Immune Thrombocytopenia, Myelodysplasia, Thrombocytopenia
Conditions
Keywords
Monoclonal antibody immobilization of platelet antigens assay, MAIPA, Anti-platelet antibodies, Thrombopoietin
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.
Interventions
BIOLOGICALBlood 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.
Sponsors
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Percentage of patients with chronic ITP | 12 months after baseline |
| serum Thrombopoietin concentration | At baseline and 12 months after baseline |
Countries
France
Contacts
CONTACTJean-François VIALLARD, Prof
PRINCIPAL_INVESTIGATORJean-François VIALLARD, Prof
University Hospital, Bordeaux
Outcome results
None listed