NCT01562821已完成2 期
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours
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
- 235
- 试验地点
- 1
- 主要终点
- The RBC transfusion requirements
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis (Child-Turcotte Score A, B, or C)
- •Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours
排除标准
- •Portal vein thrombosis
- •Clinically documented DVT (deep venous thrombosis)
- •Clinically documented symptoms of severe cardiovascular disease and/or previous myocardial/pulmonary infarction or stroke
- •Present renal insufficiency requiring dialysis
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Low dose
Experimental
干预措施: activated recombinant human factor VII (Drug)
High dose
Experimental
干预措施: activated recombinant human factor VII (Drug)
结局指标
主要结局
The RBC transfusion requirements
次要结局
- Change in coagulation-related parameters
- Adverse events
- Number of transfusion product units
研究者
研究点 (1)
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