Microporous Polysaccharide Hemospheres Epistaxis

January 25, 2017 updated by: Oswaldo A Henriquez, Emory University

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Department of Otolaryngology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Microporous Polysaccharide Hemospheres (MPH)
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.
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.
Other Names:
  • Arista
Device: 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.
Other Names:
  • Merocel
Active Comparator: Merocel (Control)
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.
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.
Other Names:
  • Arista
Device: 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.
Other Names:
  • Merocel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes (average time to resolve bleeding)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time until resolution of bleeding
Time Frame: 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.
15 minutes (average time to resolve bleeding)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Oswaldo Henriquez Ajami, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 5, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00070733

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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