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

2026年10月1日 更新者: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.

研究概览

地位

尚未招聘

研究类型

观察性的

注册 (估计的)

300

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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).

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
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).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Area Under the Receiver Operating Characteristic Curve of RET-He for Detecting Iron Deficiency
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年11月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年10月1日

首先提交符合 QC 标准的

2026年10月1日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年10月1日

更多信息

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