Epistaxis
Conditions
Keywords
Floseal® (Baxter, USA), epistaxis, nasal packing, persistent
Brief summary
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.
Detailed description
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.
Interventions
Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.
PROCEDURETraditional Nasal Packing
Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients age 18+ presenting with epistaxis that requires an ENT consult that had a first attempt at treatment by an emergency physician.
Exclusion criteria
* Patients will be excluded based on the presence of a hypo-coagulable state. Including patients actively taking anti-coagulant medications or other patients with either acquired or hereditary bleeding disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Initial Hemostasis | 4 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Level | 48 hours | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Floseal Hemostatic Matrix Floseal Hemostatic Matrix provided as treatment. | 13 |
| Traditional Nasal Packing Traditional nasal packing provided as treatment. | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Floseal Hemostatic Matrix | Traditional Nasal Packing | Total |
|---|---|---|---|
| Age, Continuous | 58.95 years | 55.08 years | 57.02 years |
| Aspirin Use | 2 Participants | 3 Participants | 5 Participants |
| Charlson Comorbidity Index | 2.31 units on a scale | 2.31 units on a scale | 2.31 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 13 participants | 13 participants | 26 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Floseal Hemostatic Matrix | Number of Participants With Initial Hemostasis | 10 Participants |
| Traditional Nasal Packing | Number of Participants With Initial Hemostasis | 11 Participants |
p-value: 1Fisher Exact
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.
Time frame: 48 hours
Population: Patients that failed initial hemostasis were traditionally packed and therefore were not able to rate either treatment or removal of the product.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Floseal Hemostatic Matrix | Patient Pain Level | Pain Score During Placement | 2.42 units on a scale |
| Floseal Hemostatic Matrix | Patient Pain Level | Pain Score During Treatment | 0.50 units on a scale |
| Floseal Hemostatic Matrix | Patient Pain Level | Pain Score During Removal | 0 units on a scale |
| Traditional Nasal Packing | Patient Pain Level | Pain Score During Placement | 7.77 units on a scale |
| Traditional Nasal Packing | Patient Pain Level | Pain Score During Treatment | 4.46 units on a scale |
| Traditional Nasal Packing | Patient Pain Level | Pain Score During Removal | 3.85 units on a scale |
Comparison: Comparison between groups for pain during placement.p-value: 0.0022Wilcoxon (Mann-Whitney)
Comparison: Comparison between groups for pain during treatment.p-value: 0.0007Wilcoxon (Mann-Whitney)
Comparison: Comparison between scores for pain during removal.p-value: 0.0021Wilcoxon (Mann-Whitney)