Clinical trial NCT01980355
Conditions: Tranexamic Acid Cancer Major Surgery
Keywords: cancer surgery oncology major surgical oncology tranexamic acid
Sponsor: Spectrum Health Hospitals
Start date: 2012-06-12; Completion date: 2020-07-29
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your surgical hospital stay.

In this study, you will receive either the drug tranexamic acid or a placebo. The placebo looks like the tranexamic acid, but does not have any active ingredient in it. The treatment you get will be chosen by chance, like flipping a coin. You will have equal chance of being given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the placebo are considered research.

Detailed description:
Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given the tranexamic acid or the placebo. Neither you nor the study doctor will know which treatment you are getting.

You will receive one 1000 mg dose of either tranexamic acid or placebo immediately before surgery. This dose of tranexamic acid or placebo will be given in your vein over 15 minutes.

Information from your medical record related to your surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with your study number instead of your name. Additionally, if you return to the hospital within 90 days after you went home from the hospital, information about that hospital visit(s) will also be collected from your medical record.

Arms: arm 1: 1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery. arm 2: Placebo given over 15 minutes into the vein once prior to surgery.
Interventions: intervention 1: Tranexamic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf: 
Version Date: 20-November-2015 
Page 1 of 5 
1. Protocol Title: The effect of tranexamic acid on blood loss and transfusion rates in major 
oncologic surgery. 
 
2. Investigator(s): G. Paul Wright, MD; Mathew H. Chung, MD 
 
3. Version Date: 20-November-2015 
 
4. Objectives: 
• 
To determine the impact of preoperative administration of tranexamic acid on blood 
loss and transfusion rates in major oncologic surgery.   
• 
To evaluate the cost-effectiveness of tranexamic acid in major oncologic surgery. 
 
5. Background: 
Tranexamic acid was first introduced in the 1960’s as a treatment for heavy menstrual 
bleeding.1 This medication inhibits fibrinolysis by inhibiting multiple plasminogen binding 
sites. In the past two decades, it’s use has been incorporated into surgical practice for 
patients undergoing open-heart surgery, liver transplantation, and urologic surgery.2-4 
Recent reports of decreased mortality in patients with traumatic hemorrhage receiving 
tranexamic acid have shown significant promise.5-6 A 2006 study published out of Taiwan 
demonstrated decreased blood loss, reduced transfusion rates, and decreased overall 
hospital cost in patients undergoing liver resections for both benign and malignant 
conditions.7 
 
Major oncologic surgeries involving the liver and gastrointestinal tract involve extensive 
dissection, which can result in significant operative blood loss requiring intra- or 
postoperative transfusion. Tranexamic acid may be a useful addition in procedures with 
significant blood loss, as previous studies indicate it is both safe and affordable. While 
reports of seizure activity have been published when used at high doses (100 mg/kg), 
standard dosing regimens have proven to be safe and effective.8,9 The beneficial effect of 
reduction in bleeding has been demonstrated without an increase in thromboembolic 
events.6 We believe tranexamic acid has potential to reduce bleeding in major oncologic 
surgery resulting in reduced blood loss and lower transfusion rates. An improvement in the 
rate of surgical complications related to bleeding may also result in decreased hospital costs 
as well. 
 
6. Setting of the Research: 
Spectrum Health Butterworth Campus.  Lemmen-Holton Cancer Pavilion. 
 
7. Resources Available to Conduct this Research: 
Approximately 15 major oncologic surgeries are performed on a monthly basis at the 
Spectrum Health Butterworth Campus. All individuals scheduled to undergo these surgeries 
that meet the eligibility criteria will be recruited for enrollment. Study personnel will include 
surgical residents with experience in surgical oncology research and knowledge of surgical 
outcome measures, with monitoring by a staff surgical oncologist. 
 
8. Study Design: 
a. Recruitment Methods 
Potential subjects will be recruited at their preoperative office visit with their surgeon 
or, if applicable, during their inpatient stay prior to surgery. Informed consent will be 
obtained by the Spectrum Health Oncology Research staff. The potential subjects 
include all patients scheduled to undergo major oncologic surgery that meet all of the 


Version Date: 20-November-2015 
Page 2 of 5 
inclusion criteria, and none of the exclusion criteria. There will be no payment to 
study subjects. We plan to enroll a total of 200 subjects, unless planned interim 
analyses determine otherwise. 
 
b. Inclusion Criteria 
• 
Subjects undergoing major oncologic surgery for standard of care purposes 
(to include, but not limited to: liver resections, radical cholecystectomy, 
pancreaticoduodenectomy (Whipple procedure), esophagectomy, 
gastrectomy, colectomy, and debulking with hyperthermic intraperitoneal 
chemotherapy, prostatectomies, nephrectomies, and partial neprectomies) 
• 
Male or female > 18 years of age 
• 
Subject agrees to participate in this study and provides informed consent 
 
Exclusion Criteria 
• 
Subjects with a history of hypercoagulopathy, deep vein thrombosis or 
pulmonary embolism 
• 
Subjects that are on anticoagulation or antiplatelet medications at the time of 
surgery other than Aspirin 
• 
Subjects with a history of TIA or Stroke 
• 
Subjects with a history of atrial fibrillation 
• 
Subjects with a known thrombus  
• 
Baseline creatinine level greater than 2.83 mg/dL 
• 
Subjects with known hypersensitivity to tranexamic acid 
• 
Adults unable to provide informed consent 
• 
Children 
• 
Pregnant women 
• 
Prisoners 
• 
Non-English speaking subjects 
• 
Any other medical condition including mental illness or substance abuse 
deemed by the investigator to be likely to interfere with a subject’s ability to 
provide informed consent, cooperate and take part in this research study 
 
c. Study Endpoints 
The primary outcome measures will be operative blood loss and transfusion rates in 
subjects undergoing the eligible procedures. Secondary outcome measures will 
include cost of hospitalization, intensive care unit length of stay, and total hospital 
length of stay. 
 
d. Procedures Involved in the Research 
The study design will be a randomized, double-blind, placebo-controlled trial. 
Following satisfaction of inclusion/exclusion criteria and enrollment into the study, 
designated pharmacy staff will be notified of the patient’s enrollment and scheduled 
timing of surgery. Designated pharmacy staff will randomize the patient and assign 
the patient a unique study number. The subject will be randomized based on a 
predetermined algorithm by the pharmacy staff to receive preoperative intravenous 
tranexamic acid or preoperative intravenous isotonic electrolyte solution as placebo. 
The preparation will be indistinguishable by nursing, surgical, or anesthesia staff. 
The tranexamic acid group will receive a 1000 mg dose immediately preceding 
surgery, administered by the anesthesiologist. Both the tranexamic acid and placebo 
will be administered via intravenous piggyback over 15 minutes. Standard daily 


Version Date: 20-November-2015 
Page 3 of 5 
laboratory measurements will continue unless clinical conditions necessitate more 
frequent monitoring. Transfusion will take place for hemoglobin levels < 7.0 g/dL or 
hemoglobin level < 10 g/dL with clinical symptoms indicating need for transfusion, 
per standard practice. Final decision on transfusion will be made according to the 
staff surgical oncologist’s discretion. 
 
Data to be recorded from operative records will include operative blood loss, 
operative time, amount of fluid received, and intraoperative transfusion requirements. 
Postoperative data including hemoglobin levels, transfusion requirements, surgical 
complications, thromboembolic events, length of ICU stay, length of hospital stay, 
and cost of inpatient stay. Subjects will be followed for 90 days postoperatively. 
Additionally, re-admission to the hospital during this time will also be recorded with 
associated complications. 
 
e. Data Management 
The study personnel will collect outcome data on a weekly basis. Data will be stored 
in a password-protected file for security. Pharmacy staff will keep a secure record of 
subjects randomized to the tranexamic acid and placebo arms respectively, which 
will be blinded from the study personnel. 
 
f. Provisions to Monitor the Data for the Safety of Subjects 
Adverse events including thromboembolic events and development of acute renal 
failure will be monitored and recorded on a weekly basis by study personnel. In the 
event an increased number of unanticipated events occur, the study will be 
temporarily stopped pending review. Review of unblinded data will be performed by 
an independent clinician, pharmacist, and statistician to determine the need to 
discontinue or resume the study. If a significant increase in adverse events is noted 
in the treatment arm, the trial will be terminated. Decisions resulting from the review 
will be discussed with the primary investigator.   
 
Interim reviews of unblinded data for statistically significant findings will be performed 
by an independent clinician, pharmacist, and statistician after every 50 subjects 
complete the study. Findings will be reviewed with the investigators, and decisions 
will be made as to whether or not the research study continues. These interim 
reviews and outcomes will be reported to the IRB. 
 
g. Withdrawal of Subjects 
Subjects will be withdrawn from the study if they experience an adverse drug 
reaction defined as anaphylaxis. Other potential side effects such as nausea, 
vomiting, or diarrhea will be treated symptomatically per standard of care. If 
refractory to standard treatment for these side effects, subjects will be withdrawn 
from the study. Subjects experiencing any thrombotic event prior to completion of 
study drug dosing schedule will be withdrawn from study. Subjects may choose at 
any time to voluntarily withdraw from the study. If subjects choose to withdraw, their 
data will not be included for analysis if they did not complete the proposed dosing 
regimen.  
 
The primary investigator may remove a subject at any time from this research study 
if it is felt to be in the best interest of the subject. 
 
 


Version Date: 20-November-2015 
Page 4 of 5 
9. Statistical Plan 
a. Sample Size Determination 
We anticipate a 15-20% reduction in transfusion rates in the tranexamic arm when 
compared with placebo treatment. A sample size of 200 total subjects, 100 in each 
arm of the study, will be required to obtain a statistically significant result with p 
<0.05. Randomization will ensure an equal number of respective surgeries between 
the treatment and placebo arms of the study. All subjects who consent to the trial 
who meet the above inclusion criteria and complete the proposed dosing regimen will 
be included in the sample size. 
 
b. Statistical Methods 
Summary statistics will be calculated. Quantitative data will be expressed as the 
mean+SEM and nominal data will be expressed as a percentage. Comparisons 
between groups for quantitative variables will be performed using the t-test. Nominal 
variables will be evaluated using the c2 test. Significance will be assessed at p<0.05.  
 
10. Risks to Subjects 
Tranexamic acid is an FDA approved medication. The safety of tranexamic acid has 
been demonstrated in a meta-analysis of the off-label use of tranexamic acid in the 
perioperative period. A theoretical risk of thromboembolic events exists, though no 
significant adverse outcomes have been reported with the proposed dosing 
schedule. Refer to Pfizer Physician Prescribing Information document for a listing of 
potential adverse effects. 
 
11. Potential Benefits to Subjects 
Potential benefits include decreased surgical blood loss resulting in decreased 
transfusion requirements. Transfusion of packed red blood cells has been associated 
with numerous potential adverse events. In addition, decreased overall hospital cost 
may occur if the study subjects experience decreased complication rates. 
 
12. Provisions to Protect the Privacy Interests of Subjects 
The study, potential risks and benefits of treatment will be discussed extensively with 
each potential subject at their preoperative office visit (or as an inpatient, if 
applicable) in a private space. Any questions they have will be answered 
accordingly. Reported data will not contain identifiable information. 
 
13. Provisions to Maintain the Confidentiality of Data 
Identifiable study data will be kept in a secure password-protected file or locked 
cabinets by study personnel. Pharmacy staff will have record of the randomization of 
each individual subject stored in a controlled, secure area. 
 
14. Medical Care and Compensation for Injury 
Any medical or surgical complications experienced relative to this research will be treated in 
accordance with current standards of care. No study funds have been set aside to 
compensate subjects for injury.  
 
15. Cost to Subjects 
Study drug, placebo, and preparation/administration will be paid for by funds 
allocated to the study, and not billed to the subjects. All other aspects of the subject’s 
care are considered standard of care, and will be billed to the patient and/or their 
insurance company.  


Version Date: 20-November-2015 
Page 5 of 5 
16. Consent Process 
Eligible subjects will be recruited at their scheduled preoperative office visit. In rare 
circumstances recruitment will take place in the inpatient setting if a preoperative visit 
is not scheduled to occur. The potential risks and benefits of the study will be 
discussed in detail by the Spectrum Health Oncology Research staff in a private 
space. All subjects will be ensured adequate time to read the research informed 
consent form, and all questions will be answered to their satisfaction. Subjects will be 
informed that the research is a voluntary option. The subject may choose to sign the 
research consent at the time of the office visit. If the subject desires additional time to 
consider the study, they may take a research consent home for review purposes, 
and they may choose to consent to involvement in the study at any time up to the 
date of their scheduled surgical procedure. 
 
17. Vulnerable Populations 
There will be no involvement of vulnerable populations in this study.   
 
18. Sharing of Results with Subjects 
Study results will not be shared with subjects until formal publication of the data.  
Results will be shared as requested at that time. 
 
19. References 
1) Vermylen J, et al. A double blind study of the effect of tranexamic acid in essential 
menorrhagia. Thromb Diath Haemorrh 1968;20(3):583-7. 
 
2) Casati V, et. al. Tranexamic acid in off-pump coronary surgery: A preliminary, randomized, 
double-blind, placebo-controlled study.  Ann Thorac Surg 2001;72:470-5. 
 
3) Massicotte L, et. al. Aprotinin versus tranexamic acid during liver transplantation: Impact on 
blood product requirements and survival.  Transplantation 2011;91:1273-8. 
 
4) Crescenti A, et. al. Intraoperative use of tranexamic acid to reduce transfusion rate in patients 
undergoing radical retropubic prostatectomy: double-blind, randomized, placebo-controlled trial.  
BMJ 2011;343:d5701. 
 
5) CRASH-2 trial collaborators.  Effects of tranexamic acid on death, vascular occlusive events, 
and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a 
randomized, placebo-controlled trial.  Lancet  2010;376:23-32. 
 
6) Cap AP, et. al.  Tranexamic acid for trauma patients: A critical review of the literature.  J 
Trauma 2011;71:S9-14 
 
7) Wu CC, et al.  Perioperative parenteral tranexamic acid in liver tumor resection.  Ann Surg 
2006;243:173-80. 
 
8) Kalavrouziotis D, et. al.  High-dose tranexamic acid is an independent predictor of early 
seizure after cardiopulmonary bypass.  Ann Thorac Surg 2011;(epub ahead of print). 
 
9) Henry DA, Carless PA, Moxey AJ, et. al.  Anti-fibrinolytic use for minimising perioperative 
allogenic blood transfusion.  Cochrane Database Syst Rev.  2011;16(3):CD001886. 

ICF_001.pdf: 
Tranexamic Acid 
Version Date: 22-August-2017 
  Page 1 of 7 
 
 
                     
 
 
 
Permission to Take Part in a Human Research Study & 
HIPAA Authorization for Release of Health Information for 
Research Purposes 
 
 
Title of research study: The effect of tranexamic acid on blood loss and transfusion rates in major 
oncologic surgery. 
 
Sponsor: Spectrum Health 
Investigators: G. Paul Wright, MD; Mathew Chung, MD; Brian Lane, MD, PhD; Andrea Wolf, MD; 
Christopher Brede, MD 
“You” refers to the subject.   
“We” refers to Spectrum Health and Spectrum Health Medical Group. 
 
We invite you to take part in a research study because you are scheduled to undergo major surgery.  
 
What you should know about a research study? 
• 
Someone will explain this research study to you. 
• 
You volunteer to be in a research study. 
• 
Whether or not you take part is up to you. 
• 
You can choose not to take part in the research study. 
• 
You can agree to take part now and later change your mind. 
• 
Whatever you decide it will not be held against you. 
• 
Feel free to ask all the questions you want before you decide. 
 
Who can I talk to? 
If you have questions, concerns, or think the research has hurt you talk to the investigator, Dr. G. 
Paul Wright, at (616) 486-6333. 
 
This research has been reviewed and approved by the Spectrum Health Institutional Review Board.  
You may talk to them at (616) 486-2031 or irb@spectrumhealth.org for any of the following: 
• 
Your questions, concerns, or complaints are not being answered by the investigator or 
research team. 
• 
You cannot reach the investigator or research team. 
• 
You want to talk to someone besides the investigator or research team. 
• 
You have questions about your rights as a research participant. 
• 
You want to get information or provide input about this research. 
 
Patient name 
DOB 
MRN 
Physician 
FIN 
SH IRB APPROVED ON: 09/19/2017 
DO NOT USE AFTER: 12/05/2017


Tranexamic Acid 
Version Date: 22-August-2017 
  Page 2 of 7 
 
Why are we doing this research? 
Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. 
Tranexamic acid is a medication that was first introduced in the 1960’s as a treatment for heavy 
menstrual bleeding. Over the past 20 years, it has been used and studied in patients undergoing 
open-heart surgery, liver transplantation and urologic surgery. We believe tranexamic acid may 
possibly decrease bleeding related to major surgery, resulting in reduced blood loss, lower blood 
transfusion rates and possibly decreased hospital costs related to your surgical hospital stay. 
 
How long will I be in the research? 
We expect that you will be in this research study for the length of time you are in the hospital for your 
major surgery and for up to 90 days after your surgery. 
 
How many people will be studied? 
We expect about 200 people here at Spectrum Health will be in this research study. 
 
What happens if I say yes, I want to be in this research? 
• 
If you are scheduled for a major surgery, you may be approached about this research study 
by your surgeon or one of the physician residents that are doing the study with your surgeon. 
This may take place in your surgeon’s office or in the hospital, if you are in the hospital. 
 
• 
You will meet with someone from the study team from the Spectrum Health Research 
Department to review this informed consent with you and answer any questions that you may 
have. If you are interested in taking part, you will be asked to sign this consent form. This may 
take place at any time prior to your scheduled major surgery, but will likely take place when 
you come to the hospital and register on the day of your surgery. 
 
• 
The pharmacy staff will be notified that you are part of this study. The designated pharmacy 
staff will assign you a study number, and they will be told when your surgery has been 
scheduled. 
 
• 
In this study, you will receive either the drug tranexamic acid or placebo. The placebo looks 
like the tranexamic acid medicine, but does not have any active ingredient in it. In this study, 
both the tranexamic acid and the placebo are considered research. 
 
• 
The treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study 
doctor will choose what treatment you get. You will have an equal chance of being given the 
tranexamic acid or the placebo. Neither you nor the study doctor will know which treatment 
you are getting.  
 
• 
You will receive one 1000 mg dose of either tranexamic acid or placebo immediately before 
surgery.  
 
• 
This dose of tranexamic acid or placebo will be given in your vein over 15 minutes.  
 
• 
As part of your regular care, you will continue to have your blood checked. If your blood count 
is low, you may require a blood transfusion, if your surgeon feels it is in your best interest.   
 
 
SH IRB APPROVED ON: 09/19/2017 
DO NOT USE AFTER: 12/05/2017


Tranexamic Acid 
Version Date: 22-August-2017 
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• 
Information from your medical record related to your surgery and recovery time in the hospital 
will be collected by medical staff assisting with this study and recorded on study forms. These 
study forms will be labeled with your study number instead of your name. Additionally, you will 
be followed for 90 days from the day of your surgery. If you return to the hospital after being 
discharge during this time information about that hospital visit(s) will also be collect from your 
medical record. 
 
• 
The tranexamic acid and placebo are considered experimental in this research study. All other 
parts of your hospital stay for your scheduled major surgery are considered part of regular 
care.  
 
What happens if I say no, I do not want to be in this research? 
Your alternative to taking part in this study is to receive the usual medical care as prescribed by your 
surgeon without the study drug (either tranexamic acid or placebo). You may decide not to take part 
in the research and it will not be held against you. A refusal to take part will involve no penalty or loss 
of benefits to which you are otherwise entitled. 
 
What happens if I say yes, but I change my mind later? 
You can agree to take part in the research now and stop at any time and it will not be held against 
you. If you stop taking part in this research, it will not result in penalty or loss of benefits to which you 
are otherwise entitled. If you decide to leave the research, contact Dr. G. Paul Wright.   
 
If you stop being in the research, already collected data may not be removed from the study 
database. You will be asked whether the investigator can continue to collect data from your routine 
medical care. If you agree, this data will be handled the same as research data. 
 
Could being in this study be bad for me? 
By taking part in this study, you will receive either tranexamic acid or placebo. You may have side 
effects from the study treatments used in this study and they will vary from person to person. 
Following, is a list of side effects that may be caused by tranexamic acid.  
 
Risks of Tranexamic Acid: 
• 
Nausea 
• 
Vomiting 
• 
Diarrhea 
• 
Dizziness 
 
Occasional: 
• 
Allergic dermatitis (skin rash) 
• 
Giddiness 
• 
Hypotension (low blood pressure) 
 
Rare: 
• 
Blood clotting events (blood clots in the legs, lungs, brain, kidneys, and eyes or other parts of 
the body) 
• 
Convulsions 
• 
Visual changes 
 
 
SH IRB APPROVED ON: 09/19/2017 
DO NOT USE AFTER: 12/05/2017


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You may experience some, all, or none of these side effects. However, life-threatening side effects 
could occur. Your study doctor does not know all the side effects that may happen and there may be 
unknown side effects that could occur. Side effects can vary from mild to very serious. Your doctor 
may provide treatment to help lessen side effects. Many side effects go away soon after you stop 
what is causing them. In some cases, side effects can be serious or long-lasting, cause you to be 
hospitalized and/or never go away. You will be monitored closely for all side effects including any that 
are unexpected. If symptoms develop, your study doctor will start appropriate treatment. You must tell 
the study doctor about any new health problems that develop while you are taking part in this study. 
You will be informed of any new information that could change your decision to be in this study.  
 
Risks of Placebo  
If placed in the group that will receive placebo, your risks will be minimal. The placebo in this study 
will look identical to tranexamic acid, but will not contain any active ingredients. Neither you, nor your 
study doctor will know whether you receive tranexamic acid or placebo, except in case of an 
emergency for further management of your care.  
 
Possible risks related to your routine care surgery will be discussed with you by your surgeon and 
addressed under a separate consent form. 
 
Under Michigan law, an HIV and hepatitis test may be done on you without your consent if a 
healthcare worker is exposed to your blood or other bodily fluids. If the results of an HIV or hepatitis 
test indicate that you are HIV or hepatitis positive, you will be told about these results and given 
information about the disease, treatment resources, and other options.  
 
If you are or become pregnant during this study, there may be additional risks to you, or to your baby.  
Some of these risks may be known, but some risks may not be known and may not be foreseeable.  
Because the risks to embryo/fetus/unborn babies and babies who are breast feeding may not be 
known or foreseeable, pregnant women and nursing mothers are not allowed to join this study. If you 
are a woman who can get pregnant, you should not become pregnant during this study. 
 
If you become pregnant during the study, you must tell the study doctor right away. It is important to 
tell your doctor because there may be risks to you or your baby if you continue in the study. 
 
Will I need to pay for any of the tests or procedures in the study? 
The study drug, placebo and the cost to prepare and give them will be paid for by the study. All other 
procedures that are part of your routine care ordered by your doctor/surgeon will be billed to your 
health insurance company or you. If your insurance company requires any co-payment or deductible, 
you will be responsible for making that payment. 
 
If your insurance is through Medicare Advantage, any routine care that is part of this study and not 
being paid for by the sponsor will be directed to traditional Medicare for payment. The traditional 
Medicare deductibles will be waived, but you will be responsible for any co-payments. Please talk to 
the study doctor if you have any questions about this. 
 
Will being in this study help me in any way? 
We cannot promise any benefits to you from your taking part in this research. However, possible 
benefits include a decrease in blood loss and prevention of blood transfusion related to your major 
surgery. You may receive no benefit.  
 
 
SH IRB APPROVED ON: 09/19/2017 
DO NOT USE AFTER: 12/05/2017


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What happens to the information you collect? 
Efforts will be made to limit your personal information, including research study and medical records, 
to people who have a need to review this information. We cannot promise complete confidentiality. 
Organizations that may inspect and copy your information for quality assurance and data analysis 
include: 
• 
The Investigator and his/her research staff 
• 
Spectrum Health staff or its agents 
• 
The Spectrum Health Institutional Review Board (IRB) and staff 
• 
Agencies that accredit the hospital or the research program 
• 
The Food and Drug Administration (FDA) 
 
Some of these organizations may be given direct access to your medical records for verification of the 
research procedures/data involved. By signing this document you are authorizing this access. 
 
We may publish the results of this research. However, we will keep your name and other identifying 
information confidential. 
 
Federal law provides additional protections of your personal information. These are described in a 
later section. 
 
Can I be removed from the research without my OK? 
Your study doctor may stop your study involvement at any time, without your permission, if he or she 
believes it is in your best interest, if you do not receive the dose of study medication or if the study is 
stopped. 
 
What if I’m injured or made sick from the research? 
If you are injured or made sick from taking part in this research study, medical care will be provided. 
No funds have been set aside to pay you in the event of a research related injury.  
 
Contact the investigator for more information. By signing this consent form you will not be waiving any 
of your legal rights which you otherwise would have if you were not participating in a research study. 
 
What else do I need to know? 
You will not be paid for taking part in this research study. 
 
A description of this clinical trial will be available on http://www.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. 
 
HIPAA Authorization for Release of Health Information for Research Purposes 
The information we are asking to use and share is called Protected Health Information (PHI). It is 
protected by a federal law called the Privacy Rule of the Health Insurance Portability and 
Accountability Act (HIPAA). In general, we cannot use or share your health information for research 
without your permission. 
 
What will be done with my information? 
Your health information will be collected and entered in a database along with the information from 
other people taking part in this study. 
 
SH IRB APPROVED ON: 09/19/2017 
DO NOT USE AFTER: 12/05/2017


Tranexamic Acid 
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Why am I being asked to release it? 
Your health information will be used to determine if receiving tranexamic acid at the time of major 
surgery decreases blood loss or the need for blood transfusions related to the surgery. This 
information will also determine whether or not receiving tranexamic acid has an impact on hospital 
costs. 
 
What will be released? 
To complete this research study, we will need to collect and release (disclose) information about you.  
This information may include:  
 
• 
Your name, date of birth, contact information, medical record number and insurance 
information. 
• 
FIN number associated with your surgical hospital stay. 
• 
FIN number(s) associated any returns to the hospital within 90 days after you are discharged 
home from your initial hospital surgical stay.  
• 
Your hospital bill for your surgical hospital stay. 
• 
Hospital bill(s) for returns to the hospital within 90 days after you are discharged home from 
your initial hospital surgical stay (if any). 
• 
Existing medical records and medical history. 
• 
New health information collected for purposes of this study. 
 
Personal identifiers collected on the study data forms released outside of Spectrum Health as 
necessary to the conduct of this research study shall be limited to dates of service for any procedures 
or treatments that occur during your participation in this research study. 
 
Who will use it or share it? 
• 
The investigator and his/her research staff  
• 
Spectrum Health staff or its agents 
• 
The Spectrum Health Institutional Review Board (IRB) and its staff 
• 
The Food and Drug Administration (FDA) 
 
Once your protected health information has been disclosed it is possible that anyone who receives 
that information may re-disclose it. Because some of these individuals who receive your protected 
health information may not be required by law to keep your information confidential, we cannot 
guarantee that your information will not be released or made available to another party once it leaves 
Spectrum Health. Therefore, we share your information only if necessary and we use all reasonable 
efforts to request that those individuals who receive your information take steps to protect your 
privacy. 
 
How long will my health information be used? 
This authorization has no expiration date.  
 
Can I stop my protected health information from being collected? 
You can tell us to stop collecting health information that can be traced to you at any time. We will 
stop, except in very limited cases if needed to comply with law, protect your safety or make sure the 
research was done properly. If you have any questions about this please ask. If you want us to stop, 
you must tell us in writing.   
 
SH IRB APPROVED ON: 09/19/2017 
DO NOT USE AFTER: 12/05/2017


Tranexamic Acid 
Version Date: 22-August-2017 
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If you decide to stop the collection of your protected health information for this research study, you 
must send a written notice to:  
 
Dr. G. Paul Wright 
145 Michigan St. NE, Suite 6274, MC317 
Grand Rapids, MI 49503 
 
Please reference the title of this research study in your written request.  
 
What happens if I do not want you to collect and release my information? 
If you decide not to authorize release of your health information as part of this study, your decision 
will in no way affect your medical care or cause you to lose any benefits to which you are entitled.  
You cannot participate in this research study if you do not authorize the use or release of your PHI. 
 
When will it be destroyed? 
We do not know when your information will no longer be used, therefore the information will be kept 
for an indefinite length of time. 
 
 
Signature Block for Capable Adult: Long Form 
Your signature below documents your permission to take part in this research and to the use and 
disclosure of your protected health information. You will receive a signed copy of this complete 
form. 
 
 
 
 
Signature of participant 
 
Date 
Time 
 
 
Printed name of participant 
 
 
 
 
Signature of person obtaining consent 
 
Date 
Time 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 
SH IRB APPROVED ON: 09/19/2017 
DO NOT USE AFTER: 12/05/2017