Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- The innate and adaptive immune response of patients with sickle cell disease that form allo-antibodies following erythrocyte transfusion, compared to patients that do not form alloantibodies following erythrocyte transfusion
研究概览
简要总结
The focus of the study is the pathophysiological mechanism of allo-antibody formation after red blood cell transfusion in sickle cell disease patients.
详细描述
The main objectives of this study are to study the role of the innate and adaptive immune response in allo-antibody formation and furthermore to identify the genetic and time dependent clinical risk factors on alloimmunization in SCD patients.
Subjects without allo-antibodies, receiving a red blood cell transfusion, will be included in this study. At 5 time points blood will be drawn from these subjects. (T0: Before transfusion, T1: 1 day after transfusion, T2: 1 week after transfusion, T3: 4 weeks after transfusion, T4: 6 months after transfusion).
At each time point specific markers of the immune system will be measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sickle cell disease
- •Receiving a red blood cell transfusion
排除标准
- •Previous positive screen for allo-antibodies
- •>25 red blood cell units in the past
结局指标
主要结局
The innate and adaptive immune response of patients with sickle cell disease that form allo-antibodies following erythrocyte transfusion, compared to patients that do not form alloantibodies following erythrocyte transfusion
时间窗: 6 months
Multiple activating and regulatory markers of the innate and adaptive immune system will be measured at the indicated time points and compared between cases and controls
次要结局
未报告次要终点