N/A
N=26
Management of Persistent Epistaxis Using Floseal Hemostatic Matrix
Epistaxis
Bottom Line
View on ClinicalTrials.gov: NCT02488135 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants With Initial Hemostasis — 10; 11 Participants — p=1.000
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Floseal Hemostatic Matrix (Device); Traditional Nasal Packing (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Initial Hemostasis |
10; 11 | 1.000 |
| SECONDARY Patient Pain Level |
2.42; 7.77; 0.50; 4.46; 0; 3.85 | 0.0022 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02488135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.