Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Thrombus resolution
研究概览
简要总结
The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment?
Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis.
详细描述
The Investigators will enroll all the consecutive pediatric patients (< 16 years old) treated with rivaroxaban (dosage based on patient's body weight - 0.9 mg/Kg/Day) due to intracardiac thrombosis (ICT) suspected by echocardiography and confirmed with cardiac computed tomography (CCT) or magnetic resonance (CMR) imaging. All the participants will be treated with enoxaparin for 7 days before the rivaroxaban implementation. The treatment will last for 3 months.
The participants will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. Bleeding severity will be assessed utilizing the Bleeding Assessment Scale in Critically Ill Children (BASIC). CCT/CMR will be repeated to confirm the thrombosis resolution. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the effective resolution of the thrombosis, or it will be continued for another 3 months if there is no resolution of the thrombosis.
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
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation
- •Given informed consent from the parents or tutors
排除标准
- •< 38 weeks of gestational birth
- •< 10 days of oral feeding and body weight
- •< 2.6 Kg
- •Any major or clinically relevant bleeding event or abnormal coagulation test results within 10 days prior to the enrollment for the whole population
结局指标
主要结局
Thrombus resolution
时间窗: 3 months
Rate of intracardiac thrombus resolution at CMR/CCT imaging
次要结局
- Bleeding(3 months)
研究者
Francesco Bianco
Principal Investigator
Azienda Ospedaliero, Universitaria Ospedali Riuniti