Research of Predictive Factors to Immune Thrombopenic Purpura
NCT ID: NCT01648556
Last Updated: 2016-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2012-09-30
2018-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire, Amiens
OTHER
Responsible Party
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Principal Investigators
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Jean Pierre MD MAROLLEAU, phD
Role: PRINCIPAL_INVESTIGATOR
CHU AMIENS
mathilde HUNAULT BERGER, Ph D
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
NADINE MAGY BERTRAND, PH D
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Besancon
Olivier FAIN, PH D
Role: PRINCIPAL_INVESTIGATOR
HOPITAL JEAN VERDIER, BONDY
BRIGITTE PAN PETESCH, D
Role: PRINCIPAL_INVESTIGATOR
CHU BREST
MICHEL LEPORRIER, PH D
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Caen
BERTRAND GODEAU, PH D
Role: PRINCIPAL_INVESTIGATOR
CHU CRETEIL
PHILIPPE BIERLING, PH D
Role: PRINCIPAL_INVESTIGATOR
EFS IVRY SUR SEINE
LOUIS TERRIOU, PH D
Role: PRINCIPAL_INVESTIGATOR
CHRU LILLE
JEAN MARC DURAND, PH D
Role: PRINCIPAL_INVESTIGATOR
LA CONCEPTION MARSEILLE
Locations
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CHU Amiens
Amiens, , France
Countries
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Central Contacts
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Facility Contacts
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Jean Pierre MAROLLEAU, MD-PhD
Role: primary
Other Identifiers
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PI2011_843_0002
Identifier Type: -
Identifier Source: org_study_id
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