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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT04800458

Collaborator

Ministry for Health and Solidarity, France (Other)

225

Enrollment

Location

Arm

47.4

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenia Immune Thrombocytopenia Myelodysplasia	Biological: Blood samples	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 19, 2021

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: thrombocytopenic patients	Biological: Blood samples If the platelet count is > 20 G / L : 50 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation If the platelet count is < 20 G / L : 30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Arm

Intervention/Treatment

Experimental: thrombocytopenic patients

Biological: Blood samples

If the platelet count is > 20 G / L : 50 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation If the platelet count is < 20 G / L : 30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Outcome Measures

Primary Outcome Measures

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

Percentage of patients with chronic ITP [12 months after baseline]
serum Thrombopoietin concentration [At baseline and 12 months after baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.