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Microporous Polysaccharide Hemospheres Epistaxis

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02466464
Enrollment
0
Registered
2015-06-09
Start date
2015-01-01
Completion date
2015-12-31
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epistaxis

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.

Interventions

DEVICEMicroporous Polysaccharide Hemospheres

Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.

DEVICENasal 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.

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of subjects with resolution of bleed15 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

MeasureTime frameDescription
Time until resolution of bleeding15 minutes (average time to resolve bleeding)Number of minutes it takes to resolve bleeding comparing the Arista powder group versus the Merocel tampon group.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026