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Microporous Polysaccharide Hemospheres Epistaxis

Sponsor
Emory University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02466464
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Microporous Polysaccharide Hemospheres
  • Device: Nasal Tampon
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Microporous Polysaccharide Hemospheres (MPH) in Management of Acute Epistaxis
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 31, 2015
Actual Study Completion Date :
Dec 31, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Microporous Polysaccharide Hemospheres (MPH)

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.

Device: Microporous Polysaccharide Hemospheres
Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.
Other Names:
  • Arista

    • Device: Nasal Tampon
    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.
    Other Names:
  • Merocel

    		•
    Active Comparator: Merocel (Control)

    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.

    Device: Microporous Polysaccharide Hemospheres
    Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.
    Other Names:
  • Arista

    • Device: Nasal Tampon
    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.
    Other Names:
  • Merocel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects with resolution of bleed [15 minutes (average time to resolve bleeding)]

      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

    1. Time until resolution of bleeding [15 minutes (average time to resolve bleeding)]

      Number of minutes it takes to resolve bleeding comparing the Arista powder group versus the Merocel tampon group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Department of Otolaryngology Clinic Atlanta Georgia United States 30308

    Sponsors and Collaborators

    • Emory University

    Investigators

    • Principal Investigator: Oswaldo Henriquez Ajami, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oswaldo A Henriquez, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT02466464
    Other Study ID Numbers:
    • IRB00070733
    First Posted:
    Jun 9, 2015
    Last Update Posted:
    Jan 26, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Epistaxis
    Polyvinyl alcohol formaldehyde foam

    Study Results

    No Results Posted as of Jan 26, 2017