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临床试验/EUCTR2011-003669-14-IT
EUCTR2011-003669-14-IT进行中(未招募)1 期

Tranexamic Acid for the treatment of significant traumatic brain injury: an international, randomised, double blind, placebo controlled trial. - CRASH-3 [Version 1.0]

ondon School Of Hygiene and Tropical Medicine0 个研究点目标入组 12,737 人开始时间: 2014年2月20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
12,737

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

  • Adult (16 years and older) with traumatic brain injury (TBI)
  • who are within 8 hours of injury
  • with any intracranial bleeding on CT scan OR GCS =12 if no scan available, and
  • who have no significant extra cranial bleeding (needing immediate blood transfusion)
  • The fundamental eligibility criterion is the responsible clinician’s ‘uncertainty’ as to whether or not to use tranexamic acid in a particular patient with TBI
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 1000
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 8000
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 1000

排除标准

  • Patients should not be randomised if the responsible clinician considers there is a clear indication for antifibrinolytic therapy
  • Patients should not be randomised if the responsible clinician considers there is a clear contraindication for antifibrinolytic therapy

研究者

发起方
ondon School Of Hygiene and Tropical Medicine

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