NCT00503126已完成2 期
Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- PK/PD and safety
研究概览
简要总结
Pharmacokinetics and safety of weight based bivalirudin in children
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant females, with an age range of birth to 16 years of age.
- •Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease.
- •Written informed consent from a legal guardian/parent.
- •Life expectancy of at least 15 days at study entry.
- •Assent of the patient if older than 8 years, whenever possible.
排除标准
- •History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit.
- •Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles.
- •Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
- •Known congenital or acquired bleeding or clotting disorder.
- •Patients undergoing renal dialysis.*
- •Weight < 2.5 kg.
- •Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).
- •Known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (Angiomax®).
- •Any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
- •Participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study.
- •Patients who have been receiving warfarin (Coumadin®) therapy and whose INR is > 1.
- •Patients who cannot be discontinued from UFH at least 30 minutes prior to study drug bolus.
- •Patients who have received a dose of LMWH within 8 hours prior to study drug bolus.
- •Patients previously enrolled in the study.
结局指标
主要结局
PK/PD and safety
时间窗: 30 days
次要结局
未报告次要终点
研究者
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