Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen
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
- 2
- 主要终点
- In vitro spontaneous CD63 (membrane protein) expression level
研究概览
简要总结
Traditionally known for their role in haemostasis, platelets have also an immune role.
Platelets play a key role in immune mediator secretion, and interact with innate and adaptive immune cells, contributing to the fight against pathogens, as viruses.
Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of the induced immune depression. Platelets activation for patients is not determined during the post-graft period, and platelet induced inflammation following a CMV infection is not described.
详细描述
The descriptive present study will determine if platelet activation is altered during the post-graft follow-up (day 30 to 90).
The activation will be studied spontaneously and after simulation by a CMV (Cytomegalovirus) antigen.
The study will also focus on inflammatory response variation, focusing on the cytokines release during the same post-graft follow-up (spontaneously and after CMV antigen stimulation).
This preliminary study could lead to a better understanding of the immune-modulator role of inflammation, controlled by the platelets, particularly in the initiation of the Graft-versus-host disease in this kind of population.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received an allogeneic haematopoietic stem cell transplant for less than 2 months for any indication ;
- •Platelets > 20 G / L (Giga per Litre) for at least 7 days without transfusion support ;
- •Patients affiliated to a social security scheme.
排除标准
- •Patients receiving antiplatelet therapy ;
- •Major protected or unable to give consent ;
- •Pregnant women ;
- •Vulnerable persons defined by French legislation.
研究组 & 干预措施
Allograft patients
Allograft patients followed at the Institut de Cancérologie Lucien Neuwirth perform blood samples during their post graft follow up in the usual practice, weekly. With the present study, two more blood tubes will be collected with the weekly blood samples.
干预措施: Blood samples (Other)
结局指标
主要结局
In vitro spontaneous CD63 (membrane protein) expression level
时间窗: 90 Days
In vitro spontaneous CD63 (membrane protein) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
In vitro spontaneous CD62P (P-selectin) expression level
时间窗: 90 Days
In vitro spontaneous CD62P (P-selectin) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation
时间窗: 90 Days
In vitro CD63 (membrane protein) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
In vitro CD62P (P-selectin) expression level after a CMV antigen stimulation
时间窗: 90 Days
In vitro CD62P (P-selectin) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
次要结局
- Level of in vitro platelet activation after a CMV antigen stimulation(90 Days)
- Level of in vitro spontaneous platelet activation(90 Days)