NCT00568893已完成4 期
An Open Label Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis and Multiple Organ Dysfunctions A Phase IV Protocol
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Safety Data
研究概览
简要总结
This trial is to obtain safety data in adult patients with severe sepsis and two sepsis-induced organ infections who receive an infusion of drotrecogin alfa (activated).
详细描述
To collect safety data while providing drotrecogin alfa (activated) for the treatment of patients with severe sepsis with multiple organ dysfunctions. Patient access to drotrecogin alfa (activated) will be provided under this protocol prior to and during its review by the Authorities of Belgium and Luxemburg for commercial release.
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
- •Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria:
- •Must be 18 years.
- •Suspected or proven infection
- •Have or have had two or more sepsis-induced organ failures sepsis
排除标准
- •Patients will be excluded from entry in this study for any of the following reasons:
- •Documented first organ dysfunction greater than 48-hours prior to start of study drug.
- •Patients greater than 135 kg in weight.
- •Patients with a platelet count less than 30,000/mm3
- •Active internal bleeding or at increased risk for bleeding
研究组 & 干预措施
1
Experimental
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
干预措施: drotrecogin alfa (activated) (Drug)
结局指标
主要结局
Safety Data
时间窗: 9 Months
次要结局
- All cause mortality data.(9 Months)
- To determine the final disposition of sepsis patients treated with drotrecogin alfa (activated)(that is, patient location at discharge from study hospital or 90 days).(9 Months)
研究者
研究点 (1)
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