Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis

Study Overview
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Brief Summary
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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.

Official Title
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Contribution of Anti-platelet Antibodies Identified With Monoclonal Antibody Immobilization of Platelet Antigens Assay (MAIPA) in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis

Conditions
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Thrombocytopenia, Immune Thrombocytopenia, Myelodysplasia

Intervention / Treatment
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* Biological: Blood samples


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thrombocytopenic patients<br> | Biological: Blood samples<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with chronic ITP |  | 12 months after baseline | 
| serum Thrombopoietin concentration |  | At baseline and 12 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monoclonal antibody immobilization of platelet antigens assay, MAIPA, Anti-platelet antibodies, Thrombopoietin