Research of Predictive Factors to Immune Thrombopenic Purpura

Study Overview
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Brief Summary
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It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.

Detailed Description
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It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI. The principal endpoint is to evaluate if the medullary cytogenetics is the predictive factor of the diagnosis of PTI in front of a thrombopenia isolated in elderly. The secondary endpoints are : to identify at the time of the diagnosis, the factors and/or predictive markers correlated in the final diagnosis of PTI or SMD to study the respective frequency of the PTI and the SMD in front of a thrombopenia seemingly isolated of the subject of more than 60 years. 200 patients will be included. 160 patients should be assessable at the end of study by considering the excluded patients, the dead and the lost sight.They will be followed every 4 months, during two years. In every visit, will be realized a clinical examination, a blood film, a haemogram. If the haemogram is abnormal, a bone marrow biopsy is realized. The patient who presents a myelodysplastic syndrome is excluded.

Official Title
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Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly

Conditions
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Purpura Thrombopenic

Intervention / Treatment
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* Other: Blood tests and bone marrow biopsy repeated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rate of platelet < 100 G/l for less than 12 months , age = ou > 60 years, haemoglobin > ou = 12 g / dl at the woman, > ou = 13 g/dl at the man, polymorphonuclear neutrophil > ou = 1.7 G/l, monocytes < ou= 1 G/l, lymphocytes < ou = à 4 G/l, VGM < 100 fL, blood film normal, informed consent, expectation of life > 6 months Exclusion Criteria: hepatomegaly, splenomegaly, hepatic abnormality, blood coagulation abnormality, antecedent of auto-immune disease, drug thrombopenia, HIV, VHB or VHC positive, antecedent of malicious tumor in the 5 years before inclusion

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with a thrombopenia isolated<br>Patients of 60 years old and more presenting a thrombopenia isolated with a rate of platelet < 100 G/l Blood tests and bone marrow biopsy repeated | Other: Blood tests and bone marrow biopsy repeated<br>* Blood tests are realized for the dosage of the TPO, the dosage of the antiplatelet antibodies, to measure isotopic lifetime of platelet. The test in corticoids by the prednisone per os is realized too. The bone marrow biopsy is realized at the inclusion and during follow-ups if the haemogram is abnormal.<br>* Other names: The test in corticoids by the prednisone per os;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the result of cytogenetics medullary | the primary endpoint corresponds to the occurence of the PTI after two years after inclusion. | two years after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dosage of the TPO |  | EVERY 4 MONTHS (followed every four months during two years apres inclusion) | 
| the result to the antibodies antiplatelet (positive or negative) for MAIPA |  | EVERY 4 MONTHS (followed every 4 months during two years after the inclusion) | 
| The isotopic lifetime of platelet | < or > 3.5 days | EVERY 4 MONTHS (followed every four months during two years apres inclusion) | 
| The test in corticoids by the prednisone per os | 1 mg / kg / day for 3 weeks The therapeutic test is considered as positive if a number of platelets is > 50 G/l with at least a doubling of the platelet rate before treatment | EVERY 4 MONTHS (followed every 4 months during two years after the inclusion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Purpura thrombopenic, Medullary cytogenetics, Myelodysplasic syndrome, bone marrow biopsy