Microporous Polysaccharide Hemospheres Epistaxis

Emory University

Status: Withdrawn

Conditions: Epistaxis

Treatments: Device: Nasal Tampon; Device: Microporous Polysaccharide Hemospheres

Study type: Interventional

Funder types: Other

Identifiers

NCT02466464

IRB00070733

Details and patient eligibility

About

The purpose of this study is to compare a new treatment for nosebleeds to the treatment that has been used for many years.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Microporous Polysaccharide Hemospheres (MPH)

Active Comparator group

Description:

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.

Treatment:

Device: Microporous Polysaccharide Hemospheres

Device: Nasal Tampon

Merocel (Control)

Active Comparator group

Description:

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.

Treatment:

Device: Microporous Polysaccharide Hemospheres

Device: Nasal Tampon