Clinical trial NCT03631355
Conditions: Anterior Cruciate Ligament Reconstruction
Sponsor: NYU Langone Health
Start date: 2018-06-06; Completion date: 2020-03-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain.

Detailed description:
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain. Patients received the standard arthroscopic ACL reconstruction with a BTB autograft and were randomized to either receiving or not receiving two individual doses of TXA intra-operatively or receive. The goal of the study is to determine and evaluate the effect of intra-operative TXA on post-operative hemarthrosis, pain reduction, and opioid consumption.

Arms: arm 1: Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients received two individual doses of intravenous TXA intra-operatively. arm 2: Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients did not receive two individual doses of intravenous TXA intra-operatively. Only the consented surgery was performed.
Interventions: intervention 1: Tranexamic Acid
Intervention descriptions: intervention 1: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.

Protocol documents:
Prot_SAP_ICF_000.pdf: 
Tranexamic Acid Has No Effect on Post-operative Hemarthrosis or Pain Control Following ACL 
Reconstruction Using Bone Patella Tendon Bone Autograft: A Double-Blinded Randomized 
Control Trial 
 
NCT03631355 
 
October 12, 2020 


Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction with BTB Autograft by the 
Administration of Intravenous Tranexamic Acid: A Double-Blind, Randomized Control Study 
 
 
 
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Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction with BTB 
Autograft by the Administration of Intravenous Tranexamic Acid: A Double-
Blind Randomized Control Study 
  
 
 
 
Regulatory Sponsor: 
Department of Orthopaedic Surgery 
301 E. 17th Street 
New York, NY 10003 
Principal Investigator: 
Michael J. Alaia, MD 
Division of Sports Medicine 
New York University Hospital for Joint Diseases 
New York, NY 10003 
Office: (646) 501-7223 
 
 
 
Protocol Number: 
18-00538 
Version Date: 
February 26, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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I. PURPOSE OF THE STUDY AND BACKGROUND 
Purpose 
The purpose of the proposed study is to evaluate the effects of administering intravenous 
tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction 
with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post 
operative pain. 
 
Rationale 
The anterior cruciate ligament (ACL) is the most common ligament injured in the knee, with as 
many as 246,000 tears occurring per year in the United States[7] Disruption of the ACL 
commonly occurs with a pivot-shift mechanism during athletic activity.  Rupture of the ACL 
leads to anterior translation of the tibia with an associated impaction of the posterolateral tibial 
plateau against the midportion of the lateral femoral condyle. Upon impact, the articular cartilage 
overlying the bone marrow edema lesion is exposed to significant loads, potentially causing 
irreversible local injury and the release of pro-inflammatory, catabolic cytokines and chemokines 
into the joint space.[10, 14, 17] This acute phase of injury is characterized clinically by pain, an 
effusion and associated decreased knee range of motion. 
 
ACL reconstruction is typically recommended in the young, active patient population in an effort 
to stabilize the knee and restore normal function. Bone-patellar tendon-bone autograft has shown 
to have the most successful outcomes. Several complications of both procedures include 
postoperative bleeding and swelling of the knee joint. There are two sources of bleeding after an 
ACL reconstruction including an intra-articular site and the donor site (extra-articular)[16]. Both 
sites can experience bleeding postoperatively leading to hemarthrosis and additional pain, which 
can prolong the recovery process. One technique utilized to reduce perioperative bleeding is the 
use of a tourniquet. Currently, other techniques are being tested to reduce perioperative bleeding. 
As a result, tranexamic acid (TXA) has been proposed as a solution to decrease these 
postoperative complications.  
TXA is a synthetic anti-fibrinolytic agent that competitively inhibits the activation of 
plasminogen to plasmin by blocking tissue plasminogen activator and at higher concentrations 
directly inhibits plasmin[4, 9]. Plasmin, an enzyme that degrades fibrin clots, fibrinogen, 
procoagulant factors V and VIII[4]. Inhibition of plasmin decreases proteolytic action thus 
leading to clot formation and stabilization[4]. TXA is indicated in patients with hemophilia for 
short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for 
replacement therapy during and following tooth extraction[13]. Administering TXA during the 
surgery will reduce the amount of plasmin in the system decreasing blood loss within and after 
the surgery. One gram of intravenous tranexamic acid (TXA) will be administrated before 
tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount 
with minimal side effects[16].TXA has already been shown to decrease perioperative bleeding in 
total knee arthroplasty and total hip arthroplasty, without increasing the risk of deep vein 
thrombosis[1, 2, 6, 8, 11, 15, 18]. 
This study is not being conducted under an IND number and will be conducted under IND 
exemption. This investigation is not intended to be reported to the FDA in support of a new 


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indication for use nor support any other significant change in the labeling or advertising for the 
drug. The investigation does not involve a route of administration or dosage level or use in a patient 
population or other factor that significantly increases the risks (or decreases the acceptability of 
the risks) associated with the use of the drug product. The route of administration (IV) and dosage 
of 1 g has been shown to be safe and effective[13, 16]. The investigation is conducted in 
compliance with the requirements for institutional review set forth in part 56 and with the 
requirements for informed consent set forth in part 50; and The investigation is conducted in 
compliance with the requirements of 312.7.  
 
We hypothesize that administration of TXA will reduce perioperative bleeding in BTB ACL 
reconstruction procedure with minimal side effects as compared to controls (no TXA). As a 
result, swelling and postoperative pain will decrease thus improving postoperative outcomes. By 
comparing two cohorts receiving the same procedure and administering TXA to one cohort, we 
can determine if the TXA affects perioperative bleeding and if decreasing perioperative bleeding 
will decrease postoperative pain and swelling.  
 
Study Design 
This will be a single-center, double-blinded randomized controlled study. The study is 
comparing blood loss and postoperative pain and swelling in two cohorts: patients undergoing 
BTB ACL reconstruction who receive TXA during surgery and patients who do not receive 
TXA. The intravenous tranexamic acid will be administered before surgery begins and after the 
tourniquet is released at the conclusion of the surgery. Blood loss will be measured via 
measuring the amount of blood in the drain at the conclusion of the surgery. Patients will be 
asked on postoperative day 1, 2 and 7 to rate their pain according to the VAS scale. Patients will 
have their knee swelling measured immediately postoperatively and at their one-week follow up 
visit.  The swelling ratio is defined as the postoperative mean circumference of upper pole of 
patella and lower pole of patella divided by the preoperative values.[9] 
 
Primary Objective 
The primary objective of the study is to determine if there are any differences in blood loss 
between patients undergoing BTB anterior cruciate ligament reconstruction who receive TXA 
compared to patients who do not receive it. 
 
Secondary Objective 
Secondary objective of the study is to determine is there is a difference in post operative pain and 
swelling between patients undergoing BTB anterior cruciate ligament reconstruction who receive 
TXA and patients who do not receive it. 
 
II. CHARACTERISTICS OF THE RESEARCH POPULATION 
Number of Subjects 
We will aim to enroll a total of 110 subjects (55 per cohort) as determined by the priori sample 
size calculator.  
 
Gender of Subjects  
Men and women will be included in this study. 


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Age of Subjects 
Subjects included study will be aged 18-60 years, inclusive. 
 
Racial and Ethnic Origin 
There are no enrollment restrictions based on race or ethnic origin. 
 
Inclusion Criteria 
Patients will be screened for eligibility using the following criteria. All study subjects must meet 
the following inclusion criteria: 
• Patients undergoing a BTB anterior cruciate ligament reconstruction 
• Patients ages 18-60, inclusive 
•  
 
Exclusion Criteria 
Patients meeting the following criteria will be excluded from participation in this study: 
• Legally incompetent or mentally impaired (e.g., minors, Alzheimer’s subjects, dementia, 
etc.) 
• Younger than 18 years of age 
• Older than 60 years of age 
• Any patient considered a vulnerable subject: pregnant women or fetuses, children, 
cognitively impaired adults, prisoners 
• history of coagulation abnormalities and thromboembolic disease or current abnormal 
coagulation test values  
• history of stroke or acute coronary syndromes within 3 months before surgery 
• Preoperative (chronic) anticoagulation therapy 
• Abnormal coagulation profile 
• Renal failure (serum creatinine > 250 μmol/L [2.83 mg/dL]) or liver cirrhosis  
• Sickle cell disease 
• ACL reconstruction by a method other than BTB 
• Patients with a history of hypersensitivity to Percocet and/or TXA 
•  
Vulnerable Subjects 
We do not intend to enroll vulnerable subjects. 
 
Subject withdrawal criteria.   
Patients are free to withdraw at any time from the study before or after surgery. 
.   
 
III. METHODS AND PROCEDURES 
Methods and Procedures  
Patients indicated and scheduled for a BTB ACL reconstruction will be identified from faculty 
surgeon case logs at the NYU Langone Health, Langone Orthopedic Hospital Sports Medicine 
Division.   After informed consent is obtained, a chart review of patients’ medications and past 


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medical histories will be performed based on their electronic medical records to identify any 
current pain medications or exclusion criteria. In order to maintain the blind, the resident assisting 
the surgeon will randomize the patient to one of two cohorts using REDCap. Both the resident and 
surgeon are members of the study team. 
- 
Cohort 1: 1 gram of intravenous tranexamic acid (TXA) before tourniquet inflation and 1 
gram of IV TXA before closure of the incision  
- 
Cohort 2: Will not receive TXA. 
The resident physician and anesthesiologist will not be blinded to the study, however the surgeon 
and study team members will remain blinded. Before the surgery begins, the resident will 
prepare the patient and the TXA will be administered (if assigned) before the tourniquet is 
placed, at which point the surgeon will be called into the room. The administration of TXA will 
not prolong the surgery and will not add any additional risks of prolonged anesthesia The 
surgeon will exit the surgery before closure at which point, the TXA will be administered (if 
assigned) and the resident physician will close the incision. 
 
Immediate post-operative management will not be affected by this study. All patients will 
receive a standardized regimen of aspirin for DVT prophylaxis and Percocet for pain 
management, which is standard of care post-operative treatment.  
 
Information to be recorded pre-operatively includes age, sex, height, weight, BMI, and American 
Society of Anesthesiology (ASA) classification. Intra-operative information will also be 
recorded, including operative time, and estimated blood loss. During the surgery, a suction 
device is utilized to remove excess blood from the surgical site and sucked into the suction drain 
and placed into a measuring cup. We will measure the perioperative blood loss by looking at the 
measuring cup and seeing how much blood is inside. The objective is to have the average blood 
loss of the cohort receiving TXA less than the cohort not receiving TXA. Knee swelling 
postoperatively will be measured using the swelling ratio. The swelling ratio is defined as the 
circumference of the operative limb divided by the circumference of the contralateral limb. Pain 
severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = 
worst pain imaginable) at 0.5, 1, 1.5, 2, 4, 6, 24, and 48 hours as well as 7 days after surgery. 
Percocet consumption will be recorded at 24 hours, 1 day, 2 days and 7 days after surgery. 
Incidence of TXA-related side effects (nausea/vomiting, itching, anxiety, increased thirst, rapid 
heartbeat) in the first 24 hours will be noted. Time to discharge from the post-anesthesia care 
unit (PACU) and time to discharge from the hospital will be recorded. Patients will be in the 
study a duration of two weeks, until their post-operative follow up visit.  
 
Data Analysis and Statistical Plan 
Statistical analysis will be performed using chi-squared and/or fisher’s exact testing depending 
on size for binary variables. An a priori power analysis was conducted to estimate the minimum 
sample size needed to achieve 83% power (1 – b) at the .05 significance level which was 
calculated to be 50 patients. Therefore, we added 10 patients to account for potential exclusions, 
totaling 110 patients. Variables used in the power calculation were taken from the literature 
including an assumed effect size of 0.5 and standard deviation (SD) of 2. This large sample size 
will provide enough information to truly determine a difference between cohorts. This sample 
size and statistical analysis was used in similar studies looking at the effects of TXA in ACL 


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reconstruction[5, 12].  
Continuous variables will be compared with paired t-tests if the data is approximately normally 
distributed.  If the data is not normally distributed, Mann-Whitney tests will be used.  All 
protected health information will be removed prior to statistical analysis. We will use patient 
subjective pain, perioperative blood loss and knee swelling data as statistical endpoints. 
Subjective pain will be measured with the VAS (visual analogue scale), perioperative blood loss 
will be measured looking at blood loss from the suction drain after surgery. We are looking for a 
statistically significant difference in perioperative blood loss between the two cohorts. The 
swelling ratio is defined as the postoperative mean circumference of upper pole of patella and 
lower pole of patella divided by the preoperative values according to our previous study[9]. The 
endpoints must be statistically significant between the two cohorts to show TXA is effective. 
 
Data and Safety Monitoring Plan 
Data monitoring will be done by Dr. Jovan Popovic, the anesthesiologist, and Dr. Alaia, the 
principal investigator will oversee the conduct of the study. They will review the following 
accumulated data quarterly.   
They will monitor whether or not: 
1. Collection and storage of patient data was performed in a sensitive and secure manner, 
as defined in the informed consent form and protocol, ensuring information is stored 
on REDCap. 
2. All study activities were conducted with primary emphasis on patient care and 
wellbeing, ensuring the patients are not in discomfort and have an abnormally high 
VAS following the surgery. 
3. If there were any adverse events, and if so were addressed appropriately and per 
protocol  
4. The risk/benefit to patients has remained the same throughout the course of the study. 
 
The study will be stopped if there are unexpected severe AE’s in more than one patient. Adverse 
events will be defined as negative reactions to the intravenous TXA during or after surgery, 
including seizures, vision problems. We will submit summaries of data and safety monitoring 
annually.   
 
Data Storage and Confidentiality 
Data recorded from this study will be organized in REDCap. Participant medical information will 
only be available to the principal investigator and research staff as necessary for data analysis. All 
patient health information will be de-identified and assigned a code. Information linking 
participants’ names, social security numbers and medical record numbers will be stored in a secure 
location separate from the medical information. No data will be shared to anyone outside of the 
study team.  
 
Adverse Event Reporting 
Information about any breach of confidentiality will be documented in the electronic data 
collection system and/or on the paper CRFs, as appropriate. It will be the responsibility of the 
Principal Investigator to report any Serious Adverse Event (SAE) that occurs during the course 


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of the prospective data collection to the Institutional Review Board (IRB) within the timeframe 
specified by NYU SoM. 
 
IV. RISK/BENEFIT ASSESSMENT 
Risk 
This study involves risk of medication side effects as well as a breech of confidentiality. 
Intravenous TXA can cause the following side effects: 
• Anxiety 
• blurred vision 
• changes in vision 
• chest pain 
• confusion 
• cough 
• dizziness or lightheadedness 
• fainting 
• fast heartbeat 
• greatly increased or decreased frequency of urination or amount of urine 
• increased thirst 
• loss of appetite 
• nausea or vomiting 
• numbness of the hands 
• pain, redness, or swelling in the arm or leg 
• sudden shortness of breath or troubled breathing 
 
Rare side effects include: 
• Convulsions or seizures 
• Orthostatic hypotension 
• sweating 
• trouble seeing 
• unusual tiredness or weakness.  
 
Protection against Risks  
Patients will be screened for any contraindication to aspirin or Percocet use. 
 
The patients will stay in the recovery unit a minimum of 3 hours after surgery as the mean duration 
of the effect of TXA is 3 hours and be monitored by the recovery unit nurses[3, 12]. Patients will 
be instructed to call the principal investigator and visit the emergency department if there is are 
any symptoms of calf swelling or chest pain within the first seven days following surgery. 
 
Additionally, all patients will be de-identified and given a code. Information linking the patient 
codes to the participants’ names and medical record numbers will be stored in a secure location 
separate from the medical information.  Access to the information linking the linkage codes with 
participant identifiers shall be restricted.   
 
Potential Benefits to the Subjects  


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Patients may experience less pain post-operatively, and may require less narcotics use, which has 
a steeper side-effect profile. However, these benefits cannot be guaranteed. 
 
Additionally, it is the hope of the research team that results of this study will benefit future 
patients and their physicians by providing more information regarding the use of acetaminophen 
after surgery.  This will allow for a more open and informed dialogue, and possibly a change 
standard of care treatment.  
 
V. INVESTIGATOR’S QUALIFICATIONS AND EXPERIENCE 
The CV, medical license, and human subjects’ tutorial completion report are attached for all 
investigators who are participating in this study.  All research personnel have medical research 
experience and are qualified to participate in this quality study. Most importantly, staff have been 
properly educated and certified with CITI training to conduct research in a matter that will 
maintain full patient confidentiality. The research coordinator for this study is trained in GCP 
principles and practices and will be responsible for compliance with GCP guidelines for all study 
investigators and research assistants. 
 
VI. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
Method of Subject Identification and Recruitment 
Appropriate patients, who meet all of the inclusion criteria and none of the exclusion criteria, who 
require a BTB ACL reconstruction, will be identified from the clinical offices of the investigator 
surgeons.  
 
Process of Consent 
Written consent will be obtained from subjects who are eligible candidates for BTB ACL 
reconstruction based upon their medical condition (as determined by their physician). The consent 
process will take place during the office visit when it is determined necessary to perform the 
procedure—at which time the investigator has determined subject’s voluntary participation has 
been upheld. Subjects will be informed about the study and the intended purpose. They will be 
given the opportunity to ask questions and receive thorough explanations. They will be made aware 
of the possible risks and anticipated benefits. They will also be informed of alternative procedures. 
Subjects will then be given another opportunity to ask questions and agree or disagree to consent. 
 
Subject Capacity 
All subjects enrolled in this study will have capacity to provide informed consent. 
 
Consent Forms 
Written consent will be obtained from the patient. 
 
Documentation of Consent 
Signed consent forms will be kept in a binder and stored in a locked file cabinet.   
 
Costs to the Subject 
Subjects will not incur any additional financial costs as a participant in this study. 
 


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Payment for Participation  
No payments/reimbursements will be provided to subjects for their participation in this study. 
 
VII. References 
 
 
1. 
Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM (2011) Tranexamic acid in total knee 
replacement: a systematic review and meta-analysis. J Bone Joint Surg Br 93:1577-1585 
2. 
Alshryda S, Sukeik M, Sarda P, Blenkinsopp J, Haddad FS, Mason JM (2014) A systematic review and 
meta-analysis of the topical administration of tranexamic acid in total hip and knee replacement. Bone Joint 
J 96-B:1005-1015 
3. 
Camarasa MA, Olle G, Serra-Prat M, Martin A, Sanchez M, Ricos P, et al. (2006) Efficacy of 
aminocaproic, tranexamic acids in the control of bleeding during total knee replacement: a randomized 
clinical trial. Br J Anaesth 96:576-582 
4. 
Chen JY, Chin PL, Moo IH, Pang HN, Tay DK, Chia SL, et al. (2016) Intravenous versus intra-articular 
tranexamic acid in total knee arthroplasty: A double-blinded randomised controlled noninferiority trial. 
Knee 23:152-156 
5. 
Chiang E-R, Chen K-H, Wang S-T, Ma H-L, Chang M-C, Liu C-L, et al. (2019) Intra-articular Injection of 
Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament 
Reconstruction: A Prospective Randomized Study. Arthroscopy: The Journal of Arthroscopic & Related 
Surgery 35:2127-2132 
6. 
Cid J, Lozano M (2005) Tranexamic acid reduces allogeneic red cell transfusions in patients undergoing 
total knee arthroplasty: results of a meta-analysis of randomized controlled trials. Transfusion 45:1302-
1307 
7. 
Frobell RB, Roos HP, Roos EM, Hellio Le Graverand MP, Buck R, Tamez-Pena J, et al. (2008) The 
acutely ACL injured knee assessed by MRI: are large volume traumatic bone marrow lesions a sign of 
severe compression injury? Osteoarthritis Cartilage 16:829-836 
8. 
Ho KM, Ismail H (2003) Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total 
hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care 31:529-537 
9. 
Huang Z, Ma J, Shen B, Pei F (2014) Combination of intravenous and topical application of tranexamic 
acid in primary total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty 29:2342-
2346 
10. 
Johnson DL, Urban WP, Jr., Caborn DN, Vanarthos WJ, Carlson CS (1998) Articular cartilage changes 
seen with magnetic resonance imaging-detected bone bruises associated with acute anterior cruciate 
ligament rupture. Am J Sports Med 26:409-414 
11. 
Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W (2009) Use of antifibrinolytic 
therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized 
trials. Thromb Res 123:687-696 
12. 
Karaaslan F, Karaoglu S, Mermerkaya MU, Baktir A (2015) Reducing blood loss in simultaneous bilateral 
total knee arthroplasty: combined intravenous-intra-articular tranexamic acid administration. A prospective 
randomized controlled trial. Knee 22:131-135 
13. 
Karaaslan F, Karaoglu S, Yurdakul E (2015) Reducing Intra-articular Hemarthrosis After Arthroscopic 
Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A 
Prospective, Randomized Controlled Trial. Am J Sports Med 43:2720-2726 
14. 
Lewis JL, Deloria LB, Oyen-Tiesma M, Thompson RC, Jr., Ericson M, Oegema TR, Jr. (2003) Cell death 
after cartilage impact occurs around matrix cracks. J Orthop Res 21:881-887 
15. 
McCormack PL (2012) Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs 
72:585-617 
16. 
Oremus K, Sostaric S, Trkulja V, Haspl M (2014) Influence of tranexamic acid on postoperative 
autologous blood retransfusion in primary total hip and knee arthroplasty: a randomized controlled trial. 
Transfusion 54:31-41 


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17. 
Theologis AA, Kuo D, Cheng J, Bolbos RI, Carballido-Gamio J, Ma CB, et al. (2011) Evaluation of bone 
bruises and associated cartilage in anterior cruciate ligament-injured and -reconstructed knees using 
quantitative t(1rho) magnetic resonance imaging: 1-year cohort study. Arthroscopy 27:65-76 
18. 
Yang ZG, Chen WP, Wu LD (2012) Effectiveness and safety of tranexamic acid in reducing blood loss in 
total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am 94:1153-1159 
 


Approved For Period: 3/3/2020 - 3/2/2021
Study #: S18-00538
Version date: 2/26/2020
Page 1 of 7
Research Subject
Informed Consent Form
Title of Study:
Reducing Hemarthrosis in Anterior Cruciate Ligament 
Reconstruction with BTB Autograft by the Administration of 
Intravenous Tranexamic Acid: A Double-Blind Randomized 
Control Study 
Study Number: S18-00538
Principal 
Investigator:
Michael Alaia, MD
Division of Sports Medicine
New York University Hospital for Joint Diseases
New York, NY 10003
Office: (646) 501-7223
Emergency 
Contact:
Michael Alaia, MD
(646) 501-7223
1. About volunteering for this research study
You are being invited to take part in a research study. Your participation is voluntary which means you 
can choose whether or not you want to take part in this study.
People who agree to take part in research studies are called “subjects” or “research subjects”. These words 
are used throughout this consent form. Before you can make your decision, you will need to know what 
the study is about, the possible risks and benefits of being in this study, and what you will have to do in 
this study. You may also decide to discuss this study and this form with your family, friends, or doctor. If 
you have any questions about the study or about this form, please ask us. If you decide to take part in this 
study, you must sign this form. We will give you a copy of this form signed by you for you to keep.
2. What is the purpose of this study?
The purpose of this study is to see if giving intravenous (IV, through a vein) tranexamic acid (TXA) to 
patients undergoing anterior cruciate ligament (ACL) reconstruction results in decreased bleeding in the 
joint and decreased post-operative pain and swelling when compared to patients who undergo ACL 
reconstruction without TXA. 
During ACL reconstruction, bleeding occurs inside the joint and from the site where the tendon is taken 
for the repair.  This can prolong the recovery process as pain and swelling occur after surgery.  TXA 
helps blood to form clots by blocking the function of plasmin (a protein) that prevents clot formation.  The 
US Food and Drug Administration (FDA) approved the use of TXA to stop excessive bleeding in people 
with hemophilia (an inherited condition affecting the body’s ability to form blood clots) undergoing tooth 
extraction.  In this study, TXA is considered an investigational drug because it is not FDA-approved for 
reducing bleeding associated with ACL reconstruction. 


Approved For Period: 3/3/2020 - 3/2/2021
Study #: S18-00538
Version date: 2/26/2020
Page 2 of 7
You are being asked to participate in this study because you are going to have ACL reconstruction surgery 
on your knee.
3.
How long will I be in the study? How many other people will be in the 
study?
You will be part of the study for 1 week, until your post op follow up visit. We expect to enroll approximately 
110 subjects in this research study.
4. What will I be asked to do in the study?
If you decide to participate in this study, you will be asked to sign this consent form prior to any research 
activities taking place. We will then review your chart for your demographics (age, sex, etc.), height and 
weight, body mass index (BMI), and medications and past medical history to confirm your eligibility to 
participate. 
If you are eligible to participate in the study, you will be randomized (assigned by chance, like flipping a 
coin) either to the group receiving TXA or the group not receiving TXA. You and your surgeon will not know 
which group you will be assigned to.  If you receive TXA, you will be getting 1 gram through an IV before 
the surgery starts and 1 gram after the surgery is complete.  Regardless of which group you are assigned 
to, you will continue your standard care as planned, which includes taking aspirin and Percocet to prevent 
clotting complications and to reduce post-operative pain.  The duration of your surgery and time under 
anesthesia will not be affected (i.e. prolonged) if you receive TXA.
We will collect information about your surgery such as how long it takes the surgeon to complete the 
operation and how much blood is lost. 
After your surgery, we will measure how much your knee has swelled.  We will monitor you for TXA side 
effects over the next 24 hours.  We will collect the time you are discharged from the post anesthesia care 
unit (PACU) as well as the time you are discharged from the hospital.  
You will be asked to report pain, side effects, and the amount of Percocet you need to take to control your 
pain. 
The pain scale we will be using is the visual analogue scale (VAS), a scale consisting of a drawn line from 
0 to 10 – you will be asked to mark where you believe your pain is (0 = no pain and 10 = the worst pain). 
These scores will be recorded at 30 minutes and 1, 2, and 4, 24, 48, hours and 1 week after surgery. 
You will also report whether you used any Percocet and, if so, the amount of Percocet taken at 24 hours, 
1 day, 2 days, and 7 days after your surgery. 
5. What are the possible risks or discomforts? 
The following are risks and discomforts that you may experience during your participation in this research 
study: 
Side effects of intravenous tranexamic acid (TXA) (<5% or fewer than 5 out of 100 people) may include: 
•
anxiety
•
blurred vision
•
changes in vision


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•
chest pain
•
confusion
•
cough
•
dizziness or lightheadedness
•
fainting
•
fast heartbeat
•
greatly increased or decreased frequency of urination or amount of urine
•
increased thirst
•
loss of appetite
•
nausea or vomiting
•
numbness of the hands
•
pain, redness, or swelling in the arm or leg
•
sudden shortness of breath or troubled breathing
Rare, but serious side effects of IV tranexamic acid (TXA) may include (< 1% or fewer than 1 out 
of 100 people)
•
convulsions or seizures
Other rare, but serious side effects of IV tranexamic acid (TXA) may include (< 0.5% or fewer than 
5 out of 1,000 people)
•
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
•
sweating
•
trouble seeing
•
unusual tiredness or weakness. 
Your doctor will go over the side effects of the standard care medications before and after the surgery. 
Potential Loss of Confidentiality: While every effort will be made to keep your information confidential, there 
is the potential risk of loss of confidentiality. In order to minimize this risk, any information that can identify 
you will be removed and replaced with a unique study ID that only the study coordinator/investigators will 
know.
In addition, this research may involve risks that are currently unforeseeable.
If any physical or psychological discomfort is experienced, or you no longer want to participate in the study, 
you can withdraw at any point and it will not affect the ongoing care you receive.
6. Can I be in the study if I am pregnant or breastfeeding?
Because taking part in this study may harm an embryo, fetus, or breastfeeding baby, you should not 
become pregnant, breastfeed a baby, or father a child while participating in this study. Risks to the 
patient include increase in blood sugar and reduced ability to fight infection. Risks to the fetus include 
hormonal imbalance. Other risks may not yet be known.
If you are currently pregnant, you will not be able participate in the study. You should not become 
pregnant while you are participating in this study. If you are able to become pregnant, you will be 
required to use a medically accepted method of birth control while you participate in the study: These 
methods include:

Hormonal methods like birth control pills, patches, vaginal rings or implants, 


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
Barrier methods such as condoms or a diaphragm used with spermicide (a foam, cream or gel that 
kills sperm), 

Intrauterine device (IUD), 

Abstinence (no sex). 
If you become or you think you have become pregnant during the study, you must tell the principal 
investigator right away and must tell your obstetrician or other health care provider caring for you during 
your pregnancy that you took part in this study. If you become pregnant, you will have to stop taking part 
in the study for safety reasons. The principal investigator may ask you to provide information about the 
outcome of your pregnancy and the health of your baby.
7. What if new information becomes available?
During the course of this study we may find more information that could be important to you. This includes 
information that might cause you to change your mind about being in the study. We will notify you as soon 
as possible if such information becomes available.
8. What are the possible benefits of the study? 
If you are randomly assigned to the group who receives the study drug, you may experience less pain and 
swelling post-operatively and may require less post-operative pain medication, such as Percocet.  
However, these benefits cannot be guaranteed. It is hoped that the knowledge gained from this study will 
be of benefit to others in the future.
9. What other choices do I have if I do not participate? 
You do not have to participate in this study to receive ongoing care for your condition.
10. Will I be paid for being in this study?
You will not be paid for your participation in this study. 
11. Will I have to pay for anything?
You and/or your health insurance may be billed for the costs of medical care during this study if these 
expenses would have happened even if you were not in the study, or if your insurance agrees in advance 
to pay.  If you have health insurance, the cost of these services will be billed to your insurance company.  
If your insurance does not cover these costs or you do not have insurance, these costs will be your 
responsibility. The cost of the study drug will be provided free of charge.
12. What happens if I am injured from being in the study? 
For medical emergencies contact 911. If you think you have been injured as a result of taking part in this 
research study, tell the principal investigator as soon as possible. The principal investigator’s name and 
phone number are listed at the top of page 1 of this consent form. 
We will offer you the care needed to treat injuries directly resulting from taking part in this research. We 
may bill your insurance company or other third parties, if appropriate, for the costs of the care you get for 
the injury, but you may also be responsible for some of them. 
There are no plans for the NYU School of Medicine or Medical Center to pay you or give you other 
compensation for the injury. You do not give up your legal rights by signing this form.


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13. When is the study over? Can I leave the Study before it ends?
This study is expected to end after all participants have completed all visits, and all information has been 
collected. This study may also be stopped or your participation ended at any time by your physician without 
your consent because:

The principal investigator feels it is necessary for your health or safety. Such an action would not 
require your consent, but you will be informed if such a decision is made and the reason for this 
decision.

You have not followed study instructions. 

The principal investigator or other body responsible for monitoring the safety of the study has 
decided to stop the study.
If you decide to participate, you are free to leave the study at any time. Leaving the study will not interfere 
with your future care, payment for your health care or your eligibility for health care benefits.
14. How will you protect my confidentiality? 
Your medical information is protected health information, or “PHI”, and is protected by federal and state 
laws, such as the Health Insurance Portability and Accountability Act, or HIPAA. This includes 
information in your research record as well as information in your medical record at NYU Langone 
Health. In compliance with NYU Langone Health policies and procedures and with HIPAA, only those 
individuals with a job purpose can access this information.
Medical information created by this research study may become part of your medical record. We may 
include your research information in your medical record for several reasons, including for the billing of 
services provided in connection with the study, to securely document any medical services you receive, 
and so that other members of the NYU Langone Health community who may treat you have access to 
important information about your health. 
You have a right to access information in your medical record.  In some cases, when necessary to 
protect the integrity of the research, you will not be allowed to see or copy certain information relating to 
the study while the study is in progress, but you will have the right to see and copy the information once 
the study is over in accordance with NYU Langone Health policies and applicable law.
15. HIPAA Authorization
As noted in the Confidentiality section above, federal law requires us, and our affiliated researchers, 
health care providers, and physician network to protect the privacy of information that identifies you and 
relates to your past, present, and future physical and mental health conditions. We are asking for your 
permission (authorization) to use and share your health information with others in connection with this 
study- in other words, for purposes of this research, including conducting and overseeing the study.  
Your treatment outside of this study, payment for your health care, and your health care benefits will not 
be affected even if you do not authorize the use and disclosure of your information for this study. 
What information may be used or shared with others in connection with this study?


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All information in your research record for this study may be used and shared with those individuals listed 
in this section. Additionally, information in your medical record that the research team believes may be 
important to the study may be accessed by those listed here. This includes, for example, results from 
your physical examinations, x-ray images, laboratory tests, procedures, questionnaires, and diaries. 
Who may use and share information in connection with this study?  
The following individuals may use, share, or receive your information for this research study:

The Principal Investigator, study coordinators, other members of the research team, and personnel 
responsible for the support or oversight of the study.

The study sponsor: Department of Orthopaedic Surgery

Governmental agencies responsible for research oversight (e.g., the Food and Drug Administration 
or FDA). 

Health care providers who provide services to you in connection with this study, and laboratories 
or other individuals who analyze your health information in connection with this study.
Your information may be re-disclosed or used for other purposes if the person who receives your 
information is not required by law to protect the privacy of the information.
What if I do not want to give permission to use and share my information for this study?
Signing this form is voluntary. You do not have to give us permission to use and share your information, 
but if you do not, you will not be able to participate in this study. 
Can I change my mind and withdraw permission to use or share my information?
Yes, you may withdraw or take back your permission to use and share your health information at any 
time for this research study.  If you withdraw your permission, we will not be able to take back information 
that has already been used or shared with others.  To withdraw your permission, send a written notice to 
the principal investigator for the study noted at the top of page 1 of this form.  If you withdraw your 
permission, you will not be able to stay in this study.
How long may my information be used or shared?  
Your permission to use or share your personal health information for this study will never expire unless 
you withdraw it.
16. Optional permission for future use
NYULMC would also like to store, use, and share your health information from this study in research 
databases or registries for future research conducted by NYULMC or its research partners. To give this 
additional permission, check the box below and write your initials where indicated. You may still participate 
in this study even if you do not give us this additional permission.
NYULMC will continue to protect the confidentiality and privacy of this information as required by law and 
our institutional polices. If you give this additional permission, you will continue to have the rights described 
in this form. You have the right to take back this additional permission at any time. 
Checking this box indicates my permission to store, use, and share my health 
information from this study in research databases or registries for future 
research conducted by NYULMC or its research partners.
Subject Initials


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17. The Institutional Review Board (IRB) and how it protects you
The IRB reviews all human research studies – including this study. The IRB follows Federal Government 
rules and guidelines designed to protect the rights and welfare of the people taking part in the research 
studies. The IRB also reviews research to make sure the risks for all studies are as small as possible. 
The NYU IRB Office number is (212) 263-4110. The NYU School of Medicine’s IRB is made up of doctors, 
nurses, non-scientists, and people from the community.
18. Who can I call with questions, or if I’m concerned about my rights as a 
research subject?
If you have questions, concerns or complaints regarding your participation in this research study or if you 
have any questions about your rights as a research subject, you should speak with the Principal 
Investigator listed on top of the page 1 of this consent form. If a member of the research team cannot be 
reached or you want to talk to someone other than those working on the study, you may contact the 
Institutional Review Board (IRB) at (212) 263-4110. 
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.
When you sign this form, you are agreeing to take part in this research study as described to you. This 
means that you have read the consent form, your questions have been answered, and you have decided 
to volunteer. 
Name of Subject (Print)
Signature of Subject
Date
Name of Person Obtaining Consent (Print)
Signature of Person Obtaining Consent
Date