Use of Microporous Polysaccharide Hemospheres (MPH) in Management of Acute Epistaxis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Emory University
- Locations
- 2
- Primary Endpoint
- Number of subjects with resolution of bleed
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Number of subjects with resolution of bleed
Time Frame: 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 Outcomes
- Time until resolution of bleeding(15 minutes (average time to resolve bleeding))
Investigators
Oswaldo A Henriquez
Principal Investigator
Emory University