Microporous Polysaccharide Hemospheres Epistaxis

NCT ID: NCT02466464

Last Updated: 2017-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epistaxis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Microporous Polysaccharide Hemospheres

Intervention Type DEVICE

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

Nasal Tampon

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Microporous Polysaccharide Hemospheres

Intervention Type DEVICE

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

Nasal Tampon

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Microporous Polysaccharide Hemospheres

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

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Arista Merocel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Emory University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oswaldo A Henriquez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oswaldo Henriquez Ajami, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Emory University Department of Otolaryngology Clinic

Atlanta, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00070733

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sirolimus for Nosebleeds in HHT
NCT05269849 COMPLETED PHASE2
Control of Epistaxis With Surgiflo
NCT01051427 TERMINATED NA
Emicizumab in Patients With Acquired Hemophilia A
NCT05345197 ACTIVE_NOT_RECRUITING PHASE2