Development of an Approach for the Differential Diagnosis of Chronic Idiopathic Thrombocytopenic Purpura and Congenital Thrombocytopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 主要终点
- Modelization of congenital thrombocytopenia test
研究概览
简要总结
The objective of this study is to provide simple and relevant clinical and biological elements to distinguish a possible Congenital Thrombocytopenia from a Chronic Idiopathic Thrombocytopenic Purpura .
详细描述
Congenital Thrombocytopenia is a group of rare diseases, often unrecognized and misdiagnosed as Chronic Idiopathic Thrombocytopenic Purpura. These Chronic Idiopathic Thrombocytopenic Purpura, which are exclusion diagnoses, are most often treated with corticosteroids or intravenous immunoglobulins and sometimes, when thrombocytopenia is refractory, splenectomy is performed. Currently, it is often before a case of thrombocytopenia refractory to the treatment of the dysimmunity syndrome that the notion of Congenital Thrombocytopenia is evoked. The percentage of false diagnoses (misdiagnosed Chronic Idiopathic Thrombocytopenic Purpura diagnoses) seems to represent to date 10 to 20% of cases.
The objective of this study is to provide simple and relevant clinical and biological elements to distinguish a possible Congenital Thrombocytopenia from a Chronic Idiopathic Thrombocytopenic Purpura.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with chronic thrombocytopenia (> 6 months) between 10 and 150 G / L, regardless of age or gender,
- •Subjects with a definite Chronic Idiopathic thrombocytopenic purpuras, - Subjects with a certain degree of certainty, sometimes pre-identified and already known at the level of the C reactive protein,
- •Subjects with chronic thrombocytopenia of undetermined origin, not definitively entering one of the 2 groups mentioned above.
排除标准
- •Thrombocytopenia less than 6 months old;
- •Patients with thrombocytopenia related to a viral or chronic infectious pathology (HIV infections or hepatitis C virus, bacterial infections with Helicobacter pillory, for example), an autoimmune disease, in particular systemic lupus and / or antiphospholipid syndrome, a bleeding disorder such as a Intra-vascular Disseminated coagulation, thrombotic microangiopathy, hypersplenism, a responsible medication intake, myelodysplastic syndrome, a pregnancy in progress.
- •Patients should not be treated with Immunoglobulin IV, rituximab or anti-CD20 less than 30 days before the date of collection.
结局指标
主要结局
Modelization of congenital thrombocytopenia test
时间窗: AT the screening
Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)
Modelization of chronic idiopathic thrombocytopenic purpura test
时间窗: AT the screening
Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)
次要结局
未报告次要终点