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

NCT ID: NCT04800458

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2027-05-31

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.

Conditions

Thrombocytopenia; Immune Thrombocytopenia; Myelodysplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

thrombocytopenic patients

Group Type: EXPERIMENTAL

Blood samples

Intervention Type: BIOLOGICAL

• 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 with acute leukemia;
• Pregnant or breastfeeding woman;
• False thrombocytopenia;
• Patient under guardianship, curatorship or any other legal protection regime.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry for Health and Solidarity, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François VIALLARD, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux - service de médecine interne

Pessac, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-François VIALLARD, Prof

Role: CONTACT

jean-françois.viallard@chu-bordeaux.fr

05.57.65.64.83 ext. +33

Facility Contacts

Jean-François VIALLARD, Prof

Role: primary

jean-françois.viallard@chu-bordeaux.fr

05.57.65.64.83 ext. +33

Other Identifiers

CHUBX 2020/61

Identifier Type: -

Identifier Source: org_study_id