Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Quantitation of adverse events
研究概览
简要总结
The purpose of the study is to determine the safety of pooled red blood cells (RBCs) compared to standard leukoreduced RBC products stored in additive solution. The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.
详细描述
This research study is enrolling subjects who are receiving RBC (red blood cell) blood transfusions as part of their treatment. In this study, we are testing a new way of preparing RBC units (pooled RBC units) for transfusion compared to the standard RBC units. We are testing this because blood transfusions may be associated with side effects that may be harmful. We have developed a new way to process RBC for transfusion to try and reduce some of those side effects.
The pooled RBC units will be made by sterilely pooling five (5) single RBC units into one container where the blood will be mixed together, and then separated into five individual RBC units, ready to be used for transfusion. The purpose of the study is to determine the safety of the blood prepared in this new way compared to standard RBC products.
The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>= 18 years
- •Hematology/ oncology or other chronic transfusion dependent patients
- •Patients who are in need of transfusion due to low hemoglobin level (<8 gm/dl)
- •Patients who only require one or two transfusion episode of 1-2 RBC units each during 60 day period
- •Currently not planning to be pregnant during the study period
排除标准
- •Previously identified alloantibodies (other than to D, C, E and K)
- •Positive direct antiglobulin test, currently or within the last year
- •Emergency transfusion
- •Patients < 18 years old
- •Need for specialized products, such as washed
- •Patients involved in other RBC transfusion clinical trial
- •Currently or planning to be pregnant within the proposed study period
结局指标
主要结局
Quantitation of adverse events
时间窗: 60 day endpoint
次要结局
- Quantitation of RBC alloantibody formation(15 and 30 minutes post-transfusion)