EpistaxisPhase 2/3MICENCT00666471
Minimally Invasive Control of Epistaxis (MICE)
A Phase 2/3 study testing MICE and SPA ligation in people with Epistaxis, run by University of Calgary at 1 site in Canada.
Trial summary
Epistaxis is a common disorder with 60% of the population suffering from one episode and 10% of these cases requiring medical attention. Between March 2006 and March 2007, in Calgary, Alberta, there were 1500 presentations of epistaxis to adult emergency rooms with 7% of these (105 patients) requiring packing with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis
- What is being tested?
- MICE and SPA ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Jun 2009
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, Presenting to Rockyview General Hospital Emergency room
- No coagulopathy (must have INR reversed before inclusion)
- Available for follow-up at 1 week and 1 month in Calgary, Alberta
- Refractory or Recurrent Epistaxis defined as:
- Refractory = unable to control epistaxis with bilateral Merocel™ Nasal Tampons fully inserted into nasal cavity
- Recurrent = epistaxis after removal of Merocel™ Nasal Tampons following outpatient packing for 48 hours
Who cannot join
- Uncorrectable coagulopathy
- Unable to comply with procedure
- Pregnancy
- Non-Calgary emergency room presentation
- Severe posterior epistaxis requiring intubation for airway protection
Trial locations and contacts
1 site in 1 country.
Canada1 site
Rockyview General Hospital / University of Calgary
Calgary, Alberta
About this study
Official title: Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis
Epistaxis is a common disorder with 60% of the population suffering from one episode and 10% of these cases requiring medical attention. Between March 2006 and March 2007, in Calgary, Alberta, there were 1500 presentations of epistaxis to adult emergency rooms with 7% of these (105 patients) requiring packing with admission. Common methods to control epistaxis include, nasal packing (88%), operative arterial ligation (10%), and arterial embolization (2%). A cost analysis demonstrated that nasal packing had a lower cost compared to embolization and arterial ligation, and all modalities had similar lengths of stay (Goddard, Otolaryng Head Neck Surg. 2006). Arterial ligation is the current recommended therapy for recurrent or refractory epistaxis, with a success rate of 98%. With the advancement of endoscopic techniques, emergency room Minimally Invasive Control of Epistaxis (M.I.C.E.) allows for selective packing and cauterization, which provides the patient with retained function of their nasal cavity and prevents a hospital admission, resulting in significant cost savings.
Hypothesis:
Does the M.I.C.E. procedure provide significant cost savings compared to operative sphenopalatine artery ligation? Null hypothesis is that there is no difference in hospital admission rates between M.I.C.E. and operative sphenopalatine artery ligation.
- Conditions
- Epistaxis
- Being tested
- MICE, SPA ligation
- Keywords
- epistaxis, Epistaxis refractory to emergency physician treatment
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICEProcedure or surgery
MICE
SPA ligationProcedure or surgery
SPA ligation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MICE Receives: Procedure: MICE |
| 2 | Active comparator | SPA ligation Receives: Procedure: SPA ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: one PI (BM) no longer felt he had clinical equipoise regarding the intervention. No adverse events.
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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666471
- Sponsor's protocol ID
- UCENT0002
- Acronym
- MICE
- Status last verified
- Jun 2009
- First submitted
- 23 Apr 2008
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis
- ClinicalTrials.gov ID
- NCT00666471
- Acronym / sponsor ID
- MICE / UCENT0002
- Conditions
- Epistaxis
- Keywords
- epistaxis, Epistaxis refractory to emergency physician treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: one PI (BM) no longer felt he had clinical equipoise regarding the intervention. No adverse events.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Apr 2008 (estimated)
- 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.
Epistaxis is a common disorder with 60% of the population suffering from one episode and 10% of these cases requiring medical attention. Between March 2006 and March 2007, in Calgary, Alberta, there were 1500 presentations of epistaxis to adult emergency rooms with 7% of these (105 patients) requiring packing with admission. Common methods to control epistaxis include, nasal packing (88%), operative arterial ligation (10%), and arterial embolization (2%). A cost analysis demonstrated that nasal packing had a lower cost compared to embolization and arterial ligation, and all modalities had similar lengths of stay (Goddard, Otolaryng Head Neck Surg. 2006). Arterial ligation is the current recommended therapy for recurrent or refractory epistaxis, with a success rate of 98%. With the advancement of endoscopic techniques, emergency room Minimally Invasive Control of Epistaxis (M.I.C.E.) allows for selective packing and cauterization, which provides the patient with retained function of their nasal cavity and prevents a hospital admission, resulting in significant cost savings.
Hypothesis:
Does the M.I.C.E. procedure provide significant cost savings compared to operative sphenopalatine artery ligation? Null hypothesis is that there is no difference in hospital admission rates between M.I.C.E. and operative sphenopalatine artery ligation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: MICEMICE |
| 2 | Active comparator | Procedure: SPA ligationSPA ligation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old, Presenting to Rockyview General Hospital Emergency room
- No coagulopathy (must have INR reversed before inclusion)
- Available for follow-up at 1 week and 1 month in Calgary, Alberta
- Refractory or Recurrent Epistaxis defined as:
Key exclusion criteria (5 listed)
- Uncorrectable coagulopathy
- Unable to comply with procedure
- Pregnancy
- Non-Calgary emergency room presentation
- Severe posterior epistaxis requiring intubation for airway protection
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 |
|---|---|---|
| MICEMICE | Procedure or surgery | 1 |
| SPA ligationSPA ligation | Procedure or surgery | 2 |
Primary outcome
Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation
Time frame: 30 days
Results and safety
The study was stopped early (reason given: one PI (BM) no longer felt he had clinical equipoise regarding the intervention. No adverse events.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MICE and SPA ligation in people with Epistaxis, run by University of Calgary 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Jun 2009. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: one PI (BM) no longer felt he had clinical equipoise regarding the intervention. No adverse events.). 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?
Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation (time frame: 30 days). 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 12 Jun 2009.