Microporous Polysaccharide Hemospheres Epistaxis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Microporous Polysaccharide Hemospheres (MPH) in Management of Acute Epistaxis

Conditions
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Epistaxis

Intervention / Treatment
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* Device: Microporous Polysaccharide Hemospheres
* Device: Nasal Tampon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microporous Polysaccharide Hemospheres (MPH)<br>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<br>* Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.<br>* Other names: Arista;Device: Nasal Tampon<br>* 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.<br>* Other names: Merocel;|
| Active Comparator: Merocel (Control)<br>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<br>* Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.<br>* Other names: Arista;Device: Nasal Tampon<br>* 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.<br>* Other names: Merocel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 minutes (average time to resolve bleeding) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until resolution of bleeding | Number of minutes it takes to resolve bleeding comparing the Arista powder group versus the Merocel tampon group. | 15 minutes (average time to resolve bleeding) |