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Minimally Invasive Control of Epistaxis (MICE)
This study is not yet open for participant recruitment.
Verified by University of Calgary, April 2008
Sponsored by: University of Calgary
Information provided by: University of Calgary
ClinicalTrials.gov Identifier: NCT00666471
  Purpose

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.


Condition Intervention Phase
Epistaxis
Procedure: MICE
Procedure: SPA ligation
Phase II
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
MICE
Procedure: MICE
MICE
2: Active Comparator
SPA ligation
Procedure: SPA ligation
SPA ligation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666471

Contacts
Contact: Joseph Dort, MD 403-220-4307 jdort@ucalgary.ca
Contact: Bradford Mechor, MD 403-944-3628 bmechor@mac.com

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

Responsible Party: University of Calgary ( Joseph C. Dort MD )
Study ID Numbers: UCENT0002
Study First Received: April 23, 2008
Last Updated: April 24, 2008
ClinicalTrials.gov Identifier: NCT00666471  
Health Authority: Canada: Ethics Review Committee

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

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Epistaxis
Emergencies
Hemorrhage

Additional relevant MeSH terms:
Pathologic Processes
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009