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Intranasal TXA for Anterior Epistaxis in the Emergency Department

Sponsor
Mercy Health Ohio (Other)
Overall Status
Suspended
CT.gov ID
NCT04054687
Collaborator
(none)
86
Enrollment
2
Locations
2
Arms
17.8
Anticipated Duration (Months)
43
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid
  • Other: Placebo
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Intranasal TXA for Anterior Epistaxis in the Emergency Department
Actual Study Start Date :
Nov 7, 2019
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bleeding cessation [15 minutes]

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

    Secondary Outcome Measures

    1. Patient satisfaction: 10 point scale [Before ED discharge (up to 24 hours) and 1 week after ED discharge]

      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

    2. Bleeding cessation [1 week]

      Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Elizabeth Boardman Hospital Boardman Ohio United States 44512
    2 St Elizabeth Youngstown Youngstown Ohio United States 44504

    Sponsors and Collaborators

    • Mercy Health Ohio

    Investigators

    • Study Chair: Timothy Barreiro, Mercy Health

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Mercy Health Ohio
    ClinicalTrials.gov Identifier:
    NCT04054687
    Other Study ID Numbers:
    • 19-001
    First Posted:
    Aug 13, 2019
    Last Update Posted:
    Sep 11, 2020
    Last Verified:
    Sep 1, 2020
    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
    Additional relevant MeSH terms:
    Epistaxis
    Emergencies
    Tranexamic Acid

    Study Results

    No Results Posted as of Sep 11, 2020