
      "valueCodeableConcept": {
        "text": "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))",
        "_text": {
          "extension": [
            {
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "fr"
                },
                {
                  "url": "content",
                  "valueString": "Patients refusants la vaccination contre Neisseria meningitidis   ou refusants une antibioprophylaxie par oracilline (En cas d'allergie à la pénicilline, une antibioprophylaxie par macrolide pourra être proposée selon les recommandations de l'ANSM (azithromycine ou roxithromycine))."
                }
              ],
              "url": "http://hl7.org/fhir/StructureDefinition/translation"
            }
          ]
        }
      },
      "exclude": true
    }
  ]
}