Research for Plasma Biomarkers Associated With Fatigue in Thrombocytopenic Patients

NCT06979765 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2025-03-26

Last updated

2026-02-03

Condition(s) studied

Thrombopenia

Investigational drug(s) / intervention(s)

blood sampling →self-administrated questionaires

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

self-administrated questionaires: 4 self administrated questionaires and scales at the inclusion

Study summary

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

Sex

ALL

Min age

8 Years

Max age

—

Healthy volunteers

Accepted

Inclusion criteria for patients (adults or minors): * 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 * Patient (or parent) having received a detailed explanation of the research project and having consent by signing the consent form before any research-specific procedure Inclusion criteria for healthy volunteers: * Age- (± 5 years) and sex-matched healthy adult controls * Non-thrombocytopenic patients and not receiving antithrombotic, SNRI or SSRI therapy or if applicable, last treatment ≥ 10 days * affiliation to social security (beneficiary or assignee) * adults who received a detailed explanation of the research project and having consent by signing the consent form before any research-specific procedure Non inclusion criteria (adults and minors): * Adult patients under legal protection (guardianship or curatorship) Thrombocytopenic patients treated with antithrombotics, serotonin reuptake inhibitors (SSRIs) or noradrenaline reuptake inhibitors (SNRIs) * Minor patients weighing less than 20 kg Non inclusion criteria for healthy adult controls: * Healthy adult volunteers under legal protection (guardianship, curatorship or safeguard of justice). * Pregnant women

Primary outcome measure(s)

Blood BDNF levels in thrombocytopenic adult and pediatric patients — At the inclusion
Measurement of BDNF levels in thrombocytopenic patients Adults and children with excessive fatigue
Fatigue questionnaire scores for adult and pediatric patients — At the inclusion
Fatigue questionnaire scores for adult and pediatric patients with excessive fatigue
BDNF blood level in Healthy volunteers — At the inclusion
Measurement of BDNF blood level in Healthy volunteers

Trial sites (1)

Facility	City	Region	Status
Hôpital Bichat-Claude Bernard	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06979765 on ClinicalTrials.gov ↗ ← All trials in France