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Nosebleeds that persist even after adequate traditional nasal packing may require aggressive treatment strategies to stop bleeding. Currently these strategies include a surgical approach to cut off blood supply to the vessel that is bleeding. FloSeal Hemostatic matrix is a gel like medical therapy that is inserted into the nose and is engineered to stop bleeding in severe cases, possibly avoiding the need for surgery. In this study the investigators will randomize patients to either receive FloSeal Hemostatix matrix or traditional nasal packing as a treatment for severe nosebleeds. The main outcome will be whether the investigators are able to stop bleeding with FloSeal or traditional packing alone and whether additional measures are necessary to stop the bleeding. The investigators will also perform a patient comfort survey and cost analysis. Even if FloSeal has equal effectiveness in treating nosebleeds as traditional packing, if it is much more comfortable for patients then it may be the favourable treatment.
Background: Epistaxis is the most common emergent consultation to otolaryngology-head & neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy¬ and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis.
Methods: A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 hours post-treatment, and 2) self-reported patient comfort at 48 hours post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Floseal Hemostatic Matrix | Experimental | Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot. |
|
| Traditional Nasal Packing | Active Comparator | Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Floseal Hemostatic Matrix | Device | Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Initial Hemostasis | Residents administering the treatments will empirically observe primary hemostasis. Any active bleeding requiring further intervention within 4 hours of treatment will be defined as failure of initial hemostasis. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Pain Level | Patients will be contacted 48 hours following treatment with either Floseal or traditional nasal packing and be asked to rate their pain on a 10-point "Visual Analog Pain Scale". They will rate their pain for: 1) the placement of the treatment, 2) the duration of the treatment AND 3) the removal of the treatment. Minimum: 0 (less pain) Maximum: 10 (more pain) Higher scores indicate more pain and lower scores indicate less pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Cote, MD, FRCS(C) | Alberta Health services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29310703 | Derived | Murray S, Mendez A, Hopkins A, El-Hakim H, Jeffery CC, Cote DWJ. Management of Persistent Epistaxis Using Floseal Hemostatic Matrix vs. traditional nasal packing: a prospective randomized control trial. J Otolaryngol Head Neck Surg. 2018 Jan 8;47(1):3. doi: 10.1186/s40463-017-0248-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Floseal Hemostatic Matrix | Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot. Floseal Hemostatic Matrix: Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe. |
| FG001 | Traditional Nasal Packing | Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis. Traditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Floseal Hemostatic Matrix | Floseal Hemostatic Matrix provided as treatment. |
| BG001 | Traditional Nasal Packing | Traditional nasal packing provided as treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Initial Hemostasis | Residents administering the treatments will empirically observe primary hemostasis. Any active bleeding requiring further intervention within 4 hours of treatment will be defined as failure of initial hemostasis. | Posted | Count of Participants | Participants | 4 hours |
|
30 days
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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 Hemostatic Matrix | Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot. Floseal Hemostatic Matrix: Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe. |
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Lack of blinding to either patient or practitioner. 30 day follow-up limit on outcomes and adverse events
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Murray | University of Alberta | 587-891-6240 | sipmurray@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2015 | Aug 22, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2018 | Oct 12, 2018 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2015 | Aug 22, 2017 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D004844 | Epistaxis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
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| Traditional Nasal Packing | Procedure | Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps. |
|
| 48 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Charlson Comorbidity Index | The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score (max: 24) , the more likely the predicted outcome will result in mortality or higher resource use. | Mean | Full Range | units on a scale |
|
| Aspirin Use | Count of Participants | Participants |
|
Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis.
Traditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.
|
|
|
| Secondary | Patient Pain Level | Patients will be contacted 48 hours following treatment with either Floseal or traditional nasal packing and be asked to rate their pain on a 10-point "Visual Analog Pain Scale". They will rate their pain for: 1) the placement of the treatment, 2) the duration of the treatment AND 3) the removal of the treatment. Minimum: 0 (less pain) Maximum: 10 (more pain) Higher scores indicate more pain and lower scores indicate less pain. | Patients that failed initial hemostasis were traditionally packed and therefore were not able to rate either treatment or removal of the product. | Posted | Mean | Full Range | units on a scale | 48 hours |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Traditional Nasal Packing | Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis. Traditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| Pain Score During Treatment |
|
|
| Pain Score During Removal |
|
|
| 0.0007 |
| Superiority |
| Comparison between scores for pain during removal. | Wilcoxon (Mann-Whitney) | 0.0021 | Superiority |