Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change from baseline in concentration of allergen specific Immunoglobin E antibodies
研究概览
简要总结
Allergic transfusion reactions are a common complication of transfusion by blood components containing plasma. This study aims to investigate passive transfer of Immunoglobin E antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent Detergent plasma.
详细描述
Prospective observation study, aiming to measure transfer of Immunoglobin E antibodies and other factors associated with allergic complications in patients receiving plasma transfusion. Samples from patients and plasma units will be investigated. Samples frozen until investigation. To assess biological relevance of findings, additional analysis of basophil reactivity will be performed and information on clinical allergy collected by use of a questionaire .
In-patients will be recruited if receiving plasma transfusion during surgery or if an allergic transfusion complication occurs.
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
- •Patients receiving plasma transfusion
排除标准
- •Patients not able to complete sampling procedure
结局指标
主要结局
Change from baseline in concentration of allergen specific Immunoglobin E antibodies
时间窗: Baseline and up to 8 weeks
Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated daily during hospital stay (anticipated up to 14 days), and 4, 6 and/or 8 weeks after transfusion.
次要结局
- Change from baseline in basophil reactivity measured by flow cytometry(Baseline and up to 8 weeks)