Intranasal TXA for Anterior Epistaxis in the Emergency Department

Phase 2

Suspended

• Conditions: Epistaxis
• Interventions: Other: Placebo; Drug: Tranexamic Acid

• Registration Number: NCT04054687
• Lead Sponsor: Mercy Health Ohio

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Study Start: 2019-11-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11
• Primary Completion: 2021-04
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	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.
TXA	Tranexamic Acid	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.

Primary Outcome Measures

Name	Time	Method
Bleeding cessation	15 minutes	After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction: 10 point scale	Before ED discharge (up to 24 hours) and 1 week after ED discharge	Patient satisfaction will be assessed at the end of the emergency department encounter, and then again via telephone call one week after discharge using a 10 point scale
Bleeding cessation	1 week	Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis

Trial Locations

Locations (2)

St Elizabeth Boardman Hospital; 🇺🇸 Boardman, Ohio, United States

St Elizabeth Youngstown; 🇺🇸 Youngstown, Ohio, United States