A Randomized Comparison of the QuikClot® Radial® Pad Versus the Standard of Care TR Band® on Hemostasis After Transradial Artery Access
Phase: NA
Conditions: Coronary Artery Disease
Sponsor: Memorial Healthcare System

Version 5.0. DEC 22, 2019 
 
 
 
 
A Randomized Comparison of the QuikClot Radial Pad versus the Standard 
of Care TR Band on Hemostasis after Transradial Artery Access (TRA) 
 
Principal Investigator 
Jonathan S. Roberts, MD 
Memorial Cardiac and Vascular Institute 
3501 Johnson Street 
Hollywood, FL 33021 
Phone: 954 265 7900 
 
Funding Sponsor 
Z-Medica, LLC 
 
 
Study Product 
QuikClotRadial Pad 
 
 
510 (K) Number 
K120782 (QuikClot Interventional Hemostatic Bandage) 
K152525 (TR Band Radial Compression Device) 
 
Protocol Number 
SAIRB-18-0021 
 
 
Current Version Date 
DEC 22, 2019 
 
 
  NCT number                                     NCT03535597 
 
 
 
 
CONFIDENTIAL 
 
This document is confidential and the property of Memorial Healthcare System.  No part of it may be transmitted, 
reproduced, published, or used by other persons without prior written authorization from the study sponsor. 
 
 
 
 
 
 
 
 
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Study Summary 
Title  
A Randomized Comparison of the QuikClot Radial Pad versus the Standard of 
Care TR Band on Hemostasis after Transradial Artery Access (TRA) 
Short Title  
QuikClot Radial pad on hemostasis after TRA   
Protocol Number  
 SAIRB-18-0021 
Methodology  
Randomized, controlled, prospective study  
Study Duration  
1 year  
Study Center(s)  
Single center   
Objectives  
To evaluate the efficacy and safety of the QuikClot Radialpad on hemostasis 
after TRA, compared to the standard of care TR Band®, with the goal to hopefully 
develop a safe and efficacious technique to achieve more rapid patent hemostasis 
after TRA, and improve patient care by optimizing radial hemostasis management.   
Number of Subjects  
 Consent up to 600 subjects with possible enrollment of 373 
Diagnosis and Main 
Inclusion Criteria  
Patients undergoing TRA for cardiac catheterization (CC) and/or percutaneous 
coronary intervention (PCI).  
Study Product, Dose, 
Route, Regimen  
The QuikClot® Radial® pad will be applied over the radial artery access site 
covered with either a Coban™ bandage or a TR Band® after TRA. Firm manual 
compression will then be applied over the QuikClot® Radial® pad after the sheath 
is removed for 5 minutes in the Coban™ cohort. The Coban™ cohort will then 
have the Coban™ bandage removed after an additional 25 minutes, then being 
covered with a Tegaderm™ dressing. In the QuikClot® Radial® pad combined 
with a TR Band® cohort, the radial sheath is removed and the TR Band® is inflated 
with 8 – 10 mL of air after a small amount of blood is noted on the QuikClot® 
Radial® pad. After 30 minutes the TR Band® is removed, leaving the QuikClot 
pad covered with the Tegaderm™ dressing over the skin entrance site, to be 
removed the following morning. 
Assigned Interventions  
Consented subjects will be randomly assigned in the cardiac cath lab upon 
completion of their procedure into the following three arms: 
Arm 1 – Standard of Care with a TR Band® 
Arm 2 – QuikClot® Radial® pad combined with a Coban™ bandage  
Arm 3-  QuikClot® Radial® pad combined with a TR Band® 
Reference therapy  
TR Band®  
 
 
 

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Table of Contents 
1. 
Introduction ......................................................................................................................................................... 1 
1.1 
Background ................................................................................................................................................... 1 
1.2. Summarized Details of Investigational Products ............................................................................................... 2 
1.2.1. Device Description ...................................................................................................................................... 2 
1.2.2. Intended Use ................................................................................................................................................ 3 
1.2.3. Technological Characteristics and Substantial Equivalence ....................................................................... 3 
1.3. Device Usage ...................................................................................................................................................... 3 
1.4. Clinical Data to date ........................................................................................................................................... 6 
1.5. Dose Rationale and Risk/Benefits .................................................................................................................... 10 
1.6. Anticoagulation ................................................................................................................................................ 11 
2. Study Objectives .................................................................................................................................................... 11 
3. Study Design .......................................................................................................................................................... 11 
3.1. General Design ................................................................................................................................................. 11 
3.2. Primary Study Endpoints .................................................................................................................................. 13 
3.3. Secondary Study Endpoint ............................................................................................................................. 13 
4. Subject Selection and Withdrawal......................................................................................................................... 14 
4.1. Inclusion Criteria .............................................................................................................................................. 14 
4.2. Exclusion Criteria ............................................................................................................................................. 14 
4.3. Subject Recruitment and Screening ................................................................................................................. 15 
4.4. Method for Assigning Subjects to Treatment Groups ...................................................................................... 15 
4.5. Compliance Monitoring .................................................................................................................................... 15 
5. Study Procedures ................................................................................................................................................... 15 
5.1. Visit 1 –At time of Standard of Care Cardiac Catheterization and/or PCI ...................................................... 15 
5.2. Visit 2 – One day after enrollment ................................................................................................................... 16 
6. Safety and Adverse Events .................................................................................................................................... 16 
6.1. Definitions ........................................................................................................................................................ 16 
6.2. Adverse Event Reporting Period .................................................................................................................... 17 
6.3. Recording of Adverse Events ........................................................................................................................... 17 
6.4. Reporting of Serious Adverse Events .............................................................................................................. 17 

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7. Data Handling and Record Keeping ........................................................................................................................ 17 
7.1. Confidentiality .................................................................................................................................................. 17 
7.2. Data Management ............................................................................................................................................. 18 
7.3. Sample Size and Statistics ................................................................................................................................ 18 
7.4. Dissemination Plan ........................................................................................................................................... 18 
8. Ethical Considerations ............................................................................................................................................. 18 
9. References ................................................................................................................................................................ 19 
10. Lists of abbreviations ............................................................................................................................................. 21 

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1. Introduction 
This document is a protocol for a prospective, randomized, open-labeled study to evaluate the safety and efficacy 
of the QuikClot® Radial® pad on hemostasis after TRA, compared to the standard of care device, the TR Band®, by 
assessment of patient tolerance of the device, local vascular complications, and the time taken to achieve hemostasis. 
This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 
part 812 and International Conference on Harmonization guidelines), applicable government regulations and 
Memorial Healthcare System research policies and procedures. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and after the study. 
1.1     Background 
There is growing interest and increased use of the radial artery (RA) as the preferred access site for cardiac 
catheterization (CC) and/or percutaneous coronary intervention (PCI) due to its proven clinical benefits, including 
fewer access-site complications,1-3  lower bleeding risks,4,5  shorter hospital stays,2,6  lower costs,2,7  and mortality 
benefits in ST-elevation myocardial infarction compared with the femoral artery (FA) approach.8,9  In addition, 
patients overwhelmingly prefer RA over FA access because of the increased comfort after the procedure. 2, 3, 7 
Radial artery occlusion (RAO), however, is still an important complication seen in up to 8% of patients undergoing 
TRA.10-12 RAO is known to be associated with use of large‐size catheters, lack of procedural anticoagulation, and 
prolonged duration of radial compression after sheath removal.10-12 Strategies such as higher dose of anticoagulation 
and shorter duration of hemostatic compression in conjunction with the patent hemostasis technique have been 
shown to reduce the incidence of RAO.10-12 Several radial compression hemostatic devices have been introduced 
into clinical practice, with the aim of aiding radial access site hemostasis and limiting vascular complications.13 The 
most common compression device used in the United States is the TR Band® (Terumo, Japan), which is the standard 
of care device now being used to obtain radial artery hemostasis after TRA. This device wraps around the wrist and 
applies direct pressure to the radial arteriotomy site, typically for 2 to 3 hours after sheath removal, to achieve 
hemostasis. It is unclear, however, if using shorter compression times will further reduce the incidence of RAO 
without compromising hemostasis. 
QuikClot® Radial® pad is a new hemostatic dressing that is composed of a kaolin-impregnated gauze. When kaolin 
contacts blood it immediately initiates the clotting cascade by activating Factor XII, resulting in shortened 
hemostasis times.14-16 Application of QuikClot® hemostatic pads over femoral artery access sites after PCI has been 
shown to reduce time to hemostasis with early ambulation.14 Recently, we applied the QuikClot® Radial® pad with 
an elastic adhesive bandage supplied by Z-Medica, LLC to achieve radial hemostasis after TRA with 5 minutes of 
manual compression followed by 25 or 55 minutes of elastic adhesive bandage compression in 20 patients. There 
was 100% successful hemostasis with the use of the QuikClot® Radial® pad in both groups with no rebleeding or 
increased complications noted when compared with the TR band®.15 Some subjects in this pilot trial complained 
about the supplied sticky elastic adhesive bandage, though. It was uncomfortable to remove because of the strong 
adhesive pulling their skin upon bandage removal. The operators also felt the elastic bandage was a bit complicated 
to apply. Because of this, we conducted another small pilot trial testing the feasibility and efficacy of using either a 
Coban™ bandage or Tegaderm™ dressing to secure the QuikClot® Radial® pad for achieving hemostasis post TRA, 
in hopes of improving patient comfort and satisfaction. The results showed that 5 minutes of initial manual 

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compression followed by 25 minutes of light compression with either a Coban™ bandage or Tegaderm™ dressing 
was successful in the 20 patients who underwent diagnostic cardiac catheterization and/or PCI, with 100% 
successful initial hemostasis without rebleeding, RAO, and other complications. This preliminary clinical 
evaluation suggested the QuikClot® Radial® pad combined with either a Coban™ bandage or Tegaderm™ dressing 
was an easy to use and effective hemostatic dressing that allowed for a short duration of compression and a painless 
hemostasis procedure without vascular or other complications noted. 
We were encouraged by the performance of the QuikClot Radial pad in the above small pilot studies. The 
small sample sizes did not allow a definitive answer as to whether reduced compression times with the QuikClot 
Radial pad would reliably allow significantly shorter hemostasis times allowing for earlier discharge from the 
hospital, lead to less RAO post procedure, or improve patient comfort. We therefore designed the first 
version of this larger, adequately powered, prospective randomized trial to investigate the safety and efficacy of 
the QuikClot Radial pad combined with either a Coban™ bandage or Tegaderm™ dressing to achieve 
hemostasis following TRA, compared to the standard of care TR Band. The QuikClot Radial pad will be 
applied over the radial artery access site using either a Coban™ bandage or only a Tegaderm™ dressing after 
TRA. Then, after sheath removal, firm manual compression will be applied over the QuikClot Radial pad 
covered by either the Coban™ bandage or the Tegaderm™ dressing for 5 minutes, followed by 25 minutes of 
light compression with the Coban™ dressing in the Coban™ cohort or 25 minutes of close observation after 
release of manual pressure in the Tegaderm™ only cohort. 
After an interim analysis of 186 subjects, and a peer data safety and monitoring board (DSMB) committee review 
of the results, we elected to stop the Tegaderm™ only arm. With a failure to obtain initial hemostasis at 5 minutes 
in approximately 30% of the subjects in this arm of the protocol, we believed there would be little chance of this 
Tegaderm™ only protocol being adopted clinically. There were no safety issues with the Tegaderm™ only arm, as 
with repeated 5 minute manual compression cycles of the QuikClot pad, hemostasis was obtained in all subjects. 
Mean hemostasis time in the Tegaderm™ only arm was 8.1 minutes. There was just clinical futility of this arm of 
the protocol as written, that was not detected in the small pilot trial performed using this protocol. 
A new arm 3 will replace the Tegaderm™ only arm. This new arm 3 will use a QuikClot Radial Pad under a 
TR Band with 30 minutes of compression. We have a large successful anecdotal experience of using a 
QuikClot Radial Pad under a TR Band with 30 minutes of compression. We and others have demonstrated 
that use of a hemostatic pad under a TR band® significantly shortenes hemostasis time, as compared to a TR 
band® alone, with no increased complications noted. [17,18]   
We will evaluate patient tolerance of the devices, local vascular complications, and the time taken to achieve 
hemostasis with the use of the QuikClot Radial pad and compare with the standard of care TR Band on 
hemostasis after TRA. The results to be obtained will refine the QuikClot Radial pad use in the setting of 
hemostasis following transradial procedures, to hopefully develop a safe and efficacious strategy to achieve more 
rapid patent hemostasis following TRA, possibly lower RAO rates with shorter compression times, and improve 
patient care by optimizing radial hemostasis management. 
1.2. Summarized Details of Investigational Products 
The below description is taken from the QuikClot 510(k) Summary, dated April 11, 2013. 
 
 

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Figure 2. Coban™ self-adherent latex- 
free wrap 
 
 
 
 
 
1.2.1. Device Description 
The QuikClot® Radial® pad is made of a soft, white, kaolin‐impregnated gauze.  The QuikClot® Radial® pad 
will be provided in a kit form that consists of a hemostatic pad and an adhesive bandage (Figure 1). The adhesive 
bandage is a Direct Pressure (DP) Bandage. The hemostatic pad is a hemostatic dressing made of soft, white, 
kaolin impregnated gauze, configured in a 0.8” diameter by 1.5” long roll. The QuikClot® Radial® pad utilizes a 
layered clay hemostat, kaolin USP, which is bound to medical gauze. The QuikClot® Radial® pad are provided in 
a sterile, intuitive, simple to use dressing format that conforms readily to the wound. The DP Dressing is a Class 1 
exempt device and serves as a fixation/compression bandage which is in contact with the hemostatic dressing, but 
is not in direct contact with the wound. In the present trial either a Coban™ bandage or a Tegaderm™ dressing 
will serve as a fixation/compression bandage instead of the supplied DP dressing to secure the QuikClot® 
Radial® pad over the arteriotomy site. 
1.2.2. Intended Use 
The QuikClot Radial pad is applied topically as an adjunct to manual compression and is indicated for the 
local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes 
utilizing introducer sheaths up to 12 Fr and up to 7 Fr and for patients on drug/induced anti-coagulation treatment. 
1.2.3. Technological Characteristics and Substantial Equivalence 
1.2.3.1. QuikClot Radial Pad 
The QuikClot Radial pad is intended for control of surface bleeding from vascular access sites, 
percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr. There are several marketed devices 
with similar indications that utilize alternate technologies to achieve the same indications as the proposed 
device, such as the Vascular Solutions D-Stat Dry, WoundStat, and the ChitoFlex™ Surgical device. The 
QuikClot Radial pad is identical in technology to the QuikClot Interventional™ hemostatic bandage. 
The QuikClot Radial pad and the predicate devices are similar in that they are all indicated as an adjunct to 
manual compression and are indicated for the control of surface bleeding from vascular access sites and 
percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic 
endovascular procedures utilizing introducer sheaths. 
1.2.3.2. 3M™ Coban™ Self‑Adherent Latex-free Wrap 
3M™ Coban™ Self‑Adherent Latex-free Wrap is a sterile, cohesive elastic wrap 
constructed from a nonwoven material and elastic fibers (Figure 2). The cohesive 
properties allow the wrap to stick to itself but not to other materials or skin. It is 
supplied in individually packaged sterile rolls. This product is not regulated under 
the FDA, and a MSDS is not required for this product by the OSHA Hazard 
Communication   Standard   (29   CFR   1910.1200)   because,   when   used   as 
recommended or under ordinary conditions, it should not present a health and 
safety hazard. Coban™ self ‑adherent wrap is intended for use as an elastic wrap 
to provide compression or support, or to secure dressings or devices. 3M Coban™ Sterile Self-Adherent Wrap 

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Figure 3. Tegaderm™ film 
dressing 
(Catalog No: 1582S, 2 X 5 yd) or a generic equivalent (CardinalHealth, Catalog No: CAH25LFS) will be used in 
this study. 
1.2.3.3. 3M™ Tegaderm™ Transparent Film Dressing 
Tegaderm™ is a transparent medical dressing manufactured by 3M™. Tegaderm™ Film 
consists of a thin film backing with a non-latex, hypoallergenic adhesive (Figure 3). The 
dressing is breathable, allowing good oxygen and moisture vapor exchange. It is 
waterproof and impermeable to liquids, bacteria, and viruses. An intact dressing protects 
the site from outside contamination. Tegaderm™ transparent dressings can be used to 
cover and protect wounds and catheter sites. Tegaderm™ transparent film dressings are 
routinely used in the Cardiac Cath Labs of MRH. 
1.3. Device Usage 
Application of the QuikClot Radial pad will be performed by properly trained interventional cardiologists. 
Application of the TR Band will be performed by properly trained interventional cardiologists or cath lab 
technicians. Proper training for physicians for either device is defined as performing 2 run in procedures prior to 
enrolling patients in this study, supervised by a cardiologist or industry representative experienced with the either 
device. For cath lab technicians, proper training will be meeting the qualifications outlined by the Memorial Cardiac 
and Vascular Institute cath lab protocol for application of the TR Band. Dr. Roberts, Dr. Pastor and Dr. Shah are 
properly trained with the use of the QuikClot Radial pad hemostatic device and TR Band. 
1.3.1. The method for using the QuikClot Radial pad with a Coban™ Self-Adherent Wrap is as follows: 
After an end-procedure ACT is drawn and the blood pressure is recorded, the arterial access sheath will be partially 
pulled  out  of  the  radial  artery, exposing approximately 4 cm of sheath. The level of the access site will be 
marked on the medial and/or lateral side of the palmar surface of the wrist with a sterile marker pen so that once 
the pad is applied and covering the access 
site, the investigator will still be able to know 
the exact level of the access site, to properly 
hold pressure in the correct spot. (Fig.4A, 
Arrows). The QuikClot  Radial pad is 
then applied over the access site, with the 
sheath still in place, with 1/3 of the pad 
being distal to the access site and 2/3 of the 
pad being proximal to the access site (Fig.4B, 
Arrows). The 3M™ Coban™ latex-free self-
adherent wrap is then gently applied, wrapping 
3-5 layers around the wrist to hold the 
QuikClot Radial pad in place (Fig 4. C). 
When application is complete, the excess self-
adherent wrap will be cut off (Fig. 4D). The 3 
– 5 layers will then be hand massaged to allow 
the layers to adhere to each other (Fig. 4E). The 
sheath is then removed from the radial artery, 
 
Fig 1. Application of the QuikClotRadial pad with the Coban™. 

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being pulled out from underneath the QuikClot Radial pad, with the investigator slightly pulling up on the 
distal portion of the pad, allowing for a small amount of bleeding to partially saturate the under surface of the 
QuikClot Radial pad to initiate the kaolin-blood reaction (Figs. 4, F and G). 5 minutes of firm manual 
compression is then held with several fingers on top of the QuikClot Radial pad, directly over the access site 
and just proximal to the access site, with the thumb wrapped under the wrist (Fig. 4H). After release of manual 
pressure, the investigator will observe for bleeding under the QuikClot Radial pad/Coban™ wrap for one 
minute (Fig. 4I). If there is not hemostasis, manual pressure will again be applied over the QuikClot Radial 
pad for another 5 minutes, and this cycle will be repeated until there is hemostasis. Once there is hemostasis, the 
previously applied Coban™ will be removed 25 minutes (± 5 minutes) after manual pressure is released, 
keeping the QuikClot Radial pad in place over the access site. A clear adhesive film dressing (Tegaderm™) is 
then applied over the QuikClot Radial pad, to be removed the following morning. If there is 
oozing/bleeding after the Tegaderm™ dressing is applied, the investigator may use his/her discretion to 
reapply manual pressure to the QuikClot Radial pad, or use mechanical compression with a TR Band.  
1.3.2. The method for application of the TR Band 
After an end-procedure ACT is drawn and the blood pressure is recorded, application of the TR Band for transradial 
hemostasis will be performed as described previously15 with the modifications described below. Briefly, the arterial 
access sheath is partially pulled out of the artery, exposing approximately 4 cm of sheath. A dry 4 inch by 4 inch 
gauze will be placed under the exposed sheath, cinched up to the skin entrance site of the sheath. The TR Band 
will be applied snuggly around the wrist, with the sheath still in place, with the green dot of the TR Band 2 – 3 
mm proximal to the skin entrance site of the sheath. 10 mL of air will then be used to inflate the TR Band. The 
sheath is then pulled out of the radial artery and out from under the TR Band. The 4 x 4 gauze is then pulled out 
from under the TR Band. If there is not hemostasis when the sheath is removed, additional air will be added in 1 
– 2 mL increments until hemostasis occurs. When there is hemostasis, radial artery patency will be assessed by the 
reverse Barbeau test and recorded. Then, the TR Band will remain in place for 60 minutes. At the end of 60 minutes 
(± 5 minutes) of compression, 2 mL of air will be removed, and then additional 2 mL at 80 minutes (± 5 minutes), 
and then 3 mL at 100 minutes (± 5 minutes), and then the remaining air slowly deflated over 30 seconds at 120 
minutes (± 5 minutes). If oozing/bleeding occurs at any point during the weaning of air, the previously removed 
amount of air will be re-inflated into the TR Band, and weaning will again commence in 20 minutes. Once all the 
air has been removed and hemostasis confirmed, the TR Band will be removed, and a Band Aid or a dry gauze 
pad under a Tegaderm™ dressing will be placed over the skin entrance site, to be removed the following morning. 
1.3.3 The method for application of the QuikClot Radial pad under a TR Band 
       After an end-procedure ACT is drawn and the blood pressure is recorded, the arterial access sheath will be partially 
pulled out of the radial artery, exposing approximately 4 cm of sheath. The level of the skin access site will be 
marked on the medial side of the palmar surface of the wrist with a sterile marker pen, so that once the pad is 
applied and covering the access site, the investigator will still be able to know the exact position of the skin access 
site, to properly apply pressure with the TR Band in the correct spot. (Fig 5. A). The QuikClot® Radial® pad is 
then applied over the access site, with the sheath still in place, with approximately 1/2 of the pad being distal to the 
skin access site and 1/2 of the pad being proximal to the access site (Fig 5. C). This is best accomplished by placing 
the seam side of a QuikClot® Radial® pad face down on the sticky side of a Tegaderm™ (Fig 5. B), centering it in 
the middle of the Tegaderm™. The Tegaderm with a QuikClot® Radial® pad stuck to it is then positioned slightly 

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Fig 5. Application of the QuikClotRadial pad under the TR Band. 
above the wrist (Fig 5. C), with the QuikClot® Radial® pad centered to the sheath, with one half of the pad above 
the skin access site and one half of the pad distal to the skin insertion site. The QuikClot® Radial® pad is then 
lowered onto the wrist, being held in the correct position with the Tegaderm dressing (Fig 5 D) A TR Band will 
then be loosely applied over the QuikClot pad covered with Tegaderm™, centering the TR Band green dot 2 – 
3 mm proximal to the marked skin entrance level (Fig 5, E). The sheath is then rapidly pulled, and the operator will 
observe for a small amount of blood on the undersurface of the QuikClot Radial Pad, then quickly fill the TR 
Band with 8 – 10 mL of air (Fig 5. F, G, H). It is very important for blood to be in contact with the kaolin, to 
initial the hemostasis reaction. If no bleeding is seen on the under surface of the QuikClot pad with the TR 
Band still being uninflated, the operator may lift up the uninflated TR Band and QuikClot pad under it, to 
initiate a small amount of bleeding, and then fill the TR Band with 8 – 10 mL of air. If there is continued 
bleeding after inflating the TR Band with 8 – 10 mL of air, additional 1 – 2 mL increments of air should be added 
to obtain hemostasis. When there is hemostasis, radial artery patency will be assessed by the reverse Barbeau test 
and recorded. After 30 minutes of compression with the TR Band, it will be deflated slowly over 1 minute. The 
deflated TR Band will be left in place for 5 minutes, to allow for rapid reinflation if bleeding occurs. If there is 
hemostasis after 5 minutes of observation with the deflated TR Band, the TR Band will be removed, leaving 
the QuikClot pad covered with the Tegaderm™ dressing. If bleeding occurs upon weaning of air, the TR Band 
will be reinflated to obtain a total of 8 – 10 mL of air in the TR Band bladder for an additional 20 minutes. The 
TR Band will then again be slowly deflated over 1 minute, leaving the deflated TR Band in place for an 
additional 5 minutes. This cycle will be repeated until there is hemostasis. The operator will have the option to 
remove the QuikClot pad, and use just a TR Band, if the subject has failed at least one subsequent re-inflation 
cycle.  
        
1.4. Clinical Data to date 
The QuikClot Radial pad has received FDA clearance for use in local management of bleeding wounds such 
as vascular access sites. It provides an alternative to other hemostatic devices and could potentially reduce 

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hemostatic time, reduce vascular complications and shorten time in hospital stay. By PubMed search with key 
words including QuikClot Radial pad, vascular access, hemostatic devices, and hemostasis showing the 
available clinical data to date regarding use of the QuikClot Radial pad as following: 

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A previous study showed that after removal of 15 minutes of compression with the QuikClotInterventionalTM pad, 
active bleeding occurred in 20% of patients, compared to 90% with 15 minutes of manual compression only after 
percutaneously accessed femoral arteries.16 
Our pilot study in 30 patients undergoing TRA demonstrated that application of the QuikClot Radial pad with 5 
minutes of manual compression followed by a light compressive elastic bandage supplied by Z-Medica LLC for 25 
minutes or 55 minutes achieved 100% hemostasis following TRA, with no increased complications noted (see Table 
below).15 
 
 
Our recent other preliminary study (data not yet published) further demonstrated that application of the QuikClot 
Radial pad with 5 minutes of initial manual compression following by 25 minutes of light compression with either 
a Coban™ bandage or Tegaderm™ dressing was successful in all 20 patients who underwent diagnostic cardiac 
catheterization and/or PCI, with 100% hemostasis without rebleeding, RAO, and other complications. This 
preliminary clinical evaluation suggests that the QuikClot Radial pad combined with either a Coban™ bandage 
or Tegaderm™ dressing is an easy to use and an effective hemostatic dressing that allowed for a short duration of 
compression and a painless hemostasis procedure. Thus, there is a need to assess the true efficacy and safety of the 
QuikClot Radial pad combined with either a Coban™ bandage or Tegaderm™ dressing in the management of 
radial hemostasis following TRA in a larger number of patients. 
1.5. Dose Rationale and Risk/Benefits 
The use of QuikClot Radial pad has been reported in patients undergoing percutaneous radial procedures, and the 
results demonstrated that application of the QuikClot Radial pad with short-term (15 minutes) radial compression 
had 20% rebleeding at the radial access site.16 Our recent preliminary results demonstrated that application of the 
QuikClot Radial pad with 5 minutes of initial manual compression following by 25 minutes of light compression 
with either a Coban™ bandage or Tegaderm™ dressing was successful in all 20 patients who underwent diagnostic 

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cardiac catheterization and/or PCI, with 100% hemostasis without rebleeding, RAO, and other complications 
(unpublished data). We therefore chose these same compression times for this proposed larger study.  
After an interim analysis of 186 subjects, with a failure to obtain initial hemostasis at 5 minutes in approximately 
30% of the subjects in the Tegaderm™ only arm of the protocol, we believed there would be little chance of this 
Tegaderm™ only protocol being adopted clinically. Our DSMB committee reviewed the results and recommended 
to stop the Tegaderm™ only arm in the prior protocol. There were no safety issues with the Tegaderm™ only arm, 
as with repeated manual compression cycles of the QuikClot pad, hemostasis was obtained in all subjects. There 
was just clinical futility of this arm of the protocol as written that was not detected in the small pilot trial performed 
using this protocol. A new arm 3 will replace the old Tegaderm™ only arm in this present revised protocol. This 
new arm 3 will use a QuikClot pad under a TR Band with 30 minutes of compression. We have a large 
successful anecdotal experience of using a QuikClot pad under a TR Band with 30 minutes of compression. 
Other hemostatic pads have been successfully used under a TR Band [17, 18]. As we have a large anecdotal 
successful experience of 30 minutes of compression with QuikClot Radial and QuikClot Interventional Pads 
under a TR Band, we choose a compression time of 30 minutes for the QuikClot/TR Band arm.  
Although the TR Band radial compression device has been used for years as the standard of care for hemostasis 
after TRA, there is no “standardized” compression/weaning technique. In a previous study, we used 40 minutes of 
compression with the TR Band
 and then began weaning. 50% of subjects had to have air re-inflated upon the initial 
weaning of the TR Band.15 Carrington reported that a 1-hour commencement of TR Band weaning following 
TRA appears to be safe, with an 84% success rate.19 Because of this, the TR Band in this study will be inflated for 
60 minutes of compression without weaning, and then weaned over the next 60 minutes to hopefully achieve a high 
rate of hemostasis with a low rate RAO. 
Potential risks may include: bleeding, pseudoaneurysm formation, hematoma, radial artery occlusion, local skin 
reaction (redness, swelling, and rash), pain, and numbness. Subjects may or may not have some or all of these risks 
from treatment with either one of the devices used in this study. The risks for the use of the QuikClot Radial pad 
are the same as for standard of care with TR Band. 
There may be an immediate potential benefit to patients. Application of the QuikClot Radial pad may shorten the 
time of compression compared with the standard of care TR Band. Shorter radial artery compression times have 
been associated with less radial artery occlusion, thus potentially reducing the incidence of post-procedural radial 
artery occlusion. The light compression with either a Coban™ may help maintain patent hemostasis. Patient 
discomfort may also be reduced by shorter compression times and lower compression pressure. 
1.6. Anticoagulation 
For diagnostic cardiac catheterization using TRA in this study, a heparin dose of 70 units/kg will be used, with a 
minimum of 4000 units and a maximum of 7000 units. For PCI, additional heparin to attain an ACT of > 250 – 300 
seconds will be used, or bivalirudin at standard FDA approved doses described in the package insert may be used 
at the operator’s discretion. The option of continuing a heparin or bivalirudin infusion after the PCI will be at the 
operator’s discretion. 
2. Study Objectives 
The objective of this study is to evaluate the safety and efficacy of a kaolin–based QuikClot Radial pad combined 

13 
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with either a Coban™ bandage or TR Band to achieve hemostasis after TRA, compared with ‘standard of care’ 
mechanical compression with the TR Band, with the aim to hopefully develop a safe and possibly superior 
hemostatic method after transradial access, thus improving patient care by optimizing radial hemostasis 
management. 
3. Study Design 
3.1. General Design 
The SPIRIT (Standard Protocol Items for randomized Trials) recommendations were followed in preparing the 
protocol.20, 21 The study is a single center, prospective, randomized, controlled trial with three arms (below) to 
compare hemostasis times and potential complications after TRA in patients undergoing diagnostic cardiac 
catheterizations and/or PCI. 
 
 
 
 
  Up to now, 217 subjects have been enrolled in this trial per the previous version of this protocol, including 73 in 
the QuikClot/Tegaderm™ arm, 72 in the TR Band only arm, and 72 in the QuikClot/Coban™ arm. This 
amended protocol will continue enrolling a total of 100 subjects for both the TR Band only and the 
QuikClot/Coban™ arms, respectively. The new arm 3, QuikClot/TR Band, will also enroll a total of 100 
subjects. In this amended protocol, a total of 373 subjects will be enrolled, including the 217 that have been 
enrolled in the prior version of the protocol, and an additional 156 subjects enrolled in this amended protocol. 
Randomization of the 156 subjects in the amended protocol will continue into the 3 cohorts. As 100 subjects will 
be needed to fill the new Arm 3, QuikClot/TR Band, and only 28 subjects will be needed to fill each of Arms 1 
and 2, i.e. the TR Band and QuikClot/Coban™ Arms,arms 1 and 2 will fill well before the new Arm 3. After 
Arms 1 and 2 are filled, participants assigned to Arms 1 and 2 will be considered screen failures. All screen 
failures in this revised protocol will be assigned into the new Arm 3, the QuikClot/TR Band arm. As the old 
arm 3 is terminated, future participants randomized into arm 3 will be considered screen failures, as our REDCap 
data base will consider them in the old Arm 3. All screen failures that occur during randomization in the additional 
156 subjects in this revised protocol will be assigned to the new Arm 3. An example of this would be a subject 
randomized to Arm 1 (TR Band) who is a diagnostic cath only, and the 50 diagnostic only cases in Arm 1 are 
already filled. This subject would then be assigned to new Arm 3, the QuikClot/TR Band arm. Another 
example would be a participant randomized to Arm 3. As the old Arm 3 from the prior protocol is now closed, any 

14 
Version 5. Dec 22, 2019 
 
 
subsequent participants randomized to Arm 3 will be considered screen failures, and will be assigned to the new 
Arm 3 of this revised protocol. Each arm of 100 patients will include 50 diagnostic-only cardiac catheterizations 
and 50 PCIs. Simultaneous accrual of diagnostic-only cardiac caths and PCIs will occur. 
 
 
 
Scheme 1. Proposed workflow for two compression devices: QuikClot® Radial® pad and TR Band® 
 
3.2. Primary Study Endpoints 
3.2.1. Initial successful hemostasis: Initial successful hemostasis is defined as no evidence of external bleeding 
from the TRA puncture site or expanding hematoma of the forearm after completion of the above described TR 
Band and QuikClot Radia pad protocols, without the need for reinflation of air in the TR Band or 
reapplication of manual pressure over the QuikClot Radialpad secured with a Coban™ bandage, or use of 
manual compression over the arteriotomy site. If an EASY grade class 1 forearm hematoma (see below section 
3.3.3) develops while either hemostatic device is in place and is successfully treated without altering the 
weaning protocol of either device (i.e. the need for reinflation of air upon weaning the TR Band or manual 
recompression of the QuikClot Radial pad after the initial 5 minute hold), this will be considered successful 
hemostasis. 
3.2.2. Total time to hemostasis: Total time to hemostasis will be calculated as the time needed from sheath removal 
to achieving complete hemostasis, as described below: 
For the QuikClot Radial pad + Coban™ bandage  arm, total time to hemostasis includes the initial 5 

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minutes of manual compression and 25 minutes of light compression with the Coban™ bandage, and plus any 
additional protocol directed recompression time needed to obtain complete hemostasis. 
For the QuikClot Radial pad + TR band arm, total time to hemostasis includes the initial 30 minutes of 
compression plus 1 minute of weaning, and any additional protocol directed recompression and/or weaning 
times needed to obtain complete hemostasis. 
For the standard of care TR Band arm, total time to hemostasis includes the initial 60 minutes of compression plus 
60 minutes of weaning, plus any additional protocol directed recompression and/or weaning time needed to obtain 
complete hemostasis. 
3.3. Secondary Study Endpoint 
3.3.1. Radial artery occlusion (RAO): RAO will be assessed one to two hours after completed hemostasis, 
using the reverse Barbeau’s test.20 Completed hemostasis in the TR Band cohort will be after the device is 
removed and the puncture site is covered with a Band-Aid or a dry gauze pad under a Tegaderm™ dressing 
without further bleeding/oozing from the access site or development of a forearm hematoma. Completed 
hemostasis in the QuikClot Radial pad/Coban™ cohort is defined as no further bleeding/oozing or 
development of a forearm hematoma after the Coban™ bandage is removed and the QuikClot Radial pad is 
secured with a Tegaderm™ dressing. Completed hemostasis in the QuikClot/TR Band cohort will be after 
the TR Band® is removed without further bleeding/oozing at the access site or development of a forearm 
hematoma. RAO is evaluated one to two hours after completed hemostasis based on previous findings which 
demonstrated the highest incidence of RAO immediately after band removal.11 
3.3.2. Patient comfort/pain: Patients will be asked to rate their comfort level associated with the hemostatic device 
they have been assigned. A verbal numeric rating scale (VNRS) will be utilized to evaluate patient comfort with 
each device. This scale will use a 0 to 10 numeric rating to assess overall discomfort or pain related to the access 
site compression with each device, where 0 indicates no discomfort or pain at all and 10 indicates the worst pain 
the patient can imagine. The research coordinator will review the VNRS with each patient just prior to assessment 
of radial artery patency with the reverse Barbeau’s test.20 The research coordinator will record the patient’s response. 
3.3.3. Access site complications: Complications related to the device will be followed up to resolution or discharge, 
whichever comes first. Research staff will observe and record bleeding and hematomas that occur related to the 
access site. The severity of bleeding and forearm hematoma will be recorded using the criteria of the Early 
Discharge after Transradial Stenting of Coronary Arteries (EASY) classification.21 See Figure below for radial 
artery hematoma classification. Cases of device failure, procedural difficulties, and evidence of vascular 
complications associated with the closure procedure will be recorded, and appropriate therapy will be given. 
 

16 
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4. Subject Selection and Withdrawal 
4.1. Inclusion Criteria 
1. Patients undergoing CC and/or PCI via the radial artery as part of their standard of care treatment 
2. Patients able and willing to give written informed consent 
3. Patient > 18 years of age 
4.2. Exclusion Criteria 
1. Patients presenting with acute ST segment elevation myocardial infarction (STEMI) 
2. Oral anticoagulation therapy as described below: 
a. If on a DOAC (direct acting oral anticoagulants – ie dabigatran, rivaroxaban, apixaban, endoxaban), 
patients will be excluded if DOAC taken within 48 hours and eGFR > 30 ml/min or DOAC taken 
within 72 hours and eGFR < 30 ml/min. 
b. If patient is on warfarin, excluded if INR > 1.5 
3. Liver Failure 
4. Life threatening illness that patient would not be expected to live more than 6 months post procedure 
5. Major unanticipated event in the cardiac cath lab (i.e. cardiac arrest) of an already consented patient, but 
before randomization, where the operator believes participation in this trial is now inappropriate. 

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Version 5. Dec 22, 2019 
 
 
 
6. Thrombocytopenia, with a platelet count of < 75,000. 
4.3. Subject Recruitment and Screening 
All eligible subjects undergoing transradial coronary procedures from our hospital will be recruited directly by the 
investigators and research staff. The subjects will be asked in the pre-procedural unit if they wish to participate in 
this study comparing the two FDA approved hemostatic devices at the completion of their radial artery access 
procedure. The investigator or his qualified designee will then obtain written informed consent according to ICH 
GCP (International Conference on Harmonization Good Clinical Practice). The completed consent forms will be 
retained by the Investigator and a copy of the consent form will be provided to the study participant. 
4.4. Method for Assigning Subjects to Treatment Groups 
Subjects undergoing CC and/or PCI via the radial artery as part of their standard of care treatment, and who have 
signed informed consent, will be randomized in the cardiac cath lab upon completion of their procedures. The 
REDCap randomization tools will be used to facilitate randomization. A statistician will create a random 
allocation table (randomization list) that will be uploaded into the REDCap project. The statistician will generate 
the random allocation table according to study design specifications as determined by the statistician and principal 
investigator. Participants will be randomized when the research coordinator enters a participant’s REDCap record 
and clicks the “Randomize” button before sheath removal by the physician. Clicking this button triggers REDCap 
to check the allocation table and display the group to which the participant should be randomly assigned. This 
assignment is permanent and not editable within the participant’s record and, like all other activity within 
REDCap, is tracked and not modifiable in the audit log. All subjects randomized into the old arm 3 
(QuikClot/Tegaderm™) by REDCap will be considered screen failures, and all screen failed subjects per this 
amended protocol will be assigned into the new arm 3 (QuikClot/TR Band), and a data collection instrument 
for the new arm 3 will be developed and added to the REDCap for this trial.  
4.5. Compliance Monitoring 
The protocol will be monitored for compliance by the Principal Investigator with oversight by the Office of 
Human Research (OHR)’s Monitoring and Compliance Officer. The task of the study monitor is to guarantee the 
best conduct of the study through frequent contacts by phone and in person with the responsible Investigator and 
research nurse/specialist, in accordance with the Monitor's Operating Procedures, with the purpose of facilitating 
the work and fulfilling the objectives of the study. 
The QuikClot Radial pad compression device and Coban™ bandages will be stored in a locked area and 
access will be limited to the research team. The QuikClot Radial pad compression device and Coban™ 
bandages will be only used as described in this trial. Subjects will receive the QuikClot Radial  pad 
compression device and Coban™ bandages without charge. 
5. Study Procedures 
Participation in the study will involve two clinical visits as follows: 
5.1. Visit 1 –At time of Standard of Care Cardiac Catheterization and/or PCI 
All subjects will be closely monitored for bleeding from the radial artery access site. Monitoring will be continued 
until complete hemostasis from the radial artery has been achieved. Use of reapplication of the QuikClot Radial 
pad or a TR band will be at the discretion of the investigator if hemostasis is not achieved at the end of compression 
period. One hour after complete hemostasis, the numeric analog pain scale will be administered and recorded by 

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Version 5. Dec 22, 2019 
 
 
the research coordinator, and then radial artery patency will be assessed by the research coordinator using the reverse 
Barbeau’s test.20 
The research coordinator will then: 
• 
Schedule a phone call (or bedside visit, if applicable, for those subjects still in the hospital) for Visit 2. 
• 
Instruct the subject to call the research coordinator the day after enrollment to notify the research team of 
any occurrence of adverse events related to the application of either device. The subject may leave a 
message on the research coordinator’s voicemail, if the research coordinator is not able to answer the 
telephone, with their condition and any adverse events. The voicemail will be checked daily. For any 
perceived serious adverse event by the subject, they should call the interventional cardiologist who 
performed the procedure or seek emergency care. 
5.2. Visit 2-One day after enrollment 
For subjects who are still in the hospital, the research coordinator will visit the subjects in their hospital room the 
day after the procedure, to assess the subject’s condition and adverse events related to application of either 
hemostatic device. For patients who are already at home the day after their procedure, the research coordinator will 
contact the subjects by telephone one day after TRA to assess the subject’s condition and adverse events related to 
application of either hemostatic device. If it is on weekend, the research coordinator will contact the subjects by 
telephone the next business day. For those subjects who cannot be reached by telephone on the first attempt, the 
research coordinator will make three attempts, once daily, to reach the subjects. 
6. Safety and Adverse Events 
6.1. Definitions 
Adverse Event: An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in 
severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. 
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• 
results in study withdrawal 
• 
is associated with a serious adverse event 
• 
is associated with clinical signs or symptoms 
• 
leads to additional treatment or to further diagnostic tests 
• 
is considered by the investigator to be of clinical significance 
Serious Adverse Event: Adverse events are classified as serious or non-serious.  A serious adverse event is any 
AE that is: 
• 
fatal 
• 
life-threatening 
• 
requires or prolongs hospital stay 
• 
results in persistent or significant disability or incapacity 
• 
a congenital anomaly or birth defect 
• 
an important medical event 
Important medical events are those that may not be immediately life threatening, but are clearly of major clinical 
significance. They may jeopardize the subject, and may require intervention to prevent one of the other serious 
outcomes noted above.  For example, drug overdose  or  abuse,  a  seizure  that  did  not  result  in  in-patient 

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Version 5. Dec 22, 2019 
 
 
 
hospitalization, or intensive treatment of bronchospasm in an emergency department would typically be considered 
serious. All adverse events that do not meet any of the criteria for serious should be regarded as non-serious adverse 
events. 
6.2. Adverse Event Reporting Period 
The study period during which adverse events must be reported is normally defined as the period from the initiation 
of any study procedures to the end of the study treatment follow-up. Only SERIOUS ADVERSE EVENTS will be 
reported on for this study. 
Any adverse event that results in hospitalization or prolonged hospitalization should be documented and reported 
as a serious adverse event unless specifically instructed otherwise in this protocol. Any condition responsible for 
surgery should be documented as an adverse event if the condition meets the criteria for and adverse event. Neither 
the condition, hospitalization, prolonged hospitalization, nor surgery are reported as an adverse event in the 
following circumstances: 
• 
Hospitalization or prolonged hospitalization for diagnostic or elective surgical procedures for a 
preexisting condition. Surgery should not be reported as an outcome of an adverse event if the 
purpose of the surgery was elective or diagnostic and the outcome was uneventful. 
• 
Hospitalization or prolonged hospitalization required to allow efficacy measurement for the study. 
• 
Hospitalization or prolonged hospitalization for therapy of the target disease of the study, unless it is 
a worsening or increase in frequency of hospital admissions as judged by the clinical investigator. 
6.3. Recording of Adverse Events 
All serious adverse events occurring during the study period must be recorded. The clinical course of each event 
should be followed until resolution, stabilization, or until it has been determined that the study treatment or 
participation is not the cause. Serious adverse events that are still ongoing at the end of the study period must be 
followed up to determine the final outcome. 
6.4. Reporting of Serious Adverse Events 
Reports of all serious adverse events (including follow-up information) will be submitted to the IRB within 10 
working days. Copies of each report and documentation of IRB notification and receipt will be kept in the Principal 
Investigator’s binder. The funding sponsor of QuikClot® Radial® pad will be notified of serious adverse events 
related to the device (FDA Medwatch report). 
7. Data Handling and Record Keeping 
7.1. Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA). Those regulations require a signed subject 
authorization informing the subject of the following: 
• 
What protected health information (PHI) will be collected from subjects in this study 
• 
Who will have access to that information and why 
• 
Who will use or disclose that information 
• 
The rights of a research subject to revoke their authorization for use of their PHI. 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, retains the 
ability to use all information collected prior to the revocation of subject authorization. 

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7.2. Data Management 
Data management will be managed by OHR of Memorial Healthcare System. Study data will be collected and 
managed using REDCap electronic data capture tools hosted at OHR of Memorial Healthcare System. REDCap 
(Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research 
studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and 
export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; 
and 4) procedures for importing data from external sources. . 
7.3. Sample Size and Statistics 
Based on the previous study17 on the use of TR Band® and our pilot study on the QuikClot Radial pad with 
either a Coban™ bandage or Tegaderm™ dressing for radial hemostasis, we anticipate an average initial 
successful hemostasis rate of 95% or higher in patients using the QuikClot Radial pad compression device, 
compared to an initial successful hemostasis rate of 84% in patients using the TR Band, and no significant 
differences between the two QuikClot Radial pad arms. Using a type 1 error of 0.05 for each of the two 
comparisons of the QuikClot Radial pad with the TR Band and power of 80% to detect an 11% difference 
in the rate of initial successful hemostasis between the TR Band arm and either QuikClot Radial pad arm, a 
sample size of 100 will be needed for each of the three arms of the trial. Assuming that there may be a 50% 
screen failure rate (patients withdraw, ulnar access is used, radial access failure, events occur during the 
procedure that the investigator does not wish to enter the subject or the diagnostic only cases of the study are 
already filled), a total of up to 600 consecutive subjects undergoing transradial diagnostic cardiac catheterization 
and/or PCI, who sign informed consent to participate, will be recruited into the three arms of the trial. 
An interim analysis was not originally planned for the study, but was conducted after enrolling 186 participants. 
The results obtained from the interim analysis showed that there was a failure to obtain initial hemostasis at 5 
minutes in approximately 30% of the subjects in the QuikClot/Tegaderm™ arm of the protocol, compared to a 
failure to obtain initial hemostasis of 11% in the TR Band cohort (odds ratio = 3.2, 95% CI, 1.2 – 8.1, p = 0.013) 
and a failure to obtain initial hemostasis of 8% in the QuikClot/Coban™ cohort (odds ratio = 4.7, 95% CI, 1.7 – 
12.1, p = 0.003). Our DSMB committee reviewed the results and recommended to stop the Tegaderm™ only 
arm. We here institute a new arm 3 using a QuikClot Radial Pad under a TR Band with 30 minutes of 
compression to replace the old arm 3 in this trial. The sample size of the new arm 3 is the same as the old arm 3, 
with 100 participants including 50 diagnostic-only cardiac catheterizations and 50 PCIs. 
Statistical summaries and analyses of data will be performed at Memorial Healthcare System. Descriptive analysis 
will be performed for all data including means and standard derivation or medians for continuous variables and 
proportions for categorical variables. The t-test will be used to describe the differences of clinical outcomes between 
the two compression devices after TRA, and a two-sided p-value of 0.05 will be considered to be statistically 
significant. 
7.4. Dissemination Plan 
The principal investigator and co-investigators of this study will be responsible for ensuring the results obtained 
from this study, irregardless of the outcomes, to be reported to Schulman Institutional Review Board (IRB) within 
a reasonable timeframe after conclusion of the study. 
8. Ethical Considerations 

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Version 5. Dec 22, 2019 
 
 
This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 
part 312 and International Conference on Harmonization guidelines), applicable government regulations and 
Institutional research policies and procedures. 
This protocol and any amendments will be submitted to a properly constituted IRB, in agreement with local legal 
prescriptions, for formal approval of the study conduct. The decision of the IRB concerning the conduct of the study 
will be made in writing to the investigator and a copy of this decision will be provided to the sponsor before 
commencement of this study. The investigator should provide a list of IRB members and their affiliate to the 
sponsor. 
All subjects for this study will be provided a consent form describing this study and providing sufficient information 
for subjects to make an informed decision about their participation in this study. The consent form will be submitted 
with the protocol for review and approval by the IRB for the study. The formal consent of a subject, using the IRB 
approved consent form, must be obtained before that subject is submitted to any study procedure. This consent 
form must be signed by the subject, and the investigator-designated research professional obtains the consent. 
9. References 
1. Eichhofer J, Horlick E, Ivanov J, et al. Decreased complication rates using the transradial compared to the 
transfemoral approach in percutaneous coronary intervention in the era of routine stenting and glycoprotein 
platelet IIb/IIIa inhibitor use: A large single-center experience. Am Heart J 2008; 156:864–870. 
2. Bertrand OF, Belisle P, Joyal D, et al. Comparison of transradial and femoral approaches for percutaneous 
coronary interventions: A systematic review and hierarchical Bayesian meta-analysis. Am Heart J 2012; 
163:632– 648. 
3. Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention in 
patients with acute coronary syndromes (RIVAL): A randomised, parallel group, multicentre trial. Lancet 2011; 
377:1409–1420. 
4. De Carlo M, Borelli G, Gistri R, et al. Effectiveness of the transradial approach to reduce bleedings in patients 
undergoing urgent coronary angioplasty with GPIIb/IIIa inhibitors for acute coronary syndromes. Catheter 
Cardiovasc Interv 2009; 74:408–415. 
5. Hamon M, Mehta S, Steg PG, et al. Impact of transradial and transfemoral coronary interventions on bleeding 
and net adverse clinical events in acute coronary syndromes. Euro Intervention 2011; 7:91–97. 
6. Amin AP, Patterson M, House JA, et al. Costs Associated With Access Site and Same-Day Discharge Among 
Medicare Beneficiaries Undergoing Percutaneous Coronary Intervention: An Evaluation of the Current 
Percutaneous Coronary Intervention Care Pathways in the United States. JACC Cardiovasc Interv. 2017; 
10:342351. 
7. Wagener JF, Rao SV. A comparison of radial and femoral access for cardiac catheterization. Trends Cardiovasc 
Med. 2015; 25:707-713. 
8. Romagnoli E, Biondi-Zoccai G, Sciahbasi A, et al. Radial versus femoral randomized investigation in 
STsegment elevation acute coronary syndrome: The RIFLE-STEACS (Radial Versus Femoral Randomized 
Investigation in ST Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol 2012; 60:2481–2489. 
9. Mehta SR, Jolly SS, Cairns J, et al. Effects of radial versus femoral artery access in patients with acute coronary 
syndromes with or without ST-segment elevation. J Am Coll Cardiol 2012; 60:2490–2499. 
10. Pancholy SB, Bernat I, Bertrand OF, et al. Prevention of radial artery occlusion after transradial catheterization: 

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Version 5. Dec 22, 2019 
 
 
The PROPHET-II randomized trial. J Am Coll Cardiol Intv 2016; 9:1992–1999. 
11. Rashid M, Kwok CS, Pancholy SB, et al. Radial artery occlusion after transradial interventions: A systematic 
review and meta-analysis. J Am Heart Assoc. 2016 Jan 25; 5(1). 
12. Pancholy SB, Patel TM. Effect of duration of hemostatic compression on radial artery occlusion after transradial 
access. Catheter Cardiovasc Interv. 2012; 79:78-81. 
13. Fernandez RS, Lee A. Effects of methods used to achieve hemostasis on radial artery occlusion following 
percutaneous coronary procedures: a systematic review. JBI Database System Rev Implement Rep. 2017; 
15:738764. 
14. Trabattone D, et al. A new kaolin-based haemostatic bandage compared with manual compression for bleeding 
control after percutaneous coronary procedures; Eur Radiol. 2011; 21: 1987-1991. 
15. Roberts JS, Niu J, Pastor-Cervantes JA. Comparison of hemostasis times with a Kaolin-based hemostatic pad 
(QuikClot Radial) vs mechanical compression (TR Band) following transradial access: a pilot prospective study. 
J Invasive Cardiol. 2017; 29:328-334. 
16. Politi L, Aprile A, et al. Randomized clinical trial on short-compression with Kaolin-filled pad: a new strategy 
to avoid early bleeding and subacute radial artery occlusion after percutaneous coronary intervention. J Interv 
Cardiol 2011; 24:65-72. 
17. Roberts JS, Niu J, Pastor-Cervantes JA. Comparison of Hemostasis Times with a Chitosan-Based Hemostatic 
Pad (Clo-SurPlus Radial™) vs Mechanical Compression (TR Band®) Following Transradial Access: A pilot 
Study. Cardiovasc Revasc Med. 2019 Oct;20(10):871-874.  
18. Van Meter C, Vasudevan A, Cuccerre JM, Schussler JM. Time to discharge following diagnostic coronary 
procedures via transradial artery approach: A comparison of Terumo band and StatSeal hemostasis. Cardiovasc 
Revasc Med. 2018 Oct;19(7 Pt A):759-761. 
19. Carrington C, Mann R, El-Jack S. An accelerated hemostasis protocol following transradial cardiac 
catheterization is safe and may shorten hospital stay: a single-center experience. J Interv Cardiol. 2009; 
22:571575. 
20. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013: new guidance for content of clinical trial protocols. 
Lancet. 2013; 381:91-92. 
21. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical 
trials. Ann Intern Med. 2013; 158:200-207. 
22. Barbeau GR, Arsenault F, Dugas L, et al. Evaluation of the ulnopalmar arterial arches with pulse oximetry and 
plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004; 147:489-493. 
23. Bertrand OF, Larose E, Rodes-Cabau J, et al. Incidence, predictors, and clinical impact of bleeding after 
transradial coronary stenting and maximal antiplatelet therapy. Am Heart J 2009; 157:164-169. 

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10. Lists of abbreviations 
 
TRA, Transradial Access 
CC, Cardiac Catheterization 
PCI,   Percutaneous Coronary Intervention 
FDA, Food and Drug Administration 
RA, Radial Artery 
FA, Femoral Artery 
RAO, Radial Artery Occlusion 
VNRS, Verbal Numerical Rating Scale 
STEMI, ST segment elevation myocardial infraction DOAC, Direct acting Oral Anticoagulants 
eGFR, Estimated Glomerular Filtration Rate 
AE, Adverse Event 
IRB, Institutional Review Board 
HIPAA, Health Insurance Portability and Accountability Act 
PHI, Protected Health Information 
CRF, Case Report form 
INR, International Normalized Ratio 
ACT, Activated clotting time 
US, United States 
REDCap: Research Electronic Data Capture