[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649849":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":31,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":10,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Centre Hospitalier Régional d'Orléans","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Elderly patients with acute inflammation",null,"Hospitalized patients aged \\>75 years admitted to hospital with an acute inflammatory episode (CRP \\> 50 mg\u002FL).",[13],"Diagnostic Test: Analysis of biological parameters",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Analysis of biological parameters","Research-specific analyses will be performed on the following blood samples:\n\n* Day 0 : reticulocyte count, reticulocyte hemoglobin content (Ret-He), percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (TSAT, %), ferritin, soluble transferrin receptor, and hepcidin.\n* CRP \\\u003C 20 mg\u002FL (pilot phase only): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), total bilirubin, albumin, and creatine phosphokinase (CPK).\n* CRP \\\u003C 10 mg\u002FL: reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, , AST, ALT, AP, total bilirubin, albumin, and CPK.\n* 5 days after CRP \\\u003C 10 mg\u002FL: same as CRP \\\u003C 10 mg\u002FL",[9],[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Moez JALLOULI, Principal Investigator","CONTACT","02 38 61 30 15","+33","moez.jallouli@chu-orleans.fr",{"name":28,"role":23,"phone":29,"phoneExt":25,"email":30},"Fanny LOUAT","0238744295","fanny.louat@chu-orleans.fr",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":10},"Centre Hospitalier Universitaire d'Orléans","RECRUITING","Orléans","Loiret","45067","France","FR",{"type":41,"coordinates":42},"Point",[43,44],1.90407,47.90248,{"lat":44,"lon":43},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100649849","iron-status-assessment-in-geriatric-elderly-100649849",false,"NCT07739524","Iron Status Assessment in Geriatric Elderly","Predicting Iron Deficiency and Related Iron Parameters Outside Inflammation in Hospitalized Elderly Patients: A Prospective Study","IRON-SAGE","Inclusion Criteria:\n\n1. Age ≥ 75 years.\n2. Hospitalization with CRP \\> 50 mg\u002FL at admission.\n3. Non-opposition expressed by patient or legally authorized representative\n\nExclusion Criteria:\n\n1. Advanced chronic kidney disease (estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or chronic dialysis.\n2. Severe hepatic impairment (Child-Pugh score B or C).\n3. Severe hematological disorders (active hematologic malignancy or known myelodysplastic syndrome) or known iron metabolism disorders that may bias the study results (e.g., thalassemia, advanced hemochromatosis).\n4. Hemoglobin \\\u003C 9g\u002FL\n5. Treatment with intravenous iron within 12 weeks or oral iron within 4 weeks prior to enrollment.\n6. Blood transfusion within 3 months prior to enrollment\n7. Ongoing treatment with erythropoiesis-stimulating agents.\n8. Ongoing cytotoxic chemotherapy.\n9. Active bleeding at the time of enrollment.\n10. Very limited life expectancy or inability to ensure follow-up (end-of-life care).\n11. Participation in another investigational medicinal product study","ALL","75 Years",{"count":59,"type":60},200,"ESTIMATED","OBSERVATIONAL","In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status.\n\nThe objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays.\n\nThe study will be conducted in two distinct phases: a pilot phase involving up to 200 patients at a single center in France, followed by a main phase involving 1,523 patients across multiple centers in France. Participants will be adults aged over 75 years who are hospitalized in a geriatric ward and present with an acute inflammatory episode (C-reactive protein \\[CRP\\] \\> 50 mg\u002FL).\n\nIn addition to routine analyses performed during hospitalization, supplementary laboratory analyses will be carried out. Following admission in hospital, patients will receive standard medical care. Upon admission or on the following day, patients, their trusted representative, or relatives will be informed about the study. If eligibility criteria are met, the patient will be enrolled.\n\nResearch-specific laboratory analyses will be performed on blood samples collected at 4 times:\n\n* the day after admission;\n* when CRP \\\u003C 20 mg\u002FL (pilot phase only);\n* when CRP \\\u003C 10 mg\u002FL;\n* five days after a CRP \\\u003C 10 mg\u002FL. These additional analyses will not require another blood sample, as they will be performed on samples collected as part of routine clinical care. They constitute the main research specific intervention.",[64,65,66],"Elderly","Acute Inflammatory Response","Iron Deficiency",[68,69,70,64,71],"Transferrin Saturation","Iron Parameters","Inflammation","Predictive model","2026-08-11",{"date":74,"type":75},"2026-08-12","ACTUAL",{"date":77,"type":75},"2026-08-04",{"date":79,"type":60},"2027-08-29",{"name":5,"class":6},1]