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Minimally Invasive Control of Epistaxis (MICE) (MICE)

Primary Purpose

Epistaxis

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
MICE
SPA ligation
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis focused on measuring epistaxis, Epistaxis refractory to emergency physician treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rockyview General Hospital / University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

MICE

SPA ligation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 23, 2008
Last Updated
June 10, 2009
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT00666471
Brief Title
Minimally Invasive Control of Epistaxis (MICE)
Acronym
MICE
Official Title
Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
one PI (BM) no longer felt he had clinical equipoise regarding the intervention. No adverse events.
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
epistaxis, Epistaxis refractory to emergency physician treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MICE
Arm Title
2
Arm Type
Active Comparator
Arm Description
SPA ligation
Intervention Type
Procedure
Intervention Name(s)
MICE
Intervention Description
MICE
Intervention Type
Procedure
Intervention Name(s)
SPA ligation
Intervention Description
SPA ligation
Primary Outcome Measure Information:
Title
Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rockyview General Hospital / University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

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Minimally Invasive Control of Epistaxis (MICE)

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