Purpura Thrombopenic
Conditions
Keywords
Purpura thrombopenic, Medullary cytogenetics, Myelodysplasic syndrome, bone marrow biopsy
Brief summary
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
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.
Interventions
OTHERBlood tests and bone marrow biopsy repeated
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.
Sponsors
Centre Hospitalier Universitaire, Amiens
Assistance Publique Hopitaux De Marseille
Henri Mondor University Hospital
Hôpital Jean Verdier
CH Abbeville
CH Compiègne
CHRU BREST
CHRU LILLE
University Hospital, Angers
Centre Hospitalier Universitaire de Besancon
CHU CAEN
CHU NICE
CHU Rennes
University Hospital, Toulouse
GROUPE HOSPITALIER INSTITUT CATHOLIQUE
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the result of cytogenetics medullary | two years after inclusion | the primary endpoint corresponds to the occurence of the PTI after two years after inclusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | EVERY 4 MONTHS (followed every four months during two years apres inclusion) | \< or \> 3.5 days |
| The test in corticoids by the prednisone per os | EVERY 4 MONTHS (followed every 4 months during two years after the inclusion) | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean Pierre MD MAROLLEAU, phD
CHU AMIENS
PRINCIPAL_INVESTIGATORmathilde HUNAULT BERGER, Ph D
University Hospital, Angers
PRINCIPAL_INVESTIGATORNADINE MAGY BERTRAND, PH D
Centre Hospitalier Universitaire de Besancon
PRINCIPAL_INVESTIGATOROlivier FAIN, PH D
HOPITAL JEAN VERDIER, BONDY
PRINCIPAL_INVESTIGATORBRIGITTE PAN PETESCH, D
CHU BREST
PRINCIPAL_INVESTIGATORMICHEL LEPORRIER, PH D
University Hospital, Caen
PRINCIPAL_INVESTIGATORBERTRAND GODEAU, PH D
CHU CRETEIL
PRINCIPAL_INVESTIGATORPHILIPPE BIERLING, PH D
EFS IVRY SUR SEINE
PRINCIPAL_INVESTIGATORLOUIS TERRIOU, PH D
CHRU LILLE
PRINCIPAL_INVESTIGATORJEAN MARC DURAND, PH D
LA CONCEPTION MARSEILLE
Outcome results
None listed