Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- The shear-induced platelet activation (SC) is considered as the primary outcome measure.
研究概览
简要总结
This is a single-center, prospective, controlled study with one eltrombopag treatment group and 2 control groups, one on standard steroid treatment, and another one untreated.
The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on shear-induced platelet activation.
详细描述
STUDY DESIGN:
Single-center (Medical University Vienna), prospective, controlled study. Patients will be recruited at the Division of Haematology and Haemostaseology at the Medical University in Vienna, one eltrombopag treatment group and 2 control groups, one on standard steroid treatment, another one untreated.
AIM OF THE STUDY:
To determine the effect of MPL agonists on shear-induced platelet activation. Data obtained from patients treated with eltrombopag shall be compared to those from untreated patients and patients on steroids. These investigations will extend previous studies that investigated platelet function without in vitro activation in patients receiving eltrombopag.
PATIENTS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Patients on eltrombopag
干预措施: eltrombopag (Drug)
2
Patients on corticosteroids
干预措施: corticosteroids (Aprednislon) (Drug)
结局指标
主要结局
The shear-induced platelet activation (SC) is considered as the primary outcome measure.
时间窗: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.
次要结局
- Rise of reticulated platelets and variation of platelet antibodies.(After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.)
研究者
Ingrid Pabinger, MD
Univ.-Prof. Dr.
Medical University of Vienna