Trial Outcomes & Findings for Management of Persistent Epistaxis Using Floseal Hemostatic Matrix (NCT NCT02488135)

Results Overview

Residents administering the treatments will empirically observe primary hemostasis. Any active bleeding requiring further intervention within 4 hours of treatment will be defined as failure of initial hemostasis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

4 hours

Results posted on

2023-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Floseal Hemostatic Matrix Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot. Floseal Hemostatic Matrix: Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.	Traditional Nasal Packing Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis. Traditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Floseal Hemostatic Matrix n=13 Participants Floseal Hemostatic Matrix provided as treatment.	Traditional Nasal Packing n=13 Participants Traditional nasal packing provided as treatment.	Total n=26 Participants Total of all reporting groups
Age, Continuous	58.95 years n=13 Participants	55.08 years n=13 Participants	57.02 years n=26 Participants
Sex: Female, Male Female	5 Participants n=13 Participants	7 Participants n=13 Participants	12 Participants n=26 Participants
Sex: Female, Male Male	8 Participants n=13 Participants	6 Participants n=13 Participants	14 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	13 participants n=13 Participants	13 participants n=13 Participants	26 participants n=26 Participants
Charlson Comorbidity Index	2.31 units on a scale n=13 Participants	2.31 units on a scale n=13 Participants	2.31 units on a scale n=26 Participants
Aspirin Use	2 Participants n=13 Participants	3 Participants n=13 Participants	5 Participants n=26 Participants

PRIMARY outcome

Timeframe: 4 hours

Residents administering the treatments will empirically observe primary hemostasis. Any active bleeding requiring further intervention within 4 hours of treatment will be defined as failure of initial hemostasis.

Outcome measures

Outcome measures
Measure	Floseal Hemostatic Matrix n=13 Participants Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot. Floseal Hemostatic Matrix: Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.	Traditional Nasal Packing n=13 Participants Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis. Traditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.
Number of Participants With Initial Hemostasis	10 Participants	11 Participants

SECONDARY outcome

Timeframe: 48 hours

Population: Patients that failed initial hemostasis were traditionally packed and therefore were not able to rate either treatment or removal of the product.

Patients will be contacted 48 hours following treatment with either Floseal or traditional nasal packing and be asked to rate their pain on a 10-point "Visual Analog Pain Scale". They will rate their pain for: 1) the placement of the treatment, 2) the duration of the treatment AND 3) the removal of the treatment. Minimum: 0 (less pain) Maximum: 10 (more pain) Higher scores indicate more pain and lower scores indicate less pain.

Outcome measures

Outcome measures
Measure	Floseal Hemostatic Matrix n=12 Participants Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot. Floseal Hemostatic Matrix: Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.	Traditional Nasal Packing n=13 Participants Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis. Traditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.
Patient Pain Level Pain Score During Placement	2.42 units on a scale Interval 0.0 to 8.0	7.77 units on a scale Interval 4.0 to 10.0
Patient Pain Level Pain Score During Treatment	0.50 units on a scale Interval 0.0 to 3.0	4.46 units on a scale Interval 0.0 to 10.0
Patient Pain Level Pain Score During Removal	0 units on a scale Interval 0.0 to 0.0	3.85 units on a scale Interval 0.0 to 10.0

Adverse Events

Floseal Hemostatic Matrix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Nasal Packing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Scott Murray

University of Alberta

Phone: 587-891-6240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place