Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

NCT02930941 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 844609
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Epistaxis

Keywords

tranexamic acid; epistaxis; emergency medicine; intranasal; TXA

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range)

  During emergency department (ED) visit

• Number of Participants With Re-bleeding at 24 Hours

  24 hours

• Number of Participants With Re-bleeding at One Week

  7 days

• Thromboembolism

  7 days

• Drug-Related Adverse Events

  during emergency department (ED) visit

Study Arms (2)

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).

Drug: Tranexamic Acid

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).

Drug: 0.9% Sodium Chloride

Interventions

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).

Also known as: Cyklokapron

Tranexamic Acid (100 mg/mL)

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).

Also known as: Saline solution

0.9% Sodium Chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with anterior epistaxis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (16)

• Morgan DJ, Kellerman R. Epistaxis: evaluation and treatment. Prim Care. 2014 Mar;41(1):63-73. doi: 10.1016/j.pop.2013.10.007.

  PMID: 24439881 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.

  PMID: 10400410 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.

  PMID: 15988431 BACKGROUND

• Kucik CJ, Clenney T. Management of epistaxis. Am Fam Physician. 2005 Jan 15;71(2):305-11.

  PMID: 15686301 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.

  PMID: 24136624 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.

  PMID: 15671968 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.

  PMID: 3286068 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.

  PMID: 7478455 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.

  PMID: 23911102 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.

  PMID: 25895714 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.

  PMID: 11231712 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.

  PMID: 25944156 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.

  PMID: 24113504 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.

  PMID: 20696726 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.

  PMID: 33612282 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.

  PMID: 31080025 BACKGROUND

MeSH Terms

Conditions

Epistaxis

Interventions

Tranexamic Acid; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

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;

Results Point of Contact

• Title: Aimee Moulin, MD
• Organization: University of California, Davis Medical Center

akmoulin@ucdavis.edu

916-703-6110

Study Officials

• Aimee Moulin, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: February 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 30, 2021
• Results First Posted: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)