Minimally Invasive Control of Epistaxis (MICE) (MICE)

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.

Study Overview

• Status: Terminated
• Conditions: Epistaxis
• Intervention / Treatment: Procedure: MICE; Procedure: SPA ligation

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Rockyview General Hospital / University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; MICE	Procedure: MICE; MICE
Active Comparator: 2; SPA ligation	Procedure: SPA ligation; SPA ligation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation	30 days

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 23, 2008
• First Submitted That Met QC Criteria: April 24, 2008
• First Posted (Estimate): April 25, 2008

Study Record Updates

• Last Update Posted (Estimate): June 12, 2009
• Last Update Submitted That Met QC Criteria: June 10, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: epistaxis; Epistaxis refractory to emergency physician treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Nose Diseases; Epistaxis
• Other Study ID Numbers: UCENT0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No