A Randomized Trial to Determine if RBCs From Donors With Iron Deficient Erythropoiesis Have Decreased Post-transfusion RBC Recovery and Whether Iron Repletion Improves Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- 51-Chromium 24-hour Post-transfusion RBC Recovery of Units
研究概览
简要总结
Primary Hypothesis
- The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting iron-deficient erythropoiesis will not meet FDA standards for clinical use.
- The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron repletion will improve significantly and will meet FDA standards for clinical use.
详细描述
Iron deficiency is common among regular blood donors, but the recovery and quality of red blood cell (RBC) units from iron-deficient donors has not been rigorously examined. Evidence from both animal and human studies indicate that when the iron supply for erythropoiesis is inadequate, the RBCs produced have multiple metabolic defects that impair their ability to tolerate refrigerated storage. Studies in a mouse model demonstrated decreased post-transfusion recovery of refrigerator-stored RBCs obtained from iron-deficient donors. The planned studies will identify human donors at greatest risk of providing RBCs with poor post-transfusion recovery by using a combination of a decreased serum ferritin concentration and increased RBC zinc protoporphyrin, as described below. To evaluate unequivocally the role of iron deficiency in poor posttransfusion RBC recovery, intravenous iron will be used for iron repletion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years old;
- •healthy (by self report);
- •body weight >110 lbs;
- •female hematocrit >=38%, male hematocrit >39%;
- •frequent blood donor (men ≥2 and female ≥1 RBC unit donations in past year);
- •ferritin <=15 ng/mL; and
- •zinc protoporphyrin >=60 µmol/mol heme.
排除标准
- •ineligible for donation based on the New York Blood Center donor autologous questionnaire;
- •taking iron supplementation;
- •C-reactive protein >10 mg/L;
- •sickle cell trait;
- •systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg;
- •heart rate <50 or >100;
- •temperature >99.5°F prior to donation;
- •temperature >100.4°F or subjective feeling of illness prior to 51-Chromium 24-hour RBC recovery study (to avoid the subject having a concurrent illness that may affect post-transfusion recovery);
- •positive results on standard blood donor infectious disease testing;
- •taking, or planning to take, iron supplements; and
- •history of severe asthma requiring hospitalization, allergic eczema (atopic dermatitis), or other atopic allergy causing anaphylaxis.
研究组 & 干预措施
Iron repletion
Subjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again, receive IV saline and undergo 24-hour PTR.
干预措施: Iron-dextran (Drug)
Iron repletion
Subjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again, receive IV saline and undergo 24-hour PTR.
干预措施: Saline (Drug)
Iron repletion
Subjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again, receive IV saline and undergo 24-hour PTR.
干预措施: Blood Donation (Procedure)
Iron repletion
Subjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again, receive IV saline and undergo 24-hour PTR.
干预措施: 24-hour PTR (Procedure)
Placebo
Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again, receive IV iron-dextran and undergo 24-hour PTR.
干预措施: Iron-dextran (Drug)
Placebo
Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again, receive IV iron-dextran and undergo 24-hour PTR.
干预措施: Saline (Drug)
Placebo
Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again, receive IV iron-dextran and undergo 24-hour PTR.
干预措施: Blood Donation (Procedure)
Placebo
Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again, receive IV iron-dextran and undergo 24-hour PTR.
干预措施: 24-hour PTR (Procedure)
结局指标
主要结局
51-Chromium 24-hour Post-transfusion RBC Recovery of Units
时间窗: Performed 42 days after blood donation
Comparison of the percentage change in 51-Chromium-labeled RBCs remaining from pre- and 24 hour post-transfusion measurement between the Iron Repletion and the Placebo group. The post-transfusion recovery represents the percent of 51-Chromium-labeled RBCs remaining in circulation 24 hours after infusion as compared to an extrapolated time zero measurement.
次要结局
- Reticulocyte Hemoglobin(End of participation (e.g., ~6 months))
- Hemoglobin(End of participation (e.g., ~6 months))
- RBC Zinc Protoporphyrin Levels(End of participation (e.g., ~6 months))
- Serum Ferritin(End of participation (e.g., ~6 months))
- Soluble Transferrin Receptor(End of participation (e.g., ~6 months))
- Hepcidin(End of participation (e.g., ~6 months))
- Transferrin Saturation(End of participation (e.g., ~6 months))
- SF-36 Physical Functioning Score(End of participation (e.g., ~6 months))
- SF-36 Role Functioning/Physical Score(End of participation (e.g., ~6 months))
- SF-36 Role Functioning/Emotional Score(End of participation (e.g., ~6 months))
- SF-36 Energy/Fatigue Score(End of participation (e.g., ~6 months))
- SF-36 Emotional Well-being Score(End of participation (e.g., ~6 months))
- SF-36 Social Functioning Score(End of participation (e.g., ~6 months))
- SF-36 Pain Score(End of participation (e.g., ~6 months))
- SF-36 General Health Score(End of participation (e.g., ~6 months))
- SF-36 Health Change Score(End of participation (e.g., ~6 months))
- Beck Depression Inventory (BDI) II Score(End of participation (e.g., ~6 months))
- Restless Legs Syndrome Rating Scale Score(End of participation (e.g., ~6 months))
- Beck Anxiety Inventory (BAI) Score(End of participation (e.g., ~6 months))
- Global Fatigue Index (GFI) Score(End of participation (e.g., ~6 months))
研究者
Eldad Arie Hod
Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
Columbia University