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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04800458
Other study ID # CHUBX 2020/61
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 19, 2021
Est. completion date May 2027

Study information

Verified date May 2024
Source University Hospital, Bordeaux
Contact Jean-François VIALLARD, Prof
Phone 05.57.65.64.83
Email jean-françois.viallard@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Immune thrombocytopenia (ITP) is an autoimmune disease but, paradoxically, and unlike other autoimmune diseases, antiplatelet antibodies are not used either for the diagnosis of the disease or for its prognosis. ITP is a diagnosis of exclusion retained after elimination of other pathologies leading to a thrombocytopenia. No major study has prospectively evaluated the diagnostic value of the presence of anti-platelet antibodies in the etiological investigation of a thrombocytopenia, nor the impact of platelet antibodies on the course of ITP. The gold standard analysis for the determination of platelet antibodies, is the "monoclonal antibody immobilization of platelet antigens" assay (MAIPA), either direct to detect autoantibodies attached to platelets, or indirect to detect circulating antiplatelet antibodies. Therefore, this work aims to study the contribution of the presence of anti-platelet antibodies detected in MAIPA to determine the autoimmune nature of a thrombocytopenia at diagnosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 225
Est. completion date May 2027
Est. primary completion date May 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient over 18 years old; - Patients with thrombocytopenia <100 G/L, checked twice, having ruled out false thrombocytopenia by platelet aggregation and acute leukemia by smear; - No treatment started; - Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research); - Person affiliated or benefiting from a social security scheme. Exclusion Criteria: - Secondary ITP; - False thrombocytopenia; - Patients who have been transfused with platelets for less than 7 days with efficacy; - Patient treated for thrombocytopenia (48 hours of corticosteroid therapy is tolerated and is not an exclusion criteria); - Patient with acute leukemia; - Pregnant or breastfeeding woman; - False thrombocytopenia; - Patient under guardianship, curatorship or any other legal protection regime.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Blood samples
Thrombopoietin : 7 ml whole blood. Anti-platelet antibodies free : 14 ml whole blood. Anti-platelet antibodies bound : If the platelet count is = 50 G / L : 14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is < 50 G / L and = 20 G / L : 28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is < 20 G / L and = 10 G / L: 42 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is < 10 G / L : 49 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation.

Locations

Country Name City State
France CHU de Bordeaux - service de médecine interne Pessac

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bordeaux Ministry for Health and Solidarity, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with a diagnosis of autoimmune thrombocytopenia among those in whom will be identified anti-platelet antibodies in direct and indirect MAIPA 12 months after baseline
Secondary Percentage of patients with chronic ITP 12 months after baseline
Secondary serum Thrombopoietin concentration At baseline and 12 months after baseline
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