Intranasal TXA for Anterior Epistaxis in the Emergency Department
Primary Purpose
Epistaxis
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Epistaxis
Eligibility Criteria
Inclusion criteria:
• Patients 18 years and older with anterior epistaxis
Exclusion criteria:
- Patients with inability to give consent
- Patients without a working telephone number
- Patients lacking the mental capacity to make their own decisions
- Patients with posterior epistaxis
- Epistaxis following major trauma
- Patients with known bleeding disorder like hemophilia and thrombocytopenia
- Prisoners
- Patients hemodynamically unstable
- Pregnant patients
- Patients with a known allergy to TXA
- Patients with a visibly bleeding vessel
- Those recently post-op nasal/sinus surgery (within ten days) will also be excluded
Sites / Locations
- St Elizabeth Boardman Hospital
- St Elizabeth Youngstown
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TXA
Saline
Arm Description
Research participants in the experimental group will receive one dose of 100mg/mL TXA soaked in a cotton pledget in the bleeding nare for a total of 15 minutes.
Research participants in the placebo group will receive one dose of normal saline (0.9%) soaked in a cotton pledget in the bleeding nare for a total of 15 minutes.
Outcomes
Primary Outcome Measures
Bleeding cessation
After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed
Secondary Outcome Measures
Patient satisfaction: 10 point scale
Patient satisfaction will be assessed at the end of the emergency department encounter, and then again via telephone call one week after discharge using a 10 point scale
Bleeding cessation
Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04054687
Brief Title
Intranasal TXA for Anterior Epistaxis in the Emergency Department
Official Title
Intranasal TXA for Anterior Epistaxis in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Suspended
Why Stopped
Due to coronavirus pandemic
Study Start Date
November 7, 2019 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mercy Health Ohio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy of and patient satisfaction with the use of intranasal tranexamic acid (TXA) for anterior nosebleeds in the emergency department (ED).
Detailed Description
Pledget soaked in either saline or TXA will be applied to the bleeding nare of the patient presenting with anterior epistaxis. After fifteen minutes, the pledget will be removed and patient reassessed.
Informed consent will be obtained prior to patient enrollment.
Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.
Patient satisfaction will be assessed in both groups during ED stay and one week after ED stay.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TXA
Arm Type
Experimental
Arm Description
Research participants in the experimental group will receive one dose of 100mg/mL TXA soaked in a cotton pledget in the bleeding nare for a total of 15 minutes.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Research participants in the placebo group will receive one dose of normal saline (0.9%) soaked in a cotton pledget in the bleeding nare for a total of 15 minutes.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
TXA
Intervention Description
Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
This group will receive pledget soaked in saline. Protocol will continue as with TXA group.
Primary Outcome Measure Information:
Title
Bleeding cessation
Description
After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Patient satisfaction: 10 point scale
Description
Patient satisfaction will be assessed at the end of the emergency department encounter, and then again via telephone call one week after discharge using a 10 point scale
Time Frame
Before ED discharge (up to 24 hours) and 1 week after ED discharge
Title
Bleeding cessation
Description
Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
• Patients 18 years and older with anterior epistaxis
Exclusion criteria:
Patients with inability to give consent
Patients without a working telephone number
Patients lacking the mental capacity to make their own decisions
Patients with posterior epistaxis
Epistaxis following major trauma
Patients with known bleeding disorder like hemophilia and thrombocytopenia
Prisoners
Patients hemodynamically unstable
Pregnant patients
Patients with a known allergy to TXA
Patients with a visibly bleeding vessel
Those recently post-op nasal/sinus surgery (within ten days) will also be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Barreiro
Organizational Affiliation
Mercy Health
Official's Role
Study Chair
Facility Information:
Facility Name
St Elizabeth Boardman Hospital
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
St Elizabeth Youngstown
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44504
Country
United States
12. IPD Sharing Statement
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Intranasal TXA for Anterior Epistaxis in the Emergency Department
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