Treatment of Nosebleeds in the Emergency Department With Powder Tranexamic Acid

NCT ID: NCT06997796

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tranexamic acid powder applied intranasally

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Tranexamic acid powder intranasally

Interventions

Tranexamic Acid

Tranexamic acid powder intranasally

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ottawa

OTHER

Sponsor Role: collaborator

Dr. Anne Conlin

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anne Conlin

Peterborough Regional Health Center Staff Otolaryngologist-Head & Neck Surgeon; Assistant Professor University of Ottawa

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Peterborough Regional Health Center; University of Ottawa

Locations

Peterborough Regional Health Centre

Peterborough, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Anne Conlin, HBA&Sc, MD, FRCSC

Role: CONTACT

aconlin@prhc.on.ca

705-743-2121

Facility Contacts

Anne Conlin, HBA&Sc, MD, FRCSC

Role: primary

aconlin@prhc.on.ca

705-743-2121

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id