Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis (APAT)
Primary Purpose
Thrombocytopenia, Immune Thrombocytopenia, Myelodysplasia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Thrombocytopenia focused on measuring Monoclonal antibody immobilization of platelet antigens assay, MAIPA, Anti-platelet antibodies, Thrombopoietin
Eligibility 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.
Sites / Locations
- CHU de Bordeaux - service de médecine interneRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
thrombocytopenic patients
Arm Description
Outcomes
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
Secondary Outcome Measures
Percentage of patients with chronic ITP
serum Thrombopoietin concentration
Full Information
NCT ID
NCT04800458
First Posted
March 11, 2021
Last Updated
February 6, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
Ministry for Health and Solidarity, France
1. Study Identification
Unique Protocol Identification Number
NCT04800458
Brief Title
Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis
Acronym
APAT
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Ministry for Health and Solidarity, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia, Immune Thrombocytopenia, Myelodysplasia
Keywords
Monoclonal antibody immobilization of platelet antigens assay, MAIPA, Anti-platelet antibodies, Thrombopoietin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
thrombocytopenic patients
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Blood samples
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage of patients with chronic ITP
Time Frame
12 months after baseline
Title
serum Thrombopoietin concentration
Time Frame
At baseline and 12 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François VIALLARD, Prof
Phone
05.57.65.64.83
Ext
+33
Email
jean-françois.viallard@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François VIALLARD, Prof
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux - service de médecine interne
City
Pessac
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François VIALLARD, Prof
Phone
05.57.65.64.83
Ext
+33
Email
jean-françois.viallard@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Jean-François VIALLARD, Prof
First Name & Middle Initial & Last Name & Degree
Pierre DUFFAU, Prof
First Name & Middle Initial & Last Name & Degree
Sophie DIMICOLI-SALAZAR, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis
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