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临床试验/NCT04054687
NCT04054687暂停2 期

Intranasal TXA for Anterior Epistaxis in the Emergency Department

Mercy Health Ohio2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年11月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
暂停
发起方
入组人数
86
试验地点
2
主要终点
Bleeding cessation

研究概览

简要总结

The objective of this study is to evaluate the efficacy of and patient satisfaction with the use of intranasal tranexamic acid (TXA) for anterior nosebleeds in the emergency department (ED).

详细描述

Pledget soaked in either saline or TXA will be applied to the bleeding nare of the patient presenting with anterior epistaxis. After fifteen minutes, the pledget will be removed and patient reassessed.

Informed consent will be obtained prior to patient enrollment.

Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.

Patient satisfaction will be assessed in both groups during ED stay and one week after ED stay.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

TXA

Experimental

Research participants in the experimental group will receive one dose of 100mg/mL TXA soaked in a cotton pledget in the bleeding nare for a total of 15 minutes.

干预措施: Tranexamic Acid (Drug)

Saline

Placebo Comparator

Research participants in the placebo group will receive one dose of normal saline (0.9%) soaked in a cotton pledget in the bleeding nare for a total of 15 minutes.

干预措施: Placebo (Other)

结局指标

主要结局

Bleeding cessation

时间窗: 15 minutes

After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed

次要结局

  • Patient satisfaction: 10 point scale(Before ED discharge (up to 24 hours) and 1 week after ED discharge)
  • Bleeding cessation(1 week)

研究者

发起方
Mercy Health Ohio
申办方类型
Other
责任方
Sponsor

研究点 (2)

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