Research on blood markers linked to fatigue in patients with low platelet counts

Research for Plasma Biomarkers Associated With Fatigue in Thrombocytopenic Patients

This study is trying to see if certain blood markers are linked to fatigue in people with low platelet counts.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT06979765 on ClinicalTrials.gov

What this trial studies

This project investigates the relationship between thrombocytopenia, a condition characterized by low platelet counts, and significant fatigue experienced by patients. It aims to explore the role of neurotrophic factors, particularly Brain-Derived Neurotrophic Factor (BDNF), which may be released from activated platelets and could influence cognitive and emotional health. The study involves blood sampling and self-administered questionnaires to assess fatigue and related symptoms in patients with thrombocytopenia. By understanding these associations, the research seeks to clarify the underlying mechanisms of fatigue in these patients.

Who should consider this trial

Good fit: Ideal candidates include adults or minors diagnosed with constitutional or autoimmune thrombocytopenia and not currently receiving certain medications.

Not a fit: Patients with thrombocytopenia who are actively treated with serotonin reuptake inhibitors, norepinephrine reuptake inhibitors, or antithrombotic therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved understanding and management of fatigue in patients with thrombocytopenia.

How similar studies have performed: While the specific approach of linking fatigue to platelet-derived neurotrophic factors is novel, related studies have indicated that fatigue is a common symptom in autoimmune conditions.

Eligibility criteria

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

Where this trial is running

Paris

• Hôpital Bichat-Claude Bernard — Paris, France (Recruiting)

Study contacts

• Principal investigator: Nadine Ajzenberg — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Nadine Ajzenberg

Conditions Thrombopenia