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临床试验/EUCTR2020-000855-11-DK
EUCTR2020-000855-11-DK进行中(未招募)1 期

STEROID TREATMENT AS ANTI-INFLAMMATORY AND NEUROPROTECTIVE AGENT FOLLOWING OUT-OF-HOSPITAL CARDIAC ARREST. A RANDOMIZED TRIAL. - STEROID TREATMENT FOR OHCA PATIENTS

Department of Cardiology, Copenhagen University Hospital Rigshospitalet0 个研究点目标入组 120 人开始时间: 2020年3月30日最近更新:
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
120

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.OHCA of presumed cardiac cause
  • 3.Unconsciousness (GCS =8) upon pre-hospital randomization
  • 4.Sustained ROSC for at least 5 minutes
  • 5.Randomization within 30 minutes of sustained ROSC
  • 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 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 80

排除标准

  • 1.Advanced life support TOR exclusion criteria
  • 2.Asystole as primary ECG rhythm
  • 3.Female of child bearing potential (female aged 15-40, decided by the treating physician)
  • 4.Known therapy limitation (known decision made of no resuscitation or intensive therapy)
  • 5.Known allergy to glucocorticoid
  • 6.Known disease making 180-day survival unlikely
  • 7.Known pre-arrest modified Rankin Scale (mRS) score of 4-5
  • 8.Temperature upon admission <30° C
  • 9.>30 minutes to sustained ROSC

研究者

发起方
Department of Cardiology, Copenhagen University Hospital Rigshospitalet

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