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| ID | Type | Description | Link |
|---|---|---|---|
| REB 2009428-01H | Other Identifier | Ottawa Hospital Research Ethics Board |
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Effectiveness of Floseal for the treatment of posterior epistaxis.
Floseal, a hemostatic agent, is an effective treatment for anterior epistaxis as well as numerous other acute bleeding conditions throughout the body. The investigators hypothesize that Floseal is an effective treatment for posterior epistaxis. If so, then this will also lead to significant cost savings in comparison to any other method of treatment of posterior epistaxis. The investigators have planned a prospective, nonblinded, nonrandomised study with a total of 40 subjects with posterior epistaxis to be included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Floseal | Experimental | Received 1 syringe of Floseal for treatment of posterior epistaxis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Floseal | Drug | Received 1 syringe of Floseal as treatment for posterior epistaxis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Floseal for the Treatment of Posterior Epistaxis. | Successful treatment using the gelatin-thrombin matrix protocol (Floseal) was any case of posterior epistaxis that stopped following the immediate application of either one or two syringes of Floseal® and the epistaxis did not resume within fourteen days of the treatment date. | Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis. | The institutional cost for the treatment of posterior epistaxis patients with posterior packing, endoscopic surgery, and endovascular embolization, at TOH were calculated and compared with the institutional cost of a patient visit for posterior epistaxis successfully treated with the study protocol using Floseal. All costs were calculated in Canadian dollars (CAD), they were converted to US dollars (USD) using the current monetary exchange rate (total CAD x 1.03= total USD). For all of the patients treated in this study, the total institution cost was $24487.53 (USD). The minimal institutional cost of successfully treating all of the study patients with endoscopic surgery, would have been $53933.89 (USD) or 2.2 times the actual expense. (Total cost 20 participants Floseal/expected total cost 20 endoscopic surgery*100)This represents savings of $29446.39 (USD) or 45.40% |
| Measure | Description | Time Frame |
|---|---|---|
| Total Institutional Cost Savings | Difference between the total institutional cost of successfully treating 20 study patients with Floseal compared to the total institutional cost of treating the same number of patient with endoscopic surgery | End of study. Cost calculated after 20 patients were treated with Floseal |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaun Kilty, MD | Ottawa Hospital Research Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23754469 | Derived | Kilty SJ, Al-Hajry M, Al-Mutairi D, Bonaparte JP, Duval M, Hwang E, Tse D. Prospective clinical trial of gelatin-thrombin matrix as first line treatment of posterior epistaxis. Laryngoscope. 2014 Jan;124(1):38-42. doi: 10.1002/lary.24240. Epub 2013 Jun 28. |
| Label | URL |
|---|---|
| Ottawa Hospital Research Institute | View source |
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Patients who presented to the emergency department with posterior epistaxis or who were already admitted to hospital for another diagnosis and had posterior epistaxis were offered enrollment. Recruitment period April 2010- April 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Floseal. | Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Floseal | Received Floseal treatment for posterior epistaxis. Floseal : Received Floseal as treatment for posterior epistaxis. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness of Floseal for the Treatment of Posterior Epistaxis. | Successful treatment using the gelatin-thrombin matrix protocol (Floseal) was any case of posterior epistaxis that stopped following the immediate application of either one or two syringes of Floseal® and the epistaxis did not resume within fourteen days of the treatment date. | Posted | Number | participants | Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment. |
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Adverse events were evaluated from the time of treatment with Floseal and up to 30 30 days after treatment with Floseal
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Floseal | Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shaun Kilty | Ottawa Hospital Research Institute | 613-798-5555 | 18514 | skilty@ottawahospital.on.ca |
| ID | Term |
|---|---|
| D004844 | Epistaxis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| C411004 | FloSeal Matrix |
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| 30 days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis. | The institutional cost for the treatment of posterior epistaxis patients with posterior packing, endoscopic surgery, and endovascular embolization, at TOH were calculated and compared with the institutional cost of a patient visit for posterior epistaxis successfully treated with the study protocol using Floseal. All costs were calculated in Canadian dollars (CAD), they were converted to US dollars (USD) using the current monetary exchange rate (total CAD x 1.03= total USD). For all of the patients treated in this study, the total institution cost was $24487.53 (USD). The minimal institutional cost of successfully treating all of the study patients with endoscopic surgery, would have been $53933.89 (USD) or 2.2 times the actual expense. (Total cost 20 participants Floseal/expected total cost 20 endoscopic surgery*100)This represents savings of $29446.39 (USD) or 45.40% | Posted | Number | percentage of expected cost | 30 days |
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| Other Pre-specified | Total Institutional Cost Savings | Difference between the total institutional cost of successfully treating 20 study patients with Floseal compared to the total institutional cost of treating the same number of patient with endoscopic surgery | Posted | Number | US Dollars | End of study. Cost calculated after 20 patients were treated with Floseal |
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| 0 |
| 20 |
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| 20 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |