Clinical trial NCT02257580
Conditions: E-Aminocaproic Acid Bilateral Varus Rotational Osteotomy
Keywords: E-Aminocaproic Acid Bilateral Varus Rotational Osteotomy Blood Loss and Transfusion Complications Safety
Sponsor: Hospital for Special Surgery, New York
Start date: 2015-04-01; Completion date: 2020-10-26
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
E-Aminocaproic acid (EACA) is an anti-fibrinolytic agent that is used to decrease blood loss and transfusion requirements after several orthopedic procedures. The aim of this prospective double-blind placebo-controlled randomized trial is to determine whether IV EACA reduces intra-operative calculated total blood loss in patients undergoing bilateral varus rotational osteotomy (VRO). This study will also investigate intraoperative cell saver utilization, transfusion of allogeneic blood, hospital length-of-stay (LOS), short term complications, and long-term outcomes.This study will provide Level I evidence and has the potential to improve outcomes in children undergoing this procedure.

Detailed description:
The participating anesthesiologists will not be blinded to study arms and hypotheses. Dr. Christopher Edmonds will be the head anesthesiologist for this study and will administer anesthetics to participants in this trial whenever his schedule makes it possible. Anesthesia will be conducted in a standardized fashion, with IV sedation using Versed and IV propofol, +/- Fentanyl and Ketamine . A Combined Spinal-Epidural (CSE) will be placed using 12.5-20 mg of bupivacaine. If a CSE is unsuccessful and an epidural and/or spinal are successfully obtained, the patient may still be included in the study. Patients not receiving neuraxial anesthesia will be excluded. If a patient requires general anesthesia, it will be induced at this time, but the patient will be excluded from the study. An arterial line and additional venous access will be obtained in standardized sterile practice. Sedation will be maintained with IV propofol. IV Valium, Toradol and IV acetaminophen will be given towards the end of the case, per anesthesiologist's discretion.

The blood pressure target will be 20-25% below baseline, which will be achieved primarily with the neuraxial anesthesia. For blood pressure above this range, the epidural will be dosed with a short-acting local anesthetic, and/or IV sedation will be titrated as per the anesthesiologist's judgment. For hypotension below this range, pressors or intravenous pressors will be given. An IV fluid bolus may also be given in the amount of 10-20cc/kg. Additional maintenance IV fluids will be given to maintain urine output of at least 0.5-1ml/kg/hr. The criteria for transfusion of blood products will be a hemoglobin level of \< 7.0 g/dL or a hemoglobin level of \< 10.0 g/dL with clinical signs of symptomatic anemia (e.g., unexplained tachycardia, hypotension unresponsive to fluids or vasopressors, change in mental status, low urine output, and shortness of breath). Blood will be administered 1 unit at a time, and the presence of symptoms or signs will be reassessed after each unit. This algorithm may be altered by the treating physician (e.g., PACU attending, surgeon, or the OR anesthesiologist), however all decisions will be supported by reasonable documentation. Drains will be removed on POD 2 unless specified by the attending surgeon. Of note, the chart of the patient will clearly indicate him/her as a study patient; a sticker will be place on the front of each participating patient's chart. Their enrollment will also be communicated in the clinician rounding notes for each patient. Drains will be labeled for each study participant as well, and nurses will record the drain outputs per their floor protocol.

Attending surgeons, orthopedic surgery residents, physician assistants and research assistants involved with this study will assist in data collection. For each patient, we will collect demographic data, pre-operative CBC data, intra-operative cell saver auto-transfusion volumes, post-operative number of packed red blood cell units transfused, post-operative CBC data, post-operative drain outputs, and post-operative complications. This information will be gathered from the peri-operative medical records and electronic medical records. Surgeons and clinical and research personnel will review medical chart and progress notes for evidence of clinically significant VTE, reoperation, hematoma, seroma, and infection.

Arms: arm 1: An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case. arm 2: Equivalent volume of normal saline prepared by the pharmacy.
Interventions: intervention 1: E-Aminocaproic acid
Intervention descriptions: intervention 1: E-Aminocaproic acid (EACA) is a synthetic lysine analog that competitively inhibits the activation of plasminogen to plasmin and subsequently decreases the degree of fibrinolysis (Faraoni,2014} and is currently being used to decrease blood loss and transfusion requirements after orthopaedic procedures.(Eubanks,2010} Multiple meta analyses and retrospective and prospective studies have shown that EACA decreases blood loss and transfusion requirements after orthopaedic surgery{ McLeod,2013; Thompson, 2005; Thompson,2008; Gill,2008; Florentino-Pineda,2001}.Results from these studies also suggest that EACA will decreased post-operative morbidity, length of hospital stay, hospital costs, and complications.{Chimento,2013; Thompson,2005; Florentino-Pineda,2001}

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After 
Bilateral VRO 
 
Protocol and Analysis Plan 
 
NCT # NCT02257580 
 
Approved 12/10/2014 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


1. What is the Study Design  
  
Experimental:  
  
Randomized controlled clinical trial (RCT) 
  
  
2. Who will be recruited and enrolled? 
  
Inclusion Criteria: 
  
Patients will be recruited from the practices of Dr. Scher and Dr. Dodwell.  Inclusion 
criteria will include the following:  
• 
Age less than or equal to 18  
• 
Scheduled for elective bilateral VRO with or without associated soft tissue and 
osseous procedures  
  
Exclusion Criteria:   
  
All patients will be asked to discontinue acetylsalicylic acid (ASA), antiplatelet agents, and 
hormone replacement and hormonal contraceptive agents at least 7 days prior to surgery. 
Other than ASA, these agents will be held 6 weeks postoperatively.   
  
• 
Preoperative use of an anticoagulant (Plavix, warfarin, lovenox, etc.)  
• 
History of hypersensitivity to EACA  
• 
History of thromboembolic event (e.g., PE or DVT)  
• 
History of renal insufficiency or failure  
• 
Congenital or acquired coagulopathy as evidence by INR >1.4 or PTT > 1.4 times 
normal, or Platelets <150,000/mm3 on preoperative laboratory testing  
• 
Use of hormone replacement therapy or hormonal contraceptive agent within 7 days prior 
to surgery  
• 
Pregnant  
• 
Breastfeeding  
• 
Older than 18 years of age  
• 
Patients not receiving neuraxial anesthesia  
  
  
This trial will be registered on ClinicalTrials.gov.  All patients undergoing bilateral VRO 
by the study surgeons (DS and ED) will be identified in their office and screened for 
eligibility as potential patients for participation in the study. A research assistant will 
review the office and operative calendars of the study surgeons each week to identify and 
recruit potential patients.  The assistant will record on the CONSORT diagram any 
reasons for ineligibility/exclusion.  
   


The surgeon, a co-investigator or research assistant will obtain consent prior to 
surgery, at the patient’s preadmission screening visit.  All authors on the protocol, in addition 
to their research assistants, will be designated to obtain consent.  
   
We will power the study to detect a 250mL difference in calculated intra-operative blood loss 
between groups.  This effect size has been used in the total hip literature, and it is considered to 
be a clinically significant difference in blood loss15. Our analysis shows that 12 patients are 
required in each arm of the study (24 patients total) to achieve 81% power with an independent-
sample t-test and statistical significance set to alpha equal to 0.05.  Expecting that 10-25% of 
patients will be excluded, we will aim to enroll a total of 30 patients in this study.  
  
  
Patients aged 18 or younger will be screened for study eligibility  
  
3. Interventions or Observations – what data are going to be collected and from what 
source?   
  
Only anesthesiologists agreeing to participate in the study will be paired with the study 
surgeons. Anesthesia will be conducted in a standardized fashion. The 
anesthesiologist will perform a neuraxial block (epidural, spinal, combined-spinal 
epidural) as well as administer general anesthesia. A neuraxial block will be placed 
using bupivicaine.  A balanced general anesthetic utilizing a combination of either 
isoflurane, sevoflurane with or without nitrous oxide, vecuronium, midazalam and 
either fentanyl, morphine or dilaudid as the narcotic will be used at the discretion of 
the anesthesiologist.  If a combined-spinal epidural is unsuccessful and an epidural 
and/or spinal are successfully obtained, the patient will still be included in the study.  
Patients not receiving neuraxial anesthesia will be excluded from the study.  Arterial 
and venous access will be obtained in the usual sterile manner for monitoring.  
   
      The blood pressure target will be 20-25% below baseline, which will be achieved 
primarily with the combination of the general anesthesia and the neuraxial 
anesthesia.  For blood pressure above this range, the epidural will be dosed with a 
short-acting local anesthetic, and/or the depth of the general anesthetic and will be 
titrated as per the anesthesiologist’s judgment.  For hypotension below this range, 
intravenous pressors, crystalloid, colloid or blood will be given. The technique of 
induced hypotension will not be utilized during these cases.  Additional maintenance 
IV fluids or colloid will be given to maintain urine output of at least 0.5-1ml/kg/hr.  
Toradol and IV acetaminophen may be given towards the end of the case per the 
anesthesiologist’s discretion.   
  
 Bilateral VRO will be performed as per the surgeon’s routine practice.  In general, the 
operative extremity will be prepped and draped in the usual sterile fashion. Prior to 
incision, the anesthesiologist will administer a loading dose of 100 mg/kg of EACA 
with a max of 4-5 grams up to 1 hour prior to incision.   During the case, an infusion 
of 33 mg/kg/hr (max of 1 gram/hr) will be maintained.  The use of EACA will be 
terminated at the end of the case.  Patients randomized to the placebo arm will be 


infused with a comparable volume of normal saline prepared by the pharmacy. All 
participating anesthesiologists will not be blinded in this study.  A direct lateral 
approach to the femur will be used, and standard surgical techniques for intra-
operative hemostasis will be utilized. The surgeon will perform bilateral femoral 
osteotomies and associated soft tissue surgery and pelvic osteotomy.  After all 
hardware is placed, the wound will be thoroughly irrigated and suctioned.  A deep 
drain will be placed on each operative side, and the wound will be closed in 
layers.  Intra-operatively, a cell saver will be used, and the volume (mL) of auto-
transfusion will be recorded.   
  
Hematocrit levels will be monitored regularly in the post-operative period.  As per protocol, a 
post-op hematocrit will be drawn in the PACU, and subsequently, daily labs will be obtained 
unless specified by the medicine or surgical attending.  Routine, daily inpatient CBC data and 
drain output will be reviewed.  Inpatient and office records will be accessed to help identify 
postoperative complications. The criteria for transfusion of blood products will be a hemoglobin 
level of < 7.0 g/dL or a hemoglobin level of < 10.0 g/dL with clinical signs of symptomatic 
anemia (e.g., unexplained tachycardia, hypotension unresponsive to fluids or vasopressors, 
change in mental status, low urine output, and shortness of breath).  Blood will be administered 1 
unit at a time, and the presence of symptoms or signs will be reassessed after each unit.  This 
algorithm may be altered by the treating physician (e.g., PACU attending, surgeon, pediatrician, 
or the OR anesthesiologist), however all decisions will be supported by reasonable 
documentation. Drains will be removed on POD 2 unless specified by the attending surgeon, and 
the 24-hour clock will begin once the patient is in the PACU. All drains, patient charts, and 
patient rooms will be clearly labeled in order to identify study patients.    
 
  
Attending surgeons, orthopedic surgery residents, physician assistants and research assistants 
involved with this study will assist in data collection.  For each patient, we will collect 
demographic data, pre-operative CBC data, intra-operative cell saver auto-transfusion 
volumes, post-operative number of packed red blood cell units transfused, post-operative 
CBC data, post-operative drain outputs, and post-operative complications. This information 
will be gathered from the peri-operative medical records and electronic medical records.   
  
A sticker will be place on the front of each participating patient’s chart identifying him or her 
as a study patient.  Their enrollment will also be communicated in the clinician rounding 
notes for each patient.  Drains will be labeled for each study participant as well, and nurses 
will record the drain outputs per their floor protocol.  
  
Data recorded from the electronic medical record will include:  
• 
Date of surgery  
• 
Patient age at the time of surgery  
• 
Patient sex  
• 
Patient height (cm) and weight (kg) at time of admission   
• 
Preoperative CBC data and coagulation study data  


• 
Postoperative hemoglobin on all inpatient days postoperatively (g/dL)  
• 
Transfusion requirement during inpatient stay (units required)   
• 
Transfusion reaction  
• 
Total 24-hour drain output  
• 
Postoperative day and time of discharge  
• 
Chart review of progress notes for evidence of clinically significant VTE   
• 
Chart review of progress notes for evidence of reoperation, hematoma, seroma, or 
postoperative infection   
  
Data recorded from the operating room record will include:  
• 
Anesthetic used (e.g., spinal/epidural, general, etc.)  
• 
Operative times (minutes)  
• 
Intra-operative transfusion requirements (units of blood)  
• 
Use of cell saver intraoperatively (auto-transfusion volume, mL)  
• 
Intra-operative complications  
  
Data recorded from outpatient postoperative office records will include:  
• 
Chart review of progress notes for evidence of clinically significant VTE through 
six weeks post-operatively  
• 
Chart review of progress notes for evidence of re-operation, hematoma, seroma, 
or postoperative infection through six weeks post-operatively  
  
  
Patients will be randomized to either the intervention or control group, as per 
randomization protocol described elsewhere in the proposal. For patients who are 
randomized to the control group, study data will be collected in the same manner as 
for the intervention group.  
  
  
All tests and imaging used in this study are considered standard of care.  
  
Randomization Process:  
 The patients will be randomized into one of 2 groups: (1) Loading dose and infusion of EACA 
(2) Equivalent volume of normal saline prepared by the pharmacy.  An EACA loading dose of 
100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision.   During the 
case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained.  The use of 
EACA will be terminated at the end of the case.  Assignment of patients will be made based on a 
sequential treatment assignment or minimization strategy in order to ensure an even distribution 
of patients in each treatment arm.  More specifically, each patient will be randomized to the 
treatment arm that would minimize differences between groups.  Randomization will be 
stratified by sex and surgery type (bilateral VRO, bilateral VRO with associated soft tissue or 
osseous procedure) so that the number of male/female patients and VRO/associated procedure 
patients will be balanced in each study group between trial arms.   
  


The Biostatistics Core of the HSS Healthcare Research Institute will randomize each patient 
based on the minimization strategy.  It will be a double-blind experiment with all parties, except 
the pharmacy, anesthesiologist, and designated research assistant, being blinded to the 
randomization schedule (surgeon, medical staff, and patient). Patient recruitment will continue 
until a total of 30 patients are enrolled. 
  
Treatment Groups:  
Bilateral VROs will be performed as per the study surgeon’s routine practice.  In general, the 
operative extremity will be prepped and draped in the usual sterile fashion. Prior to incision, the 
anesthesiologist, will administer a loading dose of 100 mg/kg of EACA with (max of 4-5 grams) 
or an equivalent volume of normal saline prepared by the pharmacy. The loading dose may be 
give up to 1 hour prior to incision. During the case, an  EACA infusion of 33 mg/kg/hr (max of 1 
gram/hr) will be maintained.  Only anesthesiologists agreeing to participate in the study will be 
paired with the study surgeons, and all anesthesiologists will be aware of a patient’s 
randomization to the treatment or placebo group.   
 
Outcome Measures  
Primary outcome: Calculated total blood loss.  
Secondary outcomes of interest: Postoperative transfusion requirements (allogeneic blood 
transfusion and intraoperative cell saver utilization), post-operative blood loss, length of stay, 
and post-operative complications.   
  
Calculated total blood loss will be determined from the difference between the preoperative 
hemoglobin and the postoperative hemoglobin (or the lowest postoperative hemoglobin during 
the hospital stay prior to transfusion).  Based on hemoglobin balance, the estimated blood loss 
will be calculated according to the formula by Nadler et al.17:  
Estimated Blood Volume (EBV) = (k1 x Height3 (m)) + (k2 x Weight (kg)) + k3  
For men, k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041  
For women, k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833  
  
Multiplying the EBV by the hematocrit (Hct) gives the red blood cell (RBC) volume.  As such, a 
change in the RBC volume can be calculated from a change in the Hct level23,24:  
Total RBC volume loss = EBV x (Hct Preop – Hct Postop)  
  
Transfusions (mean volume per unit at HSS, 250 mL) can be taken into account by calculating 
the total blood loss16:  
  
Total blood loss (L) = Total RBC volume loss + (No. of Units Transfused x 0.25) / (Hct Preop – 
Hct Postop) / 2)  
  
The rate of perioperative blood transfusions, both intraoperative and postoperative, will be 
documented for analysis.  
  
The criteria for transfusion of blood products will be a hemoglobin level of < 7.0 g/dL or a 
hemoglobin level of < 10.0 g/dL with clinical signs of symptomatic anemia (e.g., unexplained 
tachycardia, hypotension unresponsive to fluids or vasopressors, change in mental status, low 


urine ouput, and shortness of breath).  Blood will be administered 1 unit at a time, and the 
presence of symptoms or signs will be reassessed after each unit.  This algorithm may be altered 
by the treating physician (e.g., PACU attending, surgeon, or the OR anesthesiologist), however 
all decisions will be supported by reasonable documentation. Drains will be removed on POD 2 
unless specified by the attending surgeon. Of note, the chart of the patient will clearly indicate 
him/her as a study patient.  
  
VTE prophylaxis is not commonly used for pediatric patients at our institution. However, all 
patients will also receive a comprehensive approach to postoperative care comprised  of 
mechanical (sequential compressive device) prophylaxis in-house, early mobilization with 
physical therapy, medical optimization, and regional anesthesia (if appropriate).  
  
  
4. What is the long-term significance?   
  
There are certain risks associated with blood loss and blood transfusion after elective orthopaedic 
procedures in young patients.  Blood loss and transfusion requirements can be reduced with 
several blood conservation measures, including the use of pharmacological agents such as 
EACA.  If the use of IV EACA is shown to decrease blood loss and transfusion requirements 
after bilateral VROs, it will provide an efficacious and inexpensive method to reduce post-
operative morbidity and improve patient outcomes after bilateral VROs.  
  
D. SAMPLE SIZE AND DATA ANALYSIS   
    
Sample Size – 
   
1. Proposed analysis (e.g., student’s t-test, ANOVA, chi-square, regression, etc.):  
Independent samples t-test will be utilized if the data is normally distributed (or non-
parametric Mann-Whitney U test if assumption of normality is not met).  
  
2. Alpha level:  0.05  
  
3. Beta or power level:  0.81  
  
4. Primary outcome variable estimate (mean +/- s.d. for continuous outcome, 
frequency/percentage for categorical variable):    
The primary outcome of interest in total intra-operative blood loss, which will be 
summarized as mean +/- standard deviation.  Based on an analysis of the twenty-four 
consecutive cases of bilateral VROs, the mean calculated intra-operative blood loss was 
671.24mL (SD: 233.69).  
  
5. Number of groups being compared (use 1 for paired analysis within the same subjects):    
Two groups are being compared: Treatment Group (Loading Dose + Infusion) vs. Placebo Group 
(NS)  
  
6. Effect size or change expected between groups:  250cc   
  


7. Resulting number per group:  12  
  
8. Total sample size required: 24  
  
Data Analysis  
  
The primary outcome of interest (calculated total blood loss) will be presented as a mean +/- 
standard deviation and compared between the EACA and placebo groups with a two-sample t-
test. Multivariable linear regression models will also be used to adjust for any potential 
confounding due to total blood loss volume between arms after adjustment for age, sex, BMI, 
and anesthesia type. To adjust for any patients lost due to early withdrawal, we will increase our 
sample size by 3 patients in each group for a total sample size of 30 patients.  
  
Calculated total blood loss will be determined from the difference between the preoperative 
hemoglobin and the postoperative hemoglobin (or the lowest postoperative hemoglobin during 
the hospital stay prior to transfusion).  Based on hemoglobin balance, the estimated blood loss 
will be calculated according to the formula by Nadler et al.17:  
Estimated Blood Volume (EBV) = (k1 x Height3 (m)) + (k2 x Weight (kg)) + k3  
For men, k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041  
For women, k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833  
  
Multiplying the EBV by the hematocrit (Hct) gives the red blood cell (RBC) volume.  As such, a 
change in the RBC volume can be calculated from a change in the Hct level23,24:  
Total RBC volume loss = EBV x (Hct Preop – Hct Postop)  
  
Transfusions (mean volume per unit at HSS, 250 mL) can be taken into account by calculating 
the total blood loss16:  
  
Total blood loss (L) = Total RBC volume loss + (No. of Units Transfused x 0.25) / (Hct Preop – 
Hct Postop) / 2)  
  
All continuous secondary outcomes such as postoperative allogeneic blood transfusion 
requirement, intraoperative cell saver utilization, and length of hospital stay, will be analyzed in 
the same manner as the primary outcome.  
  
Complications will be reported as incidence rates with 95% confidence intervals.  
  
All hypotheses will be evaluated with two-sided tests with statistical significance set at α = 0.05.  
 
 
 
 
 


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ICF_001.pdf: 
 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 1 of 18 
 
IRB Administrative Use Only 
 
«Approval» 
«ApprovalDate» Thru «ExpirationDate» 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After 
Bilateral VRO 
 
Protocol and Analysis Plan 
 
NCT # NCT02257580 
 
12/9/2014 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 2 of 18 
 
IRB Administrative Use Only 
 
«Approval» 
«ApprovalDate» Thru «ExpirationDate» 
HOSPITAL FOR SPECIAL SURGERY 
535 East 70th Street  
New York, NY 10021 
 
 
INFORMED CONSENT TO PARTICIPATE IN RESEARCH 
 
TITLE: THE EFFECT OF INTRAVENOUS -AMINOCAPROIC ACID ON BLOOD LOSS 
AND TRANSFUSION REQUIREMENTS AFTER BILATERAL VARUS ROTATIONAL 
OSTEOTOMY (VRO):  A PROSPECTIVE, DOUBLE-BLINDED, RANDOMIZED 
CONTROLLED TRIAL  
 
PROTOCOL NO.: 
 
SPONSOR: NONE 
 
INVESTIGATOR: DAVID M. SCHER, MD 
 
SITE(S): HOSPITAL FOR SPECIAL SURGERY 
 
STUDY-RELATED PHONE NUMBER(S): 
DR. DAVID SCHER 
212-606-1253 
DR. EMILY DODWELL 
212-606-1451 
DR. ISHAAN SWARUP  
212-606-1466 
 
IRB #: 2014-303 
 
“You” may refer to you or your child. 
 
You are being asked to take part in a research study conducted by Hospital for Special Surgery 
(HSS).  You are being asked to participate in this study because you are to undergo bilateral 
varus rotational osteotomy (VRO).  
 
You will still be responsible for the cost of your medical care just as you would be if you 
were not part of this study.  For example, any co-pays, deductibles, and co-insurance 
associated with your medical care. 
 
This document provides you with information about this study.  After reading this document, any 
questions you may have will be answered.  You may take home a copy of this document to 
consider or discuss with family and friends before making your decision.  
 
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. 
  


 
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1.  WHY IS THIS STUDY BEING DONE? 
 
The purpose of this study is to determine the effect of a drug, -aminocaproic acid (EACA), on 
the blood loss and the need for blood transfusion after bilateral varus rotational osteotomy that 
you are scheduled to undergo.  Your overall participation will continue over the course of 6 
weeks after your surgery. 
 
Varus rotational osteotomy (VRO) is an elective surgery for the hip joint, typically for the 
treatment of femoral deformity in young patients. During the surgery, the femur bone is re-
oriented and possibly shortened in order to improve function and decrease pain.  In addition to 
bilateral VRO, associated soft tissue and bony procedures are often required to achieve the 
ultimate goal of maintaining a level pelvis, a balanced spine, and mobile, pain-free hips. Given 
the extent of surgery, there is a potential for increased blood loss, which may require a blood 
transfusion.  
 
The risk of excessive blood loss and blood transfusion in young patients after elective surgery 
can be reduced with certain interventions, such as medications. EACA is generally regarded as a 
safe medication that can be given intravenously (i.e., into a vein in your arm) during surgery to 
reduce surgical blood loss and the need for blood transfusion after surgery. EACA is a 
medication that works to decrease surgical bleeding by improving the body’s ability to stop 
bleeding.  Many studies have shown that EACA safely reduces bleeding and the need for 
transfusion in patients undergoing total joint replacement surgery (e.g., total hip replacement and 
total knee replacement) and spine surgery. However, no one has studied the effects of this 
medication in patients undergoing bilateral VRO.  As a result, this drug is being used in an off-
label manner, since it has not been previously studied in patients undergoing bilateral VRO.  
However, we believe that EACA may reduce blood loss during and after VRO, and thus, reduce 
the need for blood transfusion in patients undergoing this procedure. 
 
A total of 30 patients will be enrolled in this study. Patients will be divided into two groups.  One 
group will receive intravenous EACA, and the other group will receive intravenous normal saline 
during surgery.  Normal saline is an inactive substance.  In this study it serves as a “placebo” or a 
pretend treatment that is compared in this trial to EACA in order to test if the drug has a real 
effect.   
 
Apart for the administration of this medication, patients in both groups will receive the same 
care. 
 
2.  WHAT WILL YOUR PARTICIPATION REQUIRE?   
 
If you decide to be in this study, the following routine and/or experimental procedures will be 
performed:  
 
 
 


 
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Study Visit # 
Medication 
Administration 
Randomization Surgery 
Physical 
Exam 
Blood 
draw 
1) Preoperative office visit 
 
X 
 
SOC 
SOC 
2) Hospital admission 
SOC 
 
SOC 
SOC 
SOC 
3) 6-week post-op office visit 
 
 
 
SOC 
 
X=  Research procedures 
SOC= Standard of care (care you would receive if you were not participating in this study) 
 
This study will select your treatment by chance.  You will be assigned at random to one of two 
study groups.  The randomization process is comparable to (or similar to) the flip of a coin.  One 
group will receive intravenous -aminocaproic acid (EACA), and the other group will receive 
intravenous normal saline during surgery.  Normal saline is an inactive substance.  In this study it 
serves as a “placebo” or a pretend treatment that is compared in this trial with EACA in order to 
test if the drug has a real effect. It is not known if any treatment you receive will benefit you.  It 
is hoped the knowledge gained will benefit others in the future. 
 
You and/or your insurance will be responsible for any costs of all procedures performed that are 
standard of care, that is, care that you would receive even if you were not in this study. 
 
A total of 30 subjects will participate in this study at HSS.   
 
Your participation will involve a total of two study visits and your admission to the hospital, 
when you undergo your surgery.  Most visits are expected to last less than 30 minutes: 
 
1. The first study visit will be your preoperative appointment.  Your surgeon will perform 
all of his or her routine preoperative tests and exams during this visit. These are not part 
of the study.  You will be randomly assigned to one of the study groups.  You will not be 
told to which study group you are assigned.  The total time for this visit should be 
approximately 30 minutes. 
2. The second study visit will be your hospitalization, when your surgery is performed, the 
study medications will be given, and routine postoperative blood draws will be 
performed.  During these blood draws, approximately 2 teaspoons of blood will be taken.  
No additional time will be required for your participation in the study.  After surgery, you 
will receive the same care in the hospital as any other patient having undergone bilateral 
varus rotational osteotomy. 
3. The third study visit will be your 6-week appointment after surgery. As a study 
participant, your surgeon will perform a routine physical exam.  The total time for this 
visit should be approximately 30 minutes. 
  
3.  WHAT ADVERSE (BAD) EFFECTS CAN HAPPEN FROM BEING IN THE STUDY?  
WHAT RISKS ARE KNOWN ABOUT THE STUDY DRUG/STUDY DEVICE? 
 
The known effects, discomforts and foreseeable risks of physical, psychological, sociological, or 
other harm which you may reasonably expect to occur from being in this study are:    
 


 
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There is concern that a drug like -aminocaproic acid (EACA) which prevents bleeding may also 
cause a risk of blood clotting disorders, such as deep vein thrombosis (a blood clot in the leg or 
arm), pulmonary embolism (a blood clot in the lung), transient ischemic attack (sudden loss of 
blood flow to the brain that lasts for a few minutes to an hour but has no lasting effect), and 
stroke.  However, multiple studies have shown that there is not an apparent increase in the risk of 
these events in patients who have received EACA.  Since there is a theoretical risk of these 
events, the investigators will assemble an independent monitoring group of health care 
professionals at the Hospital for Special Surgery, who are not otherwise involved in the study.  
The group, called a “Data Safety Monitoring Board”, will monitor patient safety throughout the 
trial.  Also, the investigators will not permit patients to participate in the study if they have any 
of the following conditions and/or risk factors: 
- 
History of allergy to -aminocaproic acid 
- 
History of thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism, 
transient ischemic attack, and stroke) 
- 
History or evidence of kidney function problems 
- 
History of leukemia (blood cancer) 
- 
History of bleeding disorder or evidence of bleeding disorder on preoperative blood tests 
- 
Use of hormone replacement therapy or hormonal contraceptive agent (i.e., birth control) 
within 7 days prior to surgery 
- 
Currently pregnant 
- 
Currently breastfeeding 
 
As part of your surgery and post-operative care in the hospital, you may need to receive 
transfusions of blood products. These products come from healthy volunteers from the general 
population who choose to donate blood for the use of patients. Blood donors and blood products 
are carefully screened and tested to minimize the risk of transmitting any infectious disease or 
problems, but it is impossible to eliminate all risks. However, not receiving a transfusion when 
needed can carry a great risk of serious injury or death.  Alternatives to transfusion, such as 
hemoglobin substitutes, are not in general use at this time. 
 
Whether or not you are involved in this study, you will receive routine blood draws after your 
surgery to ensure your safety following the procedure.  Blood draws or “venipuncture” involves 
taking blood from a vein in your hand or arm by needle stick.  The risks associated with drawing 
blood from your arm or hand include momentary discomfort and/or bruising.  Infection, excess 
bleeding, clotting, or fainting are also possible, although unlikely.   
 
If you are placed in the “placebo” group, you will receive the same care as the patients in the 
EACA group.  There are no risks associated with being placed in the “placebo” group. 
 
Participation in this research involves the potential risk of a breach of confidentiality to your 
stored health information.  HSS tries to minimize those risks by (i) removing some direct 
identifiers from stored information (i.e., names and medical record numbers); (ii) securing, in a 
separate location, and limiting access to information that would identify you; and (iii) limiting 
access to information stored to HSS investigators. 
 


 
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There may be risks or side effects that are unknown at this time. If we learn about new risks that 
may affect your willingness to continue your participation, we will make you aware of them and 
you will be asked to re-consent to continue your participate in the study. 
 
4.  WHAT BENEFIT CAN YOU EXPECT?  
 
This study includes an investigational medication which may not give you immediate benefit or 
any benefit.  The knowledge gained may benefit others in the future. 
 
5.  COST  
Those research procedures listed in Section 2 will be covered by the study and will not be your 
financial responsibility. 
 
As indicated in Section 2, those costs which are considered Standard of Care for your treatment 
here at Hospital for Special Surgery will be your/or your insurance’s responsibility.  You will be 
responsible for any co-pays, deductibles, and co-insurance associated with your medical care, 
just as you would be for any costs billed to your health insurance outside of this study.  You will 
also be financially responsible for any medical care costs not covered by your health insurance. 
 
HSS is committed to providing financial assistance when financially warranted and consistent 
with its resources, regardless of age, gender, religion, race or sexual orientation.  So if you do not 
have health insurance, or if your health insurance does not pay for your medical care, you may 
seek financial assistance from HSS.  Eligibility determinations are made on a case-by-case basis 
in accordance with HSS’s financial assistance policy.  You will be responsible for any costs not 
covered by financial assistance, which could be all of the costs (if HSS determines that you are 
not eligible for financial assistance) or some of the costs (if financial assistance awarded by HSS 
does not cover all of the costs). For more information about the Financial Assistance 
Program or to request a Financial Assistance Application call (212) 606-1505 to speak with a 
Financial Assistance Counselor or you can visit the following site:  
http://www.hss.edu/patient-financial-assistance-notice.asp. 
 
6.  PREGNANCY <AS APPLICABLE>   
 
Due to inherent risks, HSS policy prevents pregnant women from receiving the type of 
intervention needed to qualify for this research study.  Therefore, women who are pregnant or 
nursing a child may not participate in this study.  You must confirm that, to the best of your 
knowledge, you are not now pregnant, and that you do not intend to become pregnant during the 
next year.  If you suspect that you have become pregnant during this study, you must notify the 
study doctor immediately.  
 
7.  PAYMENT FOR PARTICIPATION 
 
You will not be paid for your participation in this study.  
 
8.  COMMERCIAL ISSUES:  YOUR RIGHTS IN THE RESULTS OF THE STUDY 


 
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There are no plans to compensate you for the use of the findings of this study, or any of the 
information or biologic materials (such as blood or tissue) collected from you during the study, 
even if they are used to develop or make a commercial product (such as a drug, device, biologic 
substance, or test).   
 
9.  ALTERNATIVES:  WHAT OTHER TREATMENT IS AVAILABLE IF YOU DON’T 
WANT TO BE IN THE STUDY?  
 
You do not have to participate in this study to receive treatment for your condition.  You will be 
eligible to undergo your scheduled bilateral varus rotational osteotomy even if you do not agree 
to participate in this study. 
 
You should ask the study doctor about other alternative treatments that may be available for your 
condition.  
 
10.  WHO WILL BE ABLE TO SEE YOUR RECORDS AND PERSONAL 
INFORMATION AND KNOW THAT YOU ARE IN THE STUDY? 
 
Federal regulations give you certain rights related to your health information.  These include the 
right to know who will be able to see your information and why they will be able to see it.  The 
study doctor must obtain your authorization (permission) to use or give out any health 
information that might identify you.  
 
What information may be used or given to others?   
 
If you choose to be in the study, the study doctor will get personal information about you.  The 
information might identify you.  The study doctor may also get information about your health 
including:  
 
• Medical and research records 
• Records about phone calls 
• Records about your study visits  
• Records of physical exams 
• Laboratory, x-ray, and other test results 
• Questionnaires 
• Records about any study device you received 
 
Who may use, disclose, or receive my information? 
  
The following person(s) class(es) of persons, and/or organization(s) may use, disclose, or receive 
my information: 
• The Principal Investigator and other Investigators for this study, including your study 
doctor. 


 
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• The research coordinator, research nurses, and other members of the HSS research team 
working on this study. 
• Every research site for this study, including Hospital for Special Surgery and its affiliates, 
New York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center.  This 
includes the research staff and medical staff at each institution. 
• The Patient Advocate or Research Ombudsman at these institutions. 
• Staff members of HSS responsible for administering clinical trials and other research 
activities 
• Any laboratories and other individuals and organizations that analyze your health 
information for this study. 
• Any health care provider that you have used in the past or may use up to the time this study 
ends. 
• The United States Food and Drug Administration (FDA), the federal Office for Human 
Research Protections (OHRP), any federal agency that provides support for this study, and 
any federal, state, or local agency responsible for overseeing HSS, the study doctor, or any 
other member of the HSS research team involved in this study. 
• The members and staff of the affiliated Institutional Review Boards (IRBs) at HSS, New 
York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center.  An IRB is a 
committee of health care providers, community representatives, and others that initially 
approves and periodically reviews biomedical and behavioral research that involves human 
subjects in order to protect the rights, safety and welfare of study participants. 
• Data Safety Monitoring Boards and others authorized to monitor the conduct of this study 
for safety or quality assurance, for example a Clinical Events Committee. 
 
Why will this information be used and/or given to others?   
 
Your health information may be given to others to carry out this study.  The sponsor will analyze 
and evaluate the results of this study.  People working for the sponsor also visit HSS and other 
research sites to make sure this study is being done correctly.   
 
Your health information may be given to the FDA.  It may also be given to governmental 
agencies in other countries. This is done so the sponsor can get approval to market new products 
resulting from this study.  Your information may also be used to meet the reporting requirements 
of governmental agencies.  
 
The results of this study may be published in scientific journals or presented at medical meetings, 
but your identity will not be disclosed.   
 
What if I decide not to give permission to use and give out my health information?   
 
By signing this informed consent form, you are giving permission to use and give out your health 
information as described above.  If you refuse to give permission, you cannot be in this study.  
 
May I review or copy the information obtained from me or created about me? 
   


 
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You have the right, in accordance with Hospital policy and applicable law, to review and copy 
your health information that is created or obtained in the course of this study.  However, if you 
decide to be in this study and sign this informed consent form, you will not be able to look at or 
copy your information until after the study is completed if doing so would impact the validity of 
the study (for example, if the study is “blinded” so that during the study you will not know what 
treatment or other intervention you are receiving). 
 
May I revoke (take back) my permission?  
 
Yes. Your permission will never expire unless you revoke it.  To revoke your permission, you 
must write to the study doctor at Hospital for Special Surgery, 535 East 70th Street, New York, 
NY 10021. 
 
You may revoke your permission to use and disclose your health information at any time.  If you 
revoke your permission, you cannot continue to participate in this study.   
 
After you revoke your permission, no new health information that might identify you will be 
gathered. Information that has already been gathered may still be used and given to others. This 
would be done if the information is needed for this study to be reliable.   
 
Is my health information protected after it has been given to others?  
 
Some persons who receive your health information may not be required to protect it, and they 
may share your information with others without your permission, if permitted by laws governing 
them.  Therefore, there is a risk that your information will be released to others without your 
permission. 
 
11.  CONFLICT OF INTEREST NOTIFICATION 
HSS is concerned about possible conflicts of interest in research, and has policies that require all 
investigators and senior research staff to report to HSS significant financial interests (such as 
stock ownership, royalty payments, and consulting agreements) and relationships (such as 
membership on a scientific advisory board) that are related to their research studies.  When an 
investigator reports a significant financial interest or relationship that relates to one of his/her 
studies, HSS’s Conflict of Interest Committee for Research reviews the information to evaluate 
the risk that the interest or relationship might influence how the investigator conducts the study 
or interprets the results of the study.  HSS may also take steps to minimize that risk.   
 
 
The Conflict of Interest Committee for Research has determined that there are no 
conflicts of interest associated with this study. 
 
 
The Conflict of Interest Committee for Research has determined that there is a 
potential conflict of interest associated with this study.  Please read the information 
below carefully. 
 


 
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12.  VOLUNTARY PARTICIPATION/WITHDRAWAL 
 
Your decision to take part in this study is completely voluntary.  You are free to choose not to 
take part in the study and may change your mind and withdraw at any time.  Your relationship 
with physicians at HSS and your medical care at HSS, now or in the future, will not be affected 
in any way if you withdraw or refuse to participate.  You will not lose any benefits to which you 
are otherwise entitled. 
 
The study doctor and/or the sponsor may terminate your participation in this study at any time 
without your consent if, in their judgment, it is inadvisable for you to continue.   
 
13.  COMPENSATION FOR INJURY 
 
If you are injured as a result of participating in this study, the study doctor, other members of the 
research team, or other HSS professional medical staff will provide you with emergency medical 
treatment (or arrange to have such treatment provided to you), and will assist you in obtaining 
appropriate follow-up medical treatment. However, there is no plan to routinely provide 
compensation for additional medical care or other costs. 
 
Your health insurance may or may not pay for treatment of injuries as a result of your 
participation in this study.  
 
14.   SOURCE OF FUNDING  
 
Funding for this study will be provided by the Hospital for Special Surgery. 
 
15.  QUESTIONS   
 
If you have any additional questions later on, or if you wish to report a medical problem that may 
be related to this study, Dr. David Scher can be reached at 212-606-1253 during office hours and 
after business hours.  
 
If you have any questions about your rights as a participant in this study or any questions about 
your participation that you would like to ask an institutional representative who is not part of this 
study, you can call the Manager of the HSS Institutional Review Board at (212) 774-7154.  
 
If you would like to have more information about the Hospital’s financial disclosure review 
process in general, or in regard to this study, you may contact the Hospital’s Office of Legal 
Affairs at (212) 606-1592.   You may also ask the Hospital’s patient advocate at (212) 774-2403, 
to arrange for you to have this information. 
 
Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions.  
 
 


 
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Agreement to Participate: Witnessing and Signature 
 
To be in this study, you or your legal representative must sign the next page of this informed 
consent form. By signing the next page, you are voluntarily agreeing to be in this study at HSS. 
 
Before signing, you should be sure of the following: 
 
• You have read all of the information in this “Informed Consent to Participate in Research” 
form (or had it read to you).  
• You have discussed the implications of your being in this study with your doctor, your 
study doctor and/or the study coordinator.  
• You have had the chance to ask questions about this study. 
• You received answers to your questions. 
• If you did not understand any of the answers, you asked the study doctor or the study 
coordinator to explain them to you. 
• The information given to you is based on what is now known about the study drug(s), 
device(s), or procedure(s).  There may be other risks or complications that are not known at 
this time. 
• You have had time to think about the information and decide whether or not to be in the 
study. 
 
Please check one of the following: 
 
   I AM NOT in another research study at this time. 
 
   I AM in another research study at this time. 


 
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If you decide to be in this study: 
 
• You are expected to follow the study procedures. 
• You are expected to provide the information needed by the study doctor, the study 
coordinator, nurses, or other staff members for the study. 
• You will be told in a timely manner of any significant new information that may affect 
your willingness to stay in the study. 
• You may freely choose to stop being in the study at any time. 
 
By signing below, you are voluntarily agreeing to be in this study. 
 
You must be given a signed copy of this informed consent form to keep for yourself. 
 
 
 
______________________________________ 
_______________________________________ 
Print Name of Participant  
 
 
Signature of Participant 
 
            Date 
 
______________________________________           ______________________________________ 
Print Name of Parent/Legal Guardian (if applicable)1 
Signature of Parent/Legal Guardian  
Date 
 
______________________________________           ______________________________________ 
Print Name of Parent/Legal Guardian (if applicable)2 
Signature of Parent/Legal Guardian  
Date 
 
____________________________________ 
_______________________________________ 
Print Name of Person Obtaining Consent 
 
Signature of Person Obtaining Consent       Date 
 
 
 
_____________________________________  
As an HSS representative, please sign here to indicate that you have given a signed copy of this informed consent 
form to the participant 
 
 
NOTE TO INVESTIGATORS: 
                                                 
1 The parent or legal guardian of a child participant should sign this form on behalf of the child.  The signature of 
one parent is sufficient when the research is of minimal risk to the child, or when the research presents the prospect 
of direct benefit to the child.  The signature of both parents is required when the research involves greater than 
minimal risk with no prospect of direct benefit to the child.  The requirements for signature of both parents may be 
waived if one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has sole 
legal responsibility for the care and custody of the child.  If the participant is a child who is capable of giving assent, 
the child should also sign the attached Assent Form. 
2 The parent or legal guardian of a child participant should sign this form on behalf of the child.  The signature of 
one parent is sufficient when the research is of minimal risk to the child, or when the research presents the prospect 
of direct benefit to the child.  The signature of both parents is required when the research involves greater than 
minimal risk with no prospect of direct benefit to the child.  The requirements for signature of both parents may be 
waived if one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has sole 
legal responsibility for the care and custody of the child.  If the participant is a child who is capable of giving assent, 
the child should also sign the attached Assent Form. 


 
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• 
THE ORIGINAL OF THIS INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S STUDY FILE. 
• 
A SIGNED COPY OF THIS INFORMED CONSENT FORM MUST BE GIVEN TO THE 
PARTICIPANT. 
• 
A COPY OF THE INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S HOSPITAL MEDICAL RECORD IF THE PARTICIPANT IS (OR WILL 
BE) HOSPITALIZED AT ANY TIME DURING THE STUDY. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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Hospital for Special Surgery 
535 East 70th Street 
New York, NY  10021 
 
Assent Form for Older Adolescent (13-18) Participation in Research Study 
 
The Name of the Study is:  THE EFFECT OF INTRAVENOUS -AMINOCAPROIC ACID ON 
BLOOD LOSS AND TRANSFUSION REQUIREMENTS AFTER BILATERAL VARUS 
ROTATIONAL OSTEOTOMY (VRO):  A PROSPECTIVE, DOUBLE-BLINDED, 
RANDOMIZED CONTROLLED TRIAL 
 
The Investigator(s) is/are:  
 
DR. DAVID SCHER 
212-606-1253 
DR. EMILY DODWELL 
212-606-1451 
DR. ISHAAN SWARUP  
212-606-1466 
 
The Sponsor of the Study is: None 
 
HSS IRB #:  2014-303 
 
Introduction: 
You are being asked to take part in a research study.  Before you decide to be a part of this research study, 
you need to understand the risks and benefits so that you can make an informed decision.  This is known 
as informed consent. 
 
Once you understand the study and the tests it requires, you will be asked to sign this Assent Form if you 
want to take part in the study.  Your decision to take part in the study is voluntary.  This means that you 
are free to decide if you want to take part in the study.  You are also free to withdraw or stop taking part 
in the study at any time during the study. 
 
The Study:   
The purpose of this study is to determine the effect of a drug, -aminocaproic acid (EACA), on blood loss 
during your surgery and the need for blood transfusion after your surgery.  Your overall participation will 
continue over the course of 6 weeks after your surgery. 
 
Your surgery (called bilateral varus rotational osteotomy (VRO)) is an elective procedure for the hip joint, 
typically for the treatment of femoral deformity in young pateints. During the surgery, the surgeon 
changes the position of the femur and possibly shortens it in order to improve function and to decrease 
pain.  In addition to bilateral VRO, other procedures are often required to achieve the ultimate goal of 
maintaining a level pelvis, a balanced spine, and mobile, pain-free hips. Since this is a long and 
complicated surgery, there may be increased blood loss, which could require a blood transfusion.  
 
EACA is generally regarded as a safe medication that can be given into a vein in your arm during surgery 
that may reduce blood loss and the need for blood transfusion after your surgery.   
 


 
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A total of 30 patients will take part in this study. Patients will be divided into two groups.  One group will 
receive intravenous EACA, and the other group will receive an intravenous normal salt water solution 
(saline) during surgery. Normal saline is an inactive substance.  In this study it serves as a “placebo” or a 
pretend treatment that is compared to EACA in order to test if the drug has a real effect.  After surgery, 
you will receive the same care as any patient undergoing your same surgery. This includes routine blood 
draw from veins in your arm and/or hand. 
 
If you are willing to take part in the study, you and your parent(s) must first have the study explained to 
your satisfaction and all of your questions answered.  When you agree to participate in the study, you will 
need to sign this Assent Form, and then you and your parent(s) will also need to sign the Informed 
Consent Form.  Copies of these forms will be given to you. 
 
______________________________________  
_______________________________________ 
Print Name of Participant 
 
 
 
Signature of Participant  
              Date 
 
______________________________________            
_______________________________________ 
Print Name(s) of Parent(s)/Legal Guardian3 
 
Signature(s) of Parent(s)/Legal Guardian  Date 
 
______________________________________            
_______________________________________ 
Print Name(s) of Parent(s)/Legal Guardian 
 
Signature(s) of Parent(s)/Legal Guardian  Date 
 
____________________________________ 
 
_______________________________________ 
Print Name of Person Obtaining Assent  
 
Signature of Person Obtaining Assent     Date 
 
 
________________________________________ 
 As an HSS representative, please sign here to indicate that you have given a signed copy of this informed assent  
form to the participant 
 
 
NOTE TO INVESTIGATORS: 
• 
THE ORIGINAL OF THIS INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S STUDY FILE. 
• 
A SIGNED COPY OF THIS INFORMED CONSENT FORM MUST BE GIVEN TO THE 
PARTICIPANT. 
• 
A COPY OF THE INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S HOSPITAL MEDICAL RECORD IF THE PARTICIPANT IS (OR WILL 
BE) HOSPITALIZED AT ANY TIME DURING THE STUDY. 
 
 
 
 
 
 
 
                                                 
3  The signature of one parent is sufficient when the research is of minimal risk to the child, or when the research presents the prospect of direct 
benefit to the child.  The signature of both parents is required when the research involves greater than minimal risk with no prospect of direct 
benefit to the child.  The requirements for signature of both parents may be waived if one parent is deceased, unknown, incompetent, or not 
reasonably available, or when one parent has sole legal responsibility for the care and custody of the child.   


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 16 of 18 
 
IRB Administrative Use Only 
 
«Approval» 
«ApprovalDate» Thru «ExpirationDate» 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hospital for Special Surgery 
535 East 70th Street 
New York, NY  10021 
 
Assent Form for Young Minor (7-12) Participation in Research Study 
 
The Name of the Study is:  THE EFFECT OF INTRAVENOUS -AMINOCAPROIC ACID ON 
BLOOD LOSS AND TRANSFUSION REQUIREMENTS AFTER BILATERAL VARUS 
ROTATIONAL OSTEOTOMY (VRO):  A PROSPECTIVE, DOUBLE-BLINDED, 
RANDOMIZED CONTROLLED TRIAL 
 
The Investigator(s) is/are:  
 
DR. DAVID SCHER 
212-606-1253 
DR. EMILY DODWELL 
212-606-1451 
DR. ISHAAN SWARUP  
212-606-1466 
 
The Sponsor of the Study is: None 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 17 of 18 
 
IRB Administrative Use Only 
 
«Approval» 
«ApprovalDate» Thru «ExpirationDate» 
 
HSS IRB #:  2014-303 
 
Introduction: 
You are being asked to take part in a research study.  Before you decide to be a part of this research study, 
you need to understand the risks and benefits so that you can make an informed decision.  This is known 
as informed consent. 
 
Once you understand the study and the tests it requires, you will be asked to sign this Assent Form if you 
want to take part in the study.  Your decision to take part in the study is voluntary.  This means that you 
are free to decide if you want to take part in the study.  You are also free to withdraw or stop taking part 
in the study at any time during the study. 
 
The Study:   
The purpose of this study is to determine the effect of a drug, -aminocaproic acid (EACA), on blood loss 
during your surgery and the need for blood transfusion after your surgery.  Your overall participation will 
continue over the course of 6 weeks after your surgery. 
 
Your surgery (called varus rotational osteotomy (VRO)) is an elective procedure for hips, typically for 
treating thigh bone deformity in children. During the surgery, the surgeon changes the position of the 
thigh bone and possibly shortens it in order to help you move better and to lessen your pain.  In addition, 
other procedures are often required to achieve the ultimate goal of maintaining level hips, a balanced 
spine, and mobile, pain-free hips. Since this is a long and complicated surgery, there may be increased 
blood loss, which could require a blood transfusion.  
 
EACA is generally considered as a safe medication that can be given into a vein in your arm during 
surgery that may reduce blood loss and the need for blood transfusion after your surgery.   
 
A total of 30 patients will take part in this study. Patients will be divided into two groups.  One group will 
receive EACA, and the other group will receive a normal salt water solution (saline) during surgery.  Both 
medications will be given into a vein in your arm during surgery. Normal saline is an inactive substance.  
In this study it serves as a “placebo” or a pretend treatment that is compared to EACA in order to test if 
the drug has a real effect.  After surgery, you will receive the same care as any patient undergoing your 
same surgery. This includes routine blood draw from veins in your arm and/or hand. 
 
If you are willing to take part in the study, you and your parent(s) must first have the study explained to 
your satisfaction and all of your questions answered.  When you agree to participate in the study, you will 
need to sign this Assent Form, and then you and your parent(s) will also need to sign the Informed 
Consent Form.  Copies of these forms will be given to you. 
 
______________________________________  
_______________________________________ 
Print Name of Participant 
 
 
 
Signature of Participant  
              Date 
 
______________________________________            
_______________________________________ 
Print Name(s) of Parent(s)/Legal Guardian4 
 
Signature(s) of Parent(s)/Legal Guardian  Date 
                                                 
4  The signature of one parent is sufficient when the research is of minimal risk to the child, or when the research presents the prospect of direct 
benefit to the child.  The signature of both parents is required when the research involves greater than minimal risk with no prospect of direct 
benefit to the child.  The requirements for signature of both parents may be waived if one parent is deceased, unknown, incompetent, or not 
reasonably available, or when one parent has sole legal responsibility for the care and custody of the child.   


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 18 of 18 
 
IRB Administrative Use Only 
 
«Approval» 
«ApprovalDate» Thru «ExpirationDate» 
 
______________________________________            
_______________________________________ 
Print Name(s) of Parent(s)/Legal Guardian 
 
Signature(s) of Parent(s)/Legal Guardian  Date 
 
____________________________________ 
 
_______________________________________ 
Print Name of Person Obtaining Assent  
 
Signature of Person Obtaining Assent     Date 
 
 
________________________________________ 
 As an HSS representative, please sign here to indicate that you have given a signed copy of this informed assent  
form to the participant 
 
 
NOTE TO INVESTIGATORS: 
• 
THE ORIGINAL OF THIS INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S STUDY FILE. 
• 
A SIGNED COPY OF THIS INFORMED CONSENT FORM MUST BE GIVEN TO THE 
PARTICIPANT. 
• 
A COPY OF THE INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S HOSPITAL MEDICAL RECORD IF THE PARTICIPANT IS (OR WILL 
BE) HOSPITALIZED AT ANY TIME DURING THE STUDY.