Page 31 - Journal of Special Operations Medicine - Summer 2014

Safety and Effectiveness Evidence of
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SAM Junctional Tourniquet to Control Inguinal
Hemorrhage in a Perfused Cadaver Model

James E. Johnson, PhD; Richard Kyle Sims; Donald J. Hamilton; John F. Kragh, Jr., MD

ABSTRACT
Background: Hemorrhage from the trunk–appendage sites are susceptible to injury as they are routinely be-
junctions is a common, preventable cause of death on the yond the edge of body armor. Junctional areas can be
battlefield. The recently U.S. Food and Drug Administra- compressed to control hemorrhage, but manual com-
tion (FDA)-cleared SAM Junctional Tourniquet (SJT) pression is often difficult or ineffective in the field. Sev-
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was designed to control out-of-hospital inguinal and axil- eral junctional tourniquets have been developed in order
lary hemorrhage. The purpose of the present study was to provide reliable compression. 2
to provide safety and effectiveness data associated with
use of the SJT. Such data provided support for regulatory A high proportion of these explosion-related casualties
clearance. Methods: The SJT was tested in a perfused ca- also sustain a pelvic fracture due to the high-energy mech-
daver experiment simulating inguinal or axillary wound anism of injury. For example, patients with a bilateral
3,4
hemorrhage. Results: No safety problems or tissue dam- above-knee amputation treated at Camp Bastion Hospi-
age occurred, and flow normalized promptly after tourni- tal, Afghanistan, had a 39% incidence of associated pel-
quet removal. During SJT use, an average of 107mmHg vic fracture. This high rate of pelvic fractures led one
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occluded the distal external iliac artery in an average of military service to mandate prehospital application of a
7 seconds of inflation time; manual pressure as a control pelvic binder for all explosion-related victims. Civilian
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averaged 139mmHg. In SJT use, an average of 739mmHg pelvic fractures also have a high mortality rate, and early
occluded the axillary artery in an average of 5 seconds fracture immobilization is important for best care. 7,8
of inflation time; manual pressure as a control averaged
1237mmHg. The control was a referent that achieved re- The SAM Junctional Tourniquet (SJT, SAM Medi-
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sults that were similar in one body area but different in the cal Products, Wilsonville, OR; http://www.sammedical
other; both findings indicate the device is as safe as, if not .com/) is indicated to control junctional hemorrhage of
safer than, manual compression. Conclusion: The SJT was the inguinal and axillary areas, as well as to immobi-
shown to be safe and effective in hemorrhage control in lize and reduce pelvic fractures. It consists of a pelvic
a cadaver model for both the axillary and inguinal areas. belt to which pneumatic point pressure devices (Target
The SJT’s Target Compression Devices required pressures Compression Devices [TCDs]) are attached. The SJT was
approximately equal to or lower than manual pressure to cleared initially by the U.S. Food and Drug Administra-
achieve hemostasis in these junctional regions. tion (FDA) on March 18, 2013, and the information used
to evidence the FDA clearance included testing in a per-
Keywords: hemorrhage, trauma, groin, injuries and wounds, fused cadaver model. Junctional tourniquets have been
first aid, damage control emergency medical services, re- fielded to U.S. forces in limited numbers; for example,
suscitation, tourniquet the United States Army Medical Materiel Agency sent
460 SJTs to theater in October 2013. The purpose of the
present study is to provide data to assess in the use of the
SJT for the control of simulated junctional hemorrhage.
Introduction
More than 90% of potentially survivable battlefield
deaths today are caused by controllable hemorrhage, and Methods
in nearly 20% of such cases, the bleeding is junctional.
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Moreover, increased rates of occurrence of explosion-re- Initial Development of the SJT From a Preexisting
lated injuries have correlated with increased junctional Device Indicated for Pelvic Fracture Stabilization
hemorrhage. Unfortunately, trunk– appendage junctions The SJT (National Stock Number 6515-01-618-
are sites where regular tourniquets cannot fit, yet these 7475) was developed using the SAM Pelvic Sling as a
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