Tranexamic Acid for Nosebleeds

(Bloody SIMPLE Trial)

Overseen By Anne Conlin, HBA&Sc, MD, FRCSC

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Dr. Anne Conlin

Disqualifiers: Bleeding disorders, Thromboembolic disease, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

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

Principal Investigator

Peterborough Regional Health Center; University of Ottawa

Eligibility Criteria

This trial is for individuals experiencing nosebleeds that require emergency department care. It's not clear who can't participate since the exclusion criteria are not provided, but typically those with allergies to Tranexamic Acid or certain medical conditions might be excluded.

Inclusion Criteria

I am willing and able to follow all study requirements.

I am able to understand and agree to the study's procedures.

I am 18 years old or older.

Exclusion Criteria

I needed medical treatment for a nosebleed in the last 30 days.

I had surgery in my nose or sinuses in the last month.

Patients with other medical conditions including cognitive limitations or impairment due to substance abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive tranexamic acid powder applied intranasally to treat nosebleeds

1 day

1 visit (in-person)

Follow-up

Participants are monitored for treatment site complications, including synechiae or nasal infections

3 weeks

Treatment Details

Interventions

• Powder Tranexamic Acid

Trial Overview The study is testing if powdered Tranexamic Acid sprayed into the nose is an effective alternative to cauterization or nasal packing for stopping nosebleeds in an emergency setting.

Participant Groups

Group I: Tranexamic acid powder applied intranasally Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Dr. Anne Conlin

Lead Sponsor

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+