Clinical trial NCT05082142
Conditions: Kidney Calculi Urologic Diseases Benign Prostatic Hypertrophy
Sponsor: Northwestern University
Start date: 2021-09-17; Completion date: 2022-12-14
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP). The investigators attempt to perform HoLEP as a same-day discharge (SDD) procedure, but at Northwestern Memorial, the SDD rate is currently approximately 60%. The limiting factor in SDD is hematuria. Tranexamic acid (TXA) is a clot promoting drug that is commonly used by orthopedic, cardiac and obstetric surgeons to prevent bleeding. The primary outcome will be to assess if there is a difference in SDD rates in those who receive TXA vs. those who do not.

Secondary outcomes will assess bleeding complications (defined as unplanned ED visit/clinic visit/procedure/admission related to bleeding, clot retention, clot evacuation, need for perioperative transfusion) between participants who receive TXA vs. those do not. The study will also assess differences in perioperative complications associated with TXA including but not limited to: deep venous thrombosis, pulmonary embolism, cerebrovascular events, between the groups. The study will also assess for the duration of postoperative hematuria between groups as well as differences in operative times between the groups.

The investigators anticipate that there may be up to a 25% increase in SDD rates in those who receive TXA vs. those who do not.

Detailed description:
On the day of the surgery, the treatment assigned to the participant will be determined by chance, like flipping a coin. One arm will undergo the HoLEP procedure while receiving 1g TXA IV intraoperatively. The second arm will undergo the HoLEP procedure without receiving TXA IV intraoperatively.

After surgery, participants will receive weekly surveys via text message or email asking them to report any instances of difficulty urinating or blood in the urine. These surveys will continue for 12 weeks.

30 days after surgery, participants will come in for a standard clinical follow up appointment where they will be asked to complete a questionnaire about bleeding complications and symptoms.

12 weeks after surgery, participants will come in for their 12-week follow up and will be assessed for benign prostate hyperplasia (BPH) symptoms and their urine flow rate will be measured.

Arms: arm 1: Patients will receive intraoperative 1g TXA during the HoLEP procedure. arm 2: Patients will not receive intraoperative TXA during the HoLEP procedure.
Interventions: intervention 1: Tranexamic acid
Intervention descriptions: intervention 1: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.

Protocol documents:
ICF_001.pdf: 
Permission to Take Part in a Human Research Study 
 
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HRP-592 / v.09302020 
 
 
 
 
 
 
 
 
 
 
 
NCT05082142 
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser 
Enucleation of the Prostate (HoLEP) 
10/29/2021 
 
Consent 
 
 
 
 
 
 
 
 
 
s 


Permission to Take Part in a Human Research Study 
 
Page 2 of 8 
HRP-592 / v.09302020 
 
Title of Research Study: Tranexamic acid to improve same-day discharge rates after Holmium 
Laser Enucleation of the Prostate (HoLEP) 
Investigator: Amy Krambeck, MD 
Supported By: This research is supported by the Department of Urology.  
 
Financial Interest Disclosure:  The following disclosure is made to give you an opportunity 
to decide if this relationship will affect your willingness to participate in this research study: Your 
doctor, who is also responsible for this research study, is interested in both your clinical care 
and the conduct of this research study. You have the right to discuss this study with another 
person who is not part of the research team before deciding whether to participate in the 
research. 
 
 
Why am I being asked to take part in this research study? 
We are asking you to take part in this research study because you are undergoing holmium 
laser enucleation of the prostate (HoLEP).  
 
What should I know about a research study? 
• 
Someone will explain this research study to you. 
• 
Whether or not you take part is up to you. 
• 
You can choose not to take part. 
• 
You can agree to take part and later change your mind. 
• 
Your decision will not be held against you. 
• 
You can ask all the questions you want before you decide. 
 
Why is this research being done? 
The purpose of this study is to determine if there is a significant difference in bleeding for 
patients who receive a drug referred to as TXA (tranexamic acid) during surgery. TXA is a 
medication that works by slowing the breakdown of blood clots, which helps to prevent 
prolonged bleeding.  
 
We seek to assess differences in same day discharge and same day catheter removal rates 
after surgery between men who do and do not receive TXA.  We will also assess whether the 
rate of complications from surgery such asd deep venous thrombosis and pulmonary embolism 
are reduced for individuals who receive TXA . 
 
How long will the research last and what will I need to do? 
We expect that you will be in this research study for 3 months.  
 
Key Information:  
The first few pages of this document include a summary of this study to help you 
decide whether or not to participate. Detailed information is provided after the 
summary. 


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Before your surgical procedure, you will be randomly put in one of two groups by chance (like 
the flip of a coin).  One group will receive TXA continuously during surgery.  The other group will 
not receive TXA during surgery..   
 
If you choose not to participate in this study, you will not receive TXA during your surgery. 
Currently, TXA is not routinely given during HoLEP. However, TXA is commonly used in 
orthopedic, cardiac, otolaryngologic and gynecologic surgeries.  
 
You will be asked to complete surveys after your surgery about if you are experiencing difficulty 
with urinated or blood in the urine.  
 
More detailed information about the study procedures can be found under the section What 
happens if I say “Yes, I want to be in this research”? 
 
Is there any way being in this study could be bad for me? 
Your HoLEP surgical procedure will not be different from the treatment you would receive if you 
were not in this study.  
Side effects of TXA may include nausea, vomiting, diarrhea, and muscle pain.  
More detailed information about the risks of this study can be found under “Is there any way 
being in this study could be bad for me? (Detailed Risks)” 
 
Will being in this study help me any way? 
There are no benefits to you from your taking part in this research. We cannot promise 
any benefits to others from your taking part in this research. However, possible benefits 
to others include a reduction in potential side effects following HoLEP.  
What happens if I do not want to be in this research? 
Participation in research is completely voluntary. You decide whether or not to participate. If you 
choose to not participate, there will be no penalty to you or loss of benefit to which you are 
entitled.   
 
Your alternative to participating in this research study is to not participate. 
 
 
 
 
 
Whom can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to 
Matthew Lee at matthew.lee@nm.org.  
 
This research has been reviewed and approved by an Institutional Review Board (IRB). You 
may talk to them at (312) 503-9338 or irb@northwestern.edu if: 
• 
Your questions, concerns, or complaints are not being answered by the research team. 
• 
You cannot reach the research team. 
• 
You want to talk to someone besides the research team. 
• 
You have questions about your rights as a research participant. 
Detailed Information: 
The rest of this document includes detailed information about this study (in addition to the 
information listed above). 


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HRP-592 / v.09302020 
• 
You want to get information or provide input about this research. 
 
How many people will be studied? 
We expect about 110 people here will be in this research study. 
 
What happens if I say “Yes, I want to be in this research”? 
If you agree to be in the study, you will do the following things:  
 
Before your surgical procedure, you will be randomly put in one of two groups by chance (like 
the flip of a coin).  One group will receive TXA during surgery.  The other group will not receive 
any TXA during surgery.   
 
If you choose not to participate in this study, you will receive no TXA during your procedure.  
 
After your surgery, you will receive weekly surveys asking you to report any instances of 
difficulty urinating or blood in the urine. These surveys will be sent to you via text message. 
Normal messaging rates will apply. If you do not want to receive the survey via text,, a research 
coordinator will contact you via phone. Those will continue for 12 weeks.  
 
At your standard clinical follow up appointment (30 days after surgery), you will be asked to 
complete a questionnaire about bleeding compications and symptoms.  
At your 12 week follow up appointment you will be assessed for benign prostate hyperplasia 
(BPH) symptoms and your urine flow rate will be measured.  
What happens if I say “Yes”, but I change my mind later? 
You can leave the research at any time; it will not be held against you. 
If you decide to participate in this study, you can change your mind and decide to leave the 
study at any time in the future.  The study team will help you withdraw from the study safely.  If 
you decide to withdraw, please contact Dr. Amy Krambeck at 
amy.krambeck@northwestern.edu, or tell any member of the research team.  
Your participation may be terminated by the investigator without regard to your consent in the 
following circumstances: you do not have surgery as planned to treat your BPH. . 
 
You will be told about new information that may affect your health, welfare, or willingness to stay 
in the study.   
 
Choosing not to be in this study or to stop being in this study will not result in any penalty to you 
or loss of benefit to which you are entitled. Specifically, your choice not to be in this study will 
not negatively affect your right to any present or future medical treatment.  
 
Detailed Risks: Is there any way being in this study could be bad for me? 
Side effects of TXA may include nausea, vomiting, diarrhea, and muscle pain. In addition, you 
may feel uncomfortable answering questions included in the survey. While completing the 
survey, you can tell the researcher that you feel uncomfortable or do not want to answer a 
particular question. 


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This study involves the use of your identifiable, personal information and there is a chance that 
a loss of confidentiality could occur. The researchers have procedures in place to lessen the 
possibility of this happening.  See the section below titled: “What happens to the information 
collected for the research?”.  
 
To minimize these risks, the following actions will be taken: 
• 
While completing the survey, you can tell the researcher that you feel uncomfortable or 
do not care to answer a particular question.  
• 
We will keep all study related information in a secure database that is only accessible to 
study personnel. 
 
 
Will it cost me anything to participate in this research study? 
You and your insurance company will be charged for the health care services that you would 
ordinarily be responsible to pay. In some cases, insurance will not pay for services ordinarily 
covered because these services were performed in a research study. You should check with 
your insurance to see what services will be covered by your insurance and what you will be 
responsible to pay. 
 
Will being in this study help me in any way? 
There are no benefits to you from your taking part in this research. We cannot promise 
any benefits to others from your taking part in this research. However, possible benefits 
to others include a reduction in potential side effects following HoLEP.  
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including 
research study and medical records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information 
include the IRB and other representatives of this institution and the Food and Drug Adminitration 
(FDA). 
 
The sponsor, monitors, auditors, the IRB, the Northwestern University Office of Research 
Integrity, the US Office of Research Integrity (ORI), the US Office for the Protection of Human 
Research Protection (OHRP), and the US Food and Drug Administration (FDA) may be granted 
direct access to your medical records to conduct and oversee the research 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.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time. 
 
Data Sharing  
De-identified data from this study may be shared with the research community at large to 
advance science and health. We will remove or code any personal information that could 
identify you before files are shared with other researchers to ensure that, by current scientific 
standards and known methods, no one will be able to identify you from the information we 
share. Despite these measures, we cannot guarantee anonymity of your personal data. 


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What else do I need to know? 
If you become ill or are injured as a result of this study (medications, devices or procedures), 
you should seek medical treatment through your doctor or treatment center of choice. You 
should promptly tell the study doctor about any illness or injury.  
 
The hospital [university, researchers] will not pay for medical care required because of a bad 
outcome resulting from your participation in this research study. This does not keep you from 
seeking to be paid back for care required because of a bad outcome. 
 
You will not be compensated for your participation in this study.  
 
HIPAA Authorization 
We are committed to respect your privacy and to keep your personal information confidential.  
When choosing to take part in this study, you are giving us the permission to use your personal 
health information that includes health information in your medical records and information that 
can identify you. For example, personal health information may include your name, address, 
phone number or social security number. Your health information we may collect and use for 
this research includes:  
• 
Results of physical examinations 
• 
Medical history 
• 
Lab tests, or certain health information indicating or relating to a particular condition 
as well diaries and questionnaires 
• 
Records about study medication or drugs 
• 
Records about study devices 
 
During this study, you may be coming to a Northwestern Memorial HealthCare/Northwestern 
Medicine entity for research appointments or to get clinical services, such as lab tests, needed 
for the study.  When that happens, you will be scheduled for these services through the NMHC 
computer system.  When a clinical exam or lab is done by NMHC or one of its employees for the 
purpose of this research study, that information will be kept in both NMHC’s clinical records and 
in the study records. 
 
The following clinical providers may give the researchers information about you:  all current and 
previous health care providers, including but not limited to the Shirley Ryan AbilityLab 
(SRALAB) and Northwestern Memorial HealthCare/Northwestern Medicine entities and its 
current and future affiliates. 
 
Once we have the health information listed above, we may share some of this information with 
the following offices or entities outside of Northwestern University and its clinical partners (or 
affiliates):  the Northwestern University Institutional Review Board Office and Office for 
Research Integrity; the US Office of Research Integrity; the US Office for Human Research 
Protections; the US Food and Drug Administration.   
 
Any research information shared with outside entities will not contain your name, address, 
telephone or social security number or any other personal identifier unless disclosure of the 
identifier is necessary for review by such parties or is required by law or University policy 
[except that such information may be viewed by the Study sponsor and its partners or 
contractors at the Principal Investigator’s office]. 
 


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The following entities may receive your health information:  
 
• 
Authorized members of the Northwestern University workforce, who may need to see 
your information, such as administrative staff members from the Office for Research, 
Office for Research Integrity and members of the Institutional Review Board. 
• 
Clinical affiliates, including but not limited to the Shirley Ryan AbilityLab (SRALAB), 
Northwestern Memorial HealthCare, and the Ann & Robert H. Lurie Children’s 
Hospital of Chicago (Lurie Children’s).  Your participation in this clinical trial may be 
tracked in an electronic database and may be seen by investigators running other 
trials that you are enrolled in and by your healthcare providers.  
• 
Clinical affiliates, including but not limited to Northwestern Memorial HealthCare, for 
purposes including, but not limited to, the affiliate’s provision of care to you and/or 
the affiliate’s scheduling of appointments and/or billing activities. 
• 
Other University research centers and University contractors who are also working 
on the study, 
• 
Study monitors and auditors who make sure that the study is being done properly,  
• 
Government agencies and public health authorities, such as the Food and Drug 
Administration (FDA) and the Department of Health and Human Services (DHHS). 
 
Those persons who get your health information may not be required by Federal privacy laws 
(such as the Privacy Rule) to protect it. Some of those persons may be able to share your 
information with others without your separate permission. 
 
The results of this study may also be used for teaching, publications, or for presentation at 
scientific meetings.   
 
Unless you revoke your consent, it will expire at the end of the research study.  
 
Although you may revoke consent to participation in this research at any time and in any format, 
you must revoke authorization for use or disclosure of your health information in writing. To 
revoke your authorization, write to: 
PI’s Name: Amy Krambeck, MD 
Institution: Northwestern University 
Department: Urology 
Address: 676 N St. Clair St 
Chicago, IL, 60611 
 
You do not have to authorize the use or disclosure of your health information; however, you will 
not be allowed to take part in this research study. If you do not authorize the use or disclosure of 
your health information, it will not affect your treatment by health care providers, or the payment 
or enrollment in any health plans, or affect your eligibility for benefits. 
 
A copy of this signed consent document, information about this study, and the results of any test 
or procedure done may be included in your medical records and may be seen by your insurance 
company. 
 
 
Signature Block for Capable Adult: 
 


Permission to Take Part in a Human Research Study 
 
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Your signature documents your permission to take part in this research.  You will be provided a 
copy of this signed document. 
 
_______________________________________________      __________________ 
Signature of Participant                                                               Date 
 
_______________________________________________ 
Printed Name of Participant 
 
 
____________________________________________            __________________ 
Signature of Person Obtaining Consent                                     Date 
 
______________________________________________________ 
Printed Name of Person Obtaining Consent 

Prot_002.pdf: 
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HRP-593 / v05202020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT05082142 
 
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser 
Enucleation of the Prostate (HoLEP) 
 
10/29/2021 
 
Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL TITLE: Tranexamic acid to improve same-day discharge rates after Holmium 
Laser Enucleation of the Prostate (HoLEP) 
 
 
PRINCIPAL INVESTIGATOR: 
Amy Krambeck, MD 
Department of Urology 
amy.krambeck@nm.org 
 
VERSION DATE: 
10.29.2021 
 
  
STUDY SUMMARY: 
 
Investigational Agent(s)  
(Drugs or Devices) 
Tranexamic acid 
IND / IDE / HDE #   
Indicate 
Special Population(s) 
Children  
 Children who are wards of the state  
 Adults Unable to Consent   
 Cognitively Impaired Adults  
 Neonates of Uncertain Viability  
 Pregnant Women  
 Prisoners (or other detained/paroled individuals)  
 Students/Employees  
Sample Size 110 
Funding Source Department of Urology 
Indicate the type of consent 
to be obtained 
Written  
Verbal/Waiver of Documentation of Informed Consent 
Waiver of HIPAA Authorization  
Waiver/Alteration of Consent Process   
Site 
 Lead Site ( For A Multiple Site Research Study) 
 Data Coordinating Center (DCC) 
Research Related 
Radiation Exposure 
Yes  
 No  
DSMB / DMC / IDMC 
Yes  
No 
 
OBJECTIVES: 
 
 
This study is designed to assess if there is a significant difference in same day discharge 
rates after Holmium Laser Enucleation of the Prostate (HoLEP). We attempt to perform HoLEP 
as a same-day discharge (SDD) procedure, but at NM, our SDD rate is currently approximately 
60%.  The limiting factor in SDD is hematuria. Tranexamic acid (TXA) is a clot promoting drug 
that is commonly used by orthopedic, cardiac and obstetric surgeons to prevent bleeding. Our 


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primary outcome will be to assess if there is a difference in SDD rates in those who receive TXA 
vs. those who do not. 
 
 
Secondary outcomes will assess bleeding complications (defined as unplanned ED 
visit/clinicvisit/procedure/admission related to bleeding, clot retention, clot evacuation, need for 
perioperative transfusion) between patients who receive TXA vs. those do not.  We will also 
assess differences in perioperative complications associated with TXA including but not limited 
to: deep venous thrombosis, pulmonary embolism, cerebrovascular events, between the 
groups.  We will also assess for the duration of postoperative hematuria between groups.  
Additionally, we will assess for differences in operative times between the groups. 
 
We anticipate that there may be up to a 25% increase in SDD rates in those who receive TXA 
vs. those who do not. 
 
BACKGROUND: 
Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for 
bening prostate hypertrophy (BPH) as recommended by the American Urological Association 
(AUA) Guidelines.1 Furthermore, HoLEP is one of the few surgical options that is recommended 
by the AUA for patients on active anticoagulation given its superior hemostatic properties.1 Dr. 
Krambeck’s research team has previously shown that same-day catheter removal and same-
day discharge (SDD) was successful in approximately 87% of patients.2 This study was 
performed in a limited cohort of 207 patients.  Dr. Krambeck was recently recruited to 
Northwestern Medicine to introduce HoLEP to Chicago. Our current SDD rate is approximately 
60%.  Factors limiting discharge are primarily related to the degree of hematuria and patient 
anxiety. 
Tranexamic Acid (TXA) is an indirect fibrinolytic inhibitor and was discovered in the early 
1960s.3  Although it was initially only used in women with heavy menstrual blood loss and those 
with hereditary bleeding disorders, it is now widely used in trauma situations and orthopedic, 
cardiac, otolaryngologic, and obstetric surgeries as it is cheap, safe, and effective.3 Oral, IV, 
topical and combined methods of TXA administration also reduced blood loss and risk of 
transfusion compared to placebo for patients undergoing total hip arthroplasty.4 TXA is safe, but 
high doses of TXA (80-100 mg/kg) or TXA use in those with poor renal function have been 
associated with an increased risk of seizures.5  While there is no clear evidence of increased 
risk of thromboembolic events6, it should be used cautiously in those with a history of embolic 
events, those on hormonal contraceptives 7 
 
Use of TXA in Urologic literature has been limited. One prospective, randomized 
controlled trial studied the use of TXA in 40 men undergoing transurethral resection of the 
prostate (TURP).8 The authors found that TXA resulted in significantly less postoperative serum 
hemoglobin drop, less hemoglobin loss per gram of resected tissue, shorter OR time, and more 
resected tissue.8 In another prospective, randomized controlled trial, the authors randomized 
136 men undergoing TURP to receiving TXA or not.9 The authors found TXA resulted in 
reduced operative blood loss, the amount of blood loss per gram of resected tissue, and shorter 
OR time.  Interestingly, TXA did not decrease length of stay or catheter duration.9  In one 
systematic review analyzing the effects of TXA after transurethral resection of the prostate, the 
authors included nine studies in their meta-analysis and found that TXA reduced intraoperative 
estimated blood loss as well as the transfusion rate.10 The use of TXA in percutaneous 
nephrolithotomy (PCNL) has also been studied. A randomized, double-blinded, placebo-
controlled trial enrolled 192 patients with Guy’s stone scores III-IV.  Patients were given 1g of IV 
TXA vs. placebo at time of anesthetic induction.  The authors found that TXA administration 
during PCNL resulted in reduced blood transfusion rate, and higher stone free rates in the 
immediate postoperative period and at 3 months.11 


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Although HoLEP is one of the few surgical options recommended by the AUA for 
patients at high risk of bleeding due to its excellent hemostatic properties, for patients 
undergoing same-day discharge, hematuria is often the rate limiting factor. Currently, no studies 
have examined the use of TXA during HoLEP.  Therefore, we would like to study if the use of 
TXA during HoLEP will increase our SDD rates. 
 
STUDY ENDPOINTS: 
Primary: 
 
1) Difference in same-day discharge and same-day catheter removal rates  
 
     Secondary: 
2) Difference in medical events: defined as unplanned ED visit/clinic 
visit/procedure/admission related to bleeding, clot retention, clot evacuation, need for 
perioperative transfusion 
3) Duration of postoperative hematuria 
4) Difference in operative, enucleation and morcellation times 
5) Adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures,   
 
PROCEDURES INVOLVED: 
Visit 1 – Screening (Day -45 – Day 0) 
i. Patients will complete:  
1) Patient Informed Consent Form,  
2) HIPAA form,  
ii. Investigative site will complete: patient demographics, medical history, 
Inclusion/Exclusion Criteria 
iii. Randomization and instructions to patients on whether or not to receive 
TXA 
Visit 2 – HoLEP (Day 0) 
iv. Inclusion/Exclusion Criteria to reconfirm eligibility (only if Screening and 
HoLEP are not on the same day) 
v. Adverse Events secondary to TXA 
Catheter Removal (Day 0 or 1) 
Assessment of same day discharge and catheter removal rates 
Week 1 through resolution of hematuria 
The patient will receive a weekly computed generated text from Twilio 
(secure software integrated to REDCap) asking them to report their 
hematuria and dysuria after the procedure.  It will also ask if they have had 
any unplanned visits or interventions.  This will continue until 12 week post 
HoLEP survey 
Visit 3 – One month follow-up (Day 30) 
If patients have already reported resolution of hematuria, they will receive 
an additional questionnaire 30 days postoperatively to assess for 
bleeding complications and symptoms. 
Visit 4 – Follow-up (12 weeks Post HoLEP) 
vi. Patient will be assessed for BPH symptom related questionnaires in 
addition to urinary parameters.  Will also confirm if there were or were not 
bleeding or other complications in first 90 days postoperatively. 
Early Withdrawal Patients: The investigator will make reasonable attempts to 
ensure all enrolled patients complete the study.   
**If the patient is unable to complete the questionnaires by text, they will be 
contacted by phone call for questionnaire completion. 


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The HoLEP procedure is performed in a similar fashion by all surgeons with similar 
postoperative care plans.  Duration of postoperative catheterization is determined by the 
treating surgeon, with respect to time of surgical case completion, need for inpatient 
observation, and patient preference.  The portions of the case will not be altered regardless of 
patient being on anticoagulation or not, however the surgeon will not be blinded to the patient’s 
status of anticoagulation therapy, as this knowledge would be paramount in postoperative 
management if there were complications. 
 
DATA AND SPECIMEN BANKING 
Data will be collected and stored electronically in REDCap.  Quality assurance steps will include 
testing of database including any potential data calculated by command functions within 
REDCap (ex: age of patient at time of surgery calculated by using patient’s date of birth and 
date of surgery) by study team prior to moving to production mode.  The following quality control 
methods will be used: 1) single entry of data with random checks of accuracy, and 2) extraction 
and cleaning of data on a monthly basis that will be used for analysis every 3 months until 
completion of enrollment. 
 
Data will be accessible to only authorized members of the study team. Any presentations on the 
study or published findings will use only de-identified data.  
 
Data will be stored for 7 years after the end of the study. After this period, electronic data will be 
deleted.  
 
SHARING RESULTS WITH PARTICIPANTS 
Study results will not be shared with participants. 
 
INCLUSION AND EXCLUSION CRITERIA 
Inclusion Criteria 
• 
Males 18 -89 undergoing HoLEP 
• 
Willing to sign the Informed Consent Form  
• 
Able to read, understand, and complete patient questionnaires, pain texts, and 
medication diary. 
 
Exclusion Criteria 
• 
Allergy or hypersensitivity to TXA, history of acute venous or arterial thrombosis, 
intrinsic risk for thrombosis or thromboembolism, history of thromboembolic disease, 
hereditary thrombophilia, use of hormonal agents 
• 
Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous 
nephrolithotomy, or non-urologic surgery at the time of their HoLEP 
• 
Anticipated need for perineal urethrostomy at the time of HoLEP 
• 
Patient not undergoing catheter removal and voiding trial at Northwestern Memorial 
Hospital  
 
 
PARTICIPANT POPULATION(S) 
Accrual 
Number: 
Category/Group: 
(Adults/Children 
Special/Vulnerable 
Populations) 
Consented: 
Maximum Number to be 
Consented or 
Reviewed/Collected/Screened 
Enrolled: 
Number to Complete 
the Study or Needed 


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to Address the 
Research Question 
Local 
0 
110 
110 
 
 
 
Study-wide 
0 
110 
 
 
 
 
Total: 
0 
110 
110 
 
 
RECRUITMENT METHODS 
Enrollment into the study will be performed by a qualified research coordinator.   
After the patient completes their pre-surgical enrollment paperwork in the clinic, they will then be 
met in a private room away from the treating physicians by a qualified research coordinator who 
will discuss their potential enrollment and complete any research paperwork.  Some patients 
may be approached via telephone with virtual consent. 
 
Therefore, the initiation of enrollment will begin at the time of the office consultation visit. The 
patient will remain enrolled until she/he has completed the post-procedure follow up clinic/virtual 
visit at week 12. Data will not be collected beyond when the patient is seen at the postoperative 
clinic visit.  If the patient is unable to have a physical or virtual visit, a text follow-up will be 
performed. 
After consenting, patients will be randomized to one of two groups.  
 
Group 1 (control):  Receive intraoperative 1g TXA 
Group 2 (experimental):  No TXA 
 
Randomization to Group 1 or Group 2 will be allocated through REDCap.12 The stratified 
randomization list will be created and provided by the study statistician before the start of patient 
recruitment. 
 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
Patients will not be compensated for participating in this research.  
 
WITHDRAWAL OF PARTICIPANTS 
If a subject wishes to withdraw from the study, he/she may do so by verbal request to the 
research team.  A subject may be withdrawn from the study by a physician-investigator if 
determined to be in the subject’s best interest for medical reasons. 
 
 
RISKS TO PARTICIPANTS 
The risks in this study are no greater than the risks incurred during a HoLEP.  AUA and EAU 
guidelines support HoLEP as a size independent treatment option for BPH. 
 
Common side effects of TXA are nausea, vomiting, diarrhea, and muscle pain. 
 


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POTENTIAL BENEFITS TO PARTICIPANTS 
Patients in the TXA arm may have higher rates of success with same day discharge and same 
day catheter removal. 
 
DATA MANAGEMENT AND CONFIDENTIALITY 
Data will be collected and stored electronically in REDCap.  Quality assurance steps will include 
testing of database including any potential data calculated by command functions within 
REDCap (ex: age of patient at time of surgery calculated by using patient’s date of birth and 
date of surgery) by study team prior to moving to production mode.  The following quality control 
methods will be used: 1) single entry of data with random checks of accuracy, and 2) extraction 
and cleaning of data on a monthly basis that will be used for analysis every 3 months until 
completion of enrollment. 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
Data will be collected and stored electronically in REDCap and will only be accessible to 
members of the study team.  
Data resulting from this study will not be linked to subjects. Subjects will not be referred to by 
name of initial in any publications.  
 
CONSENT PROCESS 
Enrollment into the study will be performed by a qualified research coordinator.   
 
After the patient completes their pre-surgical enrollment paperwork in the clinic, they will then be 
met in a private room away from the treating physicians by a qualified research coordinator who 
will discuss their potential enrollment and complete any research paperwork.  Some patients 
may be approached via telephone with virtual consent. 
 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA) 
HIPAA authorization will be obtained as part of the consent. PHI from medical records and 
information collected from research and tumor samples will be protected by using coded subject 
numbers. The coded identifiers will be stored on a password protected spreadsheet stored on 
the FSM Urology server. 
 
1. 
Parsons JK BM, Dahm P, Gahndi MC, Kaplan SA, Kohler TS Lerner LB, Roehrborn CG, 
Stoffel JT, Welliver C, Wilt TJ, McVary KT. Benign Prostatic Hyperplasia: Surgical 
Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms AUA Guidelines. 
2019; 
2. 
Agarwal DK, Large T, Tong Y, et al. Same Day Discharge is a Successful Approach for 
the Majority of Patients Undergoing Holmium Laser Enucleation of the Prostate. Eur Urol 
Focus. Jan 4 2021;doi:10.1016/j.euf.2020.12.018 
3. 
Tengborn L, Blomback M, Berntorp E. Tranexamic acid--an old drug still going strong 
and making a revival. Thromb Res. Feb 2015;135(2):231-42. doi:10.1016/j.thromres.2014.11.012 
4. 
Fillingham YA, Ramkumar DB, Jevsevar DS, et al. The Efficacy of Tranexamic Acid in 
Total Hip Arthroplasty: A Network Meta-analysis. J Arthroplasty. Oct 2018;33(10):3083-3089 
e4. doi:10.1016/j.arth.2018.06.023 


STU#:  
 
Version Date:  10.29.2021 
Page 8 of 8 
HRP-593 / v05202020 
5. 
Lecker I, Wang DS, Whissell PD, Avramescu S, Mazer CD, Orser BA. Tranexamic acid-
associated seizures: Causes and treatment. Ann Neurol. Jan 2016;79(1):18-26. 
doi:10.1002/ana.24558 
6. 
Dunn CJ GK. Tranexamic Acid: A review of its use in surgery and other indications. 
Drugs. 1999;57(6):1005-1032.  
7. 
Ng W JA, Wasowicz M. Tranexamic acid: a clinical review. Anestezjologia Intensywna 
Terapia. 2015;47(4):353-364.  
8. 
Kumsar S DA, Toksoz S, Saglam HS Adsan O. Tranexamic acid decreases blood loss 
during transurethral resection of the prostate (TUR-P). Central European Journal of Urology. 
2011;64(3):156-158.  
9. 
Rannikko A, Petas A, Taari K. Tranexamic acid in control of primary hemorrhage during 
transurethral prostatectomy. Urology. Nov 2004;64(5):955-8. doi:10.1016/j.urology.2004.07.008 
10. 
Longo MA, Cavalheiro BT, de Oliveira Filho GR. Systematic review and meta-analyses 
of tranexamic acid use for bleeding reduction in prostate surgery. J Clin Anesth. Aug 
2018;48:32-38. doi:10.1016/j.jclinane.2018.04.014 
11. 
Batagello CA, Vicentini FC, Monga M, et al. Tranexamic acid in patients with complex 
stones undergoing percutaneous nephrolithotomy: a randomized, double-blinded, placebo-
controlled trial. BJU Int. Feb 25 2021;doi:10.1111/bju.15378