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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a powdered form of tranexamic acid, sprayed directly into the nose, can effectively stop nosebleeds without painful treatments like burning or packing the nose. The goal is to find a more comfortable and safer way to treat nosebleeds, especially in emergencies. Suitable participants are those currently experiencing an active nosebleed and who haven't had recent nasal surgery or specific blood-related health issues. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative medical advancements.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that tranexamic acid is generally safe and well-tolerated for treating nosebleeds. Studies have found that it can quickly stop bleeding when applied directly to the nose, reducing the need for uncomfortable treatments like nasal packing.

People who have used tranexamic acid in similar ways have not reported serious side effects. This treatment is already used in other forms, such as pills or injections, for nosebleeds and other conditions, suggesting it is safe for most people. However, since this study is in its early stages, the researchers aim to further confirm its safety when used as a nasal spray. It is important to discuss any concerns with healthcare professionals before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for nosebleeds, which often involve nasal packing or cauterization, tranexamic acid powder is applied directly inside the nose. This unique delivery method allows it to act quickly at the site of the bleed, potentially stopping it more efficiently without the discomfort of traditional methods. Researchers are excited because tranexamic acid works by stabilizing blood clots, which might lead to faster and more comfortable relief for patients experiencing nosebleeds.

What evidence suggests that tranexamic acid powder might be an effective treatment for nosebleeds?

Research has shown that tranexamic acid can effectively treat nosebleeds. Studies indicate that, when combined with nasal packing, it stops bleeding faster and reduces the chance of recurrence from 67% to 47% compared to a placebo. Another study found it decreased the need for nasal packing and shortened emergency room visits. Results also suggest that tranexamic acid, when used with pressure, is as effective as traditional nasal packing for stopping nosebleeds. In this trial, participants will receive tranexamic acid powder applied intranasally, which may offer a promising alternative to more invasive treatments like cauterization or nasal packing. ^{2 3 5 6 7}

Who Is on the Research Team?

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

Principal Investigator

Peterborough Regional Health Center; University of Ottawa

Are You a Good Fit for This Trial?

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

Pregnant and/or lactating women

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30596479/

Tranexamic acid for patients with nasal haemorrhage ...

The pooled result demonstrated a benefit of tranexamic acid compared to placebo, the risk of re-bleeding reducing from 67% to 47% (risk ratio ( ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02930941

Topical Intranasal Tranexamic Acid for Epistaxis in the ...

In previous studies, when used with nasal packing, TXA showed faster time to control of bleeding. The goal of this study is to determine the efficacy and safety ...

3.

annemergmed.com

annemergmed.com/article/S0196-0644(22)00247-5/fulltext

Intranasal Topical Application of Tranexamic Acid in ...

Tranexamic acid reduced rates of anterior nasal packing, emergency department stay of more than 2 hours, and rebleeding within 24 hours. How ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S019606442031461X

The Use of Tranexamic Acid to Reduce the Need for Nasal ...

A meta-analysis of topical tranexamic acid did not find a statistically significant difference in the cessation of bleeding in 30 minutes, but did demonstrate a ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/lary.31900

Is Topical Tranexamic Acid Effective in Treating Epistaxis?

Results from this study suggest that TXA combined with pressure is as effective as nasal packing with Merocel for anterior epistaxis. In 2020, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6517002/

Tranexamic acid for patients with nasal haemorrhage (epistaxis)

In patients with epistaxis, tranexamic acid may help stop bleeding at the time of initial administration (or very shortly thereafter), preventing the need for ...

7.

curehht.org

curehht.org/guidelines/epistaxis/

Epistaxis (Nosebleed) Management

Tranexamic acid is an oral antifibrinolytic agent that can stabilize clots by preventing premature clot lysis and has been shown to decrease intraoperative ...