Using powdered tranexamic acid to treat nosebleeds in the emergency department

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

This study is testing if a new nasal spray made from powdered tranexamic acid can help adults with nosebleeds feel better and avoid more painful treatments like packing or cauterization.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peterborough Regional Health Centre (other)
• Locations: 1 site (Peterborough, Ontario)
• Trial ID: NCT06997796 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of powdered tranexamic acid, administered as a nasal spray, for treating active nosebleeds in patients presenting to the emergency department. The study aims to evaluate whether this method can provide a safer and more comfortable alternative to traditional treatments like nasal packing and cauterization. Participants will be adults experiencing spontaneous epistaxis, and the trial will assess the outcomes of using this new intervention compared to standard practices.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing active, spontaneous nosebleeds.

Not a fit: Patients with a history of bleeding disorders or recent sinonasal surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a less invasive and more effective option for managing nosebleeds, reducing discomfort and complications for patients.

How similar studies have performed: While the use of tranexamic acid for nosebleeds has been explored, this specific approach using a powdered form is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Peterborough, Ontario

• Peterborough Regional Health Centre — Peterborough, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Anne Conlin, Assistant Professor, University of Ottawa, HBA&Sc, MD, FRCSC — Peterborough Regional Health Center; University of Ottawa
• Study coordinator: Anne Conlin, HBA&Sc, MD, FRCSC

Conditions: Epistaxis Nosebleed