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

Not Applicable

Recruiting

• Conditions: Thrombocytopenia; Immune Thrombocytopenia; Myelodysplasia
• Interventions: Biological: Blood samples

• Registration Number: NCT04800458
• Lead Sponsor: University Hospital, Bordeaux

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Study Start: 2021-05-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
thrombocytopenic patients	Blood samples	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Percentage of patients with chronic ITP	12 months after baseline
serum Thrombopoietin concentration	At baseline and 12 months after baseline

Trial Locations

Locations (1)

CHU de Bordeaux - service de médecine interne; 🇫🇷 Pessac, France