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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03009708
Acronym
FIPALLOC
Enrollment
15
Registered
2017-01-04
Start date
2017-03-21
Completion date
2017-11-06
Last updated
2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allograft

Keywords

Allograft, Cytomegalovirus, Platelets, Hematopoietic stem cells, Graft Versus Host Disease (GVH), Hemostasis, Adaptive immunity, Innate immunity, Post graft follow up

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.

Interventions

OTHERBlood samples

Two blood tubes will be collected each week during 8 weeks maximum for the present study. Samples will start at day 30 post-graft and finish at day 90 post-graft maximum.

Sponsors

Groupe sur l'Immunité des Muqueuses et Agents Pathogènes, (GIMAP)
CollaboratorUNKNOWN
Association Stéphanoise Pour la Recherche en Hématologie-Oncologie (ASPHRO)
CollaboratorUNKNOWN
Institut de Cancérologie de la Loire
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation90 DaysIn 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 spontaneous CD62P (P-selectin) expression level90 DaysIn 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 spontaneous CD63 (membrane protein) expression level90 DaysIn 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 CD62P (P-selectin) expression level after a CMV antigen stimulation90 DaysIn 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

MeasureTime frameDescription
Level of in vitro spontaneous platelet activation90 DaysLevel 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.
Level of in vitro platelet activation after a CMV antigen stimulation90 DaysLevel 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026