Microporous Polysaccharide Hemospheres Epistaxis

Epistaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02466464
• Other study ID #: IRB00070733
• Status: Withdrawn
• Phase: N/A
• First received: June 5, 2015
• Last updated: January 25, 2017
• Start date: January 1, 2015
• Est. completion date: December 31, 2015

Study information

• Verified date: January 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epistaxis

Intervention

Device:
• Microporous Polysaccharide Hemospheres
Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.
• Nasal 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.

Locations

Country	Name	City	State
United States	Emory University Department of Otolaryngology Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)