Research for Plasma Biomarkers Associated With Fatigue in Thrombocytopenic Patients

NCT06979765 | Recruiting

• 2 other identifiers: APHP2408542024-A01225-42
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombopenia

Keywords

Thrombopenia

Outcome Measures

Primary Outcomes (3)

• Blood BDNF levels in thrombocytopenic adult and pediatric patients

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

  At the inclusion

• Fatigue questionnaire scores for adult and pediatric patients

  Fatigue questionnaire scores for adult and pediatric patients with excessive fatigue

  At the inclusion

• BDNF blood level in Healthy volunteers

  Measurement of BDNF blood level in Healthy volunteers

  At the inclusion

Secondary Outcomes (22)

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

  At the inclusion

• measurement of p75NTR blood level in thrombopenic adult and pediatric patients

  At the inclusion

• measurement of TrkB blood level in thrombopenic adult and pediatric patients

  At the inclusion

• measurement of MMP9 blood level in thrombopenic adult and pediatric patients

  At the inclusion

• measurement of Serotonin blood level in thrombopenic adult and pediatric patients

  At the inclusion

Study Arms (2)

Patients

OTHER

Minor patients (8 years of age or older) and adult patients seen consecutively in a hematology consultation as part of the follow-up of their thrombocytopenia.

Biological: blood sampling; Other: self-administrated questionaires

Control group

OTHER

Control group (n=80) who will consist of healthy adult subjects (without pathology and without treatment) matched by age (± 5 years) and sex to adult patients included in the study given the possible influence of age and sex on circulating BDNF concentrations

Biological: blood sampling; Other: self-administrated questionaires

Interventions

blood sampling BIOLOGICAL

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

Control group; Patients

self-administrated questionaires OTHER

4 self administrated questionaires and scales at the inclusion

Control group; Patients

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nadine Ajzenberg

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine Ajzenberg

CONTACT

01 40.25.62.73; nadine.ajzenberg@aphp.fr

Georges Jourdi

CONTACT

01.49.95.64.11; georges.jourdi@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): March 26, 2028
• Study Completion (Estimated): June 26, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

FR (1)