Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

Phase 4

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid (100 mg/mL)	Tranexamic Acid	TXA (100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
0.9% Sodium Chloride	0.9% Sodium Chloride	0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).

Primary Outcome Measures

Name	Time	Method
Time to Control of Bleeding (Minutes, Median, Interquartile Range)	During emergency department (ED) visit	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

Secondary Outcome Measures

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