Obstructive Sleep DisorderPhase 3NCT00945412
Topical Microporous Polysaccharide Hemospheres Versus Electrocautery for Control of Pediatric Post-Tonsillectomy Bleeding
A Phase 3 study testing Micropolysaccharide Hemospheres (Arista) and Electrocautery (Monopolar suction cautery) in people with Obstructive Sleep Disorder and Obstructive Sleep Apnea, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The ultimate goal of this work is to establish a method for control bleeding after tonsillectomy in awake children. Treatment of post-tonsillectomy bleeding in children typically requires general anesthesia with currently used electrocautery techniques. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Obstructive Sleep Disorder, Obstructive Sleep Apnea, Tonsillar Hypertrophy
- What is being tested?
- Micropolysaccharide Hemospheres (Arista) and Electrocautery (Monopolar suction cautery)
- 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
- Jul 2009to Sep 2011
- Phase
- Phase 3
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Eligibility is contingent on the presence of following characteristics:
- Children and adolescents age 5-18 years old. The lower age range is chosen in order to spare younger, smaller children who have less circulating volume to decrease any potential unwarranted risks of increased bleeding. The upper age range is chosen because our ultimate focus is to determine whether this therapy can help the pediatric population prevent the need for electrocautery under anesthesia for tonsil-related bleeding.
- Obstructive sleep disorder symptomatology requiring surgical intervention. The presence of obstructive sleep disorder is determined according to the practice of the otolaryngologist investigator, and includes at least two of the following: medical history, physical exam findings, nasopharyngoscopy, lateral x-ray, sleep videotape, or polysomnography. In addition, the mean survey score on the OSD-6 (which is an instrument validated in children with obstructive sleep disorder (See Figure 2)) is at least 3, which corresponds to a moderate degree of symptoms (0 no symptoms, 6 symptoms could not be worse).
- Tonsillar or adenotonsillar hypertrophy. Tonsillar hypertrophy is defined as at least 3+ tonsillar hypertrophy on a scale of 1+ to 4+, with the following definition of grades of obstruction determined by visual inspection: 1+ 0-25%, 2+ 26-50%, 3+ 51-75%, 4+ 76-100%.
- Bilateral microdebrider tonsillotomy. This method of surgery is chosen because it (1) is a standard technique utilized by the surgeons involved in this study as treatment of obstructive tonsillar hypertrophy and (2) results in a relatively uniform, reproducible bleeding surface that requires hemostasis following tonsil removal.
Who cannot join
- Eligibility is contingent on the absence of following characteristics:
- Personal or family history of bleeding diathesis or easy bruising. The introduction of this confounder should be avoided, given that the primary outcome is adequacy of hemostasis. Given that preoperative laboratory evaluation in the setting of no suggestive history has been shown to have low predictive values for successful perioperative hemostasis, enrolled subjects receive no preoperative laboratory screening.
- Intake of non-steroidal anti-inflammatory drugs within 14 days prior to surgery. Although there are several trials that suggest that postoperative administration of these drugs may have no impact on hemorrhage, the topic remains controversial due to the large numbers of subjects required to achieve adequate power in such studies. Thus, the introduction of this potential confounder is avoided, given that the primary outcome is adequacy of hemostasis.
- Liver dysfunction. This disease state may also confound evaluation of hemostasis.
- Cardiac, renal, or blood pressure disorder. These states may make children less tolerant of hemorrhage, and so they are excluded in order to minimize risk.
- Chronic inflammation states, such as recurrent pharyngitis, may result in an increased propensity toward bleeding, and thus subjects with this potential confounder are excluded. Children with 3 or more acute pharyngitis episodes within the past year are excluded. A pharyngitis episode is defined as documentation by physician of the episode and >1 of the following: oral >38.3 degrees C, lymphadenopathy >2cm or tender lymphadenopathy, tonsil/pharyngeal exudates, group A beta hemolytic streptococcus positive, or antibiotic administration for proved/suspected streptococcal infection.
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- Implant contraindications to the use of monopolar electrocautery. Metal implants would preclude safe randomization to the electrocautery treatment arm. There are no suspected or known contraindications to application of MPH at the tonsillar fossae.
- Allergic or adverse reactions to requisite perioperative medications. The current protocol calls for the use of an antibiotic and narcotic pain medication in all subjects, with one second-line agent as a planned alternative. Thus, inability to tolerate both penicillin and macrolide antibiotics, or both oxycodone and codeine narcotics, precludes entry into the trial.
- Children whose caregivers cannot commit to the 2 week follow up schedule. This schedule includes daily calls to evaluate bleeding and pain control.
- Cognitive inability to report bleeding, adverse events, or pain control. Thus, children with mental retardation, communication disorders, developmental delay, and chronic pain states are also excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
The ultimate goal of this work is to establish a method for control bleeding after tonsillectomy in awake children. Treatment of post-tonsillectomy bleeding in children typically requires general anesthesia with currently used electrocautery techniques. Micropolysaccharide hemosphere technology is a unique absorbable agent that helps clot form. These hemospheres consist of 100% purified plant starch that enhances natural clotting by concentrating blood solids such as platelets, red blood cells, and blood proteins on the particle surfaces to form a gelled matrix. This device provides painless, non-irritating control of bleeding, and has been used effectively for control of nosebleeds in awake adult patients. This device, however, has not been tested in the tonsillar fossae in children; thus, this study is performed to determine if at least 50% of children with bleeding tonsillar fossae can be spared rescue treatment with electrocautery.
- Being tested
- Micropolysaccharide Hemospheres (Arista), Electrocautery (Monopolar suction cautery)
- Keywords
- microdebrider tonsillotomy, Post-tonsillectomy hemorrhage
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropolysaccharide Hemospheres (Arista)Device
Also called Arista
MPH is applied as an aerosolized powder which is applied to the bleeding fossa, immediately after suctioning the freshly completed tonsillotomy site to expose the tonsil bed. A separate aerosolizer is used for each patient in order to maximize uniformity per standard dose applied. Each initial dose remains in situ for up to 60 seconds in an attempt to achieve complete hemostasis with a single dose. (Prior data from MPH use has shown that 30-60 seconds is the time typically required for hemostasis for diffuse, non-arterial bleeds.) If there is persistent bleeding after this timeframe, then the bed is irrigated and suctioned and a second equivalent dose is applied.
No pressure pack and no oxymetazoline or other topical vasoconstrictor is applied in either group during these initial hemostatic steps, since they are potential confounders of hemostatic effect.
Electrocautery (Monopolar suction cautery)Device
Also called Monopolar suction cautery
Monopolar suction electrocautery is used at 20 Watts. Cautery is applied with a light surface touch until bleeding has stopped. In addition, any prominent visible vessels are cauterized.
| Study group | Role | What they receive |
|---|---|---|
| Micropolysaccharide Hemospheres (MPH) | Experimental | Not described Receives: Device: Micropolysaccharide Hemospheres (Arista) |
| Electrocautery | Active comparator | Not described Receives: Device: Electrocautery (Monopolar suction cautery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure: Adequacy of intraoperative hemostasis, as evaluated by the following metrics: 1. Requirement for rescue hemostasis. 2. Time to complete hemostasis.
Measured: 0-14 days postoperatively
Secondary outcomes (1)
The main secondary outcome measure is the number of patients with adverse events. These adverse events are expected to occur in the following forms: postoperative primary hemorrhage, postoperative secondary hemorrhage, and severe postoperative pain.
Measured: 0-14 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: PI moving to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Investigators
- Michael J Cunningham, MD, Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945412
- Sponsor's protocol ID
- 09-04-031
- Status last verified
- Dec 2010
- First submitted
- 23 Jul 2009
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Microporous Polysaccharide Hemospheres Versus Electrocautery for Control of Pediatric Post-Tonsillectomy Bleeding
- ClinicalTrials.gov ID
- NCT00945412
- Acronym / sponsor ID
- 09-04-031
- Keywords
- microdebrider tonsillotomy, Post-tonsillectomy hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI moving to another institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 24 Jul 2009 (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 ultimate goal of this work is to establish a method for control bleeding after tonsillectomy in awake children. Treatment of post-tonsillectomy bleeding in children typically requires general anesthesia with currently used electrocautery techniques. Micropolysaccharide hemosphere technology is a unique absorbable agent that helps clot form. These hemospheres consist of 100% purified plant starch that enhances natural clotting by concentrating blood solids such as platelets, red blood cells, and blood proteins on the particle surfaces to form a gelled matrix. This device provides painless, non-irritating control of bleeding, and has been used effectively for control of nosebleeds in awake adult patients. This device, however, has not been tested in the tonsillar fossae in children; thus, this study is performed to determine if at least 50% of children with bleeding tonsillar fossae can be spared rescue treatment with electrocautery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropolysaccharide Hemospheres (MPH) | Experimental | Device: Micropolysaccharide Hemospheres (Arista) |
| Electrocautery | Active comparator | Device: Electrocautery (Monopolar suction cautery) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children and adolescents age 5-18 years old. The lower age range is chosen in order to spare younger, smaller children who have less circulating volume to decrease any potential unwarranted risks of increased bleeding. The upper age range is chosen because our ultimate focus is to determine whether this therapy can help the pediatric population prevent the need for electrocautery under anesthesia for tonsil-related bleeding.
- Obstructive sleep disorder symptomatology requiring surgical intervention. The presence of obstructive sleep disorder is determined according to the practice of the otolaryngologist investigator, and includes at least two of the following: medical history, physical exam findings, nasopharyngoscopy, lateral x-ray, sleep videotape, or polysomnography. In addition, the mean survey score on the OSD-6 (which is an instrument validated in children with obstructive sleep disorder (See Figure 2)) is at least 3, which corresponds to a moderate degree of symptoms (0 no symptoms, 6 symptoms could not be worse).
- Tonsillar or adenotonsillar hypertrophy. Tonsillar hypertrophy is defined as at least 3+ tonsillar hypertrophy on a scale of 1+ to 4+, with the following definition of grades of obstruction determined by visual inspection: 1+ 0-25%, 2+ 26-50%, 3+ 51-75%, 4+ 76-100%.
- Bilateral microdebrider tonsillotomy. This method of surgery is chosen because it (1) is a standard technique utilized by the surgeons involved in this study as treatment of obstructive tonsillar hypertrophy and (2) results in a relatively uniform, reproducible bleeding surface that requires hemostasis following tonsil removal.
Key exclusion criteria (10 listed)
- Personal or family history of bleeding diathesis or easy bruising. The introduction of this confounder should be avoided, given that the primary outcome is adequacy of hemostasis. Given that preoperative laboratory evaluation in the setting of no suggestive history has been shown to have low predictive values for successful perioperative hemostasis, enrolled subjects receive no preoperative laboratory screening.
- Intake of non-steroidal anti-inflammatory drugs within 14 days prior to surgery. Although there are several trials that suggest that postoperative administration of these drugs may have no impact on hemorrhage, the topic remains controversial due to the large numbers of subjects required to achieve adequate power in such studies. Thus, the introduction of this potential confounder is avoided, given that the primary outcome is adequacy of hemostasis.
- Liver dysfunction. This disease state may also confound evaluation of hemostasis.
- Cardiac, renal, or blood pressure disorder. These states may make children less tolerant of hemorrhage, and so they are excluded in order to minimize risk.
- Chronic inflammation states, such as recurrent pharyngitis, may result in an increased propensity toward bleeding, and thus subjects with this potential confounder are excluded. Children with 3 or more acute pharyngitis episodes within the past year are excluded. A pharyngitis episode is defined as documentation by physician of the episode and >1 of the following: oral >38.3 degrees C, lymphadenopathy >2cm or tender lymphadenopathy, tonsil/pharyngeal exudates, group A beta hemolytic streptococcus positive, or antibiotic administration for proved/suspected streptococcal infection.
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 |
|---|---|---|
| Micropolysaccharide Hemospheres (Arista)Also: AristaMPH is applied as an aerosolized powder which is applied to the bleeding fossa, immediately after suctioning the freshly completed tonsillotomy site to expose the tonsil bed. A separate aerosolizer is used for each patient in order to maximize uniformity per standard dose applied. Each initial dose remains in situ for up to 60 seconds in an attempt to achieve complete hemostasis with a single dose. (Prior data from MPH use has shown that 30-60 seconds is the time typically required for hemostasis for diffuse, non-arterial bleeds.) If there is persistent bleeding after this timeframe, then the bed is irrigated and suctioned and a second equivalent dose is applied. No pressure pack and no oxymetazoline or other topical vasoconstrictor is applied in either group during these initial hemostatic steps, since they are potential confounders of hemostatic effect. | Device | Micropolysaccharide Hemospheres (MPH) |
| Electrocautery (Monopolar suction cautery)Also: Monopolar suction cauteryMonopolar suction electrocautery is used at 20 Watts. Cautery is applied with a light surface touch until bleeding has stopped. In addition, any prominent visible vessels are cauterized. | Device | Electrocautery |
Primary outcome
Primary outcome measure: Adequacy of intraoperative hemostasis, as evaluated by the following metrics: 1. Requirement for rescue hemostasis. 2. Time to complete hemostasis.
Time frame: 0-14 days postoperatively
1 secondary outcome
The main secondary outcome measure is the number of patients with adverse events. These adverse events are expected to occur in the following forms: postoperative primary hemorrhage, postoperative secondary hemorrhage, and severe postoperative pain.
Time frame: 0-14 days postoperatively
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 6 Jan 2017.
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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.
Michael J Cunningham, MD principal investigator
Massachusetts Eye and Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micropolysaccharide Hemospheres (Arista) and Electrocautery (Monopolar suction cautery) in people with Obstructive Sleep Disorder and Obstructive Sleep Apnea, run by Massachusetts Eye and Ear Infirmary 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 5 inclusion and 10 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 6 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary outcome measure: Adequacy of intraoperative hemostasis, as evaluated by the following metrics: 1. Requirement for rescue hemostasis. 2. Time to complete hemostasis. (time frame: 0-14 days postoperatively). 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 6 Jan 2017.