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

Not Applicable

Completed

• Conditions: Allograft
• Interventions: Other: Blood samples

• Registration Number: NCT03009708
• Lead Sponsor: Institut de Cancérologie de la Loire

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 Timeline

• Study First Submitted: 2016-12-30
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-04
• Study Start: 2017-03-21
• Primary Completion: 2017-09-12
• Study Completion: 2017-11-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-11
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allograft patients	Blood samples	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.

Primary Outcome Measures

Name	Time	Method
In vitro spontaneous CD63 (membrane protein) expression level	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	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	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	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 Outcome Measures

Name	Time	Method
Level of in vitro platelet activation after a CMV antigen stimulation	90 Days	Level of in vitro platelet activation after a CMV antigen stimulation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) expression level.
Level of in vitro spontaneous platelet activation	90 Days	Level of in vitro spontaneous platelet activation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) spontaneous expression level.

Trial Locations

Locations (1)

Institut de Cancérologie Lucien Neuwirth; 🇫🇷 Saint-Priest en Jarez, France