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Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02930941
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Epistaxis Drug: Tranexamic Acid Drug: 0.9% Sodium Chloride Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department
Study Start Date : February 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Drug: 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).
Other Name: Cyklokapron

Placebo Comparator: 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).
Drug: 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).
Other Name: Saline solution




Primary Outcome Measures :
  1. Time to control of bleeding [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Length of stay in the Emergency Department [ Time Frame: 1 day ]
  2. Re-bleeding within the first 24 hours [ Time Frame: 24 hours ]
  3. Re-bleeding within the first week [ Time Frame: 7 days ]
  4. Incidence of thromboembolic events [ Time Frame: 7 days ]
  5. Incidence of drug-related events [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930941


Contacts
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Contact: Aimee Moulin, MD 916-703-6110 akmoulin@ucdavis.edu
Contact: Brian Dang, PharmD 714-823-5107 brian.dang@ucdenver.edu

Locations
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United States, California
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Aimee Moulin, MD    916-703-6110    akmoulin@ucdavis.edu   
Contact: Christopher B Adams, PharmD    916-703-6110    chradams@ucdavis.edu   
Principal Investigator: Aimee Moulin, MD         
Sub-Investigator: Brian Dang, PharmD         
Sub-Investigator: Brittany Traylor, PharmD         
Sub-Investigator: Christopher B Adams, PharmD         
Sub-Investigator: Verena Schandera, MD         
Sub-Investigator: Howard McKinney Jr, PharmD         
Sub-Investigator: James Catlin Jr, PharmD         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Aimee Moulin, MD University of California, Davis
Publications of Results:

Other Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02930941    
Other Study ID Numbers: 844609
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, Davis:
tranexamic acid
epistaxis
emergency medicine
intranasal
TXA
Additional relevant MeSH terms:
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Epistaxis
Emergencies
Disease Attributes
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Signs and Symptoms, Respiratory
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants