[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659072":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":18,"interventions":13,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":22,"collaborators":13,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":13,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":13,"studyType":39,"phases":13,"briefSummary":40,"conditions":41,"keywords":46,"overallStatus":54,"whyStopped":13,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Area Under the Receiver Operating Characteristic Curve of RET-He for Detecting Iron Deficiency","The Area Under the Receiver Operating Characteristic Curve (AUC-ROC) will assess the diagnostic accuracy of Reticulocyte Hemoglobin Equivalent (RET-He, measured in pg via the Atellica HEMA 580 analyzer) in identifying iron deficiency among accepted blood donors. Iron deficiency is defined using reference biochemical markers, including serum ferritin (measured via the ADVIA Centaur XPT analyzer) and transferrin saturation (TSAT), in the context of C-reactive protein (CRP) levels to account for inflammation. The AUC-ROC score ranges from 0.5 (discrimination no better than chance) to 1.0 (perfect diagnostic discrimination).","Baseline",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","The study population consists of voluntary adult blood donors attending the Main Blood Bank at the Central Blood Transfusion Services (CBTS), Department of Clinical Pathology, Assiut University Hospitals, Assiut, Egypt. Eligible participants comprise healthy male and female donors aged 18 to 60 years who fulfill routine national and institutional donor-selection standards, including pre-donation hemoglobin eligibility thresholds (Hb ≥ 14 g\u002FdL for males and ≥ 12 g\u002FdL for females).",[19],{"label":20,"type":13,"description":21,"interventionNames":13},"Eligible Voluntary Blood Donors","Voluntary blood donors aged 18 to 60 years who meet routine institutional pre-donation eligibility criteria, including acceptable hemoglobin levels (Hb ≥ 14 g\u002FdL for males and ≥ 12 g\u002FdL for females). Enrolled participants undergo blood sampling for complete blood count (CBC) and reticulocyte hemoglobin equivalent (RET-He) using the Atellica HEMA 580 automated analyzer. Serum ferritin is assessed on the ADVIA Centaur XPT platform, alongside serum iron, total iron-binding capacity (TIBC), calculated transferrin saturation (TSAT), and C-reactive protein (CRP). Participants are evaluated for latent\u002Fsubclinical iron deficiency and followed up at their subsequent donation visit (90 days for males and 120 days for females).",{"type":23,"investigatorFullName":24,"investigatorTitle":25,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Tasneem Ashraf AbdelHafiz","Resident","100659072","reticulocyte-hemoglobin-equivalent-ret-he-in-early-detection-of-iron-deficiency-among-blood-donors-and-its-potential-impact-on-donor-eligibility-and-transfusion-safety-100659072",false,"NCT07861607","Reticulocyte Hemoglobin Equivalent (RET-He) in Early Detection of Iron Deficiency Among Blood Donors and Its Potential Impact on Donor Eligibility and Transfusion Safety","Role of Reticulocyte Hemoglobin Equivalent (RET-He) in Early Detection of Iron Deficiency Among Blood Donors and Its Potential Impact on Donor Eligibility and Transfusion Safety","Inclusion Criteria:\n\n* Voluntary blood donors eligible for donation according to standard national and institutional donor-selection criteria.\n* Adults aged 18 to 60 years.\n* Meeting accepted pre-donation hemoglobin thresholds for blood donation (hemoglobin ≥ 14.0 g\u002FdL for males and ≥ 12.0 g\u002FdL for females).\n* Both male and female donors eligible under local blood donation policies.\n* Provision of written informed consent prior to study participation.\n\nExclusion Criteria:\n\n* Known hematological disorders or chronic anemia unrelated to iron deficiency.\n* Known chronic kidney disease, active malignancy, or chronic inflammatory\u002Fautoimmune diseases.\n* History of recent blood transfusion.\n* Recent therapeutic iron treatment or regular iron supplementation within the preceding 3 months.\n* History of recent major bleeding or major surgery.\n* Inadequate or hemolyzed blood sample, or inability to obtain valid RET-He, complete blood count (CBC), or iron panel measurements.\n* Donors who withdraw consent.","ALL","18 Years","60 Years",{"count":37,"type":38},300,"ESTIMATED","OBSERVATIONAL","Blood donation is essential for healthcare, but repeated whole-blood donation can deplete the body's iron stores. Standard pre-donation screening relies on hemoglobin levels to ensure donor safety; however, a drop in hemoglobin is a late sign of iron deficiency. Consequently, donors with subclinical or latent iron depletion often pass standard pre-donation screening unnoticed.\n\nThe primary purpose of this study is to evaluate the clinical utility of Reticulocyte Hemoglobin Equivalent (RET-He) as an early laboratory marker for detecting iron deficiency among accepted blood donors. Because reticulocytes are newly formed red blood cells, RET-He reflects iron availability for hemoglobin production over the preceding few days, potentially detecting iron limitation much earlier than mature red blood cell indices or standard hemoglobin testing.\n\nIn this prospective observational study, approximately 300 eligible voluntary blood donors aged 18 to 60 years will be enrolled at the Main Blood Bank of Assiut University Hospitals. At the time of routine donation, blood samples will be analyzed for complete blood count (CBC) with RET-He, serum ferritin, iron profile (serum iron, total iron-binding capacity, and transferrin saturation), and C-reactive protein (CRP) to control for inflammation. Participants will also be reassessed at their subsequent regular donation visit (after 90 days for males and 120 days for females) to evaluate changes in iron indices over time and explore whether adding RET-He improves donor eligibility assessment and long-term donor health.",[42,43,44,45],"Iron Deficiency","Latent Iron Deficiency","Blood Donors","Iron Deficiency Anemia",[47,48,49,50,51,52,53],"Reticulocyte Hemoglobin Equivalent","RET-He","Donor Eligibility","Ferritin","Transferrin Saturation","Iron Depletion","Transfusion Safety","NOT_YET_RECRUITING","2026-10-01",{"date":57,"type":58},"2026-10-06","ACTUAL",{"date":60,"type":38},"2026-11",{"date":62,"type":38},"2027-12",{"name":5,"class":6}]