Clinical Trial: Management of Persistent Epistaxis Using Floseal Hemostatic Matrix

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

Official Title: Management of Persistent Anterior Epistaxis Using Floseal Hemostatic Matrix vs. Traditional Nasal Packing: A Prospective Randomized Controlled Trial.

Brief Summary: 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.

Detailed Summary:
Sponsor: University of Alberta

Current Primary Outcome: Hemostasis [ Time Frame: 48 hours ]

Residents administering the treatments will empirically observe primary hemostasis. Any active bleeding of greater than 15mL in 24 hours following treatment will constitute failure of hemostasis as reported by the patient.


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient Pain Level [ Time Frame: 48 hours ]

Patients will be contacted 48 hours following treatment with either Floseal or traditional nasal packing and be asked to answer a pain questionnaire relating to the entirety of their treatment.


Original Secondary Outcome: Same as current

Information By: University of Alberta

Dates:
Date Received: June 26, 2015
Date Started: July 2015
Date Completion: July 2017
Last Updated: March 8, 2016
Last Verified: March 2016