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: 8403966
• 负责人: Alan E Mast
• 金额: $ 74.82万
• 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/8403966
• 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; iron deficiency; iron supplement; male; peripheral blood; prevent; primary outcome; programs; receptor; secondary outcome

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.

总结 定期献血引起的铁缺乏是血液中心面临的一个问题。每次献血 从捐献者身上去除200到250毫克的铁。因此，许多捐助者成为铁缺乏， 多次捐赠。这对血液中心提出了挑战，近年来变得更加尖锐 由于认识到即使没有贫血，缺铁也与不良反应有关， 包括疲劳和运动耐量下降，以及神经系统症状，如 认知功能异食癖和不宁腿综合征REDS-II（NHLBI逆转录病毒流行病学供体研究-II）是 一个由位于美国各地的6个血液中心组成的联盟。REDS-II研究人员进行了一项 一项调查献血者铁状况的纵向研究，为期两年，称为REDS-II献血者 铁状态评估（RISE）。定期捐助者基线分析的结果（每年e2次捐助 （女性）或e3捐赠（男性）显示，超过三分之二的女性捐赠者和超过一半的 男性捐献者缺铁既要保护献血者的健康，又要防止输注的血液流失。 对于献血者来说，血液中心解决献血者缺铁问题的时候到了。在这里我们建议 利用三个REDS-II血液中心组成的联盟来评估潜在的干预措施， 预防/减轻献血者的铁缺乏症。拟定研究的受试者将从RISE招募 捐助者。这些捐献者的铁状态在RISE研究了两年， 评估合并4年期间实验室数据、献血经历和献血者症状的变化 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 关于他们的铁状态和适当的行动方案，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他们的铁状态。具体目标2 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毫克元素铁配制， 每次献血后，两个具体目标的主要结果是确定 通过测量血浆铁蛋白、血浆可溶性铁蛋白和血浆可溶性铁蛋白， 转铁蛋白受体和网织红细胞血红蛋白含量。次要结果是确定 干预措施改变了献血者访问的比例，从而成功采集了一个单位的血液， 它们改变了献血者就诊的比例，导致低血细胞比容延迟。三级结果是 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， 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 将提供重要的信息，各种方法的疗效，铁替代献血者 并为社区血液中心容易实施的有效计划奠定基础。