Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department
Status: | Recruiting |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/21/2018 |
Start Date: | February 2016 |
End Date: | December 2019 |
Contact: | Aimee Moulin, MD |
Email: | akmoulin@ucdavis.edu |
Phone: | 916-703-6110 |
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.
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.
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.
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.
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
We found this trial at
1
site
2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Aimee Moulin, MD
Phone: 916-703-6110
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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