Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06997796

Treatment of Nosebleeds in the Emergency Department With Powder Tranexamic Acid

Nosebleeds are very common, occurring in 60% of the population; in some patients, nosebleeds are a life-threatening emergency. To stop a nosebleed in the emergency department, doctors usually have to burn the nose (called cauterization) or insert pledgets (called nasal packing) into the nose to apply direct pressure to the bleeding site. Nasal packing can cause pain and discomfort at the time it is inserted in the nose and again when it is removed. In rare cases it can cause a range of complications: minor complications include scar bands in the nose, but serious complications of nasal packing have also occurred, including death. Nasal packing can also present risks to doctors, such as the risk of contracting airborne and bloodborne infections, like COVID-19 and HIV.

Tranexamic acid in pill form or given directly into a vein is a medication that is currently used for nosebleeds. This study looks to evaluate if tranexamic acid in powder form sprayed directly in the nose can be used as an alternative to cauterization or nasal packing for the treatment of nosebleeds.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peterborough Regional Health Centre

Peterborough, Ontario, K9J 7C6, Canada

Location status: Recruiting

Location contact

Anne Conlin, HBA&Sc, MD, FRCSC

CONTACT

[email protected]

705-743-2121

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Capable of giving informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Adults 18 years or older
  • Male or female
  • Presenting to the ED with active, spontaneous epistaxis. Anterior versus posterior epistaxis will be identified a priori. Anterior epistaxis is operationally defined as active nasal bleeding that occurs anterior to the anterior limit of the middle turbinate, visible by anterior rhinoscopy.

Exclusion criteria

  • Prior sinonasal surgery within the preceding 1 month.
  • Patients who required medical treatment for epistaxis in the preceding 30 days.
  • Septum perforation.
  • Known history of bleeding disorders, including thrombocytopenia, hemophilia, hereditary hemorrhagic telangiectasia, or von Willebrand disease.
  • History of known thromboembolic disease, including subarachnoid hemorrhage, stroke, or TIA.
  • Known history of disease of the central nervous system, including seizures, convulsions, or intra-cerebral disease processes/lesions.
  • Known or suspected history of significant skull base trauma, including skull base fracture or cerebrospinal fluid leak.
  • Known history of acquired disturbances of colour vision.
  • Known hematuria or any bleeding related to the kidney.
  • Pregnant and/or lactating women.
  • History of known allergy or sensitivity to the study medication.
  • Presence of signs or symptoms of concomitant emergent conditions, including myocardial infarction, stroke, major trauma, shock, or hemodynamic instability.
  • Patients with other medical conditions including cognitive limitations or impairment due to substance abuse.
  • Patients with any other condition that, in the opinion of the investigator, may present an unreasonable risk to the patient, may make the patient unreliable, or may interfere with the study assessments.
  • Current participation in another interventional clinical trial.

Treatment and study plan

Tranexamic Acid

Drug

Tranexamic acid powder intranasally

Primary outcomes

  1. Cessation of epistaxis

    Time frame: Day 1

    Number of participants for whom epistaxis ceased after treatment

Secondary outcomes

  1. Time to cessation of epistaxis

    Time frame: Day 1

    Measured in minutes

  2. Pain of the treatment

    Time frame: Day 1

    Participants' perception of pain will be measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain possible).

  3. Total time in the Emergency Department

    Time frame: Day 1

    Measured in minutes

  4. Number of participants who returned to the Emergency Department for treatment of epistaxis

    Time frame: within the first 24 hours and the first 5 days after treatment

Other outcomes

  1. Age

    Time frame: Day 1

  2. Anticoagulant and/or antiplatelet medication use

    Time frame: Day 1

  3. Type of epistaxis

    Time frame: Day 1

    Anterior versus posterior epistaxis

  4. Adverse events and/or patient-reported side effects

    Time frame: up to 3 weeks

  5. Treatment site complications

    Time frame: up to 3 weeks

    Participants will be examined for complications, including synechiae or nasal infections

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Conlin, HBA&Sc, MD, FRCSC

CONTACT

[email protected]

705-743-2121

Sponsors and collaborators

Lead sponsor

Dr. Anne Conlin

Other

Collaborators

  • University of Ottawa

Registry information

Official study title

Sprayed-In Medicated Powder for Less-Invasive Epistaxis Treatment Using Tranexamic Acid: The Bloody SIMPLE Treatment Pilot Study

Acronym: Bloody SIMPLE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.