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

Allograft Clinical Trial

— FIPALLOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009708
• Other study ID #: 2016-1101
• Secondary ID: 2016-A01833-48
• Status: Completed
• Phase: N/A
• Start date: March 21, 2017
• Est. completion date: November 6, 2017

Study information

• Verified date: May 2018
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 6, 2017
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allograft

Intervention

Other:
• Blood 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.

Locations

Country	Name	City	State
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest en Jarez

Sponsors (3)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In vitro spontaneous CD62P (P-selectin) expression level	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.	90 Days
Primary	In vitro spontaneous CD63 (membrane protein) expression level	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.	90 Days
Primary	In vitro CD62P (P-selectin) expression level after a CMV antigen stimulation	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.	90 Days
Primary	In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation	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.	90 Days
Secondary	Level of in vitro spontaneous platelet activation	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.	90 Days
Secondary	Level of in vitro platelet activation after a CMV antigen stimulation	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.	90 Days