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临床试验/DRKS00013102
DRKS00013102已完成不适用

Optical iron deficiency diagnostics - evaluation of a fiber optic fluorescence measurement for the determination of zinc protoporphyrin in blood donors - LFL_S4/2017

IFE-Zentrum, Klinikum der Universität München0 个研究点目标入组 100 人开始时间: 2017年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100

研究概览

简要总结

Background: Frequent blood donors are at high risk of developing iron deficiency. Currently, there is no potent screening during blood donation to detect iron deficient erythropoiesis (IDE) before anemia develops and deferral from donation is inevitable. Study Design and Methods: In addition to capillary and venous hemoglobin, the iron status of 99 frequent blood donors was assessed by various venous blood parameters and zinc protoporphyrin IX (ZnPP). ZnPP was determined by high-performance liquid chromatography (HPLC) and a new prototype fiber-optic device was employed for non-invasive measurements of ZnPP through the blood collection tubing (NI-tubing) and on lip tissue (NI-lip). We aimed to evaluate the feasibility and diagnostic value of the NI-tubing measurement for early detection of severe iron deficiency in blood donors. Results: NI-tubing and HPLC reference measurements of ZnPP showed narrow limits of agreement of 12.2 µmol ZnPP/mol heme and very high correlation (Spearman’s Rho = 0.938). Using a cutoff of 65 µmol ZnPP/mol heme, NI-tubing measurements (n = 93) identified 100% of donors with iron deficiency anemia (IDA) and an additional 38% of donors with IDE. Accordingly, NI-tubing measurements would allow detection and selective protection of particularly vulnerable donors. Conclusion: NI-tubing measurements are an accurate and simple method to implement ZnPP determination into the routine blood donation process. ZnPP was able to identify the majority of subjects with IDE and IDA and might therefore be a valuable tool to provide qualified information to donors about dietary measures and adjustments of the donation interval and thereby help to prevent IDA and hemoglobin deferral in the future.

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 69 Years(—)
性别
All

入选标准

  • Frequent blood donors (male and female) who are admitted to blood donation or who are rejected because of a too low Hb value. Frequent blood donors are persons who verifiably donated blood within the last 12 months at least 3 times (female) or 4 times (male). Written informed consent after informative discussion.

排除标准

  • Blood donors who are rejected from blood donation because of other reasons than a low Hb value. Transfusion of blood products within the last 12 months. Known iron supplementation (on-going or finished within the last 3 months). Known hemochromatosis.

研究者

发起方
IFE-Zentrum, Klinikum der Universität München

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