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临床试验/EUCTR2012-000343-26-NL
EUCTR2012-000343-26-NL进行中(未招募)1 期

ltra-early tranexamic acid after subarachnoid hemorrhage.A prospective, randomized, multicenter study. - ULTRA

Academic Medical Center, Neurosurgery0 个研究点目标入组 950 人开始时间: 2012年8月14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
950

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

  • Admission to one of the study centers or their referring hospitals
  • CT-confirmed SAH with most recent ictus less than 24 hours ago
  • Age 18 years and older
  • 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 730
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 220

排除标准

  • No proficiency of the Dutch or English language
  • No loss of consciousness after the hemorrhage with World Federation of Neurological Surgeons (WFNS) grade 1 or 2 on admission in combination with a perimesencephalic hemorrhage
  • Bleeding pattern on CT compatible with a traumatic SAH
  • Treatment for deep vein thrombosis
  • History of blood coagulation disorder
  • Pregnancy
  • Severe renal (serum creatinin >150 mmol/L) or liver failure (AST > 150 U/l or ALT > 150 U/l or AF > 150 U/l or ?-GT > 150 U/l)
  • Imminent death within 24 hours

研究者

发起方
Academic Medical Center, Neurosurgery

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