Clinical trial NCT02930941: Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department
Official title: Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Epistaxis
Keywords: tranexamic acid
epistaxis
emergency medicine
intranasal
TXA
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Control of Bleeding (Minutes, Median, Interquartile Range)
timeFrame: During emergency department (ED) visit
Secondary outcomes:
measure: Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range)
timeFrame: During emergency department (ED) visit
measure: Number of Participants With Re-bleeding at 24 Hours
timeFrame: 24 hours
measure: Number of Participants With Re-bleeding at One Week
timeFrame: 7 days
measure: Thromboembolism
timeFrame: 7 days
measure: Drug-Related Adverse Events
timeFrame: during emergency department (ED) visit
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Aimee Moulin, MD
role: PRINCIPAL_INVESTIGATOR
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