NCT04048434招募中不适用
Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- IL-6 change
研究概览
简要总结
Patients with severe CAR-T cell associated cytokine release syndrome (CRS) (defined as vasopressor dependent) will be treated with standard of care (SOC) + cytokine adsorption (6hourly for 24 hrs).
Primary endpoint is the change in plasma IL-6 between 0 and 24 hrs.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe CRS (> 3) and / or severe CRES (>3)
- •CRS/CRES onset < 6 hrs
排除标准
- •Heparine allergy
- •contraindication for anticoagulation
研究组 & 干预措施
Cyotosorb
Experimental
干预措施: Cytosorb (Device)
Standard of care (SOC)
No Intervention
结局指标
主要结局
IL-6 change
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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