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Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis (APAT)

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ClinicalTrials.gov Identifier: NCT04800458
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : May 28, 2021
Sponsor:
Collaborator:
Ministry for Health and Solidarity, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Immune Thrombocytopenia Myelodysplasia Biological: Blood samples Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : May 19, 2021
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: thrombocytopenic patients Biological: Blood samples
If the platelet count is > 20 G / L : 50 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation If the platelet count is < 20 G / L : 30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with a diagnosis of autoimmune thrombocytopenia among those in whom will be identified anti-platelet antibodies in direct and indirect MAIPA [ Time Frame: 12 months after baseline ]

Secondary Outcome Measures :
  1. Percentage of patients with chronic ITP [ Time Frame: 12 months after baseline ]
  2. serum Thrombopoietin concentration [ Time Frame: At baseline and 12 months after baseline ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (<10 days);
  • Patient with acute leukemia;
  • Pregnant or breastfeeding woman;
  • False thrombocytopenia;
  • Patient under guardianship, curatorship or any other legal protection regime.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800458


Contacts
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Contact: Jean-François VIALLARD, Prof 05.57.65.64.83 ext +33 jean-françois.viallard@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux - service de médecine interne Recruiting
Pessac, France
Contact: Jean-François VIALLARD, Prof    05.57.65.64.83 ext +33    jean-françois.viallard@chu-bordeaux.fr   
Principal Investigator: Jean-François VIALLARD, Prof         
Sub-Investigator: Pierre DUFFAU, Prof         
Sub-Investigator: Sophie DIMICOLI-SALAZAR, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
Investigators
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Principal Investigator: Jean-François VIALLARD, Prof CHU Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04800458    
Other Study ID Numbers: CHUBX 2020/61
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Monoclonal antibody immobilization of platelet antigens assay
MAIPA
Anti-platelet antibodies
Thrombopoietin
Additional relevant MeSH terms:
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Preleukemia
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Myelodysplastic Syndromes
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
 Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Bone Marrow Diseases
Precancerous Conditions
Neoplasms