To Determine the Safety and Efficacy of Oral Rivaroxaban and Standard Anticoagulant in the Treatment of Cerebrosinovenous Thrombosis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Treatment efficacy
研究概览
简要总结
The study seeks to fill the gaps regarding safety and efficacy of rivaroxaban and standard anticoagulant. therefore the current study was planned with the aim to determine the safety and efficacy of rivaroxaban and standard anticoagulant in the treatment of cerebrosinovenous thrombosis (CSVT).
详细描述
There have not been any randomized controlled trials in the country to demonstrate the efficacy, safety and outcome after the oral use of rivaroxaban in pediatric population and establish its protocol with body weight adjusted dosages in children. The findings of this study would not only add to the local data but also be of great interest to physicians and CSVT patients if an anticoagulant were found to have predictable effects and no need for therapeutic INR monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Aged 2 months to 18 years
- •Patients presenting with CSVT evident by computed tomography (CT) or magnetic resonance venography (MRV).
排除标准
- •Patients having active bleeding or having high risk of bleeding
- •Estimated glomerular filtration rate < 30 milliliter/minute per 1.73 m2.
研究组 & 干预措施
Rivaroxaban-Group
Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months.
干预措施: Rivaroxaban (Drug)
Warfarin-Group
Children received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months.
干预措施: Warfarin (Drug)
结局指标
主要结局
Treatment efficacy
时间窗: 3 months
Efficacy was considered "yes" if, after recanalization, the veins demonstrated normalization upon venography as compared to baseline.
次要结局
- Bleeding events(3 months)
- Prolonged International Normalized Ratio (INR)(3 months)
研究者
Muhammad Aamir Latif
Research consultant
RESnTEC, Institute of Research