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| Name | Class |
|---|---|
| Assistance Publique Hopitaux De Marseille | OTHER |
| Henri Mondor University Hospital | OTHER |
| Hôpital Jean Verdier | OTHER |
| CH Abbeville |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with a thrombopenia isolated | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood tests and bone marrow biopsy repeated | Other | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Pierre MD MAROLLEAU, phD | CHU AMIENS | Principal Investigator |
| mathilde HUNAULT BERGER, Ph D | University Hospital, Angers | Principal Investigator |
| NADINE MAGY BERTRAND, PH D | Centre Hospitalier Universitaire de Besancon | Principal Investigator |
| Olivier FAIN, PH D | HOPITAL JEAN VERDIER, BONDY | Principal Investigator |
| BRIGITTE PAN PETESCH, D | CHU BREST | Principal Investigator |
| MICHEL LEPORRIER, PH D | University Hospital, Caen | Principal Investigator |
| BERTRAND GODEAU, PH D | CHU CRETEIL | Principal Investigator |
| PHILIPPE BIERLING, PH D | EFS IVRY SUR SEINE | Principal Investigator |
| LOUIS TERRIOU, PH D | CHRU LILLE | Principal Investigator |
| JEAN MARC DURAND, PH D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80000 | France |
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| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| ID | Term |
|---|---|
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| UNKNOWN |
| CH Compiègne | UNKNOWN |
| CHRU BREST | UNKNOWN |
| CHRU LILLE | UNKNOWN |
| University Hospital, Angers | OTHER_GOV |
| Centre Hospitalier Universitaire de Besancon | OTHER |
| University Hospital, Caen | OTHER |
| Centre Hospitalier Universitaire de Nice | OTHER |
| Rennes University Hospital | OTHER |
| University Hospital, Toulouse | OTHER |
| GROUPE HOSPITALIER INSTITUT CATHOLIQUE | UNKNOWN |
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|
| 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) |
| LA CONCEPTION MARSEILLE |
| Principal Investigator |
| D057049 |
| Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |