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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- In vitro spontaneous CD63 (membrane protein) expression level
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients receiving antiplatelet therapy ;
- •Major protected or unable to give consent ;
- •Pregnant women ;
- •Vulnerable persons defined by French legislation.
Arms & Interventions
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.
Intervention: Blood samples (Other)
Outcomes
Primary Outcomes
In vitro spontaneous CD63 (membrane protein) expression level
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Level of in vitro platelet activation after a CMV antigen stimulation(90 Days)
- Level of in vitro spontaneous platelet activation(90 Days)