Actively Recruiting
Contribution of Anti-platelet Antibodies Identified With Monoclonal Antibody Immobilization of Platelet Antigens Assay (MAIPA) to Confirm Autoimmune Nature of Thrombocytopenia at Diagnosis
Led by University Hospital, Bordeaux · Updated on 2026-06-01
225
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Bordeaux
Lead Sponsor
M
Ministry for Health and Solidarity, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Immune thrombocytopenia (ITP) is an autoimmune disorder where the diagnosis and prognosis do not typically involve measuring antiplatelet antibodies. Unlike other autoimmune diseases, these antibodies are not standard for diagnosis. This trial aims to evaluate the role of anti-platelet antibodies detected using the Monoclonal Antibody Immobilization of Platelet Antigens (MAIPA) assay in confirming the autoimmune nature of thrombocytopenia at diagnosis, addressing a gap in current clinical knowledge. Participants will undergo blood sampling for various tests including measurement of thrombopoietin and both free and platelet-bound anti-platelet antibodies through the MAIPA assay. The amount of blood drawn depends on platelet counts, ranging from 14 ml to 49 ml for specific isolations. This is an interventional study where these biological samples will be analyzed to assess the presence of antibodies and their diagnostic value. During the study, participants will be monitored for the presence of autoimmune thrombocytopenia and chronic ITP status over 12 months. Blood tests will be conducted at baseline and after 12 months to measure serum thrombopoietin and antibody presence. The main outcome is the percentage of patients diagnosed with autoimmune thrombocytopenia based on antibody detection at 12 months, alongside secondary outcomes including chronic ITP rates and thrombopoietin levels.
CONDITIONS
Brief Title
Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Diagnosed with thrombocytopenia less than 100 G/L confirmed twice
- False thrombocytopenia ruled out by platelet aggregation test
- Acute leukemia excluded by smear
- No treatment started for thrombocytopenia
- Signed free, informed, and written consent before any study procedures
- Affiliated with or benefiting from a social security scheme
You will not qualify if you...
- Diagnosis of secondary immune thrombocytopenia
- False thrombocytopenia
- Platelet transfusion within the last 7 days with efficacy
- Treatment for thrombocytopenia started (except up to 48 hours corticosteroid therapy)
- Acute leukemia
- Pregnant or breastfeeding women
- Under guardianship, curatorship, or legal protection regime
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants undergo blood sample collection to identify anti-platelet antibodies and measure thrombopoietin concentration to confirm the autoimmune nature of thrombocytopenia at diagnosis.
1 visit (in-person)
Duration - 12 months after baseline
Participants are monitored to assess diagnosis outcomes and thrombopoietin levels 12 months after baseline.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
CHU de Bordeaux - service de médecine interne
Pessac, France
Actively Recruiting
Research Team
J
Jean-François VIALLARD, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here