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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood samples

    Biological/Vaccine

    * 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.

Treatment groups

225 Participants
are divided into 1 treatment group
Group A: thrombocytopenic patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients with a diagnosis of autoimmune thrombocytopenia among those in whom will be identified anti-platelet antibodies in direct and indirect MAIPA

Time frame
12 months after baseline

Secondary outcomes

1

Percentage of patients with chronic ITP

Time frame
12 months after baseline
2

serum Thrombopoietin concentration

Time frame
At baseline and 12 months after baseline

Other outcomes

Sponsors and contacts

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University Hospital, Bordeaux

Lead sponsor

Ministry for Health and Solidarity, France

Collaborator