Minimally Invasive Control of Epistaxis (MICE) (MICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00666471
Recruitment Status : Terminated (one PI (BM) no longer felt he had clinical equipoise regarding the intervention. No adverse events.)
First Posted : April 25, 2008
Last Update Posted : June 12, 2009
Information provided by:
University of Calgary

Brief 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 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.


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.

Condition or disease Intervention/treatment Phase
Epistaxis Procedure: MICE Procedure: SPA ligation Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis
Study Start Date : June 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: 1
Procedure: MICE

Active Comparator: 2
SPA ligation
Procedure: SPA ligation
SPA ligation

Primary Outcome Measures :
  1. Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 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

Exclusion Criteria:

  • Uncorrectable coagulopathy
  • Unable to comply with procedure
  • Pregnancy
  • Non-Calgary emergency room presentation
  • Severe posterior epistaxis requiring intubation for airway protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00666471

Canada, Alberta
Rockyview General Hospital / University of Calgary
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary

Responsible Party: Joseph C. Dort MD, University of Calgary Identifier: NCT00666471     History of Changes
Other Study ID Numbers: UCENT0002
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by University of Calgary:
Epistaxis refractory to emergency physician treatment

Additional relevant MeSH terms:
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathologic Processes