Intranasal TXA for Anterior Epistaxis in the Emergency Department

NCT04054687 | Suspended Phase 2 FDA Drug

• 1 other identifier: 19-001
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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).

Conditions

Epistaxis

Outcome Measures

Primary Outcomes (1)

• Bleeding cessation

  After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed

  15 minutes

Secondary Outcomes (2)

• Patient satisfaction: 10 point scale

  Before ED discharge (up to 24 hours) and 1 week after ED discharge

• Bleeding cessation

  1 week

Study Arms (2)

TXA

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid 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.

Also known as: TXA

TXA

Placebo OTHER

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

Also known as: Normal saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older with anterior epistaxis

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Health Ohio: lead

Study Sites (2)

St Elizabeth Boardman Hospital

Boardman, Ohio, 44512, United States

Location

St Elizabeth Youngstown

Youngstown, Ohio, 44504, United States

Location

MeSH Terms

Conditions

Epistaxis

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Timothy Barreiro

  Mercy Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: August 13, 2019
• Study Start: November 7, 2019
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

US (2)