Epistaxis NosebleedPhase 1/2Bloody SIMPLENCT06997796
Treatment of Nosebleeds in the Emergency Department With Powder Tranexamic Acid
A Phase 1/2 study testing Tranexamic Acid in people with Epistaxis Nosebleed, run by Dr. Anne Conlin at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis Nosebleed
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- May 2025to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Peterborough Regional Health Centre
Peterborough, Ontario, K9J 7C6
Anne Conlin, HBA&Sc, MD, FRCSC, 705-743-2121, aconlin@prhc.on.ca
About this study
Official title: Sprayed-In Medicated Powder for Less-Invasive Epistaxis Treatment Using Tranexamic Acid: The Bloody SIMPLE Treatment Pilot Study
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
- Being tested
- Tranexamic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Tranexamic acid powder intranasally
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid powder applied intranasally | Experimental | Not described Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of epistaxis
Number of participants for whom epistaxis ceased after treatment
Measured: Day 1
Secondary outcomes (4)
Time to cessation of epistaxis
Measured in minutes
Measured: Day 1
Pain of the treatment
Participants' perception of pain will be measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain possible).
Measured: Day 1
Total time in the Emergency Department
Measured in minutes
Measured: Day 1
Number of participants who returned to the Emergency Department for treatment of epistaxis
Measured: within the first 24 hours and the first 5 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epistaxis NosebleedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Anne Conlin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Sponsor-investigator, Dr. Anne Conlin, Peterborough Regional Health Centre
- Investigators
- Anne Conlin, Assistant Professor, University of Ottawa, HBA&Sc, MD, FRCSC, Principal investigator, Peterborough Regional Health Center; University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997796
- Sponsor's protocol ID
- 001
- Acronym
- Bloody SIMPLE
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sprayed-In Medicated Powder for Less-Invasive Epistaxis Treatment Using Tranexamic Acid: The Bloody SIMPLE Treatment Pilot Study
- ClinicalTrials.gov ID
- NCT06997796
- Acronym / sponsor ID
- Bloody SIMPLE / 001
- Conditions
- Epistaxis Nosebleed
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dr. Anne ConlinUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid powder applied intranasally | Experimental | Drug: Tranexamic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidTranexamic acid powder intranasally | Drug | Tranexamic acid powder applied intranasally |
Primary outcome
Cessation of epistaxis
Time frame: Day 1
Number of participants for whom epistaxis ceased after treatment
4 secondary outcomes
Time to cessation of epistaxis
Time frame: Day 1
Pain of the treatment
Time frame: Day 1
Total time in the Emergency Department
Time frame: Day 1
Number of participants who returned to the Emergency Department for treatment of epistaxis
Time frame: within the first 24 hours and the first 5 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Yes
Related trials for Epistaxis Nosebleed
Not yet recruitingPhase 1
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Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
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A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
RecruitingPhase 3
RADA16 for Adult Tonsillectomy
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RecruitingObservational study
Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Hereditary Hemorrhagic Telangiectasia, Arteriovenous Malformations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Conlin, Assistant Professor, University of Ottawa, HBA&Sc, MD, FRCSC principal investigator
Peterborough Regional Health Center; University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tranexamic Acid in people with Epistaxis Nosebleed, run by Dr. Anne Conlin at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Conlin, HBA&Sc, MD, FRCSC (705-743-2121, aconlin@prhc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of epistaxis (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.