Page 66 - Journal of Special Operations Medicine - Fall 2017

Evaluation of XSTAT and QuickClot Combat Gauze
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in a Swine Model of Lethal Junctional Hemorrhage
in Coagulopathic Swine

Jennifer M. Cox, BS ; Jason M. Rall, PhD *
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1

ABSTRACT
Background: Hemorrhage is associated with most potentially each has limitations that make it insufficient for some injury
survivable deaths on the battlefield. Effective and field-tested locations or wounding patterns. Junctional tourniquets are
products are lacking to treat junctional and noncompressible mainly effective when injuries are slightly distal to the junc-
injuries. XSTAT is a newly developed, U.S. Food and Drug tion, whereas REBOA is more complex to implement and
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Administration-approved product designed to treat junctional does not work for injuries of the upper torso. Hemostatic
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hemorrhage. The Committee on Tactical Combat Casualty gauzes, including QuikClot Combat Gauze (CG; Z-Medica,
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Care has recently approved the product for use as part of www.z-medica.com), are effective in controlling hemorrhage
its treatment guidelines, but data are lacking to assess its ef- in compressible sites but do not offer definitive hemostasis. 9,10
ficacy in different wounding patterns and physiologic states. Therefore, the development and testing of new products in
Methods: Dilutional coagulopathy was induced in 19 large different wounding patterns and physiological states will im-
(70–90kg), healthy, male swine by replacing 60% of each prove point-of-care treatments.
animal’s estimated blood volume with room temperature Hex-
tend . After dissection, isolation, and lidocaine incubation, XSTAT (RevMedx, http://www.revmedx.com) is a newly de-
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uncontrolled hemorrhage was initiated by transection of both veloped hemostatic device designed to treat junctional wounds
axillary artery and vein. Free bleeding was allowed to pro- in the groin or axilla by the injection of self-expanding, mini
ceed for 30 seconds until intervention with either XSTAT or sponges directly into a bleeding wound. The device has been
QuickClot Combat Gauze (CG) followed by standard back- approved by the Food and Drug Administration and is recom-
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ing. Primary outcomes were survival, hemostasis, and blood mended by the Committee on Tactical Combat Casualty Care
loss. Results: XSTAT-treated animals achieved hemostasis in (CoTCCC) to control bleeding. 11,12 It has been shown to be
less time and remained hemostatic longer than those treated more effective than CG in a swine model of junctional hemor-
with CG. Less blood was lost during the first 10 minutes after rhage. 13,14 XSTAT also is applied significantly faster than stan-
injury in the XSTAT group than the CG group. However, no dard gauze and produced pressure throughout a wound cavity
differences in survival were observed between XSTAT-treated in a simulated injury using ballistic gel. 15
and CG-treated groups. All animals died before the end of the
observation period except one in the XSTAT-treated group. The aim of this study was to compare XSTAT with CG, one
Conclusion: XSTAT performed better than CG in this model of the CoTCCC standards of care for hemostatic dressings. A
of junctional hemorrhage in coagulopathic animals. Contin- junctional injury was created in coagulopathic swine before
ued testing and evaluation of XSTAT should be performed to application of the test dressing. We hypothesized that XSTAT
optimize application and determine appropriate indications would be more effective in creating hemostasis, because it re-
for use. lies less on coagulation factors and because it produces even
pressure throughout a wound.
Keywords: XSTAT; trauma; hemorrhage; hemorrhage, junc-
tional; Combat Casualty Care Materials and Methods

Overview
This was a randomized, blinded, prospective trial. Male,
Introduction
Yorkshire–Landrace swine, weighing 70–90kg were used
Traumatic hemorrhage, particularly when occurring on the in the experimental protocol. All subjects were treated ac-
torso, is responsible for the greatest number of potentially cording to “The Guide for the Care and Use of Laboratory
survivable deaths in recent conflicts. Fast, effective, and Animals” and the animals were housed according to regu-
1,2
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easily applied treatments for junctional and noncompress- lation at an Association for Assessment and Accreditation
ible hemorrhage are needed because treating these injuries is of Laboratory Animal Care International-accredited facility.
challenging with current standards of care. Junctional tourni- The study was approved by the U.S. Air Force 59th Medi-
quets and resuscitative endovascular balloon occlusion of the cal Wing’s Institutional Animal Care and Use Committee.
aorta ( REBOA) are promising new technologies. However, Animals were excluded from analysis when the subject died
3–6
*Correspondence to jason.m.rall.ctr@mail.mil
1 Ms Cox is at the 59th Medical Wing Office of the Chief Scientist, Wilford Hall Ambulatory Surgical Center, Joint Base San Antonio-Lackland,
TX. Dr Rall is at the 59th Medical Wing Office of the Chief Scientist, Wilford Hall Ambulatory Surgical Center, Joint Base San Antonio-
2
Lackland, TX.
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