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Floseal Treatment for Posterior Epistaxis Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01098578
First received: April 1, 2010
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

Effectiveness of Floseal for the treatment of posterior epistaxis.


Condition Intervention
Epistaxis
 Drug: Floseal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Floseal Posterior Epistaxis Pilot Study (PEPIS)

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Effectiveness of Floseal for the treatment of posterior epistaxis. [ Time Frame: Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost savings of Floseal treatment in comparison to posterior packing, surgical, and embolisation treatments for posterior epistaxis. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Floseal
Will receive Floseal treatment for posterior epistaxis.
 Drug: Floseal
Will receive Floseal as treatment for posterior epistaxis.
Other Name: non applicable

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098578

Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Shaun Kilty, MD Ottawa Hospital Research Institute
  More Information

Additional Information:
Ottawa Hospital Research Institute  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01098578     History of Changes
Other Study ID Numbers: Baxter BS09-000313, REB 2009428-01H
Study First Received: April 1, 2010
Last Updated: October 16, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Posterior Epistaxis

Additional relevant MeSH terms:
Epistaxis
Nose Diseases
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013