Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Measure of Non-transferrin-bound Iron
研究概览
简要总结
Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest that certain patients transfused with blood stored for longer duration have poorer outcomes than patients transfused fresher blood. The investigators' hypothesis is that the delivery of an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood leads to changes that explain the differences in outcome between patients transfused old versus fresh blood. The investigators propose to test this hypothesis in humans by transfusing an individual's own blood, both fresh and after storage, and comparing levels of various outcome measures.
详细描述
Participants in this study will be asked to participate in a standard blood donation. The blood will be processed per standards at the investigators regional blood center (New York Blood Center) and then split into two equal units and shipped to Columbia University Medical Center for storage and transfusion. One unit will be transfused back into the same individual fresh (i.e. between 3-7 days after donation). The other unit will be transfused 42 days after donation. Blood samples will be drawn before, during, and after transfusion to measure levels of various analytes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male body weight >130 lbs, female body weight > 155 lbs
- •male height >5'1", female height >5'5"
- •hemoglobin >13.3 g/dL
排除标准
- •ineligible for donation based on the New York Blood Center autologous blood donor questionnaire
- •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 transfusion
- •positive results on standard blood donor infectious disease testing
- •pregnancy.
结局指标
主要结局
Measure of Non-transferrin-bound Iron
时间窗: four hours after transfusion
Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion.
次要结局
未报告次要终点
研究者
Steven L. Spitalnik
Professor of Pathology
Columbia University