Safety and Dose Finding Study of Xigris (Drotrecogin Alfa Activated) as an Anti-coagulant in End Stage Renal Disease (ESRD) Patients Treated With Hemodialysis (HD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean Partial Thromboplastin Time (PTT) at 30 Minutes
研究概览
简要总结
The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).
详细描述
In United States, there are over 300,000 patients with ESRD who require hemodialysis. Clinical hemodialysis takes place three times a week and is dependent on adequate anticoagulation throughout the three to four hour procedure. Infection is one of the most common causes of death for patients with ESRD treated with hemodialysis (25%).
Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C and is successfully used for treatment of adult patients with severe sepsis. In addition to its fibrinolytic properties, drotrecogin alpha has both an anti-inflammatory effect, and an anti-coagulant effect. However, there are few safety and no efficacy data on the effect of Xigris in ESRD patients as an anticoagulant.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Usually used heparin with HD
排除标准
- •H/o bleeding diathesis
- •Pt on Ticlid/plavix/warfarin
- •BASELINE PTT>50
研究组 & 干预措施
Xigris
Drotrecogin alfa activated (Xigris) used as anticoagulant in patients treated with hemodialysis.
干预措施: Drotrecogin alfa activated (Xigris) (Drug)
结局指标
主要结局
Mean Partial Thromboplastin Time (PTT) at 30 Minutes
时间窗: PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 120 Minutes
时间窗: PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 15 Minutes
时间窗: PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 60 Minutes
时间窗: PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 180 Minutes
时间窗: PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
次要结局
未报告次要终点
研究者
Mardi Gomberg -Maitland
Professor
George Washington University