EUCTR2018-002686-19-DK进行中（未招募）1 期
Interleukin-6 Receptor Antibodies for Modulating the Systemic Inflammatory Response after Out-of-Hospital Cardiac Arrest - IL-6 inhibition for modulating inflammation after cardiac arrest
Department of Cardiology, Copenhagen University Hospital Rigshospitalet0 个研究点目标入组 80 人开始时间: 2018年8月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Age = 18 years
- •2)Out-of-hospital cardiac arrest of a presumed cardiac cause
- •3)Unconsciousness upon admission
- •4)Sustained return of spontaneous circulation for more than 20 minutes
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1)Consciousness upon admission
- •2)Presumed non-cardiac cause of arrest
- •3)Unwitnessed asystole
- •4)Suspected or confirmed intracranial bleeding or stroke
- •5)Pregnancy, or females in fertile age, unless a negative serum HCG can rule out pregnancy within the inclusion window.
- •6)Temperature on admission < 30 °C
- •7)Persistent cardiogenic shock that is not reversed within the inclusion window
- •8)Known disease making 180 day survival unlikely
- •9)Known limitations in therapy
- •10)Known pre-arrest Cerebral Performance Category of 3 to 4
- •11) > 240 minutes from ROSC to randomization
- •12) Known allergies to IL-6RA
- •13) Known infection
- •14) Known hepatic cirrhosis
研究者
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