A Study of Treatment With Thrombopoietin Agonists in Patients With Idiopathic Thrombocytopenic Purpura
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Assessment of response to treatment will be clinical and laboratory assessment
研究概览
简要总结
- Assesement of response to Thrombopoietin receptor agonists (TPO-RAs) as treatment in Idiopathic thrombocytopenia purpura patients in Assiut University hospital.
- Explore side effects of Thrombopoietin receptor agonists in Idiopathic thrombocytopenia purpura .
- To study effect of thrombopoietin receptor agonists and Quality life in Idiopathic thrombocytopenia purpura patients.
详细描述
Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by reduced platelet counts (<100 × 109/L) and increased bleeding risk in the absence of other causes associated with thrombocytopenia().. It affects 2-4 per 100,000 individuals annually with an overall prevalence of about 10/100,000 individuals().
Manifestations of idiopathic thrombocytopenic purpura( ITP) can be localised haemorrhaging in skin or mucous membranes that are usually of little to no clinical consequence (petechiae, purpura, ecchymoses, epistaxis); more rarely, ITP can be associated with severe bleeding events such as intracranial haemorrhage (ICH). However, most ITP patients are asymptomatic in the presence of platelet counts greater than 50x109/L2.()
Idiopathic thrombocytopenia purpura is diagnosed in absence of secondary causes of immune mediated thrombocytopenia including autoimmune diseases (systemic lupus erthematosus , antiphospholipid antibody syndrome) lymphoproliferative disorders (chronic lymphocytic leukemia ) viral infection (hepatitis c virus , human immunodeficiency virus
The goal of treatment in patients with of idiopathic thrombocytopenic purpura is to maintain the platelet count at a level that reduces the risk of bleeding with minimal treatment-related toxic effects. Observation alone is recommended when no or mild bleeding is present and the platelet count is more than 30,000 per cubic millimeter in adults.23 Treatment in patients with a lower platelet count is indicated only if bleeding occurs or if the platelet count is very low. (For example, most experts would treat a non bleeding patient who had a platelet count of <10,000 per cubic millimeter().
Historically , the treatment of idiopathic thrombocytopenia purpura has been directed at inhibiting the production of anti platelet autoantibodies or opsonization of antibody coated platelets. However, impaired platelet production is increasingly recongnized as a contributor to thrombocytopenia in patients with idiopathic thrombocytopenia purpura.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presented with Idiopathic thrombocytopenic purpura (ITP)
- •patients above age of 18 years.
排除标准
- •patients below age of 18 years .
研究组 & 干预措施
Group 1
Group I : Romiplostim and Eltrombopag
干预措施: eltrombopag and romiplastim (Drug)
Group 2
Group II : recived corticosteroid.
干预措施: eltrombopag and romiplastim (Drug)
结局指标
主要结局
Assessment of response to treatment will be clinical and laboratory assessment
时间窗: Baseline
Platelet count should be measured weekly until a stable platelet count that is associated with an absence of bleeding symptoms is achieved for 4 weeks without adjustment and then measured monthly thereafter.
次要结局
未报告次要终点
研究者
Naira Ibrahem Ahmed Saad
A Study of Treatment with thrombopoietin agonists in patients with Idiopathic thrombocytopenic purpura
Assiut University
