Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

November 3, 2021 updated by: University of California, Davis
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During emergency department (ED) visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range)
Time Frame: During emergency department (ED) visit
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
Time Frame: 24 hours
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
Time Frame: 7 days
The number of participants with re-bleeding at one week was evaluated during the follow-up phone call
7 days
Thromboembolism
Time Frame: 7 days
Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week
7 days
Drug-Related Adverse Events
Time Frame: during emergency department (ED) visit
Patient-reported drug-related adverse events during ED visit
during emergency department (ED) visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Aimee Moulin, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 844609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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