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Clinical Trials/NCT03009708
NCT03009708CompletedNot Applicable

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

Institut de Cancérologie de la Loire2 sites in 1 country15 target enrollmentStarted: March 21, 2017Last updated:
Conditions
Interventions

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

Experimental

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)

Investigators

Sponsor
Institut de Cancérologie de la Loire
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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