Research for Plasma Biomarkers Associated With Fatigue in Thrombocytopenic Patients

ConditionThrombopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Thrombocytopenia is a clinical problem defined by a platelet count lower than 150×10⁹/L. It can be linked to various pathologies of central origin, such as decreased platelet production in the bone marrow, or peripheral origin with increased platelet destruction through autoimmune mechanisms, increased splenic sequestration, or excessive platelet consumption. Significant fatigue is often reported in association with thrombocytopenia, but its underlying pathophysiology remains unclear. One hypothesis is the role played by neurotrophic factors contained in platelets and released into the circulation following their activation, in particular the Brain-Derived Neurotrophic Factor (BDNF), which promotes the survival, growth, differentiation, and plasticity of neurons in both the central and peripheral nervous systems. Consequently, BDNF plays a key role in long-term memory, intellectual abilities, and neuroprotection.

In this context, this project aims to confirm whether platelet-origin neurotrophic biomarkers could explain the fatigue experienced by thrombocytopenic patients and whether it depends on the etiology of the thrombocytopenia.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with constitutional or autoimmune (chronic or persistent ITP with last treatment administration ≥ 3 weeks) thrombocytopenia (platelet count < 150×109/L) already diagnosed

patient not being treated and not receiving serotonin reuptake inhibitor (SSRI) or norepinephrine (SNRI) or antithrombotic treatments (antiplatelet or anticoagulant) in the 10 days prior to inclusion

affiliation to social security (beneficiary or assignee)

patient followed in consultation in one of the recruiting haematology departments

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • blood sampling

    Biological/Vaccine

    3 blood tubes will be taken during a standard check-up

  • self-administrated questionaires

    Other intervention

    4 self administrated questionaires and scales at the inclusion

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: PatientsOther 2 interventions
Group B: Control groupOther 2 interventions

Trial outcomes

Primary outcomes

1

Blood BDNF levels in thrombocytopenic adult and pediatric patients

Measurement of BDNF levels in thrombocytopenic patients Adults and children with excessive fatigue

Time frame
At the inclusion
2

Fatigue questionnaire scores for adult and pediatric patients

Fatigue questionnaire scores for adult and pediatric patients with excessive fatigue

Time frame
At the inclusion
3

BDNF blood level in Healthy volunteers

Measurement of BDNF blood level in Healthy volunteers

Time frame
At the inclusion

Secondary outcomes

1

Measurement of pro-BDNF blood level in thrombopenic adult and pediatric patients

Time frame
At the inclusion
2

measurement of p75NTR blood level in thrombopenic adult and pediatric patients

Time frame
At the inclusion
3

measurement of TrkB blood level in thrombopenic adult and pediatric patients

Time frame
At the inclusion
4

measurement of MMP9 blood level in thrombopenic adult and pediatric patients

Time frame
At the inclusion

Other outcomes

Sponsors and contacts

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