Microporous Polysaccharide Hemospheres Epistaxis

NCT02466464 | Withdrawn

• 1 other identifier: IRB00070733
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Epistaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time until resolution of bleeding

  15 minutes (average time to resolve bleeding)

Study Arms (2)

Microporous Polysaccharide Hemospheres (MPH)

ACTIVE COMPARATOR

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; Device: Nasal Tampon

Merocel (Control)

ACTIVE COMPARATOR

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; Device: Nasal Tampon

Interventions

Microporous Polysaccharide Hemospheres DEVICE

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

Also known as: Arista

Merocel (Control); Microporous Polysaccharide Hemospheres (MPH)

Nasal Tampon DEVICE

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.

Also known as: Merocel

Merocel (Control); Microporous Polysaccharide Hemospheres (MPH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Department of Otolaryngology Clinic

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Oswaldo Henriquez Ajami, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 9, 2015
• Study Start: January 1, 2015
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

US (1)