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

Thrombocytopenia Clinical Trial

— APAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800458
• Other study ID #: CHUBX 2020/61
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: Jean-François VIALLARD, Prof
• Phone: 05.57.65.64.83
• Email: jean-françois.viallard[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Myelodysplasia
• Myelodysplastic Syndromes
• Preleukemia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
France	CHU de Bordeaux - service de médecine interne	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry for Health and Solidarity, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients with chronic ITP		12 months after baseline
Secondary	serum Thrombopoietin concentration		At baseline and 12 months after baseline