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
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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