Iron Replacement in Blood Donors

献血者的铁替代

基本信息

  • 批准号:
    7332608
  • 负责人:
  • 金额:
    --
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
  • 资助国家:
    美国
  • 起止时间:
  • 项目状态:
    未结题

项目摘要

Iron deficiency in first-time and repeat blood donors presents an ongoing challenge in transfusion medicine. Iron is an essential element that is lost with each blood donation. In order for a donor to compensate for the iron lost in donating blood, iron is mobilized from the body?s iron stores and absorption of iron from the diet is increased. However, this balance is often difficult to maintain in premenopausal women and in frequent, regular blood donors. Deficiency in iron results in reduced hemoglobin values, reduced iron stores, and eventually iron deficiency anemia, if not treated. Iron deficiency presents a problem in blood centers since the minimum allowable hemoglobin for blood donation established by the FDA is 12.5 g/dL. In the Department of Transfusion Medicine at the NIH, 14.6% of donors presenting for whole blood donation and 7.7% of donors presenting for platelet apheresis donation are deferred on at least one occasion per year due to low hemoglobin values. Overall, 7.9% of visits for whole blood donation and 2.1% of visits for apheresis platelet donation result in donor deferral due to low hemoglobin. Deferral for low screening hemoglobin values negatively impacts donor recruitment, donor retention, and the ability to meet growing demands on the blood supply. Although the challenge of iron depletion in the blood donor population has been known for decades, little has been undertaken to resolve this issue. Several authors have reported data from successful short term projects demonstrating the safety and efficacy of iron replacement in donors, but larger long term studies have not been reported. The objectives of this protocol are to: (1) quantitate the prevalence of iron depletion and iron deficiency anemia in both first-time and repeat healthy individuals who present for blood donation; (2) study the effects of long-term blood donation on donors? hemoglobin levels and iron stores; (3) evaluate the safety, practicality, and efficacy of distributing oral replacement iron to blood donors; (4) determine the effect of oral iron replacement therapy on the donor pool by monitoring deferral rates for low hemoglobin before and after the initiation of an iron replacement program. The goal of these objectives is to treat and prevent iron deficiency in prospective and regular blood donors, thereby expanding the eligible donor pool and leading to increased donor satisfaction and retention by decreasing deferral rates due to low hemoglobin. Each donation of whole blood results in an iron loss of about 240 mg in men and 220 mg in women. It is known that about 6-8% of the iron given as an oral ferrous salt is absorbed daily by iron-depleted donors. Therefore, since approximately 220-240 mg of iron is lost with each blood donation, administration of 65 mg of elemental iron daily for 60 days would completely replace the iron lost through a whole blood unit donation (6% of 65 mg is 3.9 mg daily, or 234 mg over 60 days). Oral iron replacement in this study will consist of ferrous sulfate, one 325 mg tablet daily, containing 65 mg of elemental iron, to be given for 60 days at the time of a deferral for low hemoglobin. This regimen will also be repeated at the time of every future blood donation, to prevent recurrence of iron deficiency. Compliance with and tolerance to oral iron therapy and resolution of symptoms of iron deficiency will be monitored. Donors with gastrointestinal intolerance to ferrous sulfate will be offered ferrous gluconate. In this manner, each time such a donor gives a unit of blood at the NIH Department of Transfusion Medicine, they will receive a 60-pack of an oral iron tablet to replace the iron lost through the donation. These formulations of oral iron are available as over-the-counter medications, but will be provided free of charge to donors in this protocol, through the NIH pharmacy.
首次献血者和重复献血者缺铁是输血医学面临的一个持续挑战。铁是每一次献血都会丢失的一种基本元素。为了让献血者弥补献血中丢失的铁,需要从体内动员铁?S储存铁,增加对饮食中铁的吸收。然而,这种平衡在绝经前的妇女和频繁的定期献血者中往往很难维持。缺铁会导致血红蛋白值降低,铁储存减少,如果不治疗,最终会导致缺铁性贫血。铁缺乏是血液中心的一个问题,因为FDA规定的献血最低允许血红蛋白为12.5g/dL。在国立卫生研究院的输血医学部,14.6%的献血者和7.7%的献血者由于血红蛋白水平低,每年至少推迟一次献血。总体而言,7.9%的全血捐献和2.1%的采摘血小板捐献导致献血者因低血红蛋白而推迟献血。推迟筛查低血红蛋白值会对供者招募、供者留存以及满足日益增长的供血需求的能力产生负面影响。 尽管献血人群中铁耗竭的挑战几十年来就已为人所知,但几乎没有采取什么行动来解决这一问题。几位作者报告了来自成功的短期项目的数据,这些项目证明了铁替代在捐赠者中的安全性和有效性,但尚未报道更大规模的长期研究。该方案的目标是:(1)量化首次献血和重复献血的健康人中铁缺乏和缺铁性贫血的患病率;(2)研究长期献血对献血者的影响?(3)评估向献血者分发口服补铁疗法的安全性、实用性和有效性;(4)通过监测低血红蛋白人群在补铁计划启动前后的延迟率,确定口服补铁疗法对献血者库中的影响。这些目标的目的是治疗和预防潜在和定期献血者的铁缺乏,从而扩大符合条件的献血者库,并通过降低由于低血红蛋白而导致的延迟率来提高献血者的满意度和保留率。 每捐献一次全血,男性的铁损失约为240毫克,女性为220毫克。据了解,每天大约有6-8%的铁作为口服亚铁盐被缺铁的捐赠者吸收。因此,由于每次献血会损失大约220-240毫克的铁,连续60天每天服用65毫克的元素铁将完全取代全血单位献血造成的铁损失(65毫克的6%相当于每天3.9毫克,或60天234毫克)。在这项研究中,口服铁替代药物包括硫酸亚铁,每天一片325毫克,含有65毫克元素铁,在低血红蛋白延迟服用60天后服用。今后每次献血时也将重复这一方案,以防止缺铁症复发。将监测口服铁剂治疗的依从性和耐受性,以及缺铁症状的缓解情况。胃肠道对硫酸亚铁不耐受的供者将给予葡萄糖酸亚铁。通过这种方式,这样的献血者每次在NIH输血医学部献血一个单位,他们就会收到一片60包的口服铁片,以补充献血过程中失去的铁。这些口服铁制剂可以作为非处方药获得,但在该协议中,将通过NIH药房免费提供给捐赠者。

项目成果

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SUSAN F LEITMAN-KLINMAN其他文献

SUSAN F LEITMAN-KLINMAN的其他文献

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{{ truncateString('SUSAN F LEITMAN-KLINMAN', 18)}}的其他基金

COMPARATIVE STUDIES OF GRANULOCYTE COLONY-STIMULATING FACTOR AND DEXAMETHASONE, A
粒细胞集落刺激因子与地塞米松的比较研究
  • 批准号:
    6289448
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
PROPHYLACTIC CALCIUM ADMINISTRATION IN PLATELETPHERESIS
血小板去除术中的预防性补钙
  • 批准号:
    6414317
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Ther of Von Willebrand Disease w/Single-donor Cryoprecipitate Collected by Apher
Apher 收集的冯·维勒布兰德病与单一供体冷沉淀物
  • 批准号:
    6431830
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Faciliation of Peripheral Blood Stem Cell Transplants by Nat
Nat 促进外周血干细胞移植
  • 批准号:
    6431823
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Kinetic Studies Of Indium-labeled Leukocytes
铟标记白细胞的动力学研究
  • 批准号:
    6546520
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Therapeutic Efficacy Of Granulocyte Colony-stimulating F
粒细胞集落刺激F的治疗效果
  • 批准号:
    6683842
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Peripheral Blood Stem Cell Collections From NMDP Donors
来自 NMDP 捐赠者的外周血干细胞采集
  • 批准号:
    7331982
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Citrate Effects and Bone Density Changes in Serial Long-
连续长期的柠檬酸盐效应和骨密度变化
  • 批准号:
    7332515
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Acquisition of Hematopoietic Stem Cells for Second Transplants by Apheresis of Fi
通过 Fi 血浆分离术获取用于第二次移植的造血干细胞
  • 批准号:
    6103656
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:
Iron Replacement in Blood Donors
献血者的铁替代
  • 批准号:
    7593051
  • 财政年份:
  • 资助金额:
    --
  • 项目类别:

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危重儿童连续肾脏替代治疗期间反复抗凝和肾脏监测的低血容量平台
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