EpistaxisNCT02466464
Microporous Polysaccharide Hemospheres Epistaxis
A study testing Microporous Polysaccharide Hemospheres and Nasal Tampon in people with Epistaxis, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis
- What is being tested?
- Microporous Polysaccharide Hemospheres and Nasal Tampon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to consent or cooperate
- history of hereditary hemorrhagic telengectasias
- hemophilia
- clotting factor deficiencies
- history of prior surgery for epistaxis control
- nasal trauma
Show all 12Show fewer
- recent sinonasal surgery
- hemodynamic instability
- posterior bleed (as determined by Ear, Nose, Throat physician)
- visibly bleeding vessel
- allergy to product
- current diabetic ketoacidosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Department of Otolaryngology Clinic
Atlanta, Georgia, 30308
About this study
Official title: 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.
Read the 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.
- Conditions
- Epistaxis
- Being tested
- Microporous Polysaccharide Hemospheres, Nasal Tampon
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microporous Polysaccharide HemospheresDevice
Also called Arista
Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.
Nasal TamponDevice
Also called Merocel
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Microporous Polysaccharide Hemospheres; Device: Nasal Tampon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes (average time to resolve bleeding)
Secondary outcomes (1)
Time until resolution of bleeding
Number of minutes it takes to resolve bleeding comparing the Arista powder group versus the Merocel tampon group.
Measured: 15 minutes (average time to resolve bleeding)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Why it stopped: No patients were successfully recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oswaldo A Henriquez, Emory University
- Investigators
- Oswaldo Henriquez Ajami, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466464
- Sponsor's protocol ID
- IRB00070733
- Status last verified
- Jan 2017
- First submitted
- 5 Jun 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Microporous Polysaccharide Hemospheres (MPH) in Management of Acute Epistaxis
- ClinicalTrials.gov ID
- NCT02466464
- Acronym / sponsor ID
- IRB00070733
- Conditions
- Epistaxis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were successfully recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microporous Polysaccharide Hemospheres (MPH) | Active comparator | Device: Microporous Polysaccharide Hemospheres, Device: Nasal TamponSubjects 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. |
| Merocel (Control) | Active comparator | Device: Microporous Polysaccharide Hemospheres, Device: Nasal TamponSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- unable to consent or cooperate
- history of hereditary hemorrhagic telengectasias
- hemophilia
- clotting factor deficiencies
- history of prior surgery for epistaxis control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microporous Polysaccharide HemospheresAlso: AristaTwo grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing. | Device | Merocel (Control), Microporous Polysaccharide Hemospheres (MPH) |
| Nasal TamponAlso: Merocel8 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. | Device | Merocel (Control), Microporous Polysaccharide Hemospheres (MPH) |
Primary outcome
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.
1 secondary outcome
Time until resolution of bleeding
Time frame: 15 minutes (average time to resolve bleeding)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
Related trials for Epistaxis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
RecruitingPhase 3
RADA16 for Adult Tonsillectomy
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oswaldo Henriquez Ajami, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microporous Polysaccharide Hemospheres and Nasal Tampon in people with Epistaxis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with resolution of bleed (time frame: 15 minutes (average time to resolve bleeding)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.