Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04800458

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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

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