Intranasal TXA for Anterior Epistaxis in the Emergency Department

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intranasal TXA for Anterior Epistaxis in the Emergency Department

Conditions
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Epistaxis

Intervention / Treatment
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* Drug: Tranexamic Acid
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXA<br>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. | Drug: Tranexamic Acid<br>* 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.<br>* Other names: TXA;|
| Placebo Comparator: Saline<br>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. | Other: Placebo<br>* This group will receive pledget soaked in saline. Protocol will continue as with TXA group.<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding cessation | After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Before ED discharge (up to 24 hours) and 1 week after ED discharge | 
| Bleeding cessation | Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis | 1 week |