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Intranasal TXA for Anterior Epistaxis in the Emergency Department

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ClinicalTrials.gov Identifier: NCT04054687
Recruitment Status : Suspended (Due to coronavirus pandemic)
First Posted : August 13, 2019
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Mercy Health Ohio

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
Epistaxis 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 7, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Normal saline




Primary Outcome Measures :
  1. Bleeding cessation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 week ]
    Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054687


Locations
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United States, Ohio
St Elizabeth Boardman Hospital
Boardman, Ohio, United States, 44512
St Elizabeth Youngstown
Youngstown, Ohio, United States, 44504
Sponsors and Collaborators
Mercy Health Ohio
Investigators
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Study Chair: Timothy Barreiro Mercy Health
  Study Documents (Full-Text)

Documents provided by Mercy Health Ohio:
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Responsible Party: Mercy Health Ohio
ClinicalTrials.gov Identifier: NCT04054687    
Other Study ID Numbers: 19-001
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020

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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:
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Epistaxis
Emergencies
Disease Attributes
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Signs and Symptoms, Respiratory
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants