Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Description of the coagulation parameters
研究概览
简要总结
Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system.
The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase.
Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained
排除标准
- •No allergic reactions to PEG-asparaginase
结局指标
主要结局
Description of the coagulation parameters
时间窗: December 2016
The study is a prospective and descriptive study. Levels of coagulation parameters will be analyzed using Two Sample T-Test and the levels of asparaginase in serum will be analyzed by Chi2 test.
次要结局
未报告次要终点
研究者
Birgitte Klug Albertsen
MD, PhD
Aarhus University Hospital