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Terminate due to slow enrollment rate.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid (100 mg/mL) | Experimental | 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 | Placebo Comparator | 0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During emergency department (ED) visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During emergency department (ED) visit |
| Number of Participants With Re-bleeding at 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aimee Moulin, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24439881 | Background | Morgan DJ, Kellerman R. Epistaxis: evaluation and treatment. Prim Care. 2014 Mar;41(1):63-73. doi: 10.1016/j.pop.2013.10.007. | |
| 10400410 | Background | Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid (100 mg/mL) | TXA (100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s). Tranexamic Acid: TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s). |
| FG001 | 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). 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | NS Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intention-to-treat | Posted | Median | Inter-Quartile Range | minutes | During emergency department (ED) visit |
|
One week from initial ED visit
All adverse effects reported from patients were collected. Mortality was not collected beyond 7 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Burning | General disorders | Non-systematic Assessment |
Coronavirus Disease 2019 (COVID-19) pandemic significantly impacted the ability to enroll patients; early termination leading to a small number of patients; single-center study;
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aimee Moulin, MD | University of California, Davis Medical Center | 916-703-6110 | akmoulin@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 6, 2017 | May 6, 2021 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2017 | Aug 24, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004844 | Epistaxis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 0.9% Sodium Chloride | Drug | 0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s). |
|
|
The number of participants with re-bleeding at 24 Hours was evaluated during follow up phone call |
| 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 | 7 days |
| Thromboembolism | Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week | 7 days |
| Drug-Related Adverse Events | Patient-reported drug-related adverse events during ED visit | during emergency department (ED) visit |
| 15988431 | Background | Pallin DJ, Chng YM, McKay MP, Emond JA, Pelletier AJ, Camargo CA Jr. Epidemiology of epistaxis in US emergency departments, 1992 to 2001. Ann Emerg Med. 2005 Jul;46(1):77-81. doi: 10.1016/j.annemergmed.2004.12.014. |
| 15686301 | Background | Kucik CJ, Clenney T. Management of epistaxis. Am Fam Physician. 2005 Jan 15;71(2):305-11. |
| 24136624 | Background | Villwock JA, Jones K. Recent trends in epistaxis management in the United States: 2008-2010. JAMA Otolaryngol Head Neck Surg. 2013 Dec;139(12):1279-84. doi: 10.1001/jamaoto.2013.5220. |
| 15671968 | Background | Singer AJ, Blanda M, Cronin K, LoGiudice-Khwaja M, Gulla J, Bradshaw J, Katz A. Comparison of nasal tampons for the treatment of epistaxis in the emergency department: a randomized controlled trial. Ann Emerg Med. 2005 Feb;45(2):134-9. doi: 10.1016/j.annemergmed.2004.10.002. |
| 3286068 | Background | White A, O'Reilly BF. Oral tranexamic acid in the management of epistaxis. Clin Otolaryngol Allied Sci. 1988 Feb;13(1):11-6. doi: 10.1111/j.1365-2273.1988.tb00275.x. |
| 7478455 | Background | Tibbelin A, Aust R, Bende M, Holgersson M, Petruson B, Rundcrantz H, Alander U. Effect of local tranexamic acid gel in the treatment of epistaxis. ORL J Otorhinolaryngol Relat Spec. 1995 Jul-Aug;57(4):207-9. doi: 10.1159/000276741. |
| 23911102 | Background | Zahed R, Moharamzadeh P, Alizadeharasi S, Ghasemi A, Saeedi M. A new and rapid method for epistaxis treatment using injectable form of tranexamic acid topically: a randomized controlled trial. Am J Emerg Med. 2013 Sep;31(9):1389-92. doi: 10.1016/j.ajem.2013.06.043. Epub 2013 Jul 30. |
| 25895714 | Background | Utkewicz MD, Brunetti L, Awad NI. Epistaxis complicated by rivaroxaban managed with topical tranexamic acid. Am J Emerg Med. 2015 Sep;33(9):1329.e5-7. doi: 10.1016/j.ajem.2015.02.049. Epub 2015 Mar 6. No abstract available. |
| 11231712 | Background | Klepfish A, Berrebi A, Schattner A. Intranasal tranexamic acid treatment for severe epistaxis in hereditary hemorrhagic telangiectasia. Arch Intern Med. 2001 Mar 12;161(5):767. doi: 10.1001/archinte.161.5.767. No abstract available. |
| 25944156 | Background | Aguilera X, Martinez-Zapata MJ, Hinarejos P, Jordan M, Leal J, Gonzalez JC, Monllau JC, Celaya F, Rodriguez-Arias A, Fernandez JA, Pelfort X, Puig-Verdie Ll. Topical and intravenous tranexamic acid reduce blood loss compared to routine hemostasis in total knee arthroplasty: a multicenter, randomized, controlled trial. Arch Orthop Trauma Surg. 2015 Jul;135(7):1017-25. doi: 10.1007/s00402-015-2232-8. Epub 2015 May 7. |
| 24113504 | Background | Waldow T, Szlapka M, Haferkorn M, Burger L, Plotze K, Matschke K. Prospective clinical trial on dosage optimizing of tranexamic acid in non-emergency cardiac surgery procedures. Clin Hemorheol Microcirc. 2013 Jan 1;55(4):457-68. doi: 10.3233/CH-131782. |
| 20696726 | Background | Wolfe TR, Braude DA. Intranasal medication delivery for children: a brief review and update. Pediatrics. 2010 Sep;126(3):532-7. doi: 10.1542/peds.2010-0616. Epub 2010 Aug 9. |
| 33612282 | Background | Reuben A, Appelboam A, Stevens KN, Vickery J, Ewings P, Ingram W, Jeffery AN, Body R, Hilton M, Coppell J, Wainman B, Barton A. The Use of Tranexamic Acid to Reduce the Need for Nasal Packing in Epistaxis (NoPAC): Randomized Controlled Trial. Ann Emerg Med. 2021 Jun;77(6):631-640. doi: 10.1016/j.annemergmed.2020.12.013. Epub 2021 Feb 19. |
| 31080025 | Background | Akkan S, Corbacioglu SK, Aytar H, Emektar E, Dagar S, Cevik Y. Evaluating Effectiveness of Nasal Compression With Tranexamic Acid Compared With Simple Nasal Compression and Merocel Packing: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jul;74(1):72-78. doi: 10.1016/j.annemergmed.2019.03.030. Epub 2019 May 9. |
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).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Past Medical History | Count of Participants | Participants |
|
| Antiplatelet | Count of Participants | Participants |
|
| Anticoagulation | Count of Participants | Participants |
|
| Hemoglobin | grams (g) per decilitre (dL) | Mean | Full Range | g/dL |
|
| Hematocrit | percentage by volume of hemoglobin in blood | Mean | Full Range | % by volume of hemoglobin in blood |
|
| Platelet | x10^3 per microliter | Mean | Full Range | x10^3 per microliter |
|
|
|
| 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 | Intention to treat | Posted | Median | Inter-Quartile Range | minutes | During emergency department (ED) visit |
|
|
|
| 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 | Intention to treat. Lost to follow up: 1 in TXA group and 1 in NS group | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 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 | Intention-to-treat. Loss to follow-up: 1 in TXA group and 2 in NS group | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Thromboembolism | Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week | Intention to treat. Lost to follow up of 1 in TXA group and 2 in NS group. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Drug-Related Adverse Events | Patient-reported drug-related adverse events during ED visit | Intention to treat | Posted | Count of Participants | Participants | during emergency department (ED) visit |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 4 |
| 17 |
| EG001 | 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). | 0 | 18 | 0 | 18 | 0 | 18 |
| Unpleasant taste | General disorders | Non-systematic Assessment |
|
| Rhinorrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Unpleasant taste |
|