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Floseal Treatment for Posterior Epistaxis Study

Primary Purpose

Epistaxis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Floseal
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis focused on measuring Posterior Epistaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Floseal

    Arm Description

    Received 1 syringe of Floseal for treatment of posterior epistaxis.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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%

    Full Information

    First Posted
    April 1, 2010
    Last Updated
    January 21, 2015
    Sponsor
    Ottawa Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01098578
    Brief Title
    Floseal Treatment for Posterior Epistaxis Study
    Official Title
    Floseal Posterior Epistaxis Pilot Study (PEPIS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epistaxis
    Keywords
    Posterior Epistaxis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Floseal
    Arm Type
    Experimental
    Arm Description
    Received 1 syringe of Floseal for treatment of posterior epistaxis.
    Intervention Type
    Drug
    Intervention Name(s)
    Floseal
    Other Intervention Name(s)
    non applicable
    Intervention Description
    Received 1 syringe of Floseal as treatment for posterior epistaxis.
    Primary Outcome Measure Information:
    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.
    Secondary Outcome Measure Information:
    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
    Other Pre-specified Outcome Measures:
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shaun Kilty, MD
    Organizational Affiliation
    Ottawa Hospital Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23754469
    Citation
    Kilty SJ, Al-Hajry M, Al-Mutairi D, Bonaparte JP, Duval M, Hwang E, Tse D. Prospective clinical trial of gelatin-thrombin matrix as first line treatment of posterior epistaxis. Laryngoscope. 2014 Jan;124(1):38-42. doi: 10.1002/lary.24240. Epub 2013 Jun 28.
    Results Reference
    derived
    Links:
    URL
    http://www.ohri.ca
    Description
    Ottawa Hospital Research Institute

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