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Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

Primary Purpose

Epistaxis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
0.9% Sodium Chloride
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis focused on measuring tranexamic acid, epistaxis, emergency medicine, intranasal, TXA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid (100 mg/mL)

0.9% Sodium Chloride

Arm Description

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 (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Thromboembolism
Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week
Drug-Related Adverse Events
Patient-reported drug-related adverse events during ED visit

Full Information

First Posted
October 10, 2016
Last Updated
November 3, 2021
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02930941
Brief Title
Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department
Official Title
Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Terminate due to slow enrollment rate.
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
tranexamic acid, epistaxis, emergency medicine, intranasal, TXA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid (100 mg/mL)
Arm Type
Experimental
Arm Description
TXA (100 mg/1mL) sprayed in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Arm Title
0.9% Sodium Chloride
Arm Type
Placebo Comparator
Arm Description
0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Cyklokapron
Intervention Description
TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride
Other Intervention Name(s)
Saline solution
Intervention Description
0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Primary Outcome Measure Information:
Title
Time to Control of Bleeding (Minutes, Median, Interquartile Range)
Description
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
Time Frame
During emergency department (ED) visit
Secondary Outcome Measure Information:
Title
Length of Stay in the Emergency Department (Minutes, Median, Inter-Quartile Range)
Description
Length of stay was defined as time from enrollment in study to discharge from the emergency department
Time Frame
During emergency department (ED) visit
Title
Number of Participants With Re-bleeding at 24 Hours
Description
The number of participants with re-bleeding at 24 Hours was evaluated during follow up phone call
Time Frame
24 hours
Title
Number of Participants With Re-bleeding at One Week
Description
The number of participants with re-bleeding at one week was evaluated during the follow-up phone call
Time Frame
7 days
Title
Thromboembolism
Description
Patient reported thromboembolic events during follow-up phone calls at 24 hours and at one week
Time Frame
7 days
Title
Drug-Related Adverse Events
Description
Patient-reported drug-related adverse events during ED visit
Time Frame
during emergency department (ED) visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee Moulin, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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24439881
Citation
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Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department

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