NCT00067730已完成4 期
A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis
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
- 7
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).
详细描述
The purpose of this study is to determine how Drotrecogin Alfa (activated) will affect leukemia, lymphoma and myeloma patients who develop sever sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). The study will evaluate the safety of Xigris by assessing the risk of serious bleeding events, including bleeding within the brain and serious bleeding leading to death.
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
- •Participants must have Leukemia, Lymphoma or Myeloma.
- •Participants must have had hematopoietic stem cell transplantation(HSCT) within the past 60 days.
- •Participants must have infection with either vasopressor dependent septic shock or ventilator-dependent respiratory failure.
- •Participants must be on a breathing machine or require medication to maintain their blood pressure.
排除标准
- •Participants must not have increased bleeding risk due to medical conditions or medications.
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
时间窗: 10 months
次要结局
- Mortality(10 months)
- Bleeding incidence(10 months)
研究者
研究点 (1)
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Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock - PROWESS-SHOCKMedDRA version: 9.1Level: LLTClassification code 10040070Term: Septic shockSeptic shockEUCTR2007-005441-38-NLEli Lilly and Company1,500
进行中（未招募）
不适用
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock - PROWESS-SHOCKMedDRA version: 9.1Level: LLTClassification code 10040070Term: Septic shockSeptic shockEUCTR2007-005441-38-PTEli Lilly and Company1,500