An interventional study of Floseal Hemostatic Matrix and Traditional Nasal Packing in Epistaxis, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Device: Floseal Hemostatic Matrix
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.
Procedure: Traditional Nasal Packing
Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.
Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.
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.
Time frame: 4 hours
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.
Time frame: 48 hours
| Milestone | Floseal Hemostatic Matrix | Traditional Nasal Packing |
|---|---|---|
| Started | 13 | 13 |
| Completed | 13 | 13 |
| Not completed | 0 | 0 |
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.
| Participants | Floseal Hemostatic Matrix | Traditional Nasal Packing |
|---|---|---|
| Number of Participants With Initial Hemostasis | 10 | 11 |
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.
| units on a scale | Floseal Hemostatic Matrix | Traditional Nasal Packing |
|---|---|---|
| Pain Score During Placement | 2.42 (0 to 8) | 7.77 (4 to 10) |
| Pain Score During Treatment | 0.50 (0 to 3) | 4.46 (0 to 10) |
| Pain Score During Removal | 0 (0 to 0) | 3.85 (0 to 10) |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Floseal Hemostatic Matrix | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Traditional Nasal Packing | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Floseal Hemostatic Matrix | Traditional Nasal Packing | Total |
|---|---|---|---|
| Mean | 58.95 (22 to 95) | 55.08 (18 to 86) | 57.02 (18 to 95) |
| Sex: Female, Male(Participants) | Floseal Hemostatic Matrix | Traditional Nasal Packing | Total |
|---|---|---|---|
| Female | 5 | 7 | 12 |
| Male | 8 | 6 | 14 |
| Race and Ethnicity Not Collected(Participants) | Floseal Hemostatic Matrix | Traditional Nasal Packing | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Floseal Hemostatic Matrix | Traditional Nasal Packing | Total |
|---|---|---|---|
| Canada | 13 | 13 | 26 |
| Charlson Comorbidity Index(units on a scale) | Floseal Hemostatic Matrix | Traditional Nasal Packing | Total |
|---|---|---|---|
| Mean | 2.31 (0 to 7) | 2.31 (0 to 5) | 2.31 (0 to 7) |
| Aspirin Use(Participants) | Floseal Hemostatic Matrix | Traditional Nasal Packing | Total |
|---|---|---|---|
| Count of participants | 2 | 3 | 5 |
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University of Alberta