Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 3
- 主要终点
- Irregular antibodies
研究概览
简要总结
Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described.
The main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood.
The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization and to try to understand the immunological mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital
排除标准
- 未提供
研究组 & 干预措施
Control group
Allo-immunization not detected
干预措施: Blood sampling (Procedure)
Experimental group
Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion)
干预措施: Blood sampling (Procedure)
结局指标
主要结局
Irregular antibodies
时间窗: Between 2 to 4 weeks after blood transfusion
Presence/abscence of irregular antibodies
C-reactive protein (CRP)
时间窗: 1 hour before blood transfusion
CRP dosage
Heme oxygenase
时间窗: Between 2 to 4 weeks after blood transfusion
Heme oxygenase dosage
Cytokine
时间窗: Between 2 to 4 weeks after blood transfusion
Cytokine dosage
Lymphocyte typing
时间窗: Between 2 to 4 weeks after blood transfusion
Lymphocyte typing
次要结局
- Chronic or acute blood transfusion(1 hour before blood transfusion)
- Sex(1 hour before blood transfusion)
- Blood donor ethnicity(1 hour before blood transfusion)
- Blood transfusion indication(1 hour before blood transfusion)
研究者
Hanane EL KENZ
Head of Blood Bank
Brugmann University Hospital