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 Corporation0 个研究点目标入组 232 人开始时间: 2020年6月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Patients with sepsis and suspected bloodstream infection
•2. Be = 18 years old and =90 years old
•3. Adults receiving IV 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/m

•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. Antibiotic IV treatment > 12 h before screening
•5. Have neutropenia (absolute neutrophil count <500 cells/uL
•6. Have Child-Pugh Class C cirrhosis
•7. Have platelet count <30.000/uL
•8. Contraindications for heparin sodium for injection
•9. Subjects demonstrating any contraindication for this treatment as described in the IF

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