Reticulocyte Hemoglobin Equivalent (RET-He) in Early Detection of Iron Deficiency Among Blood Donors and Its Potential Impact on Donor Eligibility and Transfusion Safety

October 1, 2026 updated by: Tasneem Ashraf AbdelHafiz, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Receiver Operating Characteristic Curve of RET-He for Detecting Iron Deficiency
Time Frame: Baseline

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 1, 2026

First Submitted That Met QC Criteria

October 1, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 6, 2026

Last Update Submitted That Met QC Criteria

October 1, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RET-He in Donor Iron Status

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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