BR-PROSPECT: Biotin and Radiolabeling for the Platelet Recovery, Survival, and Post-transfusion Evaluation of Changes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bloodworks
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Primary Endpoint Recovery and Survival
研究概览
简要总结
This is a platelet transfusion study. The primary purpose of this study is to determine if Biotin, vitamin B7 is an effective way to label platelets in survival and recovery studies. This study involves using a radioactive material as well as Biotin added to platelets to track platelets in the blood. The platelets will be collected using an apheresis procedure, labeled with biotin, and stored for 3 days. After the storage period, a radioactive material will be added to a small amount of the stored biotin-treated platelets. The radiolabeled platelets will be given back to donor and follow-up blood draws will be done to see how many of the platelets are circulating.
详细描述
To evaluate the hypothesis that biotinylation of platelets stored at room temperature for 3 days is equivalent for the assessment of in vivo recovery and survival to radiolabeled platelets. The post-transfusion recovery and survival of autologous biotinylated 3-day platelets will be measured in comparison with those of autologous radiolabeled 3-day platelets from the same source. In the same fashion, "fresh" autologous biotinylated platelets, will be compared to "fresh" radiolabeled platelets according to Food and Drug Administration, FDA guidance for platelet testing.
Healthy volunteers will be asked to donate a platelet unit, which will be stored for 3 days. On the day of radiolabeling, the investigators will collect samples for metabolomics and functional assessment. The volunteers will return on day 3 and receive a radiolabeled and biotinylated aliquot of the stored unit, as well as a fresh radiolabeled platelet aliquot. The investigators will collect blood samples over the following 12 days to determine recovery, survival, function, metabolomic changes, and antibody coating of the stored platelets. During a 6-month follow-up period, the investigators will collect samples for platelet count, biotin, and platelet antibody detection, and biotin levels if antibodies are present at 1, 3, and 6 months to exclude harmful effects of the biotin-labeled platelets on healthy individuals.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal health status Meet Bloodworks Northwest guidelines for autologous apheresis platelet donation Screening chemistry/hematology lab results within normal limits negative blood donor screening panel for HIV, Hepatitis B and hepatitis C agreeable to birth control measures during the study.
排除标准
- •Clinically significant acute or chronic disease Pregnant or lactating females Participation in a clinical research study within 30 days of the platelet collection Treatment with aspirin-containing meds within 7 days of platelet collection Treatment with platelet-inhibiting meds within 14 days of platelet collection Splenectomized donor Presence of anti-biotin or antiplatelet antibody at screening
研究组 & 干预措施
Biotin labeled platelets
Donor platelets labeled with biotin,
干预措施: Biotin labeled platelets (Biological)
结局指标
主要结局
Primary Endpoint Recovery and Survival
时间窗: 12 days post infusion
Post-transfusion recovery and survival of biotinylated platelets will be assessed using flow cytometry.
次要结局
- Secondary Endpoint Platelet function(12 days post infusion)
- Secondary Endpoint Metabolomic markers(12 days post infusion)
- Secondary Endpoint Antibody coating(6 months post infusion)