Epistaxis
Conditions
Keywords
Posterior Epistaxis
Brief summary
Effectiveness of Floseal for the treatment of posterior epistaxis.
Detailed description
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.
Interventions
DRUGFloseal
Received 1 syringe of Floseal as treatment for posterior epistaxis.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age greater than 18 years of age * posterior epistaxis
Exclusion criteria
* patients with anterior epistaxis * known sensitivity to any of the materials of Floseal or the topical medications administered as part of the evaluation and treatment of epistaxis (lidocaine, xylometazoline hydrochloride) * pregnant or breast feeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Floseal for the Treatment of Posterior Epistaxis. | Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis. | 30 days | 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% |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Institutional Cost Savings | End of study. Cost calculated after 20 patients were treated with Floseal | 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 |
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Floseal Received Floseal treatment for posterior epistaxis.
Floseal : Received Floseal as treatment for posterior epistaxis. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Floseal |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 57.8 years STANDARD_DEVIATION 20.06 |
| Region of Enrollment Canada | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Floseal | Effectiveness of Floseal for the Treatment of Posterior Epistaxis. | 20 participants |
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%
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Floseal | Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis. | 45.40 percentage of expected cost |
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
Time frame: End of study. Cost calculated after 20 patients were treated with Floseal
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Floseal | Total Institutional Cost Savings | 24487.53 US Dollars |
| Endoscopic Surgery | Total Institutional Cost Savings | 53933.89 US Dollars |