Intranasal TXA for Anterior Epistaxis in the Emergency Department

NCT ID: NCT04054687

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-07
• Study Completion Date: 2021-05-31

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.

Conditions

Epistaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TXA

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.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

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.

Saline

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

This group will receive pledget soaked in saline. Protocol will continue as with TXA group.

Interventions

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.

Intervention Type: DRUG

Placebo

This group will receive pledget soaked in saline. Protocol will continue as with TXA group.

Intervention Type: OTHER

Other Intervention Names

TXA; Normal saline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mercy Health Ohio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Barreiro

Role: STUDY_CHAIR

Mercy Health

Locations

St Elizabeth Boardman Hospital

Boardman, Ohio, United States

St Elizabeth Youngstown

Youngstown, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-001

Identifier Type: -

Identifier Source: org_study_id