Minimally Invasive Control of Epistaxis (MICE)

This study has been terminated.
(one PI (BM) no longer felt he had clinical equipoise regarding the intervention. No adverse events.)
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00666471
First received: April 23, 2008
Last updated: June 10, 2009
Last verified: June 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 3
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MICE
Procedure: MICE
MICE
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Joseph C. Dort MD, University of Calgary
ClinicalTrials.gov Identifier: NCT00666471     History of Changes
Other Study ID Numbers: UCENT0002
Study First Received: April 23, 2008
Last Updated: June 10, 2009
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on September 22, 2014