A Phase 4 interventional study of Tranexamic Acid and 0.9% Sodium Chloride in Epistaxis, sponsored by University of California, Davis. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by University of California, Davis · Phase 4, Interventional, and Treatment
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.
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.
96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.
This study's enrollment of 35 is below the median of 64 across 81 interventional studies indexed under Epistaxis.
Browse Epistaxis studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Also known as: Cyklokapron
0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Also known as: Saline solution
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
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
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
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
Thromboembolism
Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week
Time frame: 7 days
Drug-Related Adverse Events
Patient-reported drug-related adverse events during ED visit
Time frame: during emergency department (ED) visit
| Milestone | Tranexamic Acid (100 mg/mL) | 0.9% Sodium Chloride |
|---|---|---|
| Started | 17 | 18 |
| Completed | 16 | 16 |
| Not completed | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
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
| minutes | TXA Group | NS Group |
|---|---|---|
| Time to Control of Bleeding (Minutes, Median, Interquartile Range) | 64 (33 to 104) | 42 (26 to 131) |
Length of stay was defined as time from enrollment in study to discharge from the emergency department
| minutes | TXA Group | NS Group |
|---|---|---|
| Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range) | 268 (195 to 607) | 346 (283 to 410) |
The number of participants with re-bleeding at 24 Hours was evaluated during follow up phone call
| Participants | TXA Group | NS Group |
|---|---|---|
| Number of Participants With Re-bleeding at 24 Hours | 3 | 9 |
The number of participants with re-bleeding at one week was evaluated during the follow-up phone call
| Participants | TXA Group | NS Group |
|---|---|---|
| Number of Participants With Re-bleeding at One Week | 2 | 6 |
Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week
| Participants | TXA Group | NS Group |
|---|---|---|
| Thromboembolism | 0 | 0 |
Patient-reported drug-related adverse events during ED visit
| Participants | TXA Group | NS Group |
|---|---|---|
| Nasal burning | 2 | 0 |
| Nasal irritation | 0 | 0 |
| Unpleasant taste | 1 | 0 |
Collected over One week from initial ED visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TXA Group | 0/17 (0%) | 0/17 (0%) | 4/17 (23.5%) |
| NS Group | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Event | TXA Group | NS Group |
|---|---|---|
| Nasal BurningGeneral disorders | 2/17 | 0/18 |
| Unpleasant tasteGeneral disorders | 1/17 | 0/18 |
| RhinorrheaGastrointestinal disorders | 1/17 | 0/18 |
| Age, Categorical(Participants) | TXA Group | NS Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 9 | 16 |
| >=65 years | 10 | 9 | 19 |
| Age, Continuous(years) | TXA Group | NS Group | Total |
|---|---|---|---|
| Mean | 61 (28 to 83) | 62 (21 to 95) | 62 (21 to 95) |
| Sex: Female, Male(Participants) | TXA Group | NS Group | Total |
|---|---|---|---|
| Female | 6 | 12 | 18 |
| Male | 11 | 6 | 17 |
| Race and Ethnicity Not Collected(Participants) | TXA Group | NS Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | TXA Group | NS Group | Total |
|---|---|---|---|
| United States | 17 | 18 | 35 |
| Past Medical History(Participants) | TXA Group | NS Group | Total |
|---|---|---|---|
| Anemia | 1 | 1 | 2 |
| Atrial Fbrillation or flutter | 4 | 2 | 6 |
| Cancer | 2 | 2 | 4 |
| Chronic Kidney Disease | 5 | 2 | 7 |
| Congestive Heart Failure | 4 | 1 | 5 |
| Diabetes | 4 | 6 | 10 |
| Hyperlipidemia | 5 | 5 | 10 |
| Ischemic Stroke | 1 | 0 | 1 |
| Obesity | 2 | 0 | 2 |
| Pulmonary Embolism | 0 | 1 | 1 |
| Deep Vein Thrombosis | 0 | 1 | 1 |
| Myocardial infarction | 1 | 0 | 1 |
| Coronary Artery Bypass | 1 | 1 | 2 |
| Hypertension | 11 | 7 | 18 |
| Antiplatelet(Participants) | TXA Group | NS Group | Total |
|---|---|---|---|
| Aspirin | 8 | 2 | 10 |
| Clopidogrel | 2 | 1 | 3 |
| Prasugrel | 1 | 0 | 1 |
| Ticagrelor | 1 | 0 | 1 |
| Anticoagulation(Participants) | TXA Group | NS Group | Total |
|---|---|---|---|
| Warfarin | 4 | 2 | 6 |
| Apixaban | 3 | 2 | 5 |
| Rivaroxaban | 0 | 0 | 0 |
| Dabigatran | 0 | 0 | 0 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Feb 2016, a primary completion of Dec 2020 and a completion of Dec 2020. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2021, 10 months after primary completion.
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This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
University of California, Davis →