ThrombocytopeniaAPATNCT04800458
Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis
A study testing Blood samples in people with Thrombocytopenia and Immune Thrombocytopenia, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia, Immune Thrombocytopenia, Myelodysplasia
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2021to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - service de médecine interne
Pessac
Jean-François VIALLARD, Prof, 05.57.65.64.83 ext. +33, jean-françois.viallard@chu-bordeaux.fr
Jean-François VIALLARD, Prof
About this study
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
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.
- Conditions
- Thrombocytopenia, Immune Thrombocytopenia, Myelodysplasia
- Being tested
- Blood samples
- Keywords
- Monoclonal antibody immobilization of platelet antigens assay, MAIPA, Anti-platelet antibodies, Thrombopoietin
- Medical subject headings
- Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic, Anemia, Refractory, with Excess of Blasts, Jacobs syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
- 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.
| Study group | Role | What they receive |
|---|---|---|
| thrombocytopenic patients | Experimental | Not described Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a diagnosis of autoimmune thrombocytopenia among those in whom will be identified anti-platelet antibodies in direct and indirect MAIPA
Measured: 12 months after baseline
Secondary outcomes (2)
Percentage of patients with chronic ITP
Measured: 12 months after baseline
serum Thrombopoietin concentration
Measured: At baseline and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start19 May 2021
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Responsible party
- Sponsor
- Investigators
- Jean-François VIALLARD, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800458
- Sponsor's protocol ID
- CHUBX 2020/61
- Acronym
- APAT
- Status last verified
- May 2026
- First submitted
- 11 Mar 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04800458
- Acronym / sponsor ID
- APAT / CHUBX 2020/61
- Conditions
- Thrombocytopenia, Immune Thrombocytopenia, Myelodysplasia
- Keywords
- Monoclonal antibody immobilization of platelet antigens assay, MAIPA, Anti-platelet antibodies, Thrombopoietin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Study start
- 19 May 2021 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thrombocytopenic patients | Experimental | Biological: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | thrombocytopenic patients |
Primary outcome
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
2 secondary outcomes
Percentage of patients with chronic ITP
Time frame: 12 months after baseline
serum Thrombopoietin concentration
Time frame: At baseline and 12 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-François VIALLARD, Prof principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Thrombocytopenia and Immune Thrombocytopenia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-François VIALLARD, Prof (05.57.65.64.83 ext. +33, jean-françois.viallard@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.