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 (FIPALLOC)

Institut de Cancérologie de la Loire

Status: Completed

Conditions: Allograft

Treatments: Other: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03009708

2016-1101

2016-A01833-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Allograft patients

Experimental group

Description:

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.

Treatment:

Other: Blood samples