Page 53 - Journal of Special Operations Medicine - Spring 2016

and have been cleared by the US Food and Drug Adminis- modifications included: (1) Using the AAJT applied di-
tration (FDA) for hemorrhage control of difficult inguinal rectly to the groin, since the instructions for use (IFU)
bleeding. Authors have reported cases of successful use were updated after the US testing; (2) The CRoC was as-
of the Combat Ready Clamp (CRoC ; Combat Medical sembled for each test, since the updated, April 2014 IFU
™
Systems; http://www.combatmedicalsystems.com), the were not yet available to the Israelis; (3) pulse absence
8,9
Abdominal Aortic and Junctional Tourniquet (AAJT ; during junctional tourniquet use was assessed by a physi-
™
Compression Works; http://compressionworks.com), cian of the instructor team and not with use of a Doppler
9
and the SAM Junctional Tourniquet (SJT; SAM Medical transducer for auscultation; and (4) pulse absence moni-
®
Products; http://www.sammedical.com). Widespread toring was for 30 seconds and not 60 seconds.
10
field ing and use of such devices have not yet occurred
but may potentially prevent battlefield casualty deaths. At the time of these studies, four models of junctional
tourniquet were available (Table 1). The junctional tour-
To assess which junctional tourniquet models work niquets (12 devices: three each of four models) were sent
well, this study was performed to compare efficacy in from the USAISR to Israel. Because the inguinal (groin)
the hands of medics—the intended users—of four mod- area was the only body region that all four tourniquets
els in controlling femoral artery blood flow in simulated shared as an indication, it was the only site that allowed
battlefield trauma care. all four models to be compared in the same testing. Uni-
lateral groin hemorrhage was simulated. All tests were
conducted in a work room of an IDF unit in May 2014.
Methods
This report details user assessments of junctional tourni- There were four junctional tourniquet models to test.
quet models; it is not research in that it is not systematic Each tester was to use each of the four models of tour-
experimentation directed toward scientific or engineering niquet on the left side and on the right side of the groin
phenomena or principles. The test plan was approved by separately to make two tests with each model on each
the Israel Defense Forces (IDF) Medical Corps’ (MC) In- side. The planned number of tests for a tester was 16
stitutional Review Board. A 2013 test plan was sent from (four models times two sides times two tests per side).
the US Institute of Surgical Research (USAISR) after ap- The total number of tests was to be 224 (14 testers, four
proval for use in the US Army Medical Department Cen- models, two sides, two tests per side).
ter and School for a proposed test by US Military Medics,
but that US testing was delayed, then subsequently ex- All medics were Special Operation Forces (SOF) Opera-
ecuted and published. The US protocol was modified; tors; all were certified by the IDF as Combat Medics.
11

Table 1 Traits of Junctional Tourniquets That Were US FDA Cleared at Testing Time
Tourniquet Abdominal Aortic and Junctional Emergency SAM Junctional
Information Combat Ready Clamp Junctional Tourniquet* Treatment Tool Tourniquet
Nickname CRoC AAJT JETT SJT
Maker Combat Medical Systems Compression Works North American SAM Medical Products
Rescue Products
City, state Fayetteville, NC Hoover, AL Greer, SC Wilsonville, OR
510(k) date(s) † 8/11/10; 4/29/13 10/18/11; 12/6/2013 ‡ 1/3/13 3/18/13, 7/24/13
FDA number(s) K102025; K130482 K112384, K133029 K123194 K123694; K131561
NSN 6515-01-589-9135 6515-01-616-4999 6515-01-616-5841 6515-01-618-7475
Cost 654 515 220 292.50
§
(est. USG in USD )
Weight (g) 799 485 651 499
Volume (L) 0.8 1.4 1.6 1.5
Indication(s) Battlefield, difficult Battlefield, difficult Difficult inguinal bleeds Difficult inguinal or
inguinal or axilla bleeds inguinal, pelvis, or axilla bleeds, or pelvic
axilla bleeds fracture immobilization
*Renamed and relabeled 6 December 2013; the prior name was Abdominal Aortic Tourniquet.
† FDA clearance date.
‡ This clearance was between test planning and test enactment.
§ Estimated for the US Government price.
FDA, US Food and Drug Administration; USG, US Government; NSN, National Stock Number; USD, US dollars.

Junctional Tourniquet Testing for Groin Hemorrhage 37