Minimally Invasive Control of Epistaxis (MICE)

Epistaxis Clinical Trial

— MICE  

Official title:

Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00666471
• Other study ID #: UCENT0002
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 23, 2008
• Last updated: June 10, 2009
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epistaxis

Intervention

Procedure:
• MICE
MICE
• SPA ligation
SPA ligation

Locations

Country	Name	City	State
Canada	Rockyview General Hospital / University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation		30 days	No