Sprayed-In Medicated Powder for Less-Invasive Epistaxis Treatment Using Tranexamic Acid: The Bloody SIMPLE Treatment Pilot Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cessation of epistaxis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Tranexamic acid powder applied intranasally
Intervention: Tranexamic Acid (Drug)
Outcomes
Primary Outcomes
Cessation of epistaxis
Time Frame: Day 1
Number of participants for whom epistaxis ceased after treatment
Secondary Outcomes
- Time to cessation of epistaxis(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)
- Pain of the treatment(Day 1)
Investigators
Dr. Anne Conlin
Peterborough Regional Health Center Staff Otolaryngologist-Head & Neck Surgeon; Assistant Professor University of Ottawa
Peterborough Regional Health Centre