Floseal Treatment for Posterior Epistaxis Study

Epistaxis Clinical Trial

Official title:

Floseal Posterior Epistaxis Pilot Study (PEPIS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098578
• Other study ID #: Baxter BS09-000313
• Secondary ID: REB 2009428-01H
• Status: Completed
• Phase: N/A
• First received: April 1, 2010
• Last updated: January 21, 2015
• Start date: April 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Effectiveness of Floseal for the treatment of posterior epistaxis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epistaxis

Intervention

Drug:
• Floseal
Received 1 syringe of Floseal as treatment for posterior epistaxis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
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.	Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment.	No
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%	30 days	No

External Links

•   Ottawa Hospital Research Institute