A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency
研究概览
简要总结
Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.
详细描述
Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with severe factor XI deficiency who will give informed consent to participate in the study
排除标准
- •patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
- •Patients who required aorto-coronary bypass or any vascular surgery
结局指标
主要结局
Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency
时间窗: 1 week
End point to be assessed the degree of bleeding following major operation under rFVIIa
次要结局
未报告次要终点