NL-OMON49017已完成不适用
Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection. - CP015
Exthera Medical Europe B.V.0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients with sepsis and suspected bloodstream infection
- •2. Be >= 18 years old and <=90 years old
- •3. Adults receiving antibiotic therapy
- •4. Increase of at least two points of the Sequential Organ Failure Assessment
- •(SOFA) score
- •5. Subjects that presents Procalcitonin (PCT) levels >0,5 ng/mL
排除标准
- •1. Subject is currently participating in another clinical investigation
- •2. Pregnant or nursing subjects and those who plan pregnancy during the
- •clinical investigation follow-up period
- •3. Presence of comorbid conditions, or other medical, social, or psychological
- •conditions that, in the investigator*s opinion, could limit the subject*s
- •ability to participate in the clinical investigation or to comply with
- •follow-up requirements, or impact the scientific soundness of the clinical
- •investigation results
- •4. The first dose of the current antibiotic therapy was > 24 h before screening
- •5. Have Child-Pugh Class C cirrhosis
- •6. Have platelet count <30.000/uL
- •7. Contraindications for heparin sodium for injection
- •8. Subjects demonstrating any contraindication for this treatment as described
研究者
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