Clinical trial NCT04800458: Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thrombocytopenia
Immune Thrombocytopenia
Myelodysplasia
Keywords: Monoclonal antibody immobilization of platelet antigens assay
MAIPA
Anti-platelet antibodies
Thrombopoietin
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry for Health and Solidarity, France
First posted: 2021-03-16
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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 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.

Primary outcomes:
measure: Percentage of patients with a diagnosis of autoimmune thrombocytopenia among those in whom will be identified anti-platelet antibodies in direct and indirect MAIPA
timeFrame: 12 months after baseline
Secondary outcomes:
measure: Percentage of patients with chronic ITP
timeFrame: 12 months after baseline
measure: serum Thrombopoietin concentration
timeFrame: At baseline and 12 months after baseline
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux - service de médecine interne
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-François VIALLARD, Prof
role: PRINCIPAL_INVESTIGATOR
References: