Intranasal TXA for Anterior Epistaxis in the Emergency Department

Mercy Health Ohio

Status and phase: Suspended; Phase 2

Conditions: Epistaxis

Treatments: Other: Placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04054687

19-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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86 participants in 2 patient groups, including a placebo group

TXA

Experimental group

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.

Treatment:

Drug: Tranexamic Acid

Saline

Placebo Comparator group

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.

Treatment:

Other: Placebo