Intranasal TXA for Anterior Epistaxis in the Emergency Department

Epistaxis Clinical Trial

Official title:

Intranasal TXA for Anterior Epistaxis in the Emergency Department

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04054687
• Other study ID #: 19-001
• Status: Suspended
• Phase: Phase 2
• Start date: November 7, 2019
• Est. completion date: May 2021

Study information

• Verified date: September 2020
• Source: Mercy Health Ohio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 86
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Epistaxis

Intervention

Drug:
• Tranexamic Acid
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.

Other:
• Placebo
This group will receive pledget soaked in saline. Protocol will continue as with TXA group.

Locations

Country	Name	City	State
United States	St Elizabeth Boardman Hospital	Boardman	Ohio
United States	St Elizabeth Youngstown	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Health Ohio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding cessation	After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed	15 minutes
Secondary	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
Secondary	Bleeding cessation	Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis	1 week