Management of Persistent Epistaxis Using Floseal Hemostatic Matrix

Recruiting in Palo Alto (17 mi)

Overseen byDavid Cote, MD, FRCS(C)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Trial Summary

What is the purpose of this trial?

Nosebleeds that persist even after adequate traditional nasal packing may require aggressive treatment strategies to stop bleeding. Currently these strategies include a surgical approach to cut off blood supply to the vessel that is bleeding. FloSeal Hemostatic matrix is a gel like medical therapy that is inserted into the nose and is engineered to stop bleeding in severe cases, possibly avoiding the need for surgery. In this study the investigators will randomize patients to either receive FloSeal Hemostatix matrix or traditional nasal packing as a treatment for severe nosebleeds. The main outcome will be whether the investigators are able to stop bleeding with FloSeal or traditional packing alone and whether additional measures are necessary to stop the bleeding. The investigators will also perform a patient comfort survey and cost analysis. Even if FloSeal has equal effectiveness in treating nosebleeds as traditional packing, if it is much more comfortable for patients then it may be the favourable treatment.

Research Team

David Cote, MD, FRCS(C)

Principal Investigator

Alberta Health services

Eligibility Criteria

Inclusion Criteria

All patients age 18+ presenting with epistaxis that requires an ENT consult that had a first attempt at treatment by an emergency physician.

Treatment Details

Interventions

Floseal Hemostatic Matrix (Hemostatic Agent)
Traditional Nasal Packing (Procedure)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Floseal Hemostatic MatrixExperimental Treatment1 Intervention

Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot.

Group II: Traditional Nasal PackingActive Control1 Intervention

Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis.