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

关爱分享者：减轻定期献血者的铁缺乏症

• 批准号: 8022742
• 负责人: Alan E Mast
• 金额: $ 87.2万
• 依托单位: VERSITI WISCONSIN, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-01-01 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8022742
• 关键词: Acute; Address; Adverse effects; Anemia; Biochemical; Blood; Blood Donations; Blood Tests; Blood donor; Caring; Clinical Research; Collection; Commit; Communities; Critical Illness; Data; Development; Diagnosis; Drug Formulations; Employee Strikes; Enrollment; Epidemiology; Evaluation; Evaluation Studies; Exercise Tolerance; Fatigue; Female; Ferritin; Ferrous Gluconate; Ferrous fumarate; Frequencies; Genes; Goals; Health; Health Personnel; Hematocrit procedure; Hemochromatosis; Hemoglobin; Hemorrhage; Human Resources; Individual; Intervention; Iron; Knowledge; Laboratories; Letters; Longitudinal Studies; Measurement; Medical; Mutation; National Heart, Lung, and Blood Institute; Neurologic; Outcome; Patients; Pica Disease; Plasma; Population; Prevalence; Procedures; Public Health; Recording of previous events; Recruitment Activity; Reporting; Research Personnel; Resistance; Resources; Restless Legs Syndrome; Reticulocytes; Retroviridae; Role; Surveys; Symptoms; Test Result; Testing; Time; Transferrin Receptor; United States; Visit; Vitamins; Whole Blood; Work; Writing; adverse outcome; base; care systems; cognitive function; experience; gastrointestinal; improved; male; peripheral blood; prevent; primary outcome; programs; receptor; secondary outcome

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: Whole blood donation removes iron from the donor and can result in iron deficiency following repeated donation. The primary objective of the proposed studies is to develop programs that will prevent/mitigate iron deficiency in regular blood donors. This will contribute to improved public health by preventing the adverse consequences of iron deficiency in blood donors such as fatigue and decreased exercise tolerance, as well as neurological symptoms such as decreased cognitive function, pica and restless leg syndrome.

描述（由申请人提供）：定期献血引起的缺铁是血液中心面临的一个问题。每次献血都会从献血者身上去除200至250毫克的铁。因此，许多捐赠者因重复捐赠而缺铁。这对血液中心提出了挑战，近年来随着认识到即使在没有贫血的情况下缺铁也与包括疲劳和运动耐量降低在内的不良反应以及神经系统症状如认知功能下降，异食癖和不宁腿综合征相关，这一挑战变得更加尖锐。REDS-II（NHLBI逆转录病毒流行病学供体研究-II）是由美国6个血液中心组成的联盟。REDS-II研究人员进行了一项纵向研究，调查献血者在两年期间的铁状态，称为REDS-II供体铁状态评估（RISE）。对定期献血者（女性每年献血2次或男性每年献血3次）的基线分析结果显示，超过三分之二的女性献血者和超过一半的男性献血者缺铁。为了保护献血者的健康，防止献血者的流失，血液中心现在应该解决献血者缺铁的问题。在这里，我们建议利用一个联盟的三个REDS-II血液中心，以评估潜在的干预措施，将防止/减轻缺铁的献血者。拟定研究的受试者将从RISE供体中招募。这些捐献者的铁状态在RISE中进行了两年的充分研究，这将使我们能够评估两项研究之间合并4年期间实验室数据、捐献经验和捐献者症状的变化。在具体目标1中，我们将确定是否为捐赠者提供有关其铁状态的准确信息和适当的行动方案，例如延长捐赠间隔或服用铁补充剂，将影响他们采取独立的措施来改善其铁状态。在具体目标2中，我们将为献血者提供60天的多种维生素供应，这些维生素由38、19或0 mg元素铁配制而成，在每次献血后服用。两个特定目标的主要结局是确定干预措施如何改变供体铁状态，通过测量血浆铁蛋白、血浆可溶性转铁蛋白受体和网织红细胞血红蛋白含量进行评估。次要结局是确定干预措施如何改变献血者访视的比例，从而成功采集一个单位的血液，以及它们如何改变献血者访视的比例，从而导致低红细胞压积延迟。三级结局是确定干预措施如何改变供体疲劳、异食癖和不宁腿综合征的患病率，如在研究开始和结束时进行的调查所评估的。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，并为社区血液中心易于实施的有效计划奠定基础。 公共卫生相关性：全血捐献会从捐献者体内去除铁，重复捐献后可能导致缺铁。拟议研究的主要目的是制定预防/减轻常规献血者缺铁的计划。这将有助于改善公众健康，防止献血者缺铁的不良后果，如疲劳和运动耐量下降，以及神经系统症状，如认知功能下降，异食癖和不宁腿综合征。