Clinical trial NCT04842292
Conditions: Covid19
Sponsor: Brittany Bissell
Start date: 2021-05-20; Completion date: 2021-09-04
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation.

Detailed description:

Arms: arm 1: Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours arm 2: Sodium chloride 0.9% 5 mL inhalation every 6 hours
Interventions: intervention 1: Heparin intervention 2: Placebo
Intervention descriptions: intervention 1: Nebulized heparin 25,000 units every 6 hours intervention 2: Sodium chloride 0.9% every 6 hours

Protocol documents:
Prot_ICF_000.pdf: 
Document Coversheet 
 
 Study Title: Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-
associated Acute Respiratory Failure 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
01/31/22 
NCT Number: 
NCT04842292 
IRB Number 
65138 
Coversheet created: 
09/20/22 
 
 


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Consent and Authorization to Participate in a Research Study 
 
KEY INFORMATION FOR COVID19 Utilization of Nebulized Heparin for Patients Receiving 
Mechanical Ventilation for COVID19-associated Acute Respiratory Failure 
 
We are asking you to choose whether or not to volunteer for a research study about the administration of heparin 
nebulization (inhalation) in patients admitted to the intensive care unit on a ventilator for COVID-19. We are asking 
you because you have been diagnosed with COVID-19 and have acute respiratory distress syndrome per your 
treatment team. This page is to give you key information to help you decide whether to participate. We have included 
detailed information after this page. Ask the research team questions. If you have questions later, the contact 
information for the research investigator in charge of the study is below.   
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?   
By doing this study, we hope to learn whether heparin, a blood thinner, when given directly to your lungs, helps 
lung improvement when compared to placebo. Your participation in this research will last about 10 days. In order 
to do this, we will collect blood from you on 3 different days and we will monitor you until hospital discharge. More 
information on this procedure are provided later in this form. 
The purpose of this research is to gather information on the safety and effectiveness of nebulized heparin. Heparin 
is approved by the Food and Drug Administration (FDA), but being tested for a different purpose. 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
If you are assigned to the placebo part of the study, you will not benefit directly, but will help to inform us and 
other healthcare professionals about the blood and how it clots in COVID-19 respiratory failure, a process which 
can be targeted for treatment. 
If you are assigned to receive heparin, it could decrease the duration you require supplemental oxygen via the 
ventilator and may allow you to be discharged from the hospital sooner.  For a complete description of potential 
benefits, refer to the Detailed Consent. 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
If you are assigned to receive heparin, this medication may carry a risk for bleeding and we highly recommend 
to your physician that you receive monitoring for such bleeding while in the ICU. About 3-5% of patients are 
reported to experience an adverse event, such as bleeding, while receiving this medication.  
You might not want to volunteer for this study if you do not want your samples used for research. That is 
perfectly fine and declining to participate in this study will not affect your clinical care in any way. For a complete 
description of risks, refer to the Detailed Consent. 
DO YOU HAVE TO TAKE PART IN THE STUDY? 
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any 
services, benefits or rights you would normally have if you choose not to volunteer.  
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS? 
If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study 
contact Brittany Bissell, PharmD, PhD of the University of Kentucky, Department of Pulmonary, Critical Care, 
and Sleep and Pharmacy Practice and Science at  
Phone: 740-541-3471 
Email: brittany.bissell@uky.edu  
If you have any concerns or questions about your rights as a volunteer in this research, contact staff in the 
University of Kentucky (UK) Office of Research Integrity (ORI) between the business hours of 8am and 5pm 
EST, Monday-Friday at 859-257-9428 or toll free at 1-866-400-9428. 
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DETAILED CONSENT: 
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
If you are pregnant, have a heparin allergy, active bleeding, a history of bleeding, or an illness which requires a 
blood thinner to be administered within the vein, you do not qualify for this study.  
WHERE WILL THE STUDY TAKE PLACE AND WHAT IS THE TOTAL AMOUNT OF TIME INVOLVED? 
The research procedures will be conducted in the Medical Intensive Care Unit (MICU) at the UK Chandler Medical 
Center. All procedures will occur during hospital stay while you are in the MICU. Each visit will take about 10 
minutes in total. The total amount of time you will be asked to volunteer for this study is up to 1 hour over the 
next 10 days.  
WHAT WILL YOU BE ASKED TO DO? 
• 
If you agree to participate, you will be asked to sign a consent form. 
• 
Your treatment will not change based on enrollment in this study.  
• 
Once the consent form is signed, we will collect one tube of blood – approximately 10 mL (2 tsp). This 
blood will be taken from a central line (a catheter in a large vein), if you have one, or a peripheral line, if 
not (a catheter within a smaller vein) 
• 
Every effort will be made to collect blood at the same time as other standard of care blood draws. If no 
additional blood draws are ordered for the day, the sample will be collected at the same time of 
medication administration to decrease your interruptions throughout the day 
• 
We will repeat this procedure at day three and day ten of your stay. 
• 
You will receive either heparin or a control agent (sodium chloride) every 6 hours while on the mechanical 
ventilator, up to 10 days total. 
• 
We will look at data from the medical chart during your stay in the hospital. 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? 
Loss of Confidentiality: Any time information is collected, there is a potential risk for loss of confidentiality. Every 
effort will be made to keep your information confidential; however, this cannot be guaranteed. 
 
Risks of Blood Draw: Risks associated with drawing blood from the intravenous line you already have are 
minimal, but may include discomfort, bruising, soreness, infection, excess bleeding, clotting, light headedness, or 
fainting. You will have up to 8 teaspoons of blood collected total as a part of this study. 
 
Risks of Study Medication: In previous studies of nebulized heparin, there has been a 3-5% increase in risk of 
bleeding. This bleeding can be serious if it is in your lungs or brain. It is an uncommon risk and can be corrected 
either surgically or with blood products.  
 
Possible Risk 
How often has it 
occurred? 
How serious is it? 
Can it be corrected? 
Bleeding anywhere 
other than lungs 
It is extremely 
uncommon 
Moderately serious 
Yes; With blood products or 
surgery 
Bleeding in lungs 
It is extremely 
uncommon 
Serious 
Yes; With blood products or 
surgery 
Heparin allergy 
It is extremely 
uncommon 
Very serious 
Yes; With blood thinners 
Changes in 
ventilator 
It is extremely 
uncommon 
Moderately serious 
Yes; by changes from your 
lung doctor 
 
 
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There is always a chance that any medical treatment can harm you. The research treatments/procedures in this 
study are no different. In addition to risks described in this consent, you may experience a previously unknown 
risk or side effect. 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
We do not know if you will get any benefit from taking part in this study. However, some people have experienced 
decreased time on the venitlator when receiving nebulized heparin during mechanical ventilation. If you receive 
placebo, you will not get any personal benefit from taking part of this study. However, if you take part in this study, 
information learned may help others with your condition. 
IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES? 
If you do not want to be in the study, there are no other choices except not to take part in the study. 
WHAT WILL IT COST YOU TO PARTICIPATE? 
You and/or your insurance company, Medicare, or Medicaid will be responsible for the costs of all care and 
treatment that you would normally receive for any conditions you may have. These are costs that are considered 
medically necessary and will be part of the care you receive even if you do not take part in this study. 
The University of Kentucky may not be allowed to bill your insurance company, Medicare, or Medicaid for the 
medical procedures done strictly for research.  
Therefore, these costs will be paid by the study. 
Your insurer, Medicare, or Medicaid, may agree to pay for the costs. However, a co-payment or deductible may 
be needed from you. The amount of this co-payment or deductible may be costly. 
WHO WILL SEE THE INFORMATION THAT YOU GIVE? 
When we write about or share the results from the study, we will write about the combined information. We will 
keep your name and other identifying information private.  
We will make every effort to prevent anyone who is not on the research team from knowing that you gave us 
information, or what that information is. Any paper records will be kept in locked file cabinets in locked offices and 
you will be given a unique subject identifier number in our electronic databases that cannot identify you.   
You should know that in some cases we may have to show your information to other people.  
For example, the law may require or permit us to share your information with:  
• 
a court or agencies, if you have a reportable disease/condition; 
• 
authorities or a mental health professional if you pose a danger to yourself or someone else (e.g. suicidal 
thoughts).  
To ensure the study Is conducted properly, officials of the Food and Drug Administration and the University 
of Kentucky may look at or copy pertinent portions of records that identify you. 
 REDCap is a secure, web-based program to capture and store data at the University of Kentucky. We will make 
every effort to safeguard your data in REDCap. However, given the nature of online surveys, we cannot 
guarantee the security of data obtained by way of the Internet.   
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY? 
You can choose to leave the study at any time. You will not be treated differently if you decide to stop taking part 
in the study. 
If you choose to leave the study early, data collected until that point will remain in the study database and may not 
be removed.  
The investigators conducting the study may need to remove you from the study. You may be removed from the 
study if: 
• 
you are not able to follow the directions, 
• 
we find that your participation in the study is more risk than benefit to you, or  
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• 
the agency paying for the study chooses to stop the study early for a number of scientific reasons.  
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEARCH STUDY AT THE SAME 
TIME AS PARTICIPATING IN THIS ONE? 
You may take part in this study if you are currently involved in another research study. It is important to let the 
investigator/your doctor know if you are in another research study. You should discuss this with the 
investigator/your doctor before you agree to participate in another research study while you are in this study. 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
If you believe you are hurt or if you get sick because of something that is due to the study, you should contact 
your nurse and medical team immediately. Once they are informed, either you or they may contact Brittany 
Bissell, PharmD, PhD at 740-541-3471  
Your medical team will determine what type of treatment, if any, is best for you at that time. 
It is important for you to understand that the University of Kentucky does not have funds set aside to pay for the 
cost of any care or treatment that might be necessary because you get hurt or sick while taking part in this study. 
Also, the University of Kentucky will not pay for any wages you may lose if you are harmed by this study. 
Medical costs related to your care and treatment because of study-related harm will be your responsibility. 
A co-payment/deductible may be needed by your insurer or Medicare/Medicaid even if your insurer or 
Medicare/Medicaid has agreed to pay the costs. The amount of this co-payment/deductible may be costly. 
You do not give up your legal rights by signing this form. 
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? 
You will not receive any rewards or payment for taking part in the study.  
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR DECISION 
TO PARTICIPATE? 
We will tell you if we learn new information that could change your mind about staying in the study. We may ask 
you to sign a new consent form if the information is provided to you after you have joined the study.  
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS? 
Generally, tests done for research purposes are not meant to provide clinical information. We will not provide 
you with individual research results.  
There is a slight possibility that during a research procedure, an investigator could discover something that could 
affect your health. If this occurs, it will be reviewed by the clinician investigator and, if necessary, discussed with 
your medical team. That information may be placed in your medical record and discussed with you. This will help 
in providing appropriate medical care.  
WHAT ELSE DO YOU NEED TO KNOW? 
If you volunteer to take part in this study, you will be one of about 50 people to do so.   
The University of Kentucky is providing financial support and/or material for this study. 
A description of this clinical trial will be available on ClinicalTrials.gov as required by U.S. Law. This website will 
not include information that can identify you. At most, the website will include a summary of the results. You can 
search this website at any time. 
WILL YOUR INFORMATION (OR SPECIMEN SAMPLES) BE USED FOR FUTURE RESEARCH? 
Your information or samples collected for this study will NOT be used or shared for future research studies, 
even if we remove the identifiable information like your name, medical record number, or date of birth. 
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AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH INFORMATION  
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to protect your 
health information. The following sections of the form describe how researchers may use your health information.   
Your health information that may be accessed, used and/or released includes: 
• 
All health information that is listed within the medical chart for this hospitalization (the hospitalization 
during which the study takes place) include but not limited to: 
• 
Demographics, including age, gender, and medical record number  
• 
Medical History and Physical Exam results related to this study 
• 
Laboratory test results 
• 
Vital signs 
• 
Medication data 
• 
Diagnostic images and findings related to this study 
• 
All diagnostic and medical procedures related to the study 
• 
Consultation reports and progress notes related to the study  
The Researchers may use and share your health information with: 
• 
The University of Kentucky’s Institutional Review Board/Office of Research Integrity; 
• 
Law enforcement agencies when required by law; 
• 
University of Kentucky representatives; 
• 
UK Hospital  
• 
Investigational Drug Service (IDS)  
The researchers agree to only share your health information with the people listed in this document.   
Should your health information be released to anyone that is not regulated by the privacy law, your health 
information may be shared with others without your permission; however, the use of your health information may 
still be regulated by applicable federal and state laws.   
You may not be allowed to participate in the research study if you do not sign this form. If you decide not to sign 
this form, it will not affect your: 
• 
Current or future healthcare at the University of Kentucky; 
• 
Current or future payments to the University of Kentucky; 
• 
Ability to enroll in any health plans (if applicable); or 
• 
Eligibility for benefits (if applicable). 
After signing the form, you can change your mind and NOT let the researcher(s) collect or release your 
health information (revoke the Authorization). If you revoke the authorization: 
• 
Send a written letter to: Brittany Bissell, PharmD, PhD inform her of your decision. Her address is: 740 
South Limestone Street, KY Clinic J530, Lexington, KY 40536 
• 
Researchers may use and release your health information already collected for this research study. 
• 
Your protected health information may still be used and released should you have a bad reaction 
(adverse event). 
The use and sharing of your information has no time limit.  
If you have not already received a copy of the Privacy Notice, you may request one. If you have any 
questions about your privacy rights, you should contact the University of Kentucky’s Privacy Officer 
between the business hours of 8am and 5pm EST, Monday-Friday at (859) 323-1184. 
 
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INFORMED CONSENT SIGNATURES 
 
This consent includes the following: 
• Key Information Page 
• Detailed Consent  
You will receive a copy of this consent form after it has been signed. 
 
 
 
___________________________________________                      _____________________ 
Signature of research subject or, if applicable,  
 
   
         Date 
*research subject’s legal representative  
 
 
 
 
 
___________________________________________ 
 
 
 
Printed name of research subject  
 
 
 
___________________________________________ 
*Printed name of research subject’s legal representative  
 
 
 
 
*If applicable, please explain Representative’s relationship to subject and include a description of 
representative’s authority to act on behalf of subject: 
________________________________________________________________________________ 
________________________________________________________________________________ 
 
 
________________________________________________________________          ___________ 
Printed name of [authorized] person obtaining informed consent and  
HIPAA authorization  
 
 
 
 
 
 
 
 
   Date 
 
 
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