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Trials / Completed

CompletedNCT01648556

Research of Predictive Factors to Immune Thrombopenic Purpura

Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
37 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERBlood tests and bone marrow biopsy repeatedBlood 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.

Timeline

Start date
2013-01-15
Primary completion
2022-12-28
Completion
2022-12-28
First posted
2012-07-24
Last updated
2026-03-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01648556. Inclusion in this directory is not an endorsement.