EpistaxisPhase 2NCT04054687
Intranasal TXA for Anterior Epistaxis in the Emergency Department
A Phase 2 study testing Tranexamic Acid in people with Epistaxis, run by Mercy Health Ohio at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the efficacy of and patient satisfaction with the use of intranasal tranexamic acid (TXA) for anterior nosebleeds in the emergency department (ED). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epistaxis
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2019to May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years and older with anterior epistaxis
Who cannot join
- Patients with inability to give consent
- Patients without a working telephone number
- Patients lacking the mental capacity to make their own decisions
- Patients with posterior epistaxis
- Epistaxis following major trauma
- Patients with known bleeding disorder like hemophilia and thrombocytopenia
Show all 12Show fewer
- Prisoners
- Patients hemodynamically unstable
- Pregnant patients
- Patients with a known allergy to TXA
- Patients with a visibly bleeding vessel
- Those recently post-op nasal/sinus surgery (within ten days) will also be excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St Elizabeth Boardman Hospital
Boardman, Ohio, 44512
St Elizabeth Youngstown
Youngstown, Ohio, 44504
About this study
The objective of this study is to evaluate the efficacy of and patient satisfaction with the use of intranasal tranexamic acid (TXA) for anterior nosebleeds in the emergency department (ED).
Read the detailed description
Pledget soaked in either saline or TXA will be applied to the bleeding nare of the patient presenting with anterior epistaxis. After fifteen minutes, the pledget will be removed and patient reassessed.
Informed consent will be obtained prior to patient enrollment.
Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.
Patient satisfaction will be assessed in both groups during ED stay and one week after ED stay.
- Conditions
- Epistaxis
- Being tested
- Tranexamic Acid, Placebo
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TXA
Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.
PlaceboOther
Also called Normal saline
This group will receive pledget soaked in saline. Protocol will continue as with TXA group.
| Study group | Role | What they receive |
|---|---|---|
| TXA | Experimental | Research participants in the experimental group will receive one dose of 100mg/mL TXA soaked in a cotton pledget in the bleeding nare for a total of 15 minutes. Receives: Drug: Tranexamic Acid |
| Saline | Placebo comparator | Research participants in the placebo group will receive one dose of normal saline (0.9%) soaked in a cotton pledget in the bleeding nare for a total of 15 minutes. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding cessation
After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed
Measured: 15 minutes
Secondary outcomes (2)
Patient satisfaction: 10 point scale
Patient satisfaction will be assessed at the end of the emergency department encounter, and then again via telephone call one week after discharge using a 10 point scale
Measured: Before ED discharge (up to 24 hours) and 1 week after ED discharge
Bleeding cessation
Patients will be contacted 1 week after ED discharge to determine whether there was a recurrence of his/her epistaxis
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start7 Nov 2019
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Due to coronavirus pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpistaxisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy Health Ohio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Barreiro, Study chair, Mercy Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054687
- Sponsor's protocol ID
- 19-001
- Status last verified
- Sep 2020
- First submitted
- 12 Mar 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal TXA for Anterior Epistaxis in the Emergency Department
- ClinicalTrials.gov ID
- NCT04054687
- Acronym / sponsor ID
- 19-001
- Conditions
- Epistaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to coronavirus pandemic
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Mercy Health OhioUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 13 Aug 2019 (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.
The objective of this study is to evaluate the efficacy of and patient satisfaction with the use of intranasal tranexamic acid (TXA) for anterior nosebleeds in the emergency department (ED).
Detailed description
Pledget soaked in either saline or TXA will be applied to the bleeding nare of the patient presenting with anterior epistaxis. After fifteen minutes, the pledget will be removed and patient reassessed.
Informed consent will be obtained prior to patient enrollment.
Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.
Patient satisfaction will be assessed in both groups during ED stay and one week after ED stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA | Experimental | Drug: Tranexamic AcidResearch participants in the experimental group will receive one dose of 100mg/mL TXA soaked in a cotton pledget in the bleeding nare for a total of 15 minutes. |
| Saline | Placebo comparator | Other: PlaceboResearch participants in the placebo group will receive one dose of normal saline (0.9%) soaked in a cotton pledget in the bleeding nare for a total of 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years and older with anterior epistaxis
Key exclusion criteria (12 listed)
- Patients with inability to give consent
- Patients without a working telephone number
- Patients lacking the mental capacity to make their own decisions
- Patients with posterior epistaxis
- Epistaxis following major trauma
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 AcidAlso: TXAEnrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1. | Drug | TXA |
| PlaceboAlso: Normal salineThis group will receive pledget soaked in saline. Protocol will continue as with TXA group. | Other | Saline |
Primary outcome
Bleeding cessation
Time frame: 15 minutes
After 15 minutes of patient receiving either pledget filled TXA or placebo, bleeding will be assessed
2 secondary outcomes
Patient satisfaction: 10 point scale
Time frame: Before ED discharge (up to 24 hours) and 1 week after ED discharge
Bleeding cessation
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
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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. This study is not recruiting at the moment.
Timothy Barreiro study chair
Mercy Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid in people with Epistaxis, run by Mercy Health Ohio at 2 sites in United States.
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 1 inclusion and 12 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: paused, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding cessation (time frame: 15 minutes). 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 11 Sep 2020.