Research of Predictive Factors to Immune Thrombopenic Purpura (PREDI-PTI)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly|
- the result of cytogenetics medullary [ Time Frame: two years after inclusion ] [ Designated as safety issue: No ]the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.
- dosage of the TPO [ Time Frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion) ] [ Designated as safety issue: No ]
- the result to the antibodies antiplatelet (positive or negative) for MAIPA [ Time Frame: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion) ] [ Designated as safety issue: No ]
- The isotopic lifetime of platelet [ Time Frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion) ] [ Designated as safety issue: No ]< or > 3.5 days
- The test in corticoids by the prednisone per os [ Time Frame: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion) ] [ Designated as safety issue: No ]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
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
patients with a thrombopenia isolated
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
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.
Other Name: The test in corticoids by the prednisone per os
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648556
|Contact: JEAN PIERRE MAROLLEAU||00 33 33 45 59 firstname.lastname@example.org|
|Amiens, France, 80000|
|Contact: Jean Pierre MAROLLEAU, MD-PhD|
|Principal Investigator: Jean-Pierre MAROLLEAU, MD-PhD|
|Sub-Investigator: Bruno ROYER, MD|
|Principal Investigator:||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||LA CONCEPTION MARSEILLE|