Page 39 - Journal of Special Operations Medicine - Spring 2016

sternum, directly over the left pectoralis major muscle. later removed without difficulty and the patient had no
XStat was found to require significantly less time (31 complications related to the XStat use (Elliot, personal
seconds versus 65 seconds) to pack into the wound and communication). Note this was not an “approved” in-
to significantly reduce the amount of blood lost during dication for XStat. It was placed intraoperatively and,
application (1.3g/kg versus 5.1g/kg) without requiring therefore, by definition, does not meet the FDA defini-
manual compression by the provider after application tion of “until surgical care is acquired.” 6
into the wound. No significant differences were found
with respect to either survival or post-treatment blood Another clarification in terminology is needed. The Ces-
loss. In contrast to the Mueller study, all animals in tero paper refers to the axillary, neck, and groin areas as
7
both the XStat and the Combat Gauze (with compres- “noncompressible regions” with respect to hemorrhage
sion) arms of the study survived. 7 control. In fact, junctional hemorrhage in these areas is
7
typically compressible. The 2012 Eastridge et al. paper
A comparison of the Combat Gauze-treated animals in notes, “Recent emphasis in battlefield trauma care has
the two studies 7,26 revealed that they were similar with focused on reducing death from noncompressible hem-
respect to skin incision size, vascular injury, pretreatment orrhage through the use of tranexamic acid, controlling
bleeding period, Combat Gauze application technique, junctional hemorrhage with the Combat Ready Clamp,
observation time, and splenectomy procedure. One vari- providing fluid resuscitation that minimizes dilutional
ation was in the fluid resuscitation procedure. Both stud- coagulopathy and providing a battlefield analgesia op-
ies infused a 500mL bolus of Hextend (BioTime; http:// tion that does not cause respiratory depression or exac-
www.biotimeinc.com) followed by additional resuscita- erbate hemorrhagic shock.” XStat will not help with
1
tion with lactated Ringer’s solution (LR) to achieve and the most common cause of preventable combat death,
maintain target mean arterial pressures (MAPs). In the which is, indeed, noncompressible hemorrhage, but that
Mueller et al. article, LR was administered to main- which originates from internal sites within the abdomi-
26
tain a target MAP between 60mmHg and 65mmHg; in nal or pleural cavities.
the Cestero study, however, the target MAP was “above
65mmHg.” Sondeen and her colleagues found that the Given the cost differential, XStat must also be shown to
7
average MAP at which rebleeding occurred in an aor- be better than the currently approved TCCC interven-
totomy bleeding model was 64mmHg. This differ- tions for junctional hemorrhage (i.e., hemostatic dress-
30
ence, therefore, might have been expected to result in ings and junctional tourniquets) in the most commonly
increased bleeding and mortality in the animals in the encountered junctional wounding patterns, to represent a
Cestero study, which was not the observed outcome. significant advance in prehospital trauma care. Compar-
7
Another variation between the studies was that the Com- ative studies with Combat Gauze were discussed earlier
bat Gauze wound packing in the Mueller study was done in this article. There are, at present, no data showing that
by Combat Medics, whereas in the Cestero study, the XStat works more effectively than the current CoTCCC-
packing was done by an experienced trauma surgeon. 7,26 recommended junctional tourniquets for wounds in the
inguinal or axillary junctional areas. Future clinical ex-
Kragh and Aden compared XStat to standard gauze perience will determine the magnitude of the additional
(Kerlix) in a gel model of a simulated wound cavity hemorrhage-control capability that combat medical pro-
and found that XStat was applied eight times faster viders will gain by adding XStat to their aid bags.
(8 seconds versus 67 seconds) than packing the cavity
with standard gauze. This study also found that XStat The FDA clearance letter notes, “The sponges expand
applied pressure more symmetrically throughout the upon contact with blood to fill the wound cavity and
wound cavity than did standard gauze. 14 provide a physical barrier and pressure that facilitates
formation of a clot.” It should be noted that a 4.5cm
6
Additional Considerations wound tract is somewhat larger than would be expected
To date, there has only been one known use of XStat in a with the entrance tract from a gunshot wound. Both
combat casualty and that was in a patient with intraop- the Mueller and the Cestero papers used a subclavian
erative bleeding from a lower-extremity gunshot wound vessel injury model that included a well-defined wound
that shattered his femur. The bleeding had not been well cavity. 7,26 The volumes of the wound cavities averaged
controlled with Combat Gauze or cautery at first opera- 136mL and 131mL, respectively, in these two studies. If
tion and required reoperation to evaluate. According to bleeding occurs from wounds with configurations that
the surgeon, the XStat worked as intended and main- do not include a well-defined cavity, the minisponges may
tained hemorrhage control while the patient was being not be able to exert pressure on the site of the vascular
resuscitated. The wound was also packed with Combat injury in the same manner that occurs with expanding
Gauze on top of the XStat to achieve maximum com- minisponges contained in a well-defined wound cav-
pression. Both the Combat Gauze and the XStat were ity. No published studies were found that address the

TCCC Guidelines: XStat Sponge for External Hemorrhage 23