Evaluating anti-platelet antibodies in diagnosing autoimmune thrombocytopenia
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
This study is testing if checking for specific antibodies in the blood can help doctors diagnose immune thrombocytopenia in adults with low platelet counts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Pessac) |
| Trial ID | NCT04800458 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of anti-platelet antibodies in diagnosing immune thrombocytopenia (ITP), an autoimmune condition characterized by low platelet counts. Using the monoclonal antibody immobilization of platelet antigens (MAIPA) assay, the research aims to determine the presence of these antibodies and their contribution to establishing the autoimmune nature of thrombocytopenia. The study focuses on patients over 18 years old with confirmed thrombocytopenia, ensuring that other causes have been ruled out. Blood samples will be collected to analyze the presence of these antibodies and their potential impact on the diagnosis and prognosis of ITP.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with thrombocytopenia confirmed to be less than 100 G/L and without prior treatment.
Not a fit: Patients with secondary ITP, false thrombocytopenia, or those who have received platelet transfusions within the last 7 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnostic accuracy for patients with immune thrombocytopenia, leading to better-targeted treatments.
How similar studies have performed: While the approach of using anti-platelet antibodies for diagnosis is novel, similar studies have not extensively evaluated this method in the context of thrombocytopenia.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pessac
- CHU de Bordeaux - service de médecine interne — Pessac, France (Recruiting)
Study contacts
- Principal investigator: Jean-François VIALLARD, Prof — University Hospital, Bordeaux
- Study coordinator: Jean-François VIALLARD, Prof
- Email: jean-françois.viallard@chu-bordeaux.fr
- Phone: 05.57.65.64.83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.