Minimally Invasive Control of Epistaxis (MICE)

NCT00666471 | Terminated Phase 2

• 1 other identifier: UCENT0002
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Epistaxis

Keywords

epistaxis; Epistaxis refractory to emergency physician treatment

Outcome Measures

Primary Outcomes (1)

• Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation

  30 days

Study Arms (2)

1

EXPERIMENTAL

MICE

Procedure: MICE

2

ACTIVE COMPARATOR

SPA ligation

Procedure: SPA ligation

Interventions

MICE PROCEDURE

MICE

1

SPA ligation PROCEDURE

SPA ligation

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, Presenting to Rockyview General Hospital Emergency room
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Rockyview General Hospital / University of Calgary

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 12, 2009

Record last verified: 2009-06

Locations

CA (1)