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

Recruiting in Palo Alto (17 mi)

Overseen byJohn Lee, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Unity Health Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

John Lee, MD, MSc

Principal Investigator

Unity Health Toronto

Eligibility Criteria

Inclusion Criteria

Active anterior epistaxis

Documented diagnosis of HHT

Treatment Details

Interventions

Floseal (Hemostatic Agent)
Packing (Other)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: HHT - FlosealExperimental Treatment2 Interventions

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. 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).