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
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.
The 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.
In 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.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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/dL for males and ≥ 12 g/dL for females).
Opis
Inclusion Criteria:
- Voluntary blood donors eligible for donation according to standard national and institutional donor-selection criteria.
- Adults aged 18 to 60 years.
- Meeting accepted pre-donation hemoglobin thresholds for blood donation (hemoglobin ≥ 14.0 g/dL for males and ≥ 12.0 g/dL for females).
- Both male and female donors eligible under local blood donation policies.
- Provision of written informed consent prior to study participation.
Exclusion Criteria:
- Known hematological disorders or chronic anemia unrelated to iron deficiency.
- Known chronic kidney disease, active malignancy, or chronic inflammatory/autoimmune diseases.
- History of recent blood transfusion.
- Recent therapeutic iron treatment or regular iron supplementation within the preceding 3 months.
- History of recent major bleeding or major surgery.
- Inadequate or hemolyzed blood sample, or inability to obtain valid RET-He, complete blood count (CBC), or iron panel measurements.
- Donors who withdraw consent.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
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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/dL for males and ≥ 12 g/dL 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/subclinical iron deficiency and followed up at their subsequent donation visit (90 days for males and 120 days for females). |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Area Under the Receiver Operating Characteristic Curve of RET-He for Detecting Iron Deficiency
Ramy czasowe: Baseline
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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
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RET-He in Donor Iron Status
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