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

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ClinicalTrials.gov Identifier: NCT02638012
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
The Ottawa Hospital
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE October 13, 2015
First Posted Date  ICMJE December 22, 2015
Last Update Posted Date June 17, 2019
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
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?
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
  • 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 ]
Change History Complete list of historical versions of study NCT02638012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • 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 Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With (HHT)
Official Title  ICMJE 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 Description

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 clot formation by converting fibrinogen to fibrin. Floseal® is hydrophilic and therefore adheres well to wet tissues. It is indicated for use as an adjunct surgical hemostat and it has recently been demonstrated to be an effective treatment for epistaxis. A prospective, randomized, controlled trial compared Floseal® to nasal packing in the treatment of acute anterior epistaxis. The results showed Floseal® to be better at initially controlling epistaxis and resulted in fewer rebleed events within a seven day follow-up period. Patients also reported less pain and greater overall satisfaction with Floseal® as compared with nasal packing. Similarly, two prospective studies have evaluated the use of Floseal® for the treatment of posterior epistaxis. These trials also showed Floseal® treatment to be an effective treatment for posterior epistaxis. Furthermore, the use of Floseal® was associated with substantial institutional cost savings.

In summary, Floseal® has been demonstrated to be an effective treatment for posterior epistaxis, regardless of origin within the nose. Recently, Floseal® has been used in patients with HHT. This case series showed that patients with anterior epistaxis due to HHT could self-administer Floseal® to treat recurrent anterior epistaxis at their home without a contact with the medical system, as would customarily occur. This directly leads to an improvement in the quality of life of the patients in this study. Impairment of the quality of life for patients with HHT is a significant concern. Compared to the normative population, all subscales of SF36, but bodily pain, have been shown to be significantly poorer in the HHT patients. Studies of HHT substantiate that disease severity is associated with poorer QoL in these patients. Treatments for epistaxis that can improve the quality of life for patients with HHT are needed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hereditary Hemorrhagic Telangiectasia (HHT)
  • Epistaxis
Intervention  ICMJE
  • Drug: Floseal
    Topical lidocaine spray (2%) is then administered using 1-2 sprays in the affected nasal cavity via the nostril that is to have Floseal® applied. Once the bleeding has stopped following application of the Floseal® a 50 cc syringe with sterile saline will be used to irrigate the treated nasal cavity to remove any excess Floseal® product as per manufacturer recommendations. This is done with the patient's head tilted downwards at a 30 degree angle so that the irrigation and excess product is removed from the nasal cavity. Once the irrigation is complete, the nasal cavity is inspected for evidence of continued bleeding.
    Other Name: Floseal hemostatic matrix
  • Other: Packing
    If bleeding is not controlled after up to two Floseal applications, the gel and clots will be removed with suction, and the patient will be treated with a standard packing treatment (standard of care).
Study Arms  ICMJE
  • Experimental: HHT - Floseal
    Once the bleeding has stopped following application of the Floseal® a 50 cc syringe with sterile saline will be used to irrigate the treated nasal cavity to remove any excess Floseal® product as per manufacturer recommendations. This is done with the patient's head tilted downwards at a 30 degree angle so that the irrigation and excess product is removed from the nasal cavity.
    Intervention: Drug: Floseal
  • Active Comparator: HHT - Standard of Care
    If bleeding is not controlled after up to two Floseal applications, the gel and clots will be removed with suction, and the patient will be treated with a standard packing treatment (standard of care).
    Intervention: Other: Packing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented diagnosis of HHT
  • Active anterior epistaxis

Exclusion Criteria:

  • A 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 and/or breast feeding woman
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: William To, BHSc, MSc 416-864-6060 ext 6591 tow@smh.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02638012
Other Study ID Numbers  ICMJE 15-057
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE The Ottawa Hospital
Investigators  ICMJE
Principal Investigator: John Lee, MD, MSc St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP