Clinical Trial: Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With (HHT)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

Brief Summary: Current management strategies for severe and recurrent epistaxis secondary to Hereditary hemorrhagic telangiectasia (HHT) include surgical procedures, and uncomfortable nasal packing, both of which are often only short-term solutions. Floseal® may provide a non-invasive and less painful treatment option for epistaxis in HHT patients. This hemostatic agent has been shown to be an effective intraoperative hemostatic agent in a number of surgical procedures including endoscopic sinus surgery. It has also been shown to be favorable over nasal packing at controlling acute anterior epistaxis. Though the efficacy of using Floseal® for epistaxis in HHT patients has been proven anecdotally in the literature it has yet to be proven in a prospective clinical trial. The results of this pilot study will provide insight into the efficacy of using Floseal® in the management of severe epistaxis in HHT patients and to assist in the development of a full-scale prospective clinical trial.

Detailed Summary:

Hereditary hemorrhagic telangiectasia (HHT), also known as Osler-Weber-Rendu syndrome, is an autosomal dominant disorder that is characterized by abnormal blood vessel development. This dysplasia manifests as mucocutaneous telangiectases and visceral arteriovenous malformations (AVM).

The most common symptom is epistaxis occurring secondary to telangiectases in the nasal mucosa in more than 90% of HHT patients. Heterogeneity exists in the severity of epistaxis experienced by HHT patients; therefore, treatments and management strategies can vary. For minor bleeding, conservative management may include preventing drying of the nasal mucosa with the use of ointments and humidification. In some cases, topical or systemic estrogen may also be used to improve the stability of the nasal mucosa, thereby reducing bleeding. Commonly, anterior nasal packing is used as a non-surgical management strategy to control major bleeding. When medical management strategies have failed, laser coagulation of the telangiectases or septodermoplasty may be considered however, these solutions are temporary as telangiectasia are known to recur. In the acute setting, embolization may be used to occlude the abnormal vasculature while maintaining blood flow to the surrounding tissue; however, this is also not an effective long-term solution. Severe and difficult to manage epistaxis has been effectively treated using the modified Young's procedure where closure of the nostril is achieved by suturing together circumferential skin and mucosa flaps.

Floseal hemostatic matrix (Floseal®) is a hemostatic agent that consists of two major components. The first are gelatin granules that swell when they come into contact with blood or other wet surfaces creating a tamponade effect. The second is a high concentration of human thrombin that promotes natural clo
Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome: Change in Epistaxis Severity Score (ESS) via a questionnaire before and one month following treatment [ Time Frame: Baseline and 1 month ]

Original Primary Outcome:

• Change in Epistaxis Severity Score (ESS) via a questionnaire before and one month following treatment [ Time Frame: Baseline and 1 month ]
  Questions include: 1) How often did you typically have nosebleeds during the past one month? 2) How long did each nosebleed typically last for you during the past one month? 3) How would you describe your typical nosebleed intensity during the past one month? 4) Have you sought medical attention outside of this research study for your nosebleeds during the past one month? 5) Are you anemic currently? 6) Have you received a red blood cell transfusion specifically for nosebleeds during the past month?
• Change in number of nose bleeds during one month period following treatment [ Time Frame: Baseline and 1 month ]
• Change in severity rating of nose bleeds during one month period following treatment [ Time Frame: Baseline and 1 month ]
  Questionnaire asks: 1) date, 2) number of nosebleeds, 3) average nosebleed severity (scale of 0 to 10, 10 being as worse as it can be)
• Change in need for additional interventions to control epistaxis during one month following Floseal® application [ Time Frame: Baseline and 1 month ]
• Change in clinical assessment of telangiectases, crusting, scarring, and active bleeding sites in the nasal cavity before and one month following treatment [ Time Frame: Baseline and 1 month ]

Current Secondary Outcome:

• Change in number of nose bleeds during one month period following treatment [ Time Frame: Baseline and 1 month ]
• Change in severity rating of nose bleeds during one month period following treatment [ Time Frame: Baseline and 1 month ]
  Questionnaire asks: 1) date, 2) number of nosebleeds, 3) average nosebleed severity (scale of 0 to 10, 10 being as worse as it can be)
• Change in need for additional interventions to control epistaxis during one month following Floseal® application [ Time Frame: Baseline and 1 month ]
• Change in clinical assessment of telangiectases, crusting, scarring, and active bleeding sites in the nasal cavity before and one month following treatment [ Time Frame: Baseline and 1 month ]

Original Secondary Outcome:

Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: October 13, 2015
Date Started: December 2015
Date Completion: October 2017
Last Updated: January 10, 2017
Last Verified: January 2017