Management of Persistent Anterior Epistaxis Using Floseal Hemostatic Matrix vs. Traditional Nasal Packing: A Prospective Randomized Controlled Trial.
Phase: NA
Conditions: Epistaxis
Sponsor: University of Alberta

 
 
 
 
 
Management of Persistent Epistaxis Using Floseal Hemostatic 
Matrix 
 
 
PROTOCOL IDENTIFYING NUMBER  
001 
 
 
PROTOCOL VERSION DATE 
June 8, 2015 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
GENERAL INFORMATION 
 
 
 
Name and title of the investigators and sub-investigators responsible for the trial with 
address and phone numbers   
 
Dr. David Côté 
1E4.07 WMC, 8440 112 Street 
University of Alberta Hospital 
Edmonton, AB, T6G 2B7 
780-407-4490 
 
Dr. Adrian Mendez 
1E4.07 WMC, 8440 112 Street 
University of Alberta 
Edmonton, AB, T6G 2B7 
780-407-4490 
 
Alexander Hopkins BSc. 
 
 
 
 
3-007 Li Ka Shing 
 
 
 
 
 
University of Alberta  
 
 
 
 
Edmonton, AB, T6G 2R3 
 
 
 
 
arhopkin@ualberta.ca  
 
 
 
 
780-407-4490  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
Study Summary 
Title 
Management of Persistent Epistaxis using Floseal Hemostatic Matrix 
Short Title 
Floseal Epistaxis Study 
Protocol Number 
001 
Phase 
Phase 4 Clinical Trial 
Methodology 
Randomized open-label Trial 
Study Duration 
1 Year 
Study Center(s) 
Single-Center, University of Alberta 
Objectives 
We wish to observe the effectiveness of Floseal Hemostatic Matrix in 
aborting persistent epistaxis with the end of bleeding being our primary 
outcome. We also wish to include measures of patient comfort and cost 
analysis of epistaxis treatment. 
Number of Subjects 
60 
Diagnosis and Main 
Inclusion Criteria 
Adult patients presenting for Otolaryngology Head and Neck Surgery 
consult in the Emergency Department with persistent epistaxis.  
Study Product, Dose,  Floseal Hemostatic Matrix, 5mL 
Duration of 
administration 
30 Minutes 
Reference therapy 
Standard nasal packing using gauze by a trained Otolaryngology 
resident 
Statistical 
Methodology 
This study is powered based on a non-inferiority analysis to compare the 
efficacy of Floseal at achieving hemostasis. We will perform standard 
chi-square statistical analysis to determine the significance of these 
outcomes. 
 
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
Table of Contents 
1  
BACKGROUND ............................................................................................................................................... 1 
1.1 
INVESTIGATIONAL AGENT ........................................................................................................................... 1 
1.2 
PRECLINICAL DATA ..................................................................................................................................... 1 
1.3 
RISK/BENEFITS ............................................................................................................................................ 1 
1.4 
DOSE RATIONALE ........................................................................................................................................ 1 
1.5 
TRIAL CONDUCT.......................................................................................................................................... 1 
1.6 
POPULATION................................................................................................................................................ 2 
1.7 
LITERATURE ................................................................................................................................................ 2 
2 
TRIAL OBJECTIVES...................................................................................................................................... 2 
3 
TRIAL DESIGN................................................................................................................................................ 2 
3.1 
PRIMARY STUDY ENDPOINTS/SECONDARY ENDPOINTS............................................................................... 2 
3.2 
STUDY DESIGN/TYPE .................................................................................................................................. 2 
3.3 
RANDOMIZATION ........................................................................................................................................ 3 
3.4 
TRIAL TREATMENT ...................................................................................................................................... 3 
3.5 
DURATION ................................................................................................................................................... 3 
3.6 
DISCONTINUATION ...................................................................................................................................... 4 
3.7 
DATA IDENTIFICATION ................................................................................................................................ 4 
4 
SELECTION AND WITHDRAWAL OF SUBJECTS .................................................................................. 4 
4.1 
INCLUSION CRITERIA ................................................................................................................................... 4 
4.2 
EXCLUSION CRITERIA.................................................................................................................................. 4 
4.3 
SUBJECT WITHDRAWAL .............................................................................................................................. 5 
4.4 
TREATMENT OF SUBJECTS ........................................................................................................................... 5 
4.5 
MEDICATION ............................................................................................................................................... 6 
5 
ASSESSMENT OF EFFICACY ...................................................................................................................... 6 
5.1 
EFFICACY PARAMETERS .............................................................................................................................. 6 
5.2 
METHOD AND TIMING ................................................................................................................................. 6 
6 
ASSESSMENT OF SAFETY ........................................................................................................................... 6 
6.1 
SAFETY PARAMETERS ................................................................................................................................. 6 
6.2 
METHOD AND TIMING ................................................................................................................................. 6 
6.3 
ADVERSE EVENT REPORTING ...................................................................................................................... 7 
6.4 
ADVERSE EVENT FOLLOW-UP ..................................................................................................................... 7 
7 
STATISTICAL PLAN ...................................................................................................................................... 7 
7.1 
STATISTICAL METHODS............................................................................................................................... 7 
7.2 
SUBJECT POPULATION(S) FOR ANALYSIS..................................................................................................... 7 
7.3 
SIGNIFICANCE.............................................................................................................................................. 7 
7.4 
TERMINATION CRITERIA.............................................................................................................................. 8 
7.5 
DEVIATION REPORTING ............................................................................................................................... 8 
8 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTATION .................................................................. 8 
9 
QUALITY CONTROL AND QUALITY ASSURANCE .............................................................................. 8 
10 
ETHICAL CONSIDERATIONS ..................................................................................................................... 8 
11 
DATA HANDLING AND RECORD KEEPING ........................................................................................... 9 
12 
SUPPLEMENTS ............................................................................................................................................... 9 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
List of Abbreviations 
 
 
 
HREB  
Health Research Ethics Board 
 
OHNS  
Otolaryngology Head and Neck Surgery 
 
 

 
 
Page 1 
 
1 Background 
 
1.1 Investigational Agent 
Floseal Hemostatic Matrix. This agent is a health Canada approved treatment option that 
is already in use in a number of hospital settings. It is a hemostatic sealant composed of a 
human thrombin containing fraction and a collagen gel-like fraction. It is applied to the 
area of active bleeding to achieve rapid hemostasis.  
 
1.2 Preclinical Data 
Floseal has been previously shown to achieve hemostasis more effectively than 
traditional methods in a number of clinical settings. These include cardiac surgery, spinal 
surgery and topical bleeding. Gel like hemostatic agents have additional advantages such 
as ease of use, conformity to irregular surfaces and their bio absorbable properties 
eliminate the need for removal. A prospective clinical trial using 10 patients at the 
University of Alberta has already been conducted, however it was not a randomized 
clinical trial and did not look at outcomes in addition to hemostasis. We wish to expand 
upon this knowledge in the context of epistaxis in this study. 
1.3 Risk/Benefits 
Potential benefits to participating in this study include: A potentially faster and more 
effective way to achieve hemostasis and abort bleeding. An increased level of comfort 
and less pain compared to traditional nasal packing. 
 
Potential risks to participating in this study include: A very small theoretical risk of 
transmission of human viruses due to the Floseal product containing human thrombin. 
This treatment is already a standard of care that is currently in use in the University of 
Alberta Hospital therefor the risks are no greater than what a patient might be exposed to 
already. Risks might also include discomfort from the placement of the packing or 
FloSeal in the nasal cavity. 
  
 
1.4 Dose Rationale  
Floseal Hemostatic Matrix comes in a standard size (5mL) and we will be using this 
dosing to achieve hemostasis. 
 
1.5 Trial Conduct 
This study will be conducted in compliance with the protocol approved by the University 
of Alberta Health Research Ethics Board (HREB), and according to Good Clinical 
Practice standards.  No deviation from the protocol will be implemented without the prior 
review and approval of the HREB except where it may be necessary to eliminate an 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
immediate hazard to a research subject.  In such case, the deviation will be reported to the 
HREB as soon as possible. 
 
1.6 Population 
Adult patients presenting to the Emergency Department at the University of Alberta who 
have persistent epistaxis and require OHNS consult. 
 
1.7 Literature 
1. Cote D, Barber B, et al. Floseal Hemostatic Matrix in Persistent Epistaxis: A 
Prospective Clinical Trial. J Oto Surgery. 2010; 39:3:304-308 
2.  Oz MC, Cosgrove DM 3rd, Badduke BR, et al. Controlled clinical trial of a novel 
hemostatic agent in cardiac surgery. Ann Thorac Surg. 2000;69:1376-1382. 
3. Oz MC, Rondinone JF, Shargill NS. FloSeal Matrix: new generation topical 
hemostatic sealant. J Card Surg. 2003;18:486-493. 
4. Renkens KL Jr, Payner TD, Leipzig TJ, et al. A multicenter, prospective, randomized 
trial evaluating a new hemostatic agent for spinal surgery. Spine. 2001;26:1645-1650. 
5. Nasso G, Piancone F, Bonifazi R, et al. Prospective, randomized clinical trial of the 
FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg. 2009;88:1520-1526. 
2 Trial Objectives 
The objective of this study is to observe the effectiveness of Floseal Hemostatic Matrix as 
a treatment option for persistent epistaxis in patients requiring OHNS consult. We will 
determine effectiveness based on its ability to abort bleeding as well as outcomes of 
patient comfort and ease of treatment. 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 favorable treatment.  
3 Trial Design 
 
3.1 Primary Study Endpoints/Secondary Endpoints 
The primary endpoint of this study will be when hemostasis is achieved and there is no 
longer any active bleeding from the nasal cavity. Our secondary endpoint will be two 
days following the intervention when we obtain the telephone questionnaire results from 
the patients about pain level and comfort of the treatment. 
 
3.2 Study Design/Type 
This study will be a prospective randomized, open-label clinical trial.    
   

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
1. Otolaryngology Service consulted for persistent epistaxis by Emergency department 
 
2. Otolaryngology resident determines whether patient meets inclusion/exclusion criteria for 
the study 
 
3. Informed Consent is obtained and participants are given a chance to ask questions 
 
4. Participants will be randomized using a sealed envelope system to either experimental or 
control group 
 
5. Group A receives traditional nasal packing 
 
Group B receives treatment using FloSeal Hemostatic Matrix 
 
6. Both Groups are followed to observe the primary endpoint of hemostasis (end of 
bleeding) 
 
7. Hospital care or discharge continues as normal 
 
8. Patients are telephoned or visited as inpatients 48 hours later to complete the comfort 
questionnaire 
 
3.3 Randomization 
This study will be randomized in an allocation concealment fashion with a randomized 
treatment group already established in an envelope in the treatment room prior to patients 
being enrolled in the study. The direct care team therefor has no control over the chosen 
treatment for the patients. Due to the nature of the treatment it is not possible to blind this 
study to either the direct care team or patient. 
3.4 Trial Treatment 
Patients in this trial will be receiving Floseal in the nasal cavity by a trained OHNS 
resident. The amount of Floseal required to stop bleeding and cover the wound site may 
vary. Floseal is packaged as a 5mL syringe set that requires set up before use. Detailed 
instructions on the use of Floseal sealant are provided in the Floseal safety monograph 
(attached in the ethics application) and residents will all have proper training. 
3.5 Duration 
The duration of treatment for patients in this study will be no longer than the standard 
practice treatment for their condition. Total time from admission to the Emergency 
Department and being seen by OHNS consult to achieve hemostasis using either Floseal 
or standard nasal packing may be variable, but should take no longer than a few hours. 
There will be an additional telephone survey completed at the patients discretion two 
days following their involvement in the study.  

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
3.6 Discontinuation 
 Patients will be undergoing all aspects of the study under the supervision of a physician 
or research coordinator and will therefor be encouraged to express any concerns they 
have so they can be addressed as promptly as possible. We will minimize risk by 
providing the physicians involved with the most training possible to ensure placement of 
the treatment is done as easily and accurately as it can be. Patients who wish to withdraw 
from the study will be able to do so at any time and will be informed of this upon 
obtaining consent for the study. 
 
As this is a minimal risk trial with a product that is already in the use in hospital settings 
it is very unlikely that we will need to discontinue the entire trial. In the unlikely event 
that this would occur, we would disclose the reasoning to the HREB and all other 
necessary regulatory agencies. 
3.7 Data Identification 
For this clinical trial we will need to have access to patient records to observe our primary 
endpoint of hemostasis as well as our secondary outcomes of patient comfort and a cost 
analysis. To obtain informed consent we will need the patients name and signature. For 
our statistical analysis we will need patient age and gender. To perform the patient 
comfort survey we will need the participant telephone number and email address.  
Surname and First Name  
Telephone Number 
Email Address   
Age at time of data collection  
Health Care Number  
Hospital Discharge Date  
4 Selection and Withdrawal of Subjects 
4.1 Inclusion Criteria 
Adult patients with persistent epistaxis that present to the Emergency Department at the 
University of Alberta Hospital and require OHNS consult for their ongoing epistaxis. 
 
4.2 Exclusion Criteria 
For this trial we will exclude any patients taking anticoagulant medication or other blood 
thinners. 
 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
4.3 Subject Withdrawal 
 Patients will be undergoing all aspects of the study under the supervision of a physician 
or research coordinator and will therefor be encouraged to express any concerns they 
have so they can be addressed as promptly as possible. We will minimize risk by 
providing the physicians involved with the most training possible to ensure placement of 
the treatment is done as easily and accurately as it can be. Patients who wish to withdraw 
from the study will be able to do so at any time and will be informed of this upon 
obtaining consent for the study. They will be instructed to speak with any member of the 
direct care or research team to withdraw him or herself from the study. Patients will not 
be replaced as this study has a rolling enrollment and we will continue until we acquire 
the proper number of participants. Data from the withdrawn participants will be 
discarded, however we will keep the record of the patient themselves and follow-up with 
them as we would any other patient in the study (if they are willing) to monitor for any 
adverse events and ensure patient safety. 
 
4.4 Treatment of Subjects 
The amount of time from patient admission to the emergency department until they are 
seen by an OHNS resident may be variable due to extraneous circumstances. Upon 
consult by OHNS if the patient meets the criteria for the study, informed consent will be 
obtained by a member of the research team (not the direct care team). They will have an 
opportunity to ask questions and sign the consent form.  
 
a.  Participants will be randomized using a sealed envelope system to either 
experimental or control group 
 
b.  Group A receives traditional nasal packing by a trained OHNS resident (merocel       
gauze) 
 
Group B receives treatment using 5 mL of Floseal Hemostatic Matrix by a trained 
OHNS resident 
 
c.  Both Groups are followed to observe the primary endpoint of hemostasis (end of 
bleeding) 
 
d. If hemostasis is not promptly achieved (as determined by the direct care team) than 
additional measures will be taken to arrest bleeding just as they would in any other non-
study situation 
 
e.  Hospital care or discharge continues as normal 
 
f.  Patients are telephoned or visited as inpatients 48 hours later to complete the 
comfort questionnaire 
 
We will have extra follow-up with these patients to observe the effects of our treatment 
on patient comfort and allow for the opportunity of a study debrief. This will occur two 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
days following their treatment and should last no more than five minutes over the 
telephone. 
 
4.5 Medication 
All other medication required by the patient or medications they are already taking will 
be continued and will not interfere with the progression of this study. 
 
5 Assessment of Efficacy 
 
5.1 Efficacy Parameters 
Efficacy of the Floseal Hemostatic Matrix will be determined by observing whether 
patients receiving either the Floseal or control treatment require additional measures to 
abort bleeding. Our primary endpoint is hemostasis, however if hemostasis is not 
adequately achieved, as determined by the OHNS resident providing direct care, than 
additional measures will be taken to abort bleeding and this will signify our primary 
endpoint. 
 
5.2 Method and Timing 
The research team will review the data obtained following each patient enrolled in the 
study to ensure that the protocol is being followed appropriately and that the primary and 
secondary endpoints are being appropriately recorded.  
 
6 Assessment of Safety 
 
6.1 Safety Parameters 
Patient safety throughout this trial will be monitored by both the direct care team and the 
research team. The direct care team will be able to contact the research team at any time 
to report and concerns that may arise regarding patient safety. The research team will also 
periodically (2-3 weeks) check in with the direct care team to ask about any concerns that 
they might have.  
 
6.2 Method and Timing 
Assessing safety will be the responsibility of the direct care team following the 
enrollment of each patient in the study. Safety concerns will be brought to the attention of 
the research team immediately if they are to arise. The research team will seek out 
concerns on a 2-3 week basis with the direct care team. Concerns will be recorded and 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
kept securely with the rest of the trial data on an encrypted computer in the research 
office. 
 
6.3 Adverse Event Reporting 
Any adverse events occurring throughout the duration of this study will be promptly 
addressed and brought to the attention of the University of Alberta HREB as well as 
Health Canada if the situation dictates.  
 
If any unseen safety concerns were to arise the protocol would be stopped and reviewed to 
determine the source of safety concerns. As this study is only observing one step in the 
treatment of the patient, their hospital care will be continued as required in all cases.  
 
6.4 Adverse Event Follow-up 
The direct care team will report any adverse events to the research team. The research team 
will follow-up with the patients in person or via telephone for the duration of treatment or 
until the adverse event has resolved. This study will not interfere with the normal care and 
treatment of these patients either before or after participation in the study.  
 
7 Statistical Plan 
 
7.1 Statistical Methods 
As this study is comparing a single experimental group to a control group we will use a 
standard statistical analysis to compare both the primary outcome of hemostasis and the 
secondary outcome results of the pain and comfort questionnaire. This is a non-inferiority 
study and has been powered as such. We will use a chi-square test to determine 
significance of any difference between the treatment and control group. 
7.2 Subject Population(s) for Analysis 
We hope to have 60 patients total enrolled in this study (30 Floseal and 30 control). This 
sample size was chosen to provide the powering listed below. This level of significance is 
based on a non-inferiority trial. We chose this trial type because we seek to quantify the 
secondary benefits for this treatment, which is already in use. All randomized subjects 
will be included in the statistical analysis based on an intention-to-treat protocol. 
7.3 Significance 
This is a non-inferiority trial with a power of 0.8, a non-inferiority limit of 5% and a 
significance level of P<0.05. 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
7.4 Termination Criteria 
Termination of this study will occur once we have enrolled the required number of 
patients or if there are any significant adverse events, which result in a decision by the 
research team to terminate the study. 
7.5 Deviation Reporting 
In the case that any changes to the statistical analysis of this trial may arise they will be 
fully disclosed. Any deviation from the original statistical plan will be amended and 
justified in the protocol and in the final report. 
 
8 Direct Access to Source Data/Documentation 
Throughout the study if direct access data is required for audit or other trial-related 
monitoring, it can be obtained by written request to Dr. David Cote. This includes access 
by any regulatory agency such as the University of Alberta HREB. 
 
9 Quality Control and Quality Assurance 
Data from the direct care team will be obtained in paper form and be scanned or 
otherwise transferred to electronic data kept on the research computer. Interim analysis 
will be done by the research team to ensure that data collection is continuing as per the 
protocol. The study coordinator (Alexander Hopkins) will review that data obtained 
following each patient enrolled in the study and ensure that it is being recorded in 
compliance with this protocol and good clinical practice requirements.  
10 Ethical Considerations 
 
This study will be conducted according to Canadian and international standards of Good 
Clinical Practice for all studies.  Applicable government regulations and University of 
Alberta research policies and procedures will also be followed. 
 
This protocol and any amendments will be submitted to the University of Alberta HREB 
for formal approval to conduct the study.  The decision of the HREB concerning the 
conduct of the study will be made in writing to the investigator.   
 
All subjects for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study.  This consent form will be submitted with the protocol for 
review and approval by the HREB.  The formal consent of a subject, using the HREB-
approved consent form, will be obtained before that subject is submitted to any study 
procedure.  This consent form must be signed by the subject or legally acceptable 
surrogate, and the investigator-designated research professional obtaining the consent.  

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
11 Data Handling and Record Keeping 
 
For confidentiality purposes all data for this study will be coded and de-identified and 
kept on an encrypted secured database in the personal office of Dr. David Cote. 
 
12 Supplements 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
Comfort Questionnaire 
 
Patient Name: _____________________ 
Researcher Filling out this form: _______________ 
 
Method of Contact (circle one):  
Telephone 
 
In Person 
 
 
Behavioural Rating Scale  
(  ) No pain 
  (  ) Pain present, but can easily be ignored 
  (  ) Pain present, cannot be ignored, but does not interfere with everyday activities  
(  ) Pain present, cannot be ignored, interferes with concentration 
  (  ) Pain present, cannot be ignored, interferes with all tasks except taking care of basic needs 
such as toileting and eating   
(  ) Pain present, cannot be ignored, rest or bedrest required  
 
Box Scale  
If a zero (0) means 'no pain', and a ten (10) means 'pain as bad as it could be', on this scale, 
what is your level of pain? 
Pain during placement: 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain during treatment: 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain during removal (if applicable): 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
 
 
Information Letter and Participant Consent Form 
 
Title of Study:  Management of Persistent Epistaxis Using Floseal Hemostatic Matrix 
 
Research Investigator/Study Coordinator:  
Supervisor: 
Alexander Hopkins BSc.  
 
 
 
Dr. David Côté 
3-007 Li Ka Shing 
 
 
 
 
1E4.07 WMC, 8440 112 Street 
University of Alberta 
 
 
 
 
University of Alberta Hospital 
Edmonton, AB, T6G 2R3 
 
 
 
Edmonton, AB, T6G 2B7 
arhopkin@ualberta.ca  
 
 
 
780-407-4490 
780-407-4490  
 
 
 
 
 
 
 
Why am I being asked to take part in this research study?   
 
You are being asked to be in this study because you have a nosebleed that has not 
stopped even after a first try at treatment in the Emergency Department. There are a number of 
treatment options for people in your situation and we are interested in studying which treatment 
has the best result at stopping bleeding quickly and is the most comfortable.  
 
The most standard treatment for severe nosebleeds is a re-packing of the nose using 
gauze by a trained Ear, Nose and Throat (ENT) specialist; this is what half of the participants in 
this study will receive. The other half of participants will be treated again by a trained ENT 
specialist using a less common (but still used) treatment called Floseal Hemostatic Matrix. We 
hope to have approximately 60 people participating in this study by the end of data collection. 
 
Before you make a decision one of the researchers will go over this form with you.  You 
are encouraged to ask questions if you feel anything needs to be made clearer.  You will be given 
a copy of this form for your records. 
 
What is the reason for doing the study? 
   
Floseal Hemostatic Matrix is a treatment that is already approved by Health Canada, and 
is currently in use in a number of hospital settings. In this study we want to know whether 
Floseal is more or less effective than simply packing the nose alone and whether it is more 
comfortable.  
 
What will I be asked to do?   
 
The amount of time required for the actual treatment in this study will be no longer than 
if you were not participating in the study. There will also be a comfort questionnaire that will be 
completed over the telephone and should take no more than 10 minutes to complete.  
 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
The treatment you will receive (either Floseal or traditional gauze packing) will be 
determined using randomization. Meaning you will have a 50/50 chance for which group you 
will be placed in. The doctor treating you will have no control over which group you are 
assigned to. In this study we will need to access your medical records to observe the 
effectiveness of the treatment and whether additional steps (such as hospital admission) were 
taken. 
 
Process 
 
 Upon completion of reading this letter you will have the opportunity to ask questions 
about the study and decide whether you would like to participate or not.  
 If you choose to participate you will sign the informed consent form. 
 You will receive a random treatment assignment and the physician will perform the 
assigned treatment (either Floseal or traditional packing). 
 Your care will continue as it normally would without participation in this study. 
 You will be contacted 48 hours following treatment and asked a few short questions 
about how you felt with the treatment. 
 
What are the risks and discomforts?   
 
 
 
As previously mentioned, Floseal is already an approved treatment for use in Canada. 
Should the Floseal not work in stopping the nosebleed, you may need to be re-packed and go to 
the operating theatre for surgical clipping of the nose vessels. There are very few risks associated 
with the use of Floseal. As some of the components of the Floseal Matrix come from human 
plasma, there is a very rare theoretical risk of transmitting an infectious agent although this has 
never previously been reported. Similarly, a component of the matrix is derived from bovine 
(cow) sources and if you have a history of allergy to cow products please let us know. 
 
It is not possible to know all of the risks that may happen in a study, but we have taken 
all reasonable safeguards to minimize any known risks to a study participant. If we find out 
anything new during the course of this research, which may change your willingness to be in the 
study, we will tell you about these findings. 
 
 
What are the benefits to me?   
 
 
Based on what we currently know about both the nose packing and Floseal treatments, it 
is possible that the Floseal treatment will be more comfortable and less painful than traditional 
packing. However, you may not get any benefit from being in this research study. We hope that 
the information from this study may help inform doctors how to best treat other people with 
severe nosebleeds in the future. 
 
 
 
 
 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
Do I have to take part in the study?   
 
Being in this study is your choice.  If you decide to be in the study, you can change your 
mind and stop being in the study at any time, and it will in no way affect the medical care that 
you are entitled to. 
 
In the event of opting out of the study your data will be withdrawn and discarded in a 
confidential manner. If you do withdraw from the study once it has started, we will attempt to 
follow up to ensure no complications arose a result of the study.  
 
Will my information be kept private?   
 
Any personal information or data we record about you will be kept confidential. No data 
relating to this study that includes your name will be released outside of the researcher’s office or 
published by the researchers. We will make every legal effort to make sure that your information 
is kept private. 
 
The investigator or their study staff may need to look at your personal health records 
throughout the study. Any personal health information that we get from these records will be 
only what is needed for the study.  
 
By signing this consent form you are saying it is okay for the study team to collect, use 
and disclose information about you from your personal health records as described above. After 
the study is done, we will still need to securely store your health data that was collected as part of 
the study. At the University of Alberta, we keep data stored for a minimum of 5 years after the 
end of the study.   
 
If you leave the study, we will not collect new health information about you, but we may 
need to keep the data that we have already collected. 
 
 
What if I have questions? 
 
If you have any questions about the research now or later, please contact Alexander Hopkins 
[780-660-1059].   
 
If you have any questions regarding your rights as a research participant, you may contact the 
Health Research Ethics Board at 780-492-2615.  This office has no affiliation with the study. 
 
Conflict of Interest 
 
We have no conflict of interest to declare. 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
This material is the property of the University of Alberta.  Do not disclose or use except as authorized.  
 
 
CONSENT 
 
Title of Study: Management of Persistent Epistaxis Using Floseal Hemostatic Matrix 
Principal Investigator: Dr. David Côté 
Phone Number: 780-407-4490 
Study Coordinator: Alexander Hopkins 
Phone Number: 780-407-4490 
 
 
Yes 
No 
 
Do you understand that you have been asked to be in a research study? 
 
 
 
Have you read and received a copy of the attached Information Sheet? 
 
 
 
Do you understand the benefits and risks involved in taking part in this research study? 
 
 
 
Have you had an opportunity to ask questions and discuss this study? 
 
 
 
Do you understand that you are free to leave the study at any time, 
 
 
without having to give a reason and without affecting your future medical care or without penalty? 
 
Has the issue of confidentiality been explained to you?  
 
 
 
Do you understand who will have access to your study records, including 
 
 
personally identifiable health information? 
 
 
Who explained this study to you? _____________________________________________________ 
 
 
I agree to take part in this study (Circle One): Yes 
 
No 
 
 
Signature of Research Participant ______________________________________________________ 
 
 
(Printed Name) ____________________________________________________________ 
 
Date:______________________________ 
 
 
I believe that the person signing this form understands what is involved in the study and voluntarily 
agrees to participate. 
 
Signature of Investigator or Designee 
________________________________ Date __________ 
 
THE INFORMATION SHEET MUST BE ATTACHED TO THIS CONSENT FORM AND A 
COPY GIVEN TO THE RESEARCH PARTICIPANT