Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Phase: NA
Conditions: Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
Sponsor: Unity Health Toronto

Prospective pilot study of Floseal® for the treatment of anterior epistaxis in patients with 
hereditary hemorrhagic telangiectasia (HHT) – Protocol and Statistical Analysis 
 
NCT02638012 
Date: April 30, 2020 
 
 

Patients afflicted with hereditary hemorrhagic telangiectasia (HHT) can suffer from frequent and 
heavy epistaxis, often requiring hospitalization for transfusions and surgical or endovascular 
procedures. As HHT patients represent a distinct group of individuals who are at increased risk 
of epistaxis, which has significant negative impact on QoL, evaluation within this specific group 
was warranted. Herein, we performed a pilot prospective clinical trial evaluating the efficacy of 
Floseal ® in managing acute epistaxis in HHT patients. 
 
Methods 
This multi-centered prospective clinical trial was registered with ClinicalTrials.gov 
(NCT02638012). Research ethics approval was received from both St. Michael’s Hospital and 
The Ottawa Hospital. 
 
Study population 
We aimed to recruit 10 patients, which is the sample size that is deemed appropriate for pilot 
studies. Patients 
age 18 and above with a documented diagnosis of HHT, and who were experiencing active 
anterior epistaxis were approached to voluntarily participate in this study. Patients were recruited 
after the Otolaryngology –Head and Neck Surgery service was consulted, eithe rthrough the 
Emergency Department, or from another in-patient service. Patients were excluded if they i) had 
aknown sensitivity to Floseal®, ii) had a known sensitivity to the topical medications 
administered as part of the evaluation and treatment of epistaxis (lidocaine, xylometazoline 
hydrochloride) or iii) were pregnant and/or breast feeding (the safety of Floseal® has not been 
established in pregnant women). 
 
Floseal® treatment 
The nasal cavity was suctioned, and the bleeding was visualized with anterior rhinoscopy. A total 
of 5 mL of Floseal ® (one standard preparation) was applied under direct visualization into the 
affected nasal cavity using the provided application catheter by a senior study investigator (JML 
or SK). Anterior nasal pressure was then applied for 5 min, and the nasal cavity was then 
reinspected 15 min after the initial application. In the event that bleeding was not controlled, an 
additional Floseal® application was to be applied. With failure to control bleeding with 2 
applications of Floseal® the protocol was to remove gel and clots with suction, and the patient 
was to be treated with a standard packing treatment (absorbable or non-absorbable) as standard 
of care. 
 
Outcome measures 
A patient-reported epistaxis questionnaire was administered as part of the study, and included the 
Epistaxis Severity 
Score (ESS). The survey is attached as part of Additional file 1. Modification to the ESS 
questionnaire included changes with regards to the timing (1 month, as compared to 3 months in 
the original ESS questionnaire). The patient-reported questionnaire was administered to all 
patients at the time of the Floseal® application (baseline), and at 1 month following treatment. 
Patients were also asked to report pain associated with application of Floseal®, rated on a visual-
analogue scale from 0 to 10, with 0 being “no pain”, and 10 being “worst pain in your life”. 
 

The primary outcome measures were achievement of hemostasis and changes in the ESS score 
between baseline and one-month follow up. Secondary outcome measures assessed subjective 
changes in epistaxis symptoms between baseline and follow up. Additionally, patients were 
reassessed clinically at 1 month follow up, capturing changes in telangiectasias, crusting, 
scarring, and active bleeding sites in the nasal cavity. Both sides of the nose were scored 
separately in each of these domains from 0 to 10, with 0 being “none” and 10 being “severe”. 
Clinical assessments were only performed by senior study investigators (JML and SK). The 
clinical assessment form is included as part of Additional file. 
 
Statistical analysis 
Descriptive statistics were used to summarize the frequency and percentage of categorical 
variables. Continuous variables were reported as mean and standard deviation. Paired t-test was 
performed to compare baseline and one month follow up differences in ESS, frequency of nose 
bleeds, and severity of nose bleeds. All statistical analyses were performed using Prism (v.7, 
GraphPad, USA), with significance set to α = 0.05.