Clinical trial NCT01648556: Research of Predictive Factors to Immune Thrombopenic Purpura
Official title: Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Purpura Thrombopenic
Keywords: Purpura thrombopenic
Medullary cytogenetics
Myelodysplasic syndrome
bone marrow biopsy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: the result of cytogenetics medullary
timeFrame: two years after inclusion
Secondary outcomes:
measure: dosage of the TPO
timeFrame: EVERY 4 MONTHS (followed every four months during two years apres inclusion)
measure: the result to the antibodies antiplatelet (positive or negative) for MAIPA
timeFrame: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)
measure: The isotopic lifetime of platelet
timeFrame: EVERY 4 MONTHS (followed every four months during two years apres inclusion)
measure: The test in corticoids by the prednisone per os
timeFrame: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU AMIENS
name: Jean Pierre MD MAROLLEAU, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: mathilde HUNAULT BERGER, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Besancon
name: NADINE MAGY BERTRAND, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL JEAN VERDIER, BONDY
name: Olivier FAIN, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU BREST
name: BRIGITTE PAN PETESCH, D
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: MICHEL LEPORRIER, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU CRETEIL
name: BERTRAND GODEAU, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: EFS IVRY SUR SEINE
name: PHILIPPE BIERLING, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU LILLE
name: LOUIS TERRIOU, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: LA CONCEPTION MARSEILLE
name: JEAN MARC DURAND, PH D
role: PRINCIPAL_INVESTIGATOR
References: