Epistaxis
Conditions
Keywords
tranexamic acid, epistaxis, emergency medicine, intranasal, TXA
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.
Interventions
DRUGTranexamic Acid
TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
DRUG0.9% 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).
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TXA Group Patients that received tranexamic (TXA)(100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s). | 17 |
| NS Group Patients that received 0.9% Sodium Chloride (NS) (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s). | 18 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Total | TXA Group | NS Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 10 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 7 Participants | 9 Participants |
| Age, Continuous | 62 years | 61 years | 62 years |
| Anticoagulation Apixaban | 5 Participants | 3 Participants | 2 Participants |
| Anticoagulation Dabigatran | 0 Participants | 0 Participants | 0 Participants |
| Anticoagulation Rivaroxaban | 0 Participants | 0 Participants | 0 Participants |
| Anticoagulation Warfarin | 6 Participants | 4 Participants | 2 Participants |
| Antiplatelet Aspirin | 10 Participants | 8 Participants | 2 Participants |
| Antiplatelet Clopidogrel | 3 Participants | 2 Participants | 1 Participants |
| Antiplatelet Prasugrel | 1 Participants | 1 Participants | 0 Participants |
| Antiplatelet Ticagrelor | 1 Participants | 1 Participants | 0 Participants |
| Hematocrit | 36.9 % by volume of hemoglobin in blood | 38 % by volume of hemoglobin in blood | 35.8 % by volume of hemoglobin in blood |
| Hemoglobin | 12.4 g/dL | 12.9 g/dL | 12 g/dL |
| Past Medical History Anemia | 2 Participants | 1 Participants | 1 Participants |
| Past Medical History Atrial Fbrillation or flutter | 6 Participants | 4 Participants | 2 Participants |
| Past Medical History Cancer | 4 Participants | 2 Participants | 2 Participants |
| Past Medical History Chronic Kidney Disease | 7 Participants | 5 Participants | 2 Participants |
| Past Medical History Congestive Heart Failure | 5 Participants | 4 Participants | 1 Participants |
| Past Medical History Coronary Artery Bypass | 2 Participants | 1 Participants | 1 Participants |
| Past Medical History Deep Vein Thrombosis | 1 Participants | 0 Participants | 1 Participants |
| Past Medical History Diabetes | 10 Participants | 4 Participants | 6 Participants |
| Past Medical History Hyperlipidemia | 10 Participants | 5 Participants | 5 Participants |
| Past Medical History Hypertension | 18 Participants | 11 Participants | 7 Participants |
| Past Medical History Ischemic Stroke | 1 Participants | 1 Participants | 0 Participants |
| Past Medical History Myocardial infarction | 1 Participants | 1 Participants | 0 Participants |
| Past Medical History Obesity | 2 Participants | 2 Participants | 0 Participants |
| Past Medical History Pulmonary Embolism | 1 Participants | 0 Participants | 1 Participants |
| Platelet | 229.8 x10^3 per microliter | 210.1 x10^3 per microliter | 248 x10^3 per microliter |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 35 participants | 17 participants | 18 participants |
| Sex: Female, Male Female | 18 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 17 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 4 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
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
Time frame: During emergency department (ED) visit
Population: Intention-to-treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TXA Group | Time to Control of Bleeding (Minutes, Median, Interquartile Range) | 64 minutes |
| NS Group | Time to Control of Bleeding (Minutes, Median, Interquartile Range) | 42 minutes |
Secondary
Drug-Related Adverse Events
Patient-reported drug-related adverse events during ED visit
Time frame: during emergency department (ED) visit
Population: Intention to treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA Group | Drug-Related Adverse Events | Nasal burning | 2 Participants |
| TXA Group | Drug-Related Adverse Events | Nasal irritation | 0 Participants |
| TXA Group | Drug-Related Adverse Events | Unpleasant taste | 1 Participants |
| NS Group | Drug-Related Adverse Events | Nasal burning | 0 Participants |
| NS Group | Drug-Related Adverse Events | Nasal irritation | 0 Participants |
| NS Group | Drug-Related Adverse Events | Unpleasant taste | 0 Participants |
Secondary
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
Time frame: During emergency department (ED) visit
Population: Intention to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TXA Group | Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range) | 268 minutes |
| NS Group | Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range) | 346 minutes |
Secondary
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
Time frame: 24 hours
Population: Intention to treat. Lost to follow up: 1 in TXA group and 1 in NS group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TXA Group | Number of Participants With Re-bleeding at 24 Hours | 3 Participants |
| NS Group | Number of Participants With Re-bleeding at 24 Hours | 9 Participants |
Secondary
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
Time frame: 7 days
Population: Intention-to-treat. Loss to follow-up: 1 in TXA group and 2 in NS group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TXA Group | Number of Participants With Re-bleeding at One Week | 2 Participants |
| NS Group | Number of Participants With Re-bleeding at One Week | 6 Participants |
Secondary
Thromboembolism
Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week
Time frame: 7 days
Population: Intention to treat. Lost to follow up of 1 in TXA group and 2 in NS group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TXA Group | Thromboembolism | 0 Participants |
| NS Group | Thromboembolism | 0 Participants |