NCT00102037已完成2 期
Evaluation of Safety of Activated Recombinant FVII as an Add-On Therapy in Spinal Surgery
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 15
- 主要终点
- Safety variables
研究概览
简要总结
This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective spinal fusion surgery.
排除标准
- •History of thrombotic disorders (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, disseminated intravascular coagulation or peripheral artery thrombosis)
- •Any trauma within the last 3 months leading to hospitalization > 24 hours
- •Angina or known coronary artery disease
结局指标
主要结局
Safety variables
时间窗: Within 30 days after surgery
次要结局
- Efficacy variables
研究者
研究点 (15)
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