Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-01-01
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
Microporous Polysaccharide Hemospheres
Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.
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.
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.
Microporous Polysaccharide Hemospheres
Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.
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.
Interventions
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Microporous Polysaccharide Hemospheres
Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* must be alert and oriented
* hemodynamically stable with a hemoglobin greater than 9 g/dL
* cooperative
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Oswaldo A Henriquez
Principal Investigator
Principal Investigators
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Oswaldo Henriquez Ajami, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Department of Otolaryngology Clinic
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00070733
Identifier Type: -
Identifier Source: org_study_id
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