Comparative Study of Radiated and Unradiated Leukocyte Transfusions for Patients With Life-threatening Infections: A Collaborative Study by the Leukemia Department and Laboratory Medicine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Number of Participants Alive at Day 30
研究概览
简要总结
The goal of this clinical research study is to compare the effectiveness of a white blood cell transfusion with radiated cells to a white blood cell transfusion with cells that have not been radiated. The safety of this procedure will also be studied.
详细描述
Radiated White Blood Cell Transfusions:
White blood cell transfusions from a volunteer donor may contain blood cells that your body can react with to produce a disorder called transfusion-associated graft versus host disease. This means that some of the injected white blood cells can reproduce in your body and react with your own tissues and create side effects. To avoid this, the blood is radiated (changed through radiation) to kill all the cells that can divide. But this radiation also may destroy some of the infection-fighting capacity of the white blood cell transfusion, this may decrease the effectiveness of these white blood cell transfusions. Radiating white blood cells is the standard procedure that has been used to treat serious, life-threatening infections.
Non-Radiated White Blood Cell Transfusions:
If the white blood cells are not radiated, it may increase the effectiveness of these white cell transfusions. This may help the white blood cells to make more infection-fighting white blood cells. But, the cells that are also responsible for the transfusion-associated graft versus host disease will not be killed. This increases the risk that you could have this complication.
Study Groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hematologic malignancy admitted to the Leukemia service.
- •Severe neutropenia defined as Absolute neutrophil count (ANC) less than or equal to
- •Persistent fever and/or signs of life threatening infection despite 48 hours on antibiotics.
- •Sign a written informed consent form.
- •Greater than 18 years of age.
排除标准
- 未提供
结局指标
主要结局
Number of Participants Alive at Day 30
时间窗: 30 Days
Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion).
次要结局
未报告次要终点