Trial Outcomes & Findings for Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With (HHT) (NCT NCT02638012)
NCT ID: NCT02638012
Last Updated: 2020-05-28
Results Overview
Questions include: 1. How often did you typically have nosebleeds during the past one month? 2. How long did each nosebleed typically last for you during the past one month? 3. How would you describe your typical nosebleed intensity during the past one month? 4. Have you sought medical attention outside of this research study for your nosebleeds during the past one month? 5. Are you anemic currently? 6. Have you received a red blood cell transfusion specifically for nosebleeds during the past month? The responses to each of the six questions are assigned a weighted integer that is multiplied by the question's coefficient. These are added to yield the raw score, which is then normalized by dividing by the maximum possible score, then multiplied by 10 to give the normalized score. Range of normalized score is 0 to 10. With 0 representing low severity, and 10 representing high severity.
COMPLETED
NA
8 participants
Baseline and 1 month
2020-05-28
Participant Flow
Participant milestones
| Measure |
Floseal Treatment
All patients within the Floseal treatment group received a total of 5 mL of Floseal (one standard preparation), applied under direct visualization into the affected nasal cavity using the provided application catheter.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Floseal Treatment
All patients within the Floseal treatment group received a total of 5 mL of Floseal (one standard preparation), applied under direct visualization into the affected nasal cavity using the provided application catheter.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Floseal Treatment
n=7 Participants
Patient baseline characteristics
|
|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 monthQuestions include: 1. How often did you typically have nosebleeds during the past one month? 2. How long did each nosebleed typically last for you during the past one month? 3. How would you describe your typical nosebleed intensity during the past one month? 4. Have you sought medical attention outside of this research study for your nosebleeds during the past one month? 5. Are you anemic currently? 6. Have you received a red blood cell transfusion specifically for nosebleeds during the past month? The responses to each of the six questions are assigned a weighted integer that is multiplied by the question's coefficient. These are added to yield the raw score, which is then normalized by dividing by the maximum possible score, then multiplied by 10 to give the normalized score. Range of normalized score is 0 to 10. With 0 representing low severity, and 10 representing high severity.
Outcome measures
| Measure |
Floseal Treatment
n=7 Participants
All patients within the Floseal treatment group received a total of 5 mL of Floseal (one standard preparation), applied under direct visualization into the affected nasal cavity using the provided application catheter.
|
|---|---|
|
Epistaxis Severity Score (ESS)
Baseline
|
5.13 score on a scale
Standard Deviation 3
|
|
Epistaxis Severity Score (ESS)
1 month follow up
|
3 score on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Data was incomplete or unavailable for all participants and so this outcome measure was not recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Data was incomplete or unavailable for all participants and so this outcome measure was not recorded.
Questionnaire asks: 1) date, 2) number of nosebleeds, 3) average nosebleed severity (scale of 0 to 10, 10 being as worse as it can be)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Data was incomplete or unavailable for all participants and so this outcome measure was not recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1 monthClinical assessment score of 1) nasal telangiectases, 2) crusting, 3) scarring, and 4) active bleeding sites. Each side of the nose is scored independently from 0 - none to 10 - severe. Range of the total score is from 0 to 80.
Outcome measures
| Measure |
Floseal Treatment
n=7 Participants
All patients within the Floseal treatment group received a total of 5 mL of Floseal (one standard preparation), applied under direct visualization into the affected nasal cavity using the provided application catheter.
|
|---|---|
|
Change in Clinical Assessment of Telangiectases, Crusting, Scarring, and Active Bleeding Sites in the Nasal Cavity Before and One Month Following Treatment
Baseline
|
17.29 score on a scale
Standard Deviation 7.70
|
|
Change in Clinical Assessment of Telangiectases, Crusting, Scarring, and Active Bleeding Sites in the Nasal Cavity Before and One Month Following Treatment
1 month follow up
|
9.57 score on a scale
Standard Deviation 7.81
|
Adverse Events
Floseal Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place