Caring for Those Who Share: Mitigating Iron Deficiency in Regular Blood Donors

摘要 定期献血导致的铁缺乏症是血液中心面临的问题。每一次献血 从捐赠者体内去除200到250毫克的铁。因此，许多捐赠者缺铁。 反复捐献。这对近年来变得更加尖锐的血液中心构成了挑战。 认识到缺铁即使在没有贫血的情况下也与不良反应有关 包括疲劳和运动耐力下降，以及神经症状，如减少 认知功能、异食癖和不宁腿综合症。REDS-II(NHLBI逆转录病毒流行病学捐赠者研究-II) 一个由6个血液中心组成的联盟，分布在美国各地。REDS-II调查人员进行了一次 一项为期两年的纵向研究，调查被称为红二献血者的献血者铁状况 铁状态评估(RISE)。经常捐赠者基线分析的结果(e每年2次捐赠 (女性)或每年3次捐赠(男性)显示，超过三分之二的女性捐赠者和超过一半的女性捐赠者 男性捐赠者缺铁。既要保护捐献者的健康，又要防止承诺的血液流失 献血者，现在是血液中心解决献血者缺铁问题的时候了。在这里，我们建议 利用三个REDS-II血液中心的联合体来评估潜在的干预措施 预防/减轻献血者缺铁。拟议研究的受试者将从RISE招募 捐赠者。这些捐赠者的铁状况经过了两年的研究，这将使我们能够 评估实验室数据、捐献经验和供者症状在四年期间的变化 在这两项研究之间。在具体目标1中，我们将确定是否向捐助者提供准确的信息 关于他们的铁状况和适当的行动方案，如延长捐献间隔或服用铁 补充剂，将影响他们采取独立的步骤来改善他们的铁状态。在具体目标2中，我们 将为捐赠者提供60天的多种维生素供应，这些维生素由38、19或0毫克的元素铁配制而成 以每一次献血为例。这两个特定目标的主要结果是确定如何 干预改变供体铁状态，通过测定血浆铁蛋白、血浆可溶性铁来评估 转铁蛋白受体和网织红细胞血红蛋白含量。次要结果是决定如何 干预措施改变了成功采集一单位血液的献血者访问的比例以及如何 它们改变了捐献者就诊的比例，导致红细胞压积较低的延迟。第三阶段的结果是 确定干预措施如何改变供者疲劳、异食癖和不宁腿综合征的患病率 通过在研究开始和结束时进行的调查进行评估。拟议研究的结果 将提供有关献血者铁替代的各种方法的有效性的重要信息 并为社区血液中心容易实施的有效计划奠定基础。

Summary Iron deficiency caused by regular blood donation is a problem facing blood centers. Each blood donation removes 200 to 250 mg of iron from the donor. Consequently, many donors become iron deficient with repeated donation. This presents a challenge to blood centers that has become more acute in recent years with the realization that iron deficiency even in the absence of anemia is associated with adverse effects including fatigue and decreased exercise tolerance, as well as neurological symptoms such as decreased cognitive function, pica and restless leg syndrome. REDS-II (NHLBI Retrovirus Epidemiology Donor Study-II) is a consortium of 6 blood centers located across the United States. REDS-II investigators performed a longitudinal study investigating the iron status of blood donors over a two year period called the REDS-II Donor Iron Status Evaluation (RISE). Results from the baseline analysis of regular donors (e 2 donations per year (females) or e 3 donations per year (males) revealed that over two-thirds of female donors and over one-half of male donors have iron deficiency. To both safeguard donor health and prevent the loss of committed blood donors, the time has come for blood centers to address this problem of donor iron deficiency. Here we propose to utilize a consortium of three of the REDS-II blood centers to assess potential interventions that will prevent/mitigate iron deficiency in blood donors. Subjects for the proposed studies will be recruited from RISE donors. The availability of these donors whose iron status is well studied for two years in RISE will allow us to assess changes in laboratory data, donation experience and donor symptoms over a combined 4-year period between the two studies. In Specific Aim 1 we will determine if providing donors with accurate information about their iron status and appropriate courses of action, such as prolonging donation intervals or taking iron supplements, will influence them to take independent steps to improve their iron status. In Specific Aim 2 we will provide donors with a 60-day supply of multiple vitamins formulated with 38, 19 or 0 mg of elemental iron to take following each blood donation. The primary outcome for both Specific Aims is to determine how the interventions change donor iron status as assessed by measurement of plasma ferritin, plasma soluble transferrin receptor and reticulocyte hemoglobin content. Secondary outcomes are to determine how the interventions change the proportion of donor visits resulting in successful collection of a unit of blood and how they change the proportion of donor visits resulting in low hematocrit deferral. Tertiary outcomes are to determine how the interventions change the prevalence of donor fatigue, pica and restless leg syndrome as assessed by a survey administered at the beginning and end of the study. Findings from the proposed studies will provide important information on the efficacy of various approaches for iron replacement in blood donors and lay the groundwork for effective programs that can be readily implemented by community blood centers.