Clinical trial NCT03653429
Conditions: Foot and Ankle Surgeries Bunion
Keywords: foot and ankle surgeries tranexamic acid wound healing blood loss
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2018-03-01; Completion date: 2018-12-31
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.

Detailed description:
Approximately 20% of all foot and ankle fractures are open. Excellent operative field without measurable bleeding remain prerequisite of most orthopedic procedures. Increase blood loss can increase the risk of infection, hematoma formation and wound complications. Presence of blood in synovium not only has direct corrosive effects but also causes increased intra capsular pressure leading to capsular fibrosis culminating as ankyloses.

Tourniquets are employed to optimize surgical field visualization thereby limiting operative duration and improving technical precision. There are several unwanted effects that can arise from use of tourniquet like neurapraxia, vascular injury, post operative swelling etc. Hence there is a growing interest in achieving the same operative goals without the use of tourniquet.

Antifibrinolytics come to one's rescue to achieve a blood sparing effect. Its efficacy in reducing intra operative and post operative blood loss is well documented in cardiac surgery, hip and knee replacement surgery and spinal surgery. Tranexamic acid is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin and tissue plasminogen activator, thereby delaying fibrinolysis and blood clot degradation. It has been effectively used as IV, oral, topical as well as intra articular dosing. The effects of IV administration lasts 8-17 hours after the initial dose. Orthopedic surgeons have incorporated TXA into multiple elective surgeries as a means of reducing blood loss and transfusion requirements. Reduced bleeding translates to decreased incidence of wound hematoma and other complications.

Effectiveness of Tranexamic acid(TXA) is unknown in foot and ankle surgeries. The aim of this study is to not only evaluate effectiveness of intravenous TXA in reducing post operative blood loss during foot and ankle surgeries but also if it modulates to reduced wound complications and reduced narcotic consumption.

Arms: arm 1: 10mg/kg intravenous tranexamic arm 2: 10mg/kg intravenous normal saline
Interventions: intervention 1: Tranexamic Acid intervention 2: Normal saline
Intervention descriptions: intervention 1: administered prior to surgical incision intervention 2: administered prior to surgical incision

Protocol documents:
Prot_SAP_000.pdf: 
 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
1 
Revised 9/2/14 
HRP-503 PROTOCOL TEMPLATE  
 
Note that, depending on the nature of your research, certain questions, directions, or entire sections below 
may not be applicable. Provide information if and when applicable, and in cases where an entire section is not 
applicable, indicate this by marking the section “N/A”.  Do not delete any sections. 
 
For any items below that are already described in the sponsor’s protocol, the investigator’s protocol,  the 
grant application, or other source documents, you may simply reference the title and page numbers of these 
documents in the sections below, rather than cutting and pasting into this document. Do not refer to the 
Sample Consent document, or information on the application form in this document.. 
 
Keep an electronic copy of this version of the document. You will need to modify this copy when making 
changes. 
 
Brief Summary of Research (250-400 words):  
In foot and ankle surgery, the prevention of postoperative hematoma in a confined 
space in the wound has a crucial impact on perioperative outcomes.  There has been 
growing emphasis on the role of antifibrinolytics to minimize bleeding and the 
formation of postoperative hematoma.  Approximately 20% of all foot and ankle 
fractures are open. Excellent operative field without measurable bleeding remain 
prerequisite of most orthopedic procedures. Increase blood loss can increase the risk 
of infection, hematoma formation and wound complications. Presence of blood in 
synovium not only has direct corrosive effects but also causes increased intra 
capsular pressure leading to capsular fibrosis culminating as ankyloses.  
                
Traditionally, tourniquets are employed to optimize surgical field visualization 
thereby limiting operative duration and improving technical precision. There are 
several unwanted effects that can arise from use of tourniquet like neurapraxia, 
vascular injury, post operative swelling etc. Hence there is a growing interest in 
achieving the same operative goals without the use of tourniquet. 
 
Antifibrinolytics can be utilized to achieve a blood sparing effect. Its efficacy in 
reducing intra operative and post operative blood loss is well documented in cardiac 
surgery, joint replacement surgery, and spine surgery. Tranexamic acid is a synthetic 
antifibrinolytic drug that competitively blocks the lysine-binding sites of 
plasminogen, plasmin and tissue plasminogen activator, thereby delaying 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
2 
Revised 9/2/14 
fibrinolysis and blood clot degradation. It has been effectively used as intravenous 
(IV), oral, topical, as well as intra articular routes of administration. The effects of 
IV administration lasts 8-17 hours after the initial dose. Orthopedic surgeons have 
incorporated TXA into multiple elective surgeries as a means of reducing blood loss 
and transfusion requirements.  
 
Effectiveness of Tranexamic acid (TXA) in postoperative outcomes is unknown in 
foot and ankle surgeries. The aim of this study is to evaluate effectiveness of 
intraoperative doses of intravenous TXA in reducing postoperative bleeding and 
hematoma formation after foot and ankle surgeries.  
 
 
1)Objectives 
Research Question: Does intraoperative administration of intravenous TXA reduce 
postoperative bleeding and hematoma formation after foot and ankle surgeries? 
Primary outcome: The incidence of wound complications classified as dehiscence, 
hematoma, necrosis and infection.  Wound healing time and length of stay will be 
evaluated.  The first follow up at surgeon’s office will be included.  
Secondary outcome: The amount of intra operative and post operative blood loss 
during the first 24 hours in patients undergoing foot and ankle surgeries. Post-
operative complete blood count (CBC), duration of surgery and intra operative fluid 
resuscitation will be recorded. Intraoperative and post operative narcotic 
consumption.  
 
2)Background 
See above. Effectiveness of Tranexamic acid (TXA) is unknown in foot and ankle 
surgeries. The aim of this study is to evaluate effectiveness of intravenous TXA in 
reducing post operative blood loss during foot and ankle surgeries.  
 
     3)Setting of the Human Research 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
3 
Revised 9/2/14 
Prospective triple blinded randomized control trial in patients undergoing foot and 
ankle surgeries. The research study will take place at Mount Sinai West hospital. 
The site PI is Yan Lai, MD, MPH. 
 
 
4)Resources Available to Conduct the Human Research 
For n=200, the feasibility of recruitment is manageable. Recruitment will be done 
through a coordination of the operating schedule and the surgeon’s office.  Patients 
presenting for preoperative visits at the surgeon’s office or the preoperative joint 
clinic will be approached. The surgeon will also provide study information 
(protocol, consent, general information) to patients in the surgeon’s office.  After 
confirmation on the operating schedule, patients will be provided detailed 
instructions the day before surgery and the final consent will be obtained at the 
surgeon’s office or joint clinic for patients at Mount Sinai West hospital. On the day 
of the surgery, the subject will meet the research team in the holding area.  The team 
will finalize participation and ask the subject about the signed consent forms and 
answer any additional questions.   The staff members on this protocol are all 
employees of Mount Sinai and will either be a resident or attending physicians that 
are included on the IRB protocol. There are three primary members of the research 
personnel: 
     a)Yan Lai, MD, MPH – Roles for Dr. Lai in this study include serving as primary 
investigator responsible for study design and planning, data collection, subject 
recruitment, manuscript writing and preparation, data analysis, safety monitoring, 
and responding to adverse events and/or complications. He is certified in PPHS/IRB 
protocols, all Citi/IRB required training in human subject protection, and has prior 
clinical research experience. He is also a board certified anesthesiologist and 
assistant professor of anesthesiology with the Icahn School of Medicine and the 
Mount Sinai Health System. 
 
     b) Poonam Pai B.H MD – Roles for Dr. Pai include serving as primary research 
coordinator involved in data collection, subject recruitment, manuscript writing and 
preparation, data analysis, safety monitoring, and responding to adverse events 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
4 
Revised 9/2/14 
and/or complications.  She has completed all of her required CITI training to be IRB 
certified and has experience in clinical research. In addition she has been a resident 
physician in anesthesiology with the Icahn School of Medicine in good standing for 
the previous three years going on her fourth. 
 
c) Ettore Vulcano MD- Roles for Dr Vulcano in this study include serving as co-
investigator responsible for study design and planning, data collection, subject 
recruitment, manuscript writing and preparation, data analysis, safety monitoring, 
and responding to adverse events and/or complications. He is certified in PPHS/IRB 
protocols, all Citi/IRB required training in human subject protection, and has prior 
clinical research experience. He is also a board certified orthopedic surgeon and 
assistant professor, department of Orthopedic surgery with the Icahn School of 
Medicine and the Mount Sinai Health System. 
 
There are institutional processes to ensure that all persons assisting with the protocol 
will be well informed.  The research personnel will conduct regular meetings and 
department email updates to review the results and safety data of the study.  The 
research personnel will initiate the formation of a safety monitoring board for 
adverse effects, complications, or complaints from patient subjects. 
 
  5) Study Design 
Prospective triple blinded randomized control trial. The surgeon will also provide 
study information (protocol, consent, general information) to patients in the 
surgeon’s office.   Recruitment will be done through a coordination of the operating 
schedule and the surgeon’s office.  Patients presenting for preoperative visits at the 
surgeon’s office or the preoperative joint clinic will be approached. On the day of 
the surgery, the subject will meet the research team in the holding area.  The team 
will finalize participation and ask the subject about the signed consent forms and 
answer any additional questions.  All patients will be provided with copies of the 
IRB protocol and consent if they wish to have it. Copy of the consent form will be 
sent in a secured email to the potential subject. The email will be secured by 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
5 
Revised 9/2/14 
entering in [SECURE] in the e-mail subject line.  Once recruited blinding 
assessments will be done by the study team.  
 
Patients will be assigned randomly using a computer- generated table of numbers to 
either TXA group (Tranexamic acid group) or placebo (saline group). Patients 
assigned to TXA group will receive 10mg/kg IV TXA in a 100cc normal saline bag 
at the time of induction and a second dose prior to skin closure. Patients in the 
placebo group will receive 100cc normal saline IV at the time of induction and a 
second dose prior to skin closure. Otherwise, the patient, surgeon, and 
anesthesiologist in the case will be blinded.   
 
a) Recruitment methods: Patients will be recruited and consented at the surgeons 
office or pre-operative testing/Joint clinic. 
 
b) Inclusion and Exclusion Criteria 
 Inclusion criteria: ASA (American Society of Anesthesiology) class I-IV, age 18-     
75.  
Exclusion criteria: ASA class V, patient refusal, patients with known coagulopathy 
disorder, renal insufficiency, hepatic dysfunction, serious cardiac disease, patients 
receiving antiplatelet and/or anticoagulant drugs, or an allergy to TXA or will be 
excluded.  
 
c)Number of Subjects 
 
We intend to recruit 200 patients. 
Based on a confidence level of 99% with a Z score of 2.58, standard deviation of .5 
and a confidence interval of 10% our sample size should be 166. For ease of 
statistical calculations we rounded up to 200 patients. Literature search reveals only 
one previous study where TXA has been used in calcaneal fractures. Xie et al 
concluded in a study with 90 patients that TXA reduces post operative blood loss. 
We intend to use a higher sample size to see any statistical significance. 
 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
6 
Revised 9/2/14 
ss = 
Z 2 * (p) * (1-p) 
c 2 
 
Where: 
Z 
= 
Z 
value 
(2.58 
for 
99% 
confidence 
level)  
p = percentage picking a choice, expressed as decimal (.5 used for sample size 
needed) 
c = confidence interval, expressed as decimal  (e.g., .01= ±1) 
 
Sample size= [(2.58^2)(.5)(.5)]/(.1^2)=166 subjects 
For effect size, we expect a Cos d medium effect of 0.5.  
Intergroup comparisons will be performed using the Mann-Whitney U test. 
Qualitative data will be compared using the chi-square test or Fisher’s exact test. 
Only p < .05 will be considered statistically significant.  
 
 
d)Study Timelines 
      2018-2019 and subsequent data analysis. The subject’s participation will be from 
time of enrollment in the pre-operative period until first postoperative day. The first 
follow up visit at the surgeons office will be included as well. Estimated date of 
enrollment completion will be when 200 eligible subjects are enrolled in final data 
analysis.  Estimate date for study completion will be June 2018. 
 
 
 
 
 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
7 
Revised 9/2/14 
e)Endpoints 
Conclusion of data analysis and evaluation of significance of findings, as measured 
by primary and secondary outcomes listed under Objectives (item #1) for purposes 
of quality improvement. 
 
f)Procedures Involved in the Human Research 
Prospective randomized controlled trial and data analysis only. TXA group and 
placebo group. Intraoperative care of the patient will be provided by an anesthesia 
team member who is a part of the Mount Sinai System. The anesthesia provider will 
not be aware of the randomization of the patient.  Standard post-operative orders 
will be written for patients during their time in the PACU. 
 
g)Specimen Banking 
 N/A  
 
h)Data Management and Confidentiality 
Data collected in excel file to be de-identified after initial collection. Excel file be 
subsequently encrypted and shared only between the above listed investigators via 
secure Mt. Sinai (chpnet) electronic mail.   
The information included in the data will be medical record number, age, gender, 
ASA class, type of surgery, duration of surgery, the amount of intra operative and 
post operative blood loss during the first 24 hours in patients will be collected. 
Wound complications (eg dehiscence, hematoma, necrosis and infection), wound 
healing time and length of stay will be evaluated. Post operative complete blood 
count will be recorded. The first follow up at surgeon’s office will be the other data 
collected. 
Only the research personnel will have access to the data. The data will be stored as a 
hard copy files and on a secure spreadsheet. The research personnel is responsible 
for the receipt of the data. The PI will keep the hard copies secure and any electronic 
data will be encrypted. No personal identifiers will be used. The data will undergo 
statistical analysis 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
8 
Revised 9/2/14 
 
 
i)Provisions to Monitor the Data to Ensure the Safety of Subjects 
      Part I: Elements of Data and Safety Monitoring Plan 
MSSM Principal Monitor: 
 
Last Name: Lai 
First Name: Yan 
Academic Title: Attending Physician, Assistant Professor 
Department: Anesthesiology 
Mailing Address: Mount Sinai West 1000 10th Avenue, New York, NY 10019 
Phone: 212-523-6915 
Fax:  
E-mail: ylai@chpnet.org 
 
 
MSSM Additional Monitor: 
 
Last Name: Pai B.H 
First Name: Poonam 
Academic Title: Research Personnel, Physician 
Department: Anesthesiology 
Mailing Address: Mount Sinai West 1000 10th Avenue, New York, NY 10019 
Phone: 212-523-6915 
Fax:  
E-mail: phebbalasankatte@chpnet.org 
 
MSSM Additional Monitor: 
 
Last Name: Vulcano 
First Name: Ettore 
Academic Title: Attending Physician, Assistant Professor 
Department: Orthopedic Surgery 
Mailing Address: 425, west 59th street, 5th floor, New York, NY 10019 
Phone: 212-523-7342 
Fax:  
E-mail: Ettore.vulcano@mountsinai.org 
 
 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
9 
Revised 9/2/14 
The principal monitor is a board certified anesthesiologist thus minimizing the risk 
to the subjects and further optimizing their health and wellbeing. Adverse events 
will be monitored as a standard of care everyone receives regardless of participation 
in the study. The safety and data information will be reviewed on a daily basis until 
the desired sample size is achieved. All temporary and/or permanent suspensions 
will be reported. Prospective chart review for quality data analysis without potential 
for danger to subjects. 
All anesthesiologists involved in patient care will be prepared for the prevention and 
rescue for any complications involving IV TXA.  
 
j) Withdrawal of Subjects 
 Patients may withdraw from the study at any given time by contacting any member 
of the research study group. Data will not be collected on patients who wish to 
withdraw. Patients do not need to withdraw consent in writing. 
 
6) Risks to Subjects 
If patients are injured or made sick from taking part in this research study, medical 
care will be provided. Generally, this care will be billed to the patient or their 
insurance in the ordinary manner and the patient will be responsible for all treatment 
costs not covered insurance, including deductibles, co-payments and coinsurance.  
This does not prevent the patient from seeking payment for injury related to 
malpractice or negligence. Contact the investigator for more information. 
 
As with any medication, there is a possibility of an allergic reaction. Although rare, 
possible complications include hypersensitivity reaction, bleeding or local site 
infection, and chance of any vascular event.  There is a possible risk of private 
information with procedures in place to minimize the risk. 
 
7)Provisions for Research Related Harm/Injury 
If patients are injured or made sick from taking part in this research study, medical 
care will be provided. Generally, this care will be billed to the patient or their 
insurance in the ordinary manner and the patient will be responsible for all treatment 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
10 
Revised 9/2/14 
costs not covered insurance, including deductibles, co-payments and coinsurance.  
This does not prevent the patient from seeking payment for injury related to 
malpractice or negligence. Contact the investigator for more information. 
 
8)Potential Benefits to Subjects 
It is important to know that you may not get any benefit from taking part in this 
research.  Others may not benefit either. However, possible benefits may be 
improved with knowledge about how the reduced blood loss helps in better surgical 
outcome.  
 
9)Provisions to Protect the Privacy Interests of Subjects 
Patients will be appropriately educated about the research study. Any questions or 
concerns they have will be adequately addressed and patients will have the option to 
decline participation. Patients will be given as much time as they need to review the 
consent form. The study personnel will be approaching the subjects. Privacy will be 
maintained by not including any identifiers such as names or addresses in the data 
collected.  
The identities of human subjects whose data is being studied will be de-identified as 
per HIPAA Privacy Rule. 
 
10)Economic Impact on Subjects 
Patients will not incur any additional cost for participating in the study. The 
medications used are part of a standard anesthetic regimen that will be billed to 
subject’s insurance as bundled standard of anesthesia care.  The cost of the 
procedure is overall unaffected.   
 
11)Payments to Subjects 
 Patients will not be reimbursed for their participation. 
 
 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
11 
Revised 9/2/14 
 
12)Consent Process 
Informed consent will be obtained prior to the procedure. Both the HRP-090 (SOP) 
Informed Consent Process for Research and the HRP-091 (SOP) Written Documentation of Consent 
will 
be 
followed 
by 
the 
study 
team. 
These 
documents 
are 
both 
available 
at 
http://icahn.mssm.edu/research/resources/program-for-the-protection-
of-human-subjects/irb-members-palette. 
 
13)Process to Document Consent in Writing 
The patients will receive a paper copy of the IRB approved consent packet and will 
sign in the designated areas to confirm consent of participation.  They will have the 
option of have a copy of the consent and may ask for a personal copy of the consent.  
 
14)Vulnerable Populations 
Indicate specifically whether you will include (target) or exclude each of the following 
populations: 
I
n
c
l
u
d
e 
E
x
c
l
u
d
e 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
 
X 
Wards of the State (e.g. foster children) 
 
X 
Pregnant women 
 
X 
Prisoners 
 
15)Multi-Site Human Research (Coordinating Center) 


 
Protocol Name: 
EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE 
SURGERIES - A RANDOMISED CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD 347-569-4816 
ETTORE VULCANO MD 
 
Date Revised: 
7/23/2017 
Study Number: 
 IF# 2089572, GCO#17-04301 
 
12 
Revised 9/2/14 
This study will be performed within the Mount Sinai West Hospital. No additional 
centers will be involved. 
 
16)Community-Based Participatory Research 
This does not apply to our study. 
 
17)Sharing of Results with Subjects 
Results will not be shared with the patients since the study will take time to 
complete.  Patients can request results if they contact the PI by writing. 
 
18)External IRB Review History 
This does not apply to our study. 
 
19)Control of Drugs, Biologics, or Devices  
Not applicable.  IV TXA are routinely used in orthopedic surgeries. 
 
 

ICF_001.pdf: 
THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
                                                                        Mount Sinai West  
 
 
Page 1 of 9 
 
 
Study ID #: HSM#17-00775/IRB-17-01997  
 
       Form Version Date:10/23/2017 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
TITLE OF RESEARCH STUDY: 
Title: EFFICACY OF TRANEXAMIC ACID IN FOOT AND ANKLE SURGERIES - A RANDOMIZED 
CONTROLLED TRIAL 
PRINCIPAL INVESTIGATOR (HEAD RESEARCHER) NAME AND CONTACT INFORMATION: 
Name: Yan Lai, MD 
Physical Address: Mount Sinai West, 1000 10th Avenue, New York, NY 10019  
Mailing Address:  Department of Anesthesiology Mount Sinai West 1000 10th Avenue, New York, NY 
10019 
Phone: 212-523-6915 
WHAT IS A RESEARCH STUDY? 
A research study is when scientists try to answer a question about something that we don’t know 
enough about.  Participating may not help you or others.   
People volunteer to be in a research study.  The decision about whether or not to take part is totally 
up to you. You can also agree to take part now and later change your mind. Whatever you decide is 
okay.  It will not affect your ability to get medical care within the Mount Sinai Health System.   
Someone will explain this research study to you. Feel free to ask all the questions you want before 
you decide.  Any new information that develops during this research study that might make you 
change your mind about participating will be given to you promptly. 
Basic information about this study will appear on the website http://www.ClinicalTrials.gov.  There are 
a few reasons for this:  the National Institutes of Health (NIH) encourages all researchers to post their 
research; some medical journals only accept articles if the research was posted on the website; and, 
for research studies the U.S. Food and Drug Administration (FDA) calls "applicable clinical trials” 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. 
PURPOSE OF THIS RESEARCH STUDY: 
The purpose of our study is to evaluate if tranexamic acid, a medication which commonly helps promote 
blood clots if given intravenously reduces blood loss in patients undergoing foot and ankle. 
 
This medication is routinely used in orthopedic surgeries to reduce blood loss during the surgery. 
Reduced blood loss avoids the need to blood transfusion and provides better operating conditions for the 
surgeon. Our study attempts to find out if tranexamic acid is effective in reducing blood loss in foot and 
ankle surgeries.  


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
                                                                        Mount Sinai West  
 
 
Page 2 of 9 
 
 
Study ID #: HSM#17-00775/IRB-17-01997  
 
       Form Version Date:10/23/2017 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
You may qualify to take part in this research study because you are a healthy individual between the 
ages of 18 and 75 undergoing foot and ankle surgery. Funds for conducting this research are 
provided by Mount Sinai. 
LENGTH OF TIME AND NUMBER OF PEOPLE EXPECTED TO PARTICIPATE 
Your participation in this research study is expected to last from the day of surgery to first post 
operative visit at the surgeon’s office.   
The total number of people expected to take part in this research study is 200 participants.  
DESCRIPTION OF WHAT’S INVOLVED: 
If you agree to participate in this research study at the Mount Sinai West hospital, the following 
information describes what may be involved.  
On the day of your surgery your anesthesia provider will perform a history and physical. This involves 
discussing your medical and surgical history and reviewing your allergies as well as your medications 
along with a focused physical exam.  A small catheter, known as an intravenous (IV) line, will also be 
placed in one of your veins in preparation for your surgery.   
After discussing the anesthetic plan with your anesthesia provider you will be entering the operating 
room. Based on which group you have been randomly assigned to, either tranexamic acid medication 
or placebo in the form of normal saline, will be administered to you by infusing through the 
intravenous catheter that was inserted in your vein(intravenous catheter or IV line),at the start of the 
procedure and towards the end of the procedure while you are under anesthesia. You will randomly 
be assigned to either of the treatment groups and each subject has an equal chance of being in either 
group. Randomization will occur via a computer software number generator that will assign you to 
either of the groups. 
A placebo is a substance (in this case normal saline) with no therapeutic effect. You will randomly be 
assigned to either of the treatment groups and each subject has an equal chance of being in either 
group. If you have been assigned to the tranexamic acid group, you will have received tranexamic 
acid by intravenous method at the start of your surgery and towards the end while you are under 
anesthesia. If you have been assigned to the placebo group, you will receive a placebo (normal 
saline) at the start of your surgery and towards the end of the surgery while you are under anesthesia. 
All patients undergoing anesthesia are required to have an intravenous line placed. The amount of 
blood loss during your entire surgery will be recorded. Blood loss will be measured in terms of number 
of lap pads used and blood collected in the canister. 
After surgery you will be transferred to the post anesthesia care unit (PACU) also known as the 
recovery room. Your pain scores will be assessed and treated. 
The amount of blood loss during the first 24 hours during your hospital stay will be recorded. The 
number of days of hospitalization will be be recorded.  


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
                                                                        Mount Sinai West  
 
 
Page 3 of 9 
 
 
Study ID #: HSM#17-00775/IRB-17-01997  
 
       Form Version Date:10/23/2017 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
During the first follow up visit at surgeon’s office the following information like any associated wound 
complication, wound healing time, incidence of infection will be recorded. Your blood will be collected 
to assess blood counts also. 
The use of tranexemic acid in orthopedic surgeries is currently the standard of care to reduce blood 
loss. There are currently no standards or guidelines for the preference of tranexamic acid in foot and 
ankle studies and its efficacy in reducing blood loss which is the focus of this research study.   
The study treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study 
doctor will choose what study treatment you get. You will have an equal chance of being given each 
study treatment. You will not be told which study treatment you are getting, however your study doctor 
will know. 
YOUR RESPONSIBILITIES IF YOU TAKE PART IN THIS RESEARCH: 
If you decide to take part in this research study you will be responsible for the following things: Your 
participation in this research study is expected to last from the time you meet your surgeon at his 
office, your anesthesia providers on the day of your surgery and until the first office visit back at your 
surgeon’s office.   
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION: 
You will not be paid for participating in this research study. Being in this research study will not lead to 
extra costs to you. You will not be reimbursed for your travel or time that may be required for study 
visits.  
POSSIBLE BENEFITS: 
It is important to know that you may not get any benefit from taking part in this research.  Others may 
not benefit either.  However, possible benefits may be reduced blood loss during your surgery. 
REASONABLY FORESEEABLE RISKS AND DISCOMFORTS: 
Risk of loss of private information; this risk always exists, but there are procedures in place to 
minimize the risk.   
As with any medication, there is a possibility of an allergic reaction. Although rare, possible 
complications include hypersensitivity reaction, bleeding or local site infection, thrombosis and 
chance of any vascular event.  There is a possible risk of private information with procedures 
in place to minimize the risk. 
OTHER POSSIBLE OPTIONS TO CONSIDER: 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
                                                                        Mount Sinai West  
 
 
Page 4 of 9 
 
 
Study ID #: HSM#17-00775/IRB-17-01997  
 
       Form Version Date:10/23/2017 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
You may decide not to take part in this research study without any penalty.  The choice is totally up to 
you. 
 
IN CASE OF INJURY DURING THIS RESEARCH STUDY: 
If you believe that you have suffered an injury related to this research as a participant in this study, 
you should contact the Principal Investigator.  
 
ENDING PARTICIPATION IN THE RESEARCH STUDY: 
You may stop taking part in this research study at any time without any penalty. This will not affect 
your ability to receive medical care at any of the Mount Sinai Health System hospitals or to receive 
any benefits to which you are otherwise entitled. 
If you decide to stop being in the research study, please contact the Principal Investigator or the 
research staff. You may also withdraw your permission for the use and disclosure of any of your 
protected information for research, but you must do so in writing to the Principal Investigator at the 
address on the first page. Even if you withdraw your permission, the Principal Investigator for the 
research study may still use the information that was already collected if that information is necessary 
to complete the research study. Your health information may still be used or shared after you 
withdraw your authorization if you have an adverse event (a bad effect) from participating in the 
research study. 
Withdrawal without your consent: The study doctor, the sponsor or the institution may stop your 
involvement in this research study at any time without your consent. This may be because the 
research study is being stopped, the instructions of the study team have not been followed, the 
investigator believes it is in your best interest, or for any other reason. If specimens or data have been 
stored as part of the research study, they too can be destroyed without your consent. 
 
CONTACT PERSON(S): 
If you have any questions, concerns, or complaints at any time about this research, or you think the 
research has hurt you, please contact the office of the research team and/or the Principal Investigator 
at (212)-523-6915. 
This research has been reviewed and approved by an Institutional Review Board. You may reach a 
representative of the Program for Protection of Human Subjects at the Icahn School of Medicine at 
Mount Sinai at telephone number (212) 824-8200 during standard work hours for any of the reasons 
listed below. This office will direct your call to the right person within the Mount Sinai Health System: 
 
Your questions, concerns, or complaints are not being answered by the research team. 
 
You cannot reach the research team. 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
                                                                        Mount Sinai West  
 
 
Page 5 of 9 
 
 
Study ID #: HSM#17-00775/IRB-17-01997  
 
       Form Version Date:10/23/2017 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
You are not comfortable talking to the research team. 
 
You have questions about your rights as a research subject. 
 
You want to get information or provide input about this research. 
DISCLOSURE OF FINANCIAL INTERESTS: 
Sometimes, physicians/researchers receive payments for consulting or similar work performed for 
industry.  Effective September 2014 Mount Sinai reviews only payments to an individual totaling more 
than $5,000 a year per entity when determining potential conflicts of interest.  If you have questions 
regarding industry relationships, we encourage you to talk your physician/researcher or visit our 
website at http://icahn.mssm.edu/ where Mount Sinai publicly discloses the industry relationships of 
our faculty.  
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION: 
As you take part in this research project it will be necessary for the research team and others to use 
and share some of your private protected health information. Consistent with the federal Health 
Insurance Portability and Accountability Act (HIPAA), we are asking your permission to receive, use 
and share that information. 
What protected health information is collected and used in this study, and might also be disclosed 
(shared) with others? 
 
As part of this research project, the research team at the hospital(s) involved in the research will 
collect your name, address, telephone number, and medical record number. 
The researchers will also get information from your medical record including pertinent medical history, 
type of surgery and type of anesthesia delivered.  
During the study the researchers will gather information by: 
 
taking a medical history (includes current and past medications or therapies, illnesses, 
conditions or symptoms, family medical history, allergies, etc.) 
 
doing a physical examination that generally also includes blood pressure reading, heart rate, 
breathing rate and temperature 
 
completing the tests, procedures, questionnaires and interviews explained in the description 
section of this consent. 
Why is your protected health information being used? 
Your personal contact information is important to be able to contact you during the study. Your health 
information and the results of any tests and procedures being collected as part of this research study 
will be used for the purpose of this study as explained earlier in this consent form. The results of this 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
                                                                        Mount Sinai West  
 
 
Page 6 of 9 
 
 
Study ID #: HSM#17-00775/IRB-17-01997  
 
       Form Version Date:10/23/2017 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
study could be published or presented at scientific meetings, lectures, or other events, but would not 
include any information that would let others know who you are, unless you give separate permission 
to do so. 
The Principal Investigator may also use and share the results of these tests and procedures to treat 
you in collaboration with others in the Mount Sinai Health System.  
The research team and other authorized members of The Mount Sinai Health System (“Mount Sinai”) 
workforce may use and share your information to ensure that the research meets legal, institutional or 
accreditation requirements. For example, the School’s Program for the Protection of Human Subjects 
is responsible for overseeing research on human subjects, and may need to see your information. If 
you receive any payments for taking part in this study, the Mount Sinai Finance Department may need 
your name, address, social security number, payment amount, and related information for tax 
reporting purposes.  If the research team uncovers abuse, neglect, or reportable diseases, this 
information may be disclosed to appropriate authorities.  
Who, outside Mount Sinai, might receive your protected health information? 
As part of the study, the Principal Investigator, study team and others in the Mount Sinai workforce 
may disclose your protected health information, including the results of the research study tests and 
procedures, to the following people or organizations: (It is possible that there may be changes to the 
list during this research study; you may request an up-to-date list at any time by contacting the 
Principal Investigator.) 
- 
Other collaborating research center(s) and their associated research/clinical staff who are 
working with the investigators on this project: Mount Sinai Hospital, Mount Sinai St. Luke’s 
- 
A Data Safety Monitoring Board or other committee that will monitor the study on an 
ongoing basis for safety. 
- 
The United States Department of Health and Human Services and the Office of Human 
Research Protection. 
 
In all disclosures outside of Mount Sinai, you will not be identified by name, social security number, 
address, telephone numbers or any other direct personal identifier unless disclosure of the direct 
identifier is required by law. Some records and information disclosed may be identified with a unique 
code number. The Principal Investigator will ensure that the key to the code will be kept in a locked 
file, or will be securely stored electronically. The code will not be used to link the information back to 
you without your permission, unless the law requires it, or rarely if the Institutional Review Board 
allows it after determining that there would be minimal risk to your privacy. It is possible that a sponsor 
or their representatives, a data coordinating office, a contract research organization, may come to 
inspect your records. Even if those records are identifiable when inspected, the information leaving 
the institution will be stripped of direct identifiers.  Additionally, when applicable, the monitors, 
auditors, the IRB, the Office of Human Subjects Protection (OHRP) of the Department of Health and 
Human Services as well as the Food and Drug Administration (FDA) will be granted direct access to 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
                                                                        Mount Sinai West  
 
 
Page 7 of 9 
 
 
Study ID #: HSM#17-00775/IRB-17-01997  
 
       Form Version Date:10/23/2017 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
your medical records for verification of the research procedures and data. OHRP and FDA are 
authorized to remove information with identifiers if necessary to complete their task. 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. 
For how long will Mount Sinai be able to use or disclose your protected health information? Your 
authorization for use of your protected health information for this specific study does not expire. 
Will you be able to access your records? 
During your participation in this study, you will not be able to access your medical records. This will be 
done to prevent the knowledge of study results from affecting the reliability of the study. Your 
information will be available should an emergency arise that would require your treating physician to 
know this information to best treat you. You will have access to your medical record and any study 
information that is part of that record when the study is over or earlier, if possible. The investigator is 
not required to release to you research information that is not part of your medical record. 
Do you need to give us permission to obtain, use or share your health information? 
NO! If you decide not to let us obtain, use or share your health information you should not sign this 
form, and you will not be allowed to volunteer in the research study. If you do not sign, it will not affect 
your treatment, payment or enrollment in any health plans or affect your eligibility for benefits. 
Can you change your mind? 
You may withdraw your permission for the use and disclosure of any of your protected information for 
research, but you must do so in writing to the Principal Investigator at the address on the first page. 
Even if you withdraw your permission, the Principal Investigator for the research study may still use 
your protected information that was already collected if that information is necessary to complete the 
study. Your health information may still be used or shared after you withdraw your authorization if you 
should have an adverse event (a bad effect) from being in the study. If you withdraw your permission 
to use your protected health information for research that means you will also be withdrawn from the 
research study, but standard medical care and any other benefits to which you are entitled will not be 
affected. You can also tell us you want to withdraw from the research study at any time without 
canceling the Authorization to use your data. 
If you have not already received it, you will also be given The Hospital’s Notice of Privacy Practices 
that contains more information about how The Hospital uses and discloses your protected health 
information. 
It is important for you to understand that once information is disclosed to others outside Mount Sinai, 
the information may be re-disclosed and will no longer be covered by the federal privacy protection 
regulations. However, even if your information will no longer be protected by federal regulations, 
where possible, Mount Sinai has entered into agreements with those who will receive your information 
to continue to protect your confidentiality. 
If as part of this research project your medical records are being reviewed, or a medical history is 
being taken, it is possible that HIV-related information may be revealed to the researchers.  If that is 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
                                                                        Mount Sinai West  
 
 
Page 8 of 9 
 
 
Study ID #: HSM#17-00775/IRB-17-01997  
 
       Form Version Date:10/23/2017 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
the case, the following information concerns you.  If this research does not involve any review of 
medical records or questions about your medical history or conditions, then the following section may 
be ignored.   
_________________________________________________________________________________ 
Notice Concerning HIV-Related Information 
If you are authorizing the release of HIV-related information, you should be aware that the recipient(s) is 
(are) prohibited from re-disclosing any HIV-related information without your authorization unless permitted 
to do so under federal or state law.  You also have a right to request a list of people who may receive or 
use your HIV-related information without authorization.  If you experience discrimination because of the 
release or disclosure of HIV-related information, you may contact the New York State Division of Human 
Rights at (888) 392-3644 or the New York City Commission on Human Rights at (212) 306-5070.  These 
agencies are responsible for protecting your rights. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
                                                                        Mount Sinai West  
 
 
Page 9 of 9 
 
 
Study ID #: HSM#17-00775/IRB-17-01997  
 
       Form Version Date:10/23/2017 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
Signature Block for Capable Adult 
Your signature below documents your permission to take part in this research and to the use and 
disclosure of your protected health information. A signed and dated copy will be given to you. 
 
 
 
Signature of subject 
 
Date  
 
 
 
Printed name of subject 
 
Time 
  
 
 
 
Person Explaining Study and Obtaining Consent  
 
 
 
Signature of person obtaining consent 
 
Date  
 
 
 
Printed name of person obtaining consent 
 
Time  
 
 
Witness Section: For use when a witness is required to observe the consent process,, 
document below (for example, subject is illiterate or visually impaired, or this accompanies a 
short form consent): 
My signature below documents that the information in the consent document and any other 
written information was accurately explained to, and apparently understood by, the subject, and 
that consent was freely given by the subject. 
 
 
 
Signature of witness to consent process 
 
Date  
 
 
 
Printed name of person witnessing consent process 
 
Time