Back to resultsMicroporous Polysaccharide Hemospheres Epistaxis
Primary Purpose
Epistaxis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microporous Polysaccharide Hemospheres
Nasal Tampon
Sponsored by
About this trial
This is an interventional treatment trial for Epistaxis
Eligibility Criteria
Inclusion Criteria:
- acute epistaxis who have failed conservative measures (including application of pressure and application of oxymetazoline spray) and for which the Otolaryngology service has been consulted
- must be alert and oriented
- hemodynamically stable with a hemoglobin greater than 9 g/dL
- cooperative
Exclusion Criteria:
- unable to consent or cooperate
- history of hereditary hemorrhagic telengectasias
- hemophilia
- clotting factor deficiencies
- history of prior surgery for epistaxis control
- nasal trauma
- recent sinonasal surgery
- hemodynamic instability
- posterior bleed (as determined by Ear, Nose, Throat physician)
- visibly bleeding vessel
- allergy to product
- current diabetic ketoacidosis
Sites / Locations
- Emory University Department of Otolaryngology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Microporous Polysaccharide Hemospheres (MPH)
Merocel (Control)
Arm Description
Subjects with acute epistaxis will receive microporous polysaccharide hemospheres (Arista) powder. In the event that Arista fails to assist in resolving nosebleed in 15 minutes, subjects will be promptly escalated to the control group and will receive Merocel.
Subjects with acute epistaxis will receive standard-of-care treatment, nasal tampon (Merocel). In the event that Merocel fails to assist in resolving nosebleed in 15 minutes, subjects will be promptly escalated to the MPH group and will receive Arista powder.
Outcomes
Primary Outcome Measures
Number of subjects with resolution of bleed
Resolution of bleeding is determined by cessation of blood flow anteriorly from the nares as well as posteriorly in the pharynx. This will be determined by the otolaryngology resident or attending managing the patient during the study.
Secondary Outcome Measures
Time until resolution of bleeding
Number of minutes it takes to resolve bleeding comparing the Arista powder group versus the Merocel tampon group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02466464
Brief Title
Microporous Polysaccharide Hemospheres Epistaxis
Official Title
Use of Microporous Polysaccharide Hemospheres (MPH) in Management of Acute Epistaxis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No patients were successfully recruited
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare a new treatment for nosebleeds to the treatment that has been used for many years.
Detailed Description
Nosebleeds are a common condition which affect many Americans every day.The standard treatment in this hospital for nosebleeds that do not resolve with squeezing the nose or nasal spray is to place a nasal packing (aka nasal tampon) into the nose. This is an effective treatment in most cases, but patients may find it to be uncomfortable. The investigators will be comparing the standard nasal packing with a new type of powder which may also stop nosebleeds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microporous Polysaccharide Hemospheres (MPH)
Arm Type
Active Comparator
Arm Description
Subjects with acute epistaxis will receive microporous polysaccharide hemospheres (Arista) powder. In the event that Arista fails to assist in resolving nosebleed in 15 minutes, subjects will be promptly escalated to the control group and will receive Merocel.
Arm Title
Merocel (Control)
Arm Type
Active Comparator
Arm Description
Subjects with acute epistaxis will receive standard-of-care treatment, nasal tampon (Merocel). In the event that Merocel fails to assist in resolving nosebleed in 15 minutes, subjects will be promptly escalated to the MPH group and will receive Arista powder.
Intervention Type
Device
Intervention Name(s)
Microporous Polysaccharide Hemospheres
Other Intervention Name(s)
Arista
Intervention Description
Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.
Intervention Type
Device
Intervention Name(s)
Nasal Tampon
Other Intervention Name(s)
Merocel
Intervention Description
8 cm of Merocel dressing will be placed into one or both sides of your nose for the next three to five days and will then be removed by the physician.
Primary Outcome Measure Information:
Title
Number of subjects with resolution of bleed
Description
Resolution of bleeding is determined by cessation of blood flow anteriorly from the nares as well as posteriorly in the pharynx. This will be determined by the otolaryngology resident or attending managing the patient during the study.
Time Frame
15 minutes (average time to resolve bleeding)
Secondary Outcome Measure Information:
Title
Time until resolution of bleeding
Description
Number of minutes it takes to resolve bleeding comparing the Arista powder group versus the Merocel tampon group.
Time Frame
15 minutes (average time to resolve bleeding)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute epistaxis who have failed conservative measures (including application of pressure and application of oxymetazoline spray) and for which the Otolaryngology service has been consulted
must be alert and oriented
hemodynamically stable with a hemoglobin greater than 9 g/dL
cooperative
Exclusion Criteria:
unable to consent or cooperate
history of hereditary hemorrhagic telengectasias
hemophilia
clotting factor deficiencies
history of prior surgery for epistaxis control
nasal trauma
recent sinonasal surgery
hemodynamic instability
posterior bleed (as determined by Ear, Nose, Throat physician)
visibly bleeding vessel
allergy to product
current diabetic ketoacidosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oswaldo Henriquez Ajami, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Department of Otolaryngology Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
12. IPD Sharing Statement
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Microporous Polysaccharide Hemospheres Epistaxis
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