NCT02566525已完成不适用
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 8
- 主要终点
- Assessment of Serious Device Related Adverse Events
研究概览
简要总结
Prospective, multi-center, randomized, feasibility clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective, cardiac surgery requiring cardiopulmonary bypass with anticipated duration of >180 minutes
排除标准
- •Platelet count < 20,000/ uL
- •Body mass index <18
- •Pregnant women
- •Life expectancy of <14 days
- •End stage organ disease
- •Active infection
- •Undergoing cardiac transplant or ventricular assist device explant, isolated primary coronary artery bypass grafting (CABG) or single valve procedure
- •Contraindication to anticoagulation with heparin
- •Declined informed consent
结局指标
主要结局
Assessment of Serious Device Related Adverse Events
时间窗: From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days)
The primary safety endpoint of this trial was to determine the product safety profile through the assessment of serious device related AEs through discharge from the ICU.
次要结局
- 30 Day All Cause Mortality(From time of enrollment through 30 days post procedure)
- Adverse Event Rates(through 30 days)
- Time in the ICU(From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days))
研究者
研究点 (8)
Loading locations...
相似试验
终止
不适用
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac SurgeryElective Cardiac SurgeryNCT03384875CytoSorbents, Inc186
已完成
不适用
Hemoadsorption With CytoSorb® in Post-Cardiac Arrest SyndromeCardiac ArrestNCT03523039Centre Hospitalier Universitaire Vaudois21
已完成
3 期
Assessing the Effects of CytoSorb Hemoperfusion on the Development on ImmunoparalysisImmune DeficiencyHemoperfusionBlood PurificationSepsisNCT04643639Radboud University Medical Center24
终止
4 期
A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid MalignancyAnemiaNCT02624141Hoffmann-La Roche10
已完成
2 期
Heart Failure and AnemiaHeart FailureAnemiaNCT00049985Amgen300