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NCT Number: NCT04800458

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

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.

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Key information

Conditions

Thrombocytopenia Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Immune Thrombocytopenia Jacobs syndrome Myelodysplasia Myelodysplastic Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - service de médecine interne

Pessac, France

Location status: Recruiting

Location contact

Jean-François VIALLARD, Prof

CONTACT

jean-franç[email protected]

05.57.65.64.83 ext. +33

Jean-François VIALLARD, Prof

PRINCIPAL_INVESTIGATOR

Pierre DUFFAU, Prof

SUB_INVESTIGATOR

Sophie DIMICOLI-SALAZAR, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood samples

Biological
  • 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.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-François VIALLARD, Prof

CONTACT

jean-franç[email protected]

05.57.65.64.83 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Ministry for Health and Solidarity, France

Registry information

Official study 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

Acronym: APAT

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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