NCT01562574已完成3 期
A Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombi-nant Factor VIIa (rFVIIa/ NovoSeven®) With Standard Haemostatic Replacement Therapy, and Standard Haemostatic Replacement Ther-apy Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Time from reversal of heparin with protamine sulphate to chest closure
研究概览
简要总结
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained from parent or legal guardian before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject
- •Children with complex congenital heart disease requiring corrective surgery with cardiopulmonary bypass (CPB)
排除标准
- •Congenital heart disease that does not require CPB surgery
研究组 & 干预措施
Activated recombinant human factor VII
Experimental
干预措施: activated recombinant human factor VII (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Time from reversal of heparin with protamine sulphate to chest closure
次要结局
- Number of units/volume of fresh frozen plasma (FFP) and/or platelets and/or red-cell concentrates transfused during surgery and in the post-surgery period
- Blood loss
- Adverse events
研究者
研究点 (1)
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