N/A
N=8
Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT) · Epistaxis
Bottom Line
View on ClinicalTrials.gov: NCT02638012 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Epistaxis Severity Score (ESS) — 5.13; 3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Floseal (Drug); Packing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Unity Health Toronto
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epistaxis Severity Score (ESS) |
5.13; 3 | — |
| SECONDARY Change in Number of Nose Bleeds During One Month Period Following Treatment |
— | — |
| SECONDARY Change in Severity Rating of Nose Bleeds During One Month Period Following Treatment |
— | — |
| SECONDARY Change in Need for Additional Interventions to Control Epistaxis During One Month Following Floseal® Application |
— | — |
| SECONDARY Change in Clinical Assessment of Telangiectases, Crusting, Scarring, and Active Bleeding Sites in the Nasal Cavity Before and One Month Following Treatment |
17.29; 9.57 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of HHT
- Active anterior epistaxis
Exclusion Criteria
- A known sensitivity to any of the materials of Floseal® or the topical medications administered as part of the evaluation and treatment of epistaxis (lidocaine, xylometazoline hydrochloride)
- Pregnant and/or breast feeding woman
Data sourced from ClinicalTrials.gov (NCT02638012). 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.