RecruitingNot ApplicableNCT06979765

Research for Plasma Biomarkers Associated With Fatigue in Thrombocytopenic Patients


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

280 participants

Start Date

Mar 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 Years

Inclusion Criteria13

  • 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
  • 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
  • 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
  • Healthy adult volunteers under legal protection (guardianship, curatorship or safeguard of justice).
  • Pregnant women

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Interventions

BIOLOGICALblood sampling

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

OTHERself-administrated questionaires

4 self administrated questionaires and scales at the inclusion


Locations(1)

Hôpital Bichat-Claude Bernard

Paris, France

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NCT06979765