Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

Study Overview
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Brief Summary
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It is estimated that epistaxis results in 4.5 million emergency department visits per year throughout the United States. Due to the adverse effects of standard treatment options for epistaxis, tranexamic acid (TXA) may be considered an attractive option. In previous studies, when used with nasal packing, TXA showed faster time to control of bleeding. The goal of this study is to determine the efficacy and safety of topical intranasal TXA applied via atomizer for patients with epistaxis who present to the emergency department.

Detailed Description
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This is a prospective, randomized, single-center, double-blinded, placebo controlled study comparing efficacy and safety of topical intranasal tranexamic acid for epistaxis. The primary outcome was time to control of bleeding and secondary outcomes were length of stay in the emergency department, re-bleeding within the first 24 hours, and re-bleeding at one week. Safety outcomes were the incidence of thromboembolic events and other drug-related adverse events. Patients aged 18 years of age or older and diagnosed with anterior epistaxis were included. Patients were excluded if they were unable to consent, do not have a valid telephone number, pregnant women, prisoners, cognitively impaired individuals, diagnosis of posterior epistaxis, major trauma, bleeding disorder (such as thrombocytopenia or hemophilia), hemodynamically unstable, or had a known hypersensitivity to study medication. Patients were randomly assigned to tranexamic acid treatment group or placebo group. After consenting, patients received TXA (100 mg/1mL) or 0.9% sodium chloride (1 mL) in to the affected nostril(s) via intranasal atomization device. If bleeding did not cease, two repeat doses were allowed and after twenty minutes of continued bleeding the study physician could treat with any additional treatment options. Patients were contacted via telephone within one week to inquire about incidences of re-bleeding or any complications.

Official Title
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Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

Conditions
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Epistaxis

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: 0.9% Sodium Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with anterior epistaxis Exclusion Criteria: Unable to consent, do not have a valid telephone number, pregnant women, prisoners, cognitively impaired individuals, diagnosis of posterior epistaxis, major trauma, bleeding disorder (such as thrombocytopenia or hemophilia), hemodynamically unstable, or had a known hypersensitivity to study medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid (100 mg/mL)<br>TXA (100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s). | Drug: Tranexamic Acid<br>* TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).<br>* Other names: Cyklokapron;|
| Placebo Comparator: 0.9% Sodium Chloride<br>0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s). | Drug: 0.9% Sodium Chloride<br>* 0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Control of Bleeding (Minutes, Median, Interquartile Range) | Time to control of bleeding was defined as the time from the start of enrollment and direct pressure and administration of study drug to the resolution of bleeding | During emergency department (ED) visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range) | Length of stay was defined as time from enrollment in study to discharge from the emergency department | During emergency department (ED) visit | 
| Number of Participants With Re-bleeding at 24 Hours | The number of participants with re-bleeding at 24 Hours was evaluated during follow up phone call | 24 hours | 
| Number of Participants With Re-bleeding at One Week | The number of participants with re-bleeding at one week was evaluated during the follow-up phone call | 7 days | 
| Thromboembolism | Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week | 7 days | 
| Drug-Related Adverse Events | Patient-reported drug-related adverse events during ED visit | during emergency department (ED) visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergency medicine, intranasal, TXA, tranexamic acid, epistaxis