Treatment of Nosebleeds in the Emergency Department With Powder Tranexamic Acid

NCT06997796 | Recruiting Phase 1

• 1 other identifier: 001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epistaxis Nosebleed

Outcome Measures

Primary Outcomes (1)

• Cessation of epistaxis

  Number of participants for whom epistaxis ceased after treatment

  Day 1

Secondary Outcomes (4)

• Time to cessation of epistaxis

  Day 1

• Pain of the treatment

  Day 1

• Total time in the Emergency Department

  Day 1

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

  within the first 24 hours and the first 5 days after treatment

Other Outcomes (5)

• Age

  Day 1

• Anticoagulant and/or antiplatelet medication use

  Day 1

• Type of epistaxis

  Day 1

Study Arms (1)

Tranexamic acid powder applied intranasally

EXPERIMENTAL

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Tranexamic acid powder intranasally

Tranexamic acid powder applied intranasally

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Anne Conlin: lead
• University of Ottawa: collaborator

Study Sites (1)

Peterborough Regional Health Centre

Peterborough, Ontario, K9J 7C6, Canada

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Anne Conlin, Assistant Professor, University of Ottawa, HBA&Sc, MD, FRCSC

  Peterborough Regional Health Center; University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Conlin, HBA&Sc, MD, FRCSC

CONTACT

705-743-2121; aconlin@prhc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Peterborough Regional Health Center Staff Otolaryngologist-Head & Neck Surgeon; Assistant Professor University of Ottawa

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 30, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)