RBC Survival Validation in Adult Humans Under Condition of Normal RBC Survival
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants That Had bRBC Detectable at 70 Days Post-intervention
研究概览
简要总结
The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused. Investigators will study this by collecting blood samples from participants, "labeling" RBCs with a naturally occurring vitamin, biotin. The RBCs will then be re-infused back into the participant and blood samples will be taken weekly for 10 weeks to assess the number of labeled cells in the samples.
详细描述
The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused.
In this study, blood is collected from healthy subjects, processed into packed red blood cell units, and either immediately afterwards or 40-42 days later the packed red blood cells are labeled with biotin. The biotin-labeled red blood cells are then re-infused back to the donor (autologous transfusion). Blood samples are then taken from the subject every week for up to 70 days (10 weeks) to track survival of the labeled red blood cells.
This study also seeks to demonstrate that biotin-labeled RBCs can be safely transfused back to autologous subjects without any adverse reactions. All participants will be followed to watch for the development of antibodies against biotin-labeled RBCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •in good health
排除标准
- •anemia (defined as hemoglobin < 8 g/dL)
- •chronic disease, including diabetes, heart or lung disease, poorly managed hypertension, and peripheral vascular disease
- •ongoing consumption of biotin or raw egg supplements
- •history of a bleeding disorder
- •evidence of anemia at initial screening
- •women who are pregnant or plan to become pregnant
研究组 & 干预措施
Biotin-Labeled Red Blood Cell (RBC) Infusion
Blood will be drawn from participants and labeled with biotin before being re-infused back to the participant. Blood samples will be obtained weekly over 10 weeks.
干预措施: Biotin-Labeled Red Blood Cells (RBCs) (Drug)
结局指标
主要结局
Number of Participants That Had bRBC Detectable at 70 Days Post-intervention
时间窗: 70 days post-intervention
The length of time biotin-labeled RBCs can be detected following re-infusion. The number of participants was determined at day 70 by taking blood samples from each of them
Length of Time Differentially Labeled Biotin-labeled RBCs Can be Distinguished From One Another
时间窗: Up to 112 days
The length of time that the three different concentrations of biotin labeling on the RBCs can be distinguished from one another will be determined by taking blood samples from each participant for 70 days
次要结局
- Number of Participants Experiencing Adverse Events(Up to 12 months)