EpistaxisPhase 4NCT02930941

Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

A Phase 4 study testing Tranexamic Acid and 0.9% Sodium Chloride in people with Epistaxis, run by University of California, Davis at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Epistaxis
What is being tested?: Tranexamic Acid and 0.9% Sodium Chloride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Feb 2016to 31 Dec 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with anterior epistaxis

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, Davis Medical Center
Sacramento, California, 95817

Other trials in United States

About this study

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.

Read the 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.

Conditions: Epistaxis
Being tested: Tranexamic Acid, 0.9% Sodium Chloride
Keywords: tranexamic acid, epistaxis, emergency medicine, intranasal, TXA
Medical subject headings: Epistaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tranexamic AcidDrug
Also called Cyklokapron
TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
0.9% Sodium ChlorideDrug
Also called Saline solution
0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).

Study groups in NCT02930941
Study group	Role	What they receive
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). Receives: 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). Receives: Drug: 0.9% Sodium Chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: During emergency department (ED) visit

Secondary outcomes (5)

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
Measured: 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
Measured: 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
Measured: 7 days
Thromboembolism
Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week
Measured: 7 days
Drug-Related Adverse Events
Patient-reported drug-related adverse events during ED visit
Measured: during emergency department (ED) visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201631 Dec 2020

First posted12 Oct 2016 (estimated)
Study startFeb 2016
Primary completion31 Dec 2020
Study completion31 Dec 2020

Why it stopped: Terminate due to slow enrollment rate.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (16)Papers the sponsor has linked to this study.
Other trials for EpistaxisStudies of the same condition, open and under way.
More trials run by University of California, DavisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02930941
Sponsor's protocol ID: 844609
Status last verified: Nov 2021
First submitted: 10 Oct 2016
Last updated: 30 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
Individual data sharing: No

Publications

Morgan DJ, Kellerman R. Epistaxis: evaluation and treatment. Prim Care. 2014 Mar;41(1):63-73. doi: 10.1016/j.pop.2013.10.007.
PubMed 24439881
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.
PubMed 10400410
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.
PubMed 15988431
Kucik CJ, Clenney T. Management of epistaxis. Am Fam Physician. 2005 Jan 15;71(2):305-11.
PubMed 15686301
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.
PubMed 24136624
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.
PubMed 15671968
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.
PubMed 3286068
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.
PubMed 7478455
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.
PubMed 23911102
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.
PubMed 25895714
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.
PubMed 11231712
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.
PubMed 25944156
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.
PubMed 24113504
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.
PubMed 20696726
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.
PubMed 33612282

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
RecruitingPhase 3
RADA16 for Adult Tonsillectomy
Postoperative Pain

All Epistaxis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department
ClinicalTrials.gov ID: NCT02930941
Acronym / sponsor ID: 844609
Conditions: Epistaxis
Keywords: tranexamic acid, epistaxis, emergency medicine, intranasal, TXA
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminate due to slow enrollment rate.
Enrolment: 35 participants (actual)
Lead sponsor: University of California, DavisUniversity, hospital or other
Study start: Feb 2016
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 12 Oct 2016 (estimated)
Results: Posted 30 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tranexamic Acid (100 mg/mL)	Experimental	Drug: Tranexamic AcidTXA (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	Drug: 0.9% Sodium Chloride0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diagnosed with anterior epistaxis

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tranexamic AcidAlso: CyklokapronTXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).	Drug	Tranexamic Acid (100 mg/mL)
0.9% Sodium ChlorideAlso: Saline solution0.9% 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

Primary outcome

Time to Control of Bleeding (Minutes, Median, Interquartile Range)
Time frame: 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

5 secondary outcomes

Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range)
Time frame: During emergency department (ED) visit
Number of Participants With Re-bleeding at 24 Hours
Time frame: 24 hours
Number of Participants With Re-bleeding at One Week
Time frame: 7 days
Thromboembolism
Time frame: 7 days
Drug-Related Adverse Events
Time frame: during emergency department (ED) visit

Results and safety

Results posted to the registry on 30 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tranexamic Acid (100 mg/mL)	17	16
0.9% Sodium Chloride	18	16

Primary outcome: Time to Control of Bleeding (Minutes, Median, Interquartile Range)

Time frame: During emergency department (ED) visit. Median (Inter-Quartile Range). Unit: minutes

Measure	TXA Group n = 17	NS Group n = 18
Value	64 (33 to 104)	42 (26 to 131)

Population analysed: Intention-to-treat

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: One week from initial ED visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TXA Group	0 of 17 (0%)	4 of 17 (23.5%)	0 of 17
NS Group	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): 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;

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24439881Morgan DJ, Kellerman R. Epistaxis: evaluation and treatment. Prim Care. 2014 Mar;41(1):63-73. doi: 10.1016/j.pop.2013.10.007.
Background: PubMed 10400410Dunn 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.
Background: PubMed 15988431Pallin 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.
Background: PubMed 15686301Kucik CJ, Clenney T. Management of epistaxis. Am Fam Physician. 2005 Jan 15;71(2):305-11.
Background: PubMed 24136624Villwock 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.
Background: PubMed 15671968Singer 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.
Background: PubMed 3286068White 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.
Background: PubMed 7478455Tibbelin 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.
Background: PubMed 23911102Zahed 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.
Background: PubMed 25895714Utkewicz 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.
Background: PubMed 11231712Klepfish 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.
Background: PubMed 25944156Aguilera 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.
Individual participant dataSharing planned: No

Related trials for Epistaxis

Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
RecruitingPhase 3
RADA16 for Adult Tonsillectomy
Postoperative Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aimee Moulin, MD principal investigator

University of California, Davis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic Acid and 0.9% Sodium Chloride in people with Epistaxis, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Control of Bleeding (Minutes, Median, Interquartile Range) (time frame: During emergency department (ED) visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02930941, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.