NCT04800458 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2021-05-19 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 225 participants in total. It began in 2021-05-19 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Jean-François VIALLARD, Prof
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT04800458 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04800458 currently recruiting?
Yes, NCT04800458 is actively recruiting participants. Contact the research team at jean-françois.viallard@chu-bordeaux.fr for enrollment information.
Where is the NCT04800458 trial being conducted?
This trial is being conducted at Pessac, France.
Who is sponsoring the NCT04800458 clinical trial?
NCT04800458 is sponsored by University Hospital, Bordeaux. The principal investigator is Jean-François VIALLARD, Prof at University Hospital, Bordeaux. The trial plans to enroll 225 participants.