The Prospective Randomized Controlled Clinical Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The levels of platelet
研究概览
简要总结
This study evaluates the addition of Eltrombopag after Hematopoietic stem cell transplantation (HSCT) to improve the engraftment of hematopoietic stem cell. Half of the participants will receive Eltrombopag,while the other will not receive the Eltrombopag.
详细描述
With the progress of transplantation technology，allogeneic hematopoietic stem cell transplantation is becoming an important treatment for hematological diseases and the long-term survival of patients is gradually improved. However, thrombocytopenia after transplantation has always been an important complication. Studies have shown that about 20% patients had different degrees of thrombocytopenia. Eltrombopag could promote hematopoietic stem cell proliferation and differentiation in vitro studies. It has also been widely used in the treatment of immune thrombocytopenia (ITP) and aplastic anemia(AA) and increased platelet levels in such diseases. Eltrombopag is also used to treat poor platelet engraftment after transplantation and the effective rate is about 60%-80%. Therefore, the application of Eltrombopag at early time after transplantation might promote platelet engraftment and reduce platelet transfusions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with definite diagnosis of hematological diseases, more than 30 kg, age18-60 years, gender and race are not limited;
- •Acceptance of allogeneic hematopoietic stem cell transplantation;
- •Voluntary acceptance of the study
排除标准
- •Patients with severe organ dysfunction or disease；
- •Patients who cannot tolerate oral Eltrombopag therapy;
- •Patients who refuse all-HSCT and Eltrombopag treatment;
- •Patients that investigator believed not suitable for enrollment.
研究组 & 干预措施
Treatment Group
The patients will receive Eltrombopag treatment after transplantation at d1.
干预措施: Eltrombopag (Drug)
结局指标
主要结局
The levels of platelet
时间窗: 3 years
The levels of platelet at 30 days after transplantation
The engraftment of platelet
时间窗: 3 years
the day of platelet engraftment
次要结局
- The number of platelet transfusions(3 years)
研究者
Wang Xin
Director of Hematology Department
Shandong Provincial Hospital