NCT00043277已完成2 期
Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.
研究概览
简要总结
The goals of this study are:
- To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
- To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
- To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
详细描述
The goals of this study are:
- To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
- To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
- To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.
- •Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.
- •Age less than 6 months .
- •Gestational age greater than 35 weeks
- •Expected life expectancy at least 14 days.
- •No contraindication to anticoagulation i.e. bleeding complications.
排除标准
- •Active or recent (less than 7 days) bleeding.
- •Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.
- •Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
- •Refusal to undergo blood transfusion should it become necessary.
- •Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial.
- •Baseline prolonged PT (>18 secs) or aPTT (>55 secs)
- •Platelet count < 50,000 cells/mm3
- •Birth Trauma
- •Planned or indicated surgery within 30 days
- •Major or minor bleeding event
结局指标
主要结局
Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.
次要结局
- In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.
研究者
研究点 (2)
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