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临床试验/EUCTR2016-001530-10-GB
EUCTR2016-001530-10-GB进行中(未招募)1 期

A randomised controlled trial of topical intranasal tranexamic acid versus placebo to reduce the need for nasal packing in patients presenting to the Emergency Department with spontaneous epistaxis. - Novel use of TXA to reduce the need for nasal packing in epistaxis

Royal Devon & Exeter NHS Foundation Trust0 个研究点目标入组 450 人开始时间: 2018年10月21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)
入组人数
450

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

  • Potential participants must satisfy the following criteria to be enrolled in the study:
  • Aged 18 or over
  • Presenting to the ED with spontaneous, atraumatic epistaxis, unresolved with simple first aid and standard initial therapy.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 200
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 250

排除标准

  • Potential participants meeting any of the following criteria will be excluded from study participation:
  • Clinical evidence of shock, as determined by the treating clinician, or requirement for resuscitation (including but not limited to systolic BP< 90 mmHg).
  • Known allergy to TXA
  • Lacking capacity
  • Unwilling to give consent
  • No telephone or unwilling to be contacted by telephone
  • Known paranasal, nasopharyngeal or nasal cavity malignancy
  • Pregnancy
  • Sent to ED for specialist ENT treatment
  • Already undergone pre-hospital nasal packing
  • Prior participation in the study (i.e. received allocated treatment)
  • Prisoners
  • Epistaxis caused by trauma (excluding simple nose picking)
  • Known haemophilia

研究者

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