Clinical trial NCT02488135: Management of Persistent Epistaxis Using Floseal Hemostatic Matrix
Official title: Management of Persistent Anterior Epistaxis Using Floseal Hemostatic Matrix vs. Traditional Nasal Packing: A Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epistaxis
Keywords: Floseal® (Baxter, USA)
epistaxis
nasal packing
persistent
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: Background: Epistaxis is the most common emergent consultation to otolaryngology-head \& neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy¬ and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis.

Methods: A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 hours post-treatment, and 2) self-reported patient comfort at 48 hours post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed.

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.

Exclusion Criteria:

* Patients will be excluded based on the presence of a hypo-coagulable state. Including patients actively taking anti-coagulant medications or other patients with either acquired or hereditary bleeding disorders.

Primary outcomes:
measure: Number of Participants With Initial Hemostasis
timeFrame: 4 hours
Secondary outcomes:
measure: Patient Pain Level
timeFrame: 48 hours
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: Alberta Health services
name: David Cote, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murray S, Mendez A, Hopkins A, El-Hakim H, Jeffery CC, Cote DWJ. Management of Persistent Epistaxis Using Floseal Hemostatic Matrix vs. traditional nasal packing: a prospective randomized control trial. J Otolaryngol Head Neck Surg. 2018 Jan 8;47(1):3. doi: 10.1186/s40463-017-0248-5.