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 : February 9, 2023

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Ministry for Health and Solidarity, France

Information provided by (Responsible Party):

University Hospital, Bordeaux

Study Description

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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Immune thrombocytopenia

Genetic and Rare Diseases Information Center resources: Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenia Myelodysplastic Syndromes

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: thrombocytopenic patients	Biological: Blood samples Thrombopoietin : 7 ml whole blood. Anti-platelet antibodies free : 14 ml whole blood. Anti-platelet antibodies bound : If the platelet count is ≥ 50 G / L : 14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is < 50 G / L and ≥ 20 G / L : 28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is < 20 G / L and ≥ 10 G / L: 42 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is < 10 G / L : 49 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation.

Arm

Intervention/treatment

Experimental: thrombocytopenic patients

Biological: Blood samples

Thrombopoietin : 7 ml whole blood.
Anti-platelet antibodies free : 14 ml whole blood.
Anti-platelet antibodies bound :

If the platelet count is ≥ 50 G / L : 14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is < 50 G / L and ≥ 20 G / L : 28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is < 20 G / L and ≥ 10 G / L: 42 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is < 10 G / L : 49 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation.

Outcome Measures

Primary Outcome Measures :

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 :

Percentage of patients with chronic ITP [ Time Frame: 12 months after baseline ]
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 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.

Contacts and Locations

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:	February 9, 2023
Last Verified:	February 2023
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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Thrombocytopenia Immune System Diseases Preleukemia Purpura, Thrombocytopenic, Idiopathic Myelodysplastic Syndromes Blood Platelet Disorders Hematologic Diseases Purpura, Thrombocytopenic Purpura Blood Coagulation Disorders	Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Hemorrhage Pathologic Processes Skin Manifestations Bone Marrow Diseases Precancerous Conditions Neoplasms

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