Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- the result of cytogenetics medullary
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Blood tests and bone marrow biopsy repeated (Other)
结局指标
主要结局
the result of cytogenetics medullary
时间窗: two years after inclusion
the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.
次要结局
- The isotopic lifetime of platelet(EVERY 4 MONTHS (followed every four months during two years apres inclusion))
- 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))