IMPACT OF THERAPEUTIC PLASMA EXCHANGE ON ACQUIRED VACCINAL ANTI-SARS-CoV-2 ANTIBODIES.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Analysis of the variation of the anti-SARS-CoV-2 antibodies with plasma exchange procedures
研究概览
简要总结
Context:
Therapeutic plasma exchange is an extracorporeal blood purification technique that removes pathogenic substances (including antibodies) from plasma. This technique also combines an immunomodulatory effect. The impact on the anti-SARS-CoV-2 titre and the humoral and cellular responses in the general population benefiting from therapeutic plasma exchanges is not known at this time.
The purpose of this study is to evaluate the evolution of anti-SARS-CoV-2 antibodies' titre over time in vaccinated adult patients treated with therapeutic plasma exchange.
Research question and associated variables:
Prospective non-drug interventional study on the possible variation of anti-SARS-CoV-2 antibody titre in adult patients regularly treated with therapeutic plasma exchange.
Study population: any adult patient vaccinated against SARS-CoV-2 (any type of vaccine) and regularly receiving therapeutic plasma exchange in the adult hematology department of the Cliniques universitaires Saint Luc in Brussels, Belgium.
Number of subjects expected to be enrolled: 10-15
详细描述
Not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adult patients vaccinated against SARS-CoV-2 (any type of vaccine) and regularly receiving therapeutic plasma exchange in the adult hematology department of the Cliniques universitaires Saint Luc.
排除标准
- •Patients treated with therapeutic plasma exchange for an acute condition at the intensive care unit
- •Patients unable to sign the ICF or unwilling to participate to the study
研究组 & 干预措施
Evolution of anti-SARS-CoV-2 titer over time in vaccinated adult patients treated with TPE.
Assessment of the possible variation of anti-SARS-CoV-2 antibody titer in adult patients regularly treated with therapeutic plasma exchange.
For each patient included in this study, 3 blood samples of 5 ml(serum) will be collected at well-defined time points: at the beginning of an TPE session, at the end of the same session, and at the beginning of the consecutive TPE session.
干预措施: Evolution of antibodies titre (Diagnostic Test)
结局指标
主要结局
Analysis of the variation of the anti-SARS-CoV-2 antibodies with plasma exchange procedures
时间窗: 3 months
Evolution of anti-SARS-CoV-2 antibodies titre over time in vaccinated adult patients treated with TPE.
次要结局
未报告次要终点