Intranasal TXA for Anterior Epistaxis in the Emergency Department

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).

Study Overview

• Status: Suspended
• Conditions: Epistaxis
• Intervention / Treatment: Drug: Tranexamic Acid; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Boardman, Ohio, United States, 44512
      • St Elizabeth Boardman Hospital
    • Youngstown, Ohio, United States, 44504
      • St Elizabeth Youngstown

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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 Names: TXA
PLACEBO_COMPARATOR: 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.	Other: Placebo; This group will receive pledget soaked in saline. Protocol will continue as with TXA group.; Other Names: Normal saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mercy Health Ohio
• Investigators: Study Chair: Timothy Barreiro, Mercy Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2019
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (ACTUAL): August 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Hemorrhage; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Nose Diseases; Emergencies; Epistaxis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 19-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes