Microporous Polysaccharide Hemospheres Epistaxis

Not Applicable

Withdrawn

• Conditions: Epistaxis
• Interventions: Device: Microporous Polysaccharide Hemospheres; Device: Nasal Tampon

• Registration Number: NCT02466464
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-09
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Microporous Polysaccharide Hemospheres (MPH)	Nasal Tampon	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.
Merocel (Control)	Nasal Tampon	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 (MPH)	Microporous Polysaccharide Hemospheres	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.
Merocel (Control)	Microporous Polysaccharide Hemospheres	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Emory University Department of Otolaryngology Clinic; 🇺🇸 Atlanta, Georgia, United States