RecruitingNot ApplicableNCT04800458

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

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

Sponsor

University Hospital, Bordeaux

Enrollment

225 participants

Start Date

May 19, 2021

Study Type

INTERVENTIONAL

Conditions

Thrombocytopenia Immune Thrombocytopenia Myelodysplasia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a blood test called the MAIPA assay (which detects antibodies against platelets) can help doctors determine whether a low platelet count (thrombocytopenia) is caused by an autoimmune condition at the time of first diagnosis. Currently it can be difficult to know the cause of low platelet counts early on, and this test could help guide treatment decisions sooner. Participants will have their blood drawn and tested with the MAIPA assay at the time of their diagnosis. Researchers will track outcomes to see how accurate this test is at identifying autoimmune thrombocytopenia (also called ITP). You may be eligible if: - You are 18 years of age or older - You have a confirmed low platelet count below 100 G/L on at least two occasions - False thrombocytopenia and acute leukemia have been ruled out - You have not yet started treatment for your low platelets (short-term corticosteroids for up to 48 hours are allowed) You may NOT be eligible if: - Your thrombocytopenia has a secondary (non-autoimmune) cause - You have acute leukemia - You have recently received a platelet transfusion (within 7 days) with improvement - You are pregnant or breastfeeding - You are under legal guardianship Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBlood 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.