NCT01563458已完成2 期
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Reduction of Bleeding in Subjects Undergoing Orthotopic Liver Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Total number of RBC units transfused during the perioperative period
研究概览
简要总结
This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo orthotopic liver transplantation
- •Liver disease classified as Child-Turcotte (Pughs modification) score B or C
排除标准
- •Previous liver transplantation
- •Scheduled multi-organ transplantation
- •Scheduled for living related donor transplantation
- •Present renal insufficiency requiring dialysis
- •Pregnancy
研究组 & 干预措施
High dose
Experimental
干预措施: activated recombinant human factor VII (Drug)
Low dose
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
Total number of RBC units transfused during the perioperative period
次要结局
- Number of RBC units transfused by surgical phase
- Adverse events
- Changes in coagulation related parameters
研究者
研究点 (1)
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