Research of Predictive Factors to Immune Thrombopenic Purpura
- Conditions
- Purpura Thrombopenic
- Interventions
- Other: Blood tests and bone marrow biopsy repeated
- Registration Number
- NCT01648556
- Lead Sponsor
- Centre Hospitalier Universitaire, Amiens
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patients with a thrombopenia isolated Blood tests and bone marrow biopsy repeated 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The isotopic lifetime of platelet EVERY 4 MONTHS (followed every four months during two years apres inclusion) \< or \> 3.5 days
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 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
Trial Locations
- Locations (1)
CHU Amiens
🇫🇷Amiens, France