Floseal Treatment for Posterior Epistaxis Study

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01098578
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Duration (Months): 19

Study Details

Study Description

Brief Summary

Effectiveness of Floseal for the treatment of posterior epistaxis.

Condition or Disease	Intervention/Treatment	Phase
Epistaxis	Drug: Floseal	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Floseal Posterior Epistaxis Pilot Study (PEPIS)
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Floseal Received 1 syringe of Floseal for treatment of posterior epistaxis.	Drug: Floseal; Received 1 syringe of Floseal as treatment for posterior epistaxis.; Other Names: non applicable

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ottawa Hospital Research Institute

Investigators

• Principal Investigator: Shaun Kilty, MD, Ottawa Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Ottawa Hospital Research Institute

Publications

None provided.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01098578
• Other Study ID Numbers: Baxter BS09-000313; REB 2009428-01H
• First Posted: Apr 2, 2010
• Last Update Posted: Jan 26, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Ottawa Hospital Research Institute: Posterior Epistaxis
• Additional relevant MeSH terms: Epistaxis

Study Results

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

Arm/Group Title	Floseal.
Arm/Group Description	Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Floseal
Arm/Group Description	Received Floseal treatment for posterior epistaxis. Floseal : Received Floseal as treatment for posterior epistaxis.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 60%
>=65 years	8 40%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.8 (20.06)
Sex: Female, Male (Count of Participants)
Female	10 50%
Male	10 50%
Region of Enrollment (participants) [Number]
Canada	20 100%

Outcome Measures

1. Primary Outcome

Title	Effectiveness of Floseal for the Treatment of Posterior Epistaxis.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Floseal
Arm/Group Description	Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
Measure Participants	20
Number [participants]	20 100%

2. Secondary Outcome

Title	Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Floseal
Arm/Group Description	Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
Measure Participants	20
Number [percentage of expected cost]	45.40

3. Other Pre-specified Outcome

Title	Total Institutional Cost Savings
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FLOSEAL	Endoscopic Surgery
Arm/Group Description	Institutional cost of treating all study patients with Floseal for posterior epistaxis	The calculated minimal institutional cost if all the study patients had been treated with endoscopic surgery for posterior epistaxis
Measure Participants	20	20
Number [US Dollars]	24487.53	53933.89

Adverse Events

Time Frame	Adverse events were evaluated from the time of treatment with Floseal and up to 30 30 days after treatment with Floseal
Arm/Group Title	Floseal
Arm/Group Description	Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
All Cause Mortality
	Floseal
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Floseal
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Floseal
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.