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NCT Number: NCT03009708

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

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.

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Key information

Conditions

Allograft Graft vs Host Disease Immune System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42 270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Samples

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Level of in vitro spontaneous platelet activation

    Time frame: 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.

  2. Level of in vitro platelet activation after a CMV antigen stimulation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de la Loire

Other

Collaborators

  • Association Stéphanoise Pour la Recherche en Hématologie-Oncologie (ASPHRO)
  • Groupe sur l'Immunité des Muqueuses et Agents Pathogènes, (GIMAP)

Registry information

Acronym: FIPALLOC

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 4, 2017
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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