Duration of Red Blood Cell Storage Prior to Transfusion and Non-Transferrin-Bound Iron
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Non-transferrin-bound Iron Level (AUC)
研究概览
简要总结
This study will determine the minimal duration of red blood cell (RBC) storage that leads to increases in circulating non-transferrin-bound iron in healthy human volunteers post-transfusion. The results from this study will help guide national guidelines for appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food and Drug Administration (FDA) criteria. The overall objective of this research is to improve the safety of refrigerated storage of red blood cells before transfusion.
详细描述
Recent studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Red cells may be stored in a refrigerator prior to transfusion for up to 42 days by current FDA standards. Refrigerator storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased delivery of hemoglobin-iron to certain parts of the body. The investigators have preliminary data in mice and humans suggesting that delivery of a significant iron load from aged red cells leads to the production of a potentially toxic form of circulating iron called non-transferrin-bound iron.
In this prospective study of healthy volunteers, each subject will be randomized to receive transfusion of one RBC unit after 1, 2, 3, 4, 5, or 6 weeks of storage. The primary outcome will be the 24 hr area under the curve (AUC) of the serum non-transferrin bound iron concentration calculated from samples collected at 0, 2, 4, 6, 8, 10, 12, 14 and 24 hours after transfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 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
- •18-65 years old
- •Body weight >110 lbs
- •Hemoglobin >12.5 g/dL
排除标准
- •Ineligible for donation based on the New York Blood Center 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 (this is to avoid having a concurrent illness affect post-transfusion measurements);
- •Positive results on standard blood donor infectious disease testing
- •Positive urine pregnancy test
研究组 & 干预措施
Transfusion of PRBC stored for 5 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.
干预措施: Packed red blood cells (Other)
Transfusion of PRBC stored for 1 week
Subjects will receive blood transfusion with packed red blood cells stored for 1 week.
干预措施: Blood Transfusion (Procedure)
Transfusion of PRBC stored for 1 week
Subjects will receive blood transfusion with packed red blood cells stored for 1 week.
干预措施: Packed red blood cells (Other)
Transfusion of PRBC stored for 2 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.
干预措施: Blood Transfusion (Procedure)
Transfusion of PRBC stored for 2 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks.
干预措施: Packed red blood cells (Other)
Transfusion of PRBC stored for 3 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.
干预措施: Blood Transfusion (Procedure)
Transfusion of PRBC stored for 3 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks.
干预措施: Packed red blood cells (Other)
Transfusion of PRBC stored for 4 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.
干预措施: Blood Transfusion (Procedure)
Transfusion of PRBC stored for 4 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks.
干预措施: Packed red blood cells (Other)
Transfusion of PRBC stored for 5 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks.
干预措施: Blood Transfusion (Procedure)
Transfusion of PRBC stored for 6 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.
干预措施: Blood Transfusion (Procedure)
Transfusion of PRBC stored for 6 weeks
Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks.
干预措施: Packed red blood cells (Other)
结局指标
主要结局
Non-transferrin-bound Iron Level (AUC)
时间窗: 0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion
Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).
次要结局
未报告次要终点
研究者
Steven L. Spitalnik
Professor of Pathology and Cell Biology
Columbia University