Management of Junctional Hemorrhage in Tactical Combat Casualty Care: TCCC Guidelines–Proposed Change 13-03 Russ S. Kotwal, MD; Frank K. Butler, MD; Kirby R. Gross, MD; John F. Kragh Jr., MD; Bijan S. Kheirabadi, PhD; David G. Baer, PhD; Michael A. Dubick, PhD; Todd E. Rasmussen, MD; Michael A. Weber, MD; Jeffrey A. Bailey, MD ABSTRACT The vast majority of combat casualties who die from Clamp be used to control junctional hemorrhage on their injuries do so prior to reaching a medical treatment the battlefield, the Assistant Secretary of Defense for facility. Although most of these deaths result from non- Health Affairs directed that the Committee on TCCC survivable injuries, efforts to mitigate combat deaths (CoTCCC) also considers the other junctional tour- can still be directed toward primary prevention through niquets that have been recently cleared by the FDA.3 modification of techniques, tactics, and procedures and secondary prevention through improvement and use of Background personal protective equipment. For deaths that result from potentially survivable injuries, mitigation efforts More aggressive and definitive control of external hem- should be directed toward primary and secondary pre- orrhage had a profound impact on the survival of U.S. vention as well as tertiary prevention through medical casualties from Afghanistan and Iraq. The combined ef- care with an emphasis toward prehospital care as dic- forts by the U.S. Special Operations Command (USSO- tated by the fact that the preponderance of casualties COM), U.S. Central Command (USCENTCOM), and die in the prehospital environment. Since the majority U.S. Army Institute of Surgical Research (USAISR) led of casualties with potentially survivable injuries died to a much expanded use of prehospital tourniquets early from hemorrhage, priority must be placed on interven- in the current wars. TCCC guidelines advocated for a tions, procedures, and training that mitigate death from change in the tourniquet use paradigm from the inter- truncal, junctional, and extremity exsanguination. In vention of last resort to the intervention of first resort for response to this need, multiple novel and effective junc- life-threatening extremity hemorrhage. This change was tional tourniquets have recently been developed. one of the most significant medical breakthroughs of the war. Estimates of lives saved by tourniquet use suggest Keywords: junctional hemorrhage, Tactical Combat Casu- that 1,000 to 2,000 U.S. military Servicemembers’ lives alty Care Guidelines were saved by the application of prehospital extremity tourniquets during the current conflicts.4 Combat units that train all of their members in external hemorrhage control techniques have seen remarkable success in re- Proximate Cause for the Proposed Change ducing preventable deaths on the battlefield.5 1. Now that extremity tourniquets are in widespread use by the U.S. military, junctional hemorrhage is With preventable deaths from extremity hemorrhage the most common cause of death from compressible greatly reduced by tourniquet use, junctional hemor- hemorrhage.1 rhage has surpassed extremity hemorrhage as the lead- 2. The current Tactical Combat Casualty Care (TCCC) ing cause of death from external hemorrhage.1 Guidelines mention only the Combat Ready Clamp as a junctional tourniquet.2 Since this recommenda- Another factor contributing to the increasing incidence tion was approved, three other devices have been of death from junctional hemorrhage is the expanded cleared by the U.S. Food and Drug Administration use of anti-personnel, pressure-activated improvised ex- (FDA) for junctional hemorrhage control. plosive devices (IEDs) in the Combined Joint Operat- 3. In his letter of 5 August 2013 approving the Defense ing Area–Afghanistan (CJOA-A), which was first noted Health Board recommendation that the Combat Ready in the summer of 2010. Junctional hemorrhage is one 85 Report Documentation Page Form Approved OMB No. 0704-0188 Public reporting burden for the collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Washington Headquarters Services, Directorate for Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to a penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE 2. REPORT TYPE 3. DATES COVERED 01 NOV 2013 N/A - 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER Management of Junctional Hemorrhage in Tactical Combat Casualty 5b. GRANT NUMBER Care: TCCC Guidelines?Proposed Change 13-03. 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER Kotwal R. S., Butler F. K., Gross K. R., Kheirabadi B. S., Baer D. G., 5e. TASK NUMBER Dubick M. A., Rasmussen T. E., Weber M. A., Bailey J. A., 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION United States Army Institute of Surgical Research, JBSA Fort Sam REPORT NUMBER Houston, TX 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S ACRONYM(S) 11. SPONSOR/MONITOR’S REPORT NUMBER(S) 12. DISTRIBUTION/AVAILABILITY STATEMENT Approved for public release, distribution unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT 15. SUBJECT TERMS 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF 18. NUMBER 19a. NAME OF ABSTRACT OF PAGES RESPONSIBLE PERSON a. REPORT b. ABSTRACT c. THIS PAGE UU 9 unclassified unclassified unclassified Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18 component of the injury complex produced by these • Easy to use; requires minimal training or familiarization dismounted IED attacks that has become known as Dis- • Quickly applied mounted Complex Blast Injury (DCBI).6 • Does not slip on tightening or in use • Provides easy release of compression A comprehensive study of U.S. combat fatalities from • Easy to reapply 2001 to 2011 noted that 17.5% (171/976) of poten- • Long shelf life tially preventable prehospital deaths resulted from junc- tional hemorrhage.1 In January 2013, a USCENTCOM Pelvic fractures may be seen in association with junc- and Joint Trauma System (JTS) report on prehospital tional bleeding in dismounted IED attacks.12 Medics trauma care in Afghanistan noted the above findings from the United Kingdom (UK) carry pelvic binders and advocated for more research and expanded fielding to use on individuals with suspected pelvic fractures.7 of junctional tourniquets.7 The junctional tourniquets that are applied circumfer- entially around the pelvis may also provide some sta- Junctional hemorrhage is defined for the purposes of bilization of pelvic fractures.12 U.S. Army 68W combat this discussion as hemorrhage that occurs at the junc- medics are also taught to apply pelvic binders for casu- tion of an extremity with the torso of the body at an alties who have suspected pelvic fractures (MAJ Char- anatomic location that precludes the effective use of an lie Day and Mr. Jeff Mott, personal communication, extremity tourniquet to control the bleeding. The defini- 25 July 2013). tion also includes the base of the neck.8 A Performance Improvement (PI) project at the JTS re- Junctional hemorrhage includes bleeding from: the viewed a series of 504 U.S. Servicemembers who suf- groin proximal to the inguinal ligament, the buttocks, fered traumatic amputations as a result of IED blast. the gluteal and pelvic areas, the perineum, the axilla This PI project identified the frequent association of and shoulder girdle, and the base of the neck. The le- proximal traumatic amputation, pelvic fracture, and thality of limb injuries is less than junctional areas as massive transfusion. In this series, 16% (9/55) of Ser- hemorrhage is slower due to the smaller lumen size of vicemembers with a unilateral above knee amputation the injured vessels.8 Junctional hemorrhage also includes (AKA) had a pelvic fracture and 78% (43/55) required extremity bleeding from sites too proximal for effective a massive transfusion (MT, required a minimum of 10 use of extremity tourniquets. units of blood during the first 24 hours post injury). Of Servicemembers with bilateral traumatic AKA, 30% Junctional hemorrhage is compressible hemorrhage. (27/90) had a pelvic fracture and 100% (90/90) re- Compressible hemorrhage can be controlled in the pre- quired MT. Of Servicemembers with one AKA and one hospital environment. As survival from trauma cor- below knee amputation (BKA), 32% (25/78) had a pel- relates with the time elapsed during evacuation to an vic fracture and 92% (72/78) required MT. The pres- injury-dictated required capability, first responders must ence of a traumatic AKA is strongly associated with a be afforded the capability to successfully compress and casualty who is at high risk for pelvic fracture and MT. control junctional hemorrhage through optimal training A device that affords stability to a pelvic fracture and and effective equipment. mitigates hemorrhage from an amputation site would be of great value to combat casualties with this pattern of injury. Hemorrhage from a traumatic AKA can be Discussion managed with a tourniquet in many cases. However, for those with a very proximal AKA, a junctional device Desirable Traits of Junctional Tourniquets would be of great potential benefit (COL Kirby Gross, The desirable traits of candidate devices for junctional personal communication, 9 July 2013). hemorrhage control have been defined9–11: “This data suggests dismounted casualties with a trau- • Stops bleeding effectively from junctional areas such matic amputation higher than a BKA level warrant as the groin, pelvis, buttock, shoulder, or neck empiric application of a pelvic binder. Should the am- • Compresses bleeding from sites where regular tour- putation be so high that a tourniquet is ineffective, the niquets cannot be applied junctional component of the Junctional Emergency • Safe to use Treatment Tool (JETT) or SAM Junctional Tourniquet • Can be used effectively for prehospital care on the warrants application. Should the pelvic binder be ap- battlefield and in tactical situations plied at the appropriate level, the ventral aspect of the • Small with low profile binder immediately overlies the common femoral ar- • Lightweight tery” (COL Kirby Gross, personal communication, 9 • Low-cost July 2013). 86 Journal of Special Operations Medicine Volume 13, Edition 4/Winter 2013 FDA-Cleared Tourniquets for assist hemostasis after diagnostic or therapeutic cath- Control of Junctional Hemorrhage eterization of femoral artery or vein.”16 As of May 2013, four devices have been cleared by the “Unlike the CRoC, the FemoStop device has too large FDA for junctional hemorrhage control. Of note is that a cube to fit in medic’s backpack and may not generate the Abdominal Aortic Tourniquet (AAT™) is a truncal sufficient pressure to either directly control bleeding of tourniquet, while the other three devices listed here are large junctional wounds or compress proximal iliac ves- junctional tourniquets. sels remotely to secure hemostasis in case of high leg amputation.”16 Abdominal Aortic Tourniquet (AAT™) Website: http://www.speeroptech.com/page6/ The application time of the CRoC should not exceed 4 “The abdominal aortic tourniquet (AAT) is a pneu- hours. matic belt that allows for the constant delivery of pres- sure over a specific area for a prolonged period. The Junctional Emergency Treatment Tool (JETT™) device has shown efficacy and safety in a swine model Website: http://www.narescue.com/portal. for aortic occlusion for up to 60 minutes. The device is aspx?CN=73330B0D4AFF designed to be applied in less than a minute by a single The Junctional Emergency Treatment Tool (JETT) responder. The belt is placed around the abdomen with was developed through a joint effort between the Univer- the inflatable section over the umbilicus. The buckle is sity of Texas Health Science Center for Translational In- manually cinched down, and then, the device is further jury Research and North American Rescue Products. This tightened by the use of a windlass located on the front device incorporates a windlass and is designed to treat of the device. The pneumatic bladder is then inflated.”8 junctional hemorrhage in both the military and the civil- ian prehospital environments. It incorporates both a pelvic The authors of a recent study note that the AAT oc- binder application and bilateral pads designed to occlude cludes blood flow at the level of the infrarenal aorta.12 unilateral or bilateral common femoral artery blood flow In addition to controlling junctional hemorrhage, aortic to the lower extremities. The device can be used instead compression at this level might also help with hemor- of manual pressure, allowing the healthcare provider to rhage control in the pelvis, since flow in the internal iliac attend to other casualties. The JETT consists of a belt as- arteries and their branches would also be expected to be sembly, with two trapezoidal pressure pads and threaded occluded. Application time should not exceed 1 hour. T-handles. Application time should not exceed 4 hours. The AAT is absolutely contraindicated in pregnancy and in patients with known abdominal aortic aneurysms. It SAM® Junctional Tourniquet is relatively contraindicated in penetrating abdominal Website: http://www.sammedical.com/products/ trauma.13 the-sam-junctional-tourniquet/ Combat Ready Clamp (CRoC™) The SAM Junctional Tourniquet for hemorrhage control Website: http://www.combatmedicalsystems.com/ is designed to control bleeding in areas where standard CRoC-Combat-Ready-Clamp-p/31-200.htm tourniquets would not be effective, such as with IED or “In 2009 inspired by Lister’s abdominal tourniquet, blast injuries or high level amputations. Its components the Combat Ready Clamp (CRoC) was designed to ex- include a belt and two pneumatically inflatable bladders ert mechanical pressure directly over the wound or in- called Target Compression Devices (TCDs). The TCD is directly over the groin area to occlude underlying blood placed at or proximal to the injury site and inflated until vessels and stop hemorrhage. It has also been FDA- the bleeding stops. Two TCDs can be used to occlude cleared for use in control of axillary hemorrhage.”8,14 blood flow bilaterally if needed.8 The SAM Junctional The CRoC has been shown to be efficacious in a cadaver Tourniquet also has FDA clearance for stabilizing pel- model of axillary junctional bleeding.15 vic fractures and for controlling junctional bleeding in the axillary area. Application time should not exceed “The final design has a small cube (stored dimensions: 4 hours. The SAM Junctional Splint is FDA-cleared for height, 3.5 in; width, 11.5 in; diameter, 1.5 in) with an junctional bleeding in the inguinal and axillary areas aluminum structure that weighs 1.6 lb. In 2010, it re- and to stabilize suspected pelvic fractures.17 ceived the U.S. Food and Drug Administration approval as a medical device for the control of difficult inguinal Review of the Available Evidence hemorrhage on the battlefield.”16 on Junctional Hemorrhage Control Devices “The CRoC is similar to an existing pneumatic com- There are no prospective trials that support the efficacy pression device FemoStop that is used in hospitals to of current FDA-cleared junctional hemorrhage control Management of Junctional Hemorrhage in Tactical Combat Casualty Care 87 devices on casualties in the prehospital environment. hospital. By the time of his arrival in the Emergency De- The available evidence as discussed in this report are partment, his end-tidal CO had gone from 0.6–5.4kPa 2 laboratory studies and case reports. and his carotid pulse had returned. The casualty sur- vived and had no evidence of renal failure or ischemic In a study of the four FDA-cleared junctional hemor- bowel in the first 48 hours after his initial operation.21 rhage control devices and manual compression using a manikin bleeding model, hemorrhage was successfully There is a case report pending publication for the off- controlled with all four devices. The average times to label use of the AAT on a civilian patient with a gunshot achieve hemorrhage control were AAT, 102 seconds; wound to the left axillary area. He had uncontrolled CRoC, 59 seconds, JETT, 41 seconds; and SAM, 26 sec- hemorrhage from the two wounds and was in hem- onds. The average blood loss for each junctional tourni- orrhagic shock. The AAT was placed in the left axil- quet was AAT, 787ml; CRoC, 581ml; JETT, 342ml; and lary area with the strap tightened around the opposite SAM, 35ml.18 shoulder. The hemorrhage was controlled using this technique.22 AAT In a recent study from the UK, the authors note that A 2006 study of nine human subjects showed that flow “the ideal device for lower extremity junctional trauma through the common femoral artery could be stopped would prevent all infra-umbilical blood flow, not dam- with compression of the abdominal aorta with dumb- age or penetrate tissues, be re-applicable after release, be bells weighing from 80 to 140 lb.19 The study noted that: rapidly applied by feel and be secure in transit. One such “The amount of time the volunteers could tolerate the potential device is the Abdominal Aortic Tourniquet or compression was not measured. However, in a real-life AAT. (Compression Works, Birmingham, AL, USA).” In situation, responders and victims would be motivated this study of 16 human subjects, AAT application was differently. Last, maintaining ongoing compression at a tolerated by all 16 participants. Blood flow in the com- pressure equal to a 120-lb dumbbell may not only ex- mon femoral artery was completely stopped in 15 of the haust medical personnel but also commit them to con- 16 participants. The balloon remained inflated for less tinue to exert the pressure indefinitely. It may be helpful than 1 minute during the study and normal tri-phasic if a lightweight mechanical device able to be left alone flow resumed in all subjects immediately following de- once set in place, could achieve such compression.”19 flation of the balloon. No complications were reported either during or after the study.12 In another human study, the AAT application resulted in the interruption of blood flow in the common femoral By occluding the aorta above its bifurcation when ap- artery in seven of nine volunteer subjects. Cessation of plied, the AAT has the potential to be able to control flow was achieved at a median pressure of 180mm Hg pelvic bleeding from the branches of the internal iliac (range 150–230mm Hg).20 arteries. On a numeric rating scale for pain of 0–10, the median Several participants in the 7 August 2013 CoTCCC discomfort experienced by volunteer subjects at a pres- “Management of Junctional Hemorrhage in Tactical sure sufficient to cause cessation of flow was 7 (range Combat Casualty Care TCCC Guidelines–Proposed 3–10). This discomfort returned to 0 after the device Change 13-03” teleconference noted reliability issues in was removed.20 that the AAT was easily broken in their experience and use of the device during training. As the AAT is a truncal There is a recently published case report of AAT use by tourniquet by design, it directs pressure in a broad man- a deployed military physician who requested to remain ner over more than just a junctional area, and has a rela- anonymous for operational security reasons. The casu- tive contraindication for penetrating abdominal trauma. alty had bilateral traumatic amputations of his lower These characteristics must also be considered if procure- extremities. He was reported to be unresponsive with no ment of the current AAT device is done exclusively with carotid pulse at the time he was loaded onto the evacu- the intent for junctional hemorrhage control. ation helicopter. Combat Application Tourniquets were applied to both legs, but a pool of bright red blood was Since many of the casualties from Afghanistan have both noted on the stretcher between his legs. Treatment in- junctional bleeding and penetrating abdominal injuries, cluded: intraosseous access, rapid sequence intubation, the AAT would be contraindicated for these individu- blood transfusion, tranexamic acid, and calcium chlo- als. Both trauma surgeons and combat medics expressed ride. Despite the above, he continued to do poorly and concerns about recommending this truncal tourniquet as an AAT was applied. He also received 2 units of plasma a result of the short duration of application, the contra- and three of packed red blood cells prior to arrival at the indication in penetrating abdominal injury, the reliability 88 Journal of Special Operations Medicine Volume 13, Edition 4/Winter 2013 problems noted above, the discomfort produced by the A few comments about the Combat Ready Clamp were inflation of the device, and possible adverse effects on obtained from combat medics, corpsmen, and PJs dur- the casualty’s ventilation. ing the USCENTCOM-JTS review of prehospital care in Afghanistan conducted during November 2012 and are as follows7: CRoC The CRoC was found to be successful at controlling “209. Medics report that the Combat Ready hemorrhage in a perfused cadaver model when used Clamp (CRoC) is too bulky and heavy to carry for several different inguinal wound patterns: one on missions and takes too much time to assem- wound, two ipsilateral wounds with hemorrhage from ble and apply. (BAF Role I–1st Infantry Divi- one artery (common iliac artery), and bilateral inguinal sion, Shadow DUSTOFF; Role I–75th Ranger wounds (compression of the origins of bilateral com- Regiment) The optimal fielding of this device mon iliac arteries).15 might be in a pre-assembled configuration and carried on tactical vehicles and evacuation air- The CRoC was noted to be effective in both swine mod- craft. (CoTCCC Chairman)” els and perfused cadaver models of bleeding.23 “226. The CRoC may apply pressure too dis- tally for many casualties. There is interest in the The CRoC controlled bleeding from a 6-mm femoral ar- abdominal aortic tourniquet. The UK places teriotomy in a swine model of groin wounding. Hemor- more emphasis than the US on prehospital use rhage was controlled in all six animals in the study for 1 of pelvic binders in casualties with suspected hour. Removal of the clamp at 1 hour, however, resulted pelvic fractures (Bastion Role III–UK)” in rebleeding in five of six experiments, and all five of these animals exsanguinated during the second hour of “232. ...RECON corpsmen like the CRoC and observation despite continuous fluid resuscitation.16 carry it routinely; the CRoC is carried preas- sembled; the CRoC MUST be rechecked after CRoC preparation and application were noted to take application; 8404s do not carry the CRoC… 1–2 minutes (even with some pre-assembly), during (Bastion Role I–USMC/USN)” which time a casualty could lose a significant amount of blood from a junctional wound.16 A manikin study used the CRoC to control simulated junctional bleeding. The study found that the CRoC was An Afghani male was injured by an explosion in Kan- effective in this laboratory setting and that the surface dahar province in 2011. The casualty sustained a very the casualty rested on made some difference in CRoC proximal left lower extremity traumatic amputation, application. Six subjects were successful in all nine of too proximal for application of an extremity tourniquet. their iterations of CRoC use. The CRoC users were able When the evacuation helicopter arrived, the casualty to control the simulated bleeding in a mean time of less was alert and oriented, but in early hemorrhagic shock. than one minute.25 There was little active bleeding when the evacuation providers first evaluated the casualty. The bleeding from JETT his amputation site became more severe just as the evac- uation helicopter took off from the point of injury. The The JETT was found to be successful at controlling bi- medic on the evacuation aircraft applied direct pressure lateral lower extremity junctional hemorrhage in a per- on the wound, initially with a hand and then with his fused cadaver model.26 knee while preparing the CRoC for use. The CRoC was assembled and applied in approximately 90 seconds, There are two unpublished cases of successful JETT use in resulting in prompt and sustained hemorrhage control. civilian trauma patients with junctional hemorrhage (Dr The patient’s condition stabilized. When he reached the John Holcomb, personal communication, August 2013). Afghani hospital near Kandahar; however, he was tri- aged as expectant and the CRoC was removed. The ca- There was one use of the JETT in a U.S. military casu- sualty subsequently exsanguinated from his injuries.24 alty in whom junctional hemorrhage was reported to be controlled, but the casualty did not survive (Mr Ricardo There are other anecdotal reports of the CRoC being Flores, personal communication, August 2013). used successfully on combat casualties in Afghanistan and casualties in the United States, although no case re- Although the JETT is not currently FDA-cleared for treat- ports or case series have been formally published at the ment of pelvic fractures, current investigations support- time of this review, and none reported to the extent of ing such an indication are under way (Dr Keith Gates, the Tovmassian case. personal communication, August 2013). Unpublished Management of Junctional Hemorrhage in Tactical Combat Casualty Care 89 data from a recent study conducted by the University injuries, including bleeding from sites where tourniquets of Texas Health Science Center for Translational Injury could not be applied, such as junctional hemorrhage.29 Research and the Texas Trauma Institute show that the JETT device compresses pelvic fractures and has the The application of Combat Gauze with direct pressure potential to improve hemorrhage control from both on the bleeding site will help to minimize blood loss dur- junctional hemorrhage and pelvic fractures (Dr John ing assembly and application of junctional tourniquets Holcomb, personal communication, August 2013). and should be used for preliminary hemorrhage control. If other team members are available to help, they may be recruited to perform direct pressure while the medic SAM Junctional Tourniquet readies the junctional tourniquet. No case reports or case series were published at the time of this review. The SAM Junctional Tourniquet is “It is recommended that these junctional tourniquet de- also FDA cleared for the treatment of suspected pelvic vices be removed only when the option of immediate fractures. proximal surgical hemorrhage control is available. This may include endovascular control as well as external sur- The characteristics of the four junctional tourniquets gical vascular occlusion. Specific surgical technique for discussed above are summarized in Table 1. gaining control will depend on the device that has been placed, the supplies and resources immediately available, and the skills and capability of the operating surgeon.”8 Technique for Use of Junctional Tourniquet Combat Gauze is currently recommended by the CoTCCC Conclusions for external hemorrhage at a site not amenable to tourni- quet placement.27,28 There are now three junctional tourniquets and one trun- cal tourniquet (the AAT) cleared by the FDA for control Combat Gauze has been reported to be safe and effective of junctional hemorrhage. The junctional tourniquets in controlling external hemorrhage in complex combat are important new tools for combat medical personnel Table 1 Prehospital Tourniquets Cleared by FDA for Control of Junctional Hemorrhage Abdominal Aortic Junctional Emergency SAM Junctional Name Tourniquet Combat Ready Clamp Treatment Tool Tourniquet Nickname AAT CRoC JETT SJT Maker Compression Works Combat Medical Systems North American Rescue SAM Medical Products Products City, State Hoover, AL Fayetteville, NC Greer, SC Wilsonville, OR 510(k) Date(s) 10/18/11 8/11/10; 4/29/13 1/3/13 3/18/13; 7/24/13 FDA Number(s) K112384 K102025; K130482 K123194 K123694; K131561 NSN 6515-01-616-4999 6515-01-589-9135 6515-01-616-5841 6515-01-618-7475 Cost ($ USD, 572 512 225 279 est. USG) Weight (gm) 485 799 651 499 Cube (L) 1.4 0.8 1.6 1.5 Indication(s) Battlefield, difficult Battlefield, difficult Difficult inguinal Difficult inguinal inguinal bleeds and inguinal bleeds; bleeds and proximal bleeds; difficult axilla proximal extremity axilla and proximal extremity wounds where bleeds; pelvic fracture wounds where extremity wounds where tourniquets are not immobilization and tourniquets are tourniquets are not effective proximal extremity not effective effective wounds where tourniquets are not effective Contraindication(s) Pregnancy; N/A N/A N/A abdominal aortic aneurysm; penetrating abdominal trauma 90 Journal of Special Operations Medicine Volume 13, Edition 4/Winter 2013 to have available for use to control hemorrhage from Proposed New Wording in the TCCC Guidelines junctional areas. Tactical Field Care There is presently insufficient evidence to make a rec- 4b. Bleeding: If the bleeding site is appropriate for use of ommendation for which of the four currently cleared a junctional tourniquet, immediately apply a CoTCCC- devices is the optimal choice for junctional hemorrhage recommended junctional tourniquet. Do not delay in control. the application of the junctional tourniquet once it is ready for use. Combat Gauze applied with direct pres- Because of the relatively short maximum duration of sure should be used if a junctional tourniquet is not application (one hour) recommended for the AAT and available or while the junctional tourniquet is being the relative contraindication to using this device in pen- readied for use. etrating abdominal trauma (which is often present in conjunction with junctional hemorrhage), the AAT has Tactical Evacuation Care significant limitations that make it the device of last re- 3b. Bleeding: If the bleeding site is appropriate for use of sort among the four devices being considered for junc- a junctional tourniquet, immediately apply a CoTCCC- tional hemorrhage control. The AAT is a truncal rather recommended junctional tourniquet . Do not delay in the than a junctional tourniquet. application of the junctional tourniquet once it is ready for use. Combat Gauze applied with direct pressure The three CoTCCC-recommended junctional tourniquets should be used if a junctional tourniquet is not available are: or while the junctional tourniquet is being readied for use. 1. The Combat Ready Clamp Level of evidence: Class C30 2. The Junctional Emergency Treatment Tool 3. The SAM Junctional Tourniquet Vote: The proposed change noted above passed by the required 2/3 or greater majority of the CoTCCC voting The JETT and the SAM may also play an important role members. in stabilizing pelvic fractures, which are often seen in association with proximal lower extremity amputations Considerations for Performance and junctional hemorrhage. Improvement and Further Research Junctional hemorrhage control should be started with 1. Medical personnel who monitor performance im- Combat Gauze and direct pressure while the junctional provement or conduct research should gather and tourniquet is being prepared and applied. Note that if analyze data on junctional tourniquet use in the pre- junctional bleeding is controlled with Combat Gauze hospital environment in conjunction with morbidity and direct pressure alone, there may not be an immedi- and mortality outcomes for both military and civil- ate need for the junctional tourniquet. ian casualties. 2. Military medical personnel who conduct research, work at training centers, or work at centers for les- Proposed Change sons learned should gather and analyze feedback from combat medics, corpsmen, and PJs about their Current Wording in the TCCC Guidelines experiences with all of the FDA-cleared junctional tourniquets as well as the AAT. Tactical Field Care 4b. Bleeding: “If a lower extremity wound is not amenable Disclaimers to tourniquet application and cannot be controlled by he- mostatics/dressings, consider immediate application of me- The recommendation contained herein is the current po- chanical direct pressure including CoTCCC recommended sition of the Department of Defense Joint Trauma Sys- devices such as the Combat Ready Clamp (CRoC).” tem Committee on Tactical Combat Casualty Care. This recommendation is intended to be a guideline only and Tactical Evacuation Care is not a substitute for clinical judgment. 3b. Bleeding: “If a lower extremity wound is not amena- ble to tourniquet application and cannot be controlled This document was reviewed by the Director of the by hemostatics/dressings, consider immediate applica- Joint Trauma System, the Public Affairs Office, and the tion of mechanical direct pressure including CoTCCC Operational Security Office at the U.S. Army Institute recommended devices such as the Combat Ready Clamp of Surgical Research and approved for unlimited public (CRoC).” release as of 26 August 2013. Management of Junctional Hemorrhage in Tactical Combat Casualty Care 91 Disclosures junctional hemorrhage in swine. J Trauma Acute Care Surg. 2013;74:1260–1265. None of the authors have a financial interest in the 17. Food and Drug Administration, Department of Health products or companies discussed in this manuscript. and Human Services. US FDA 510(k) number: K131561; device name: SAM Junctional Tourniquet (SJT). Letter to SAM Medical Products dated 24 July 2013. References 18. Kragh JF Jr, Mann-Salinas EA, Kotwal RS, et al. Labora- 1. Eastridge BJ, Mabry R, Seguin P, et al. Death on the battle- tory assessment of out-of-hospital interventions to control field (2001–2011): implications for the future of combat junctional bleeding from the groin in a manikin model. casualty care. J Trauma Acute Care Surg. 2012;73:S431– Am J Emerg Med. 2013;31:1276–1278. S437. 19. Blaivas M, Shiver S, Lyon M, Adhikari S. Control of 2. Dickey NW, Jenkins DH. Combat Ready Clamp Addi- hem orrhage in critical femoral or inguinal penetrating tion to the Tactical Combat Casualty Care Guidelines wounds—an ultrasound evaluation. Prehosp Disaster Med. 2011–07. Defense Health Board memorandum, dated 23 2006;21:379–382. September 2011. 20. Lyon M, Shiver SA, Greenfield EM, et al. Use of a novel 3. Woodson J. Defense Health Board Recommendation, abdominal aortic tourniquet to reduce or eliminate flow in “Combat Ready Clamp (CRoC)—Addition to the Tacti- the common femoral artery in human subjects. J Trauma cal Combat Casualty Care Guidelines, 2011-07.” Assis- Acute Care Surg. 2012;73:S103–S105. tant Secretary of Defense for Health Affairs letter, dated 5 21. Anonymous. Abdominal Aortic Tourniquet use in Af- August 2013. ghanistan. J Spec Oper Med. 2013;13:1–2. 4. Andersen RC, Shawen SB, Kragh JF Jr, et al. Special top- 22. Croushorn J, McLester J, Thomas G, McCord SR. Case ics. J Am Acad Orthop Surg. 2012;20:S94–S98. Report: Abdominal Aortic Tourniquet use on upper junc- 5. Kotwal RS, Montgomery HR, Kotwal BM, et al. Elimi- tional hemorrhage resulting from a gunshot wound in- nating preventable death on the battlefield. Arch Surg. volving the axilla. J Spec Oper Med. 2013. 2011;146:1350–1358. 23. Dubick MA, Kragh JF Jr. Evaluations of the Combat 6. Caravalho J. Dismounted complex blast injury. Report of Ready Clamp to control bleeding in human cadavers, the Army Dismounted Complex Blast Injury Task Force, manikins, swine femoral artery model and swine car- dated 18 June 2011. casses. USAISR Institutional Report, U.S. Army Institute 7. Kotwal RS, Butler FK, Edgar EP, et al. Saving lives on of Surgical Research, Fort Sam Houston, Texas, dated the battlefield: a Joint Trauma System review of pre- June 2012. hospital trauma care in Combined Joint Operating Area– 24. Tovmassian RV, Kragh JF Jr, Dubick MA, et al. Combat Afghanistan (CJOA-A), dated 30 January 2013. Ready Clamp medic technique. J Spec Oper Med. 2012; 8. Joint Theater Trauma System Clinical Practice Guide- 12:72–78. line: External hemorrhage control devices. Joint Trauma 25. Mann-Salinas EA, Kragh JF Jr, Dubick MA, et al. Assess- System Clinical Practice Guidelines Website: http://usaisr ment of users to control simulated junctional hemorrhage .amedd.army.mil/clinical_practice_guidelines.html, pending with the Combat Ready Clamp (CRoC™). Int J Burns publication 2013. Trauma. 2013;3:49–54. Epub Jan 24 2013. 9. Kragh JF Jr, Murphy C, Dubick MA, et al. New tourni- 26. Gates KS, Baer L, Holcomb JB. Evaluation of a junctional quet device concepts for battlefield hemorrhage control. tourniquet designed for combat, a human tissue study. U.S. Army Med Dept J. 2011;Apr–Jun:38–48. Pending publication 2013. 10. U.S. Army Medical Research and Materiel Command Re- 27. Butler FK, Giebner SD, McSwain N, et al; National As- quest for Information on Junctional Hemorrhage Control sociation of Emergency Medical Technicians. Prehospital Devices, 2009. Trauma Life Support Manual, 7th Military Edition. St 11. U.S. Army Medical Research and Materiel Command Re- Louis, MO: Mosby; 2010. quest for Information on Junctional Hemorrhage Control 28. Butler FK, Blackbourne LH. Battlefield trauma care then Devices, 2012. and now: A decade of tactical combat casualty care. J 12. Taylor DM, Coleman M, Parker PJ. The evaluation of an Trauma Acute Care Surg. 2012;73:S395–S402. abdominal aortic tourniquet for the control of pelvic and 29. Ran Y, Hadad E, Daher S, et al. QuikClot Combat Gauze lower limb haemorrhage. Mil Med. 2013. In press. use for hemorrhage control in military trauma: January 13. Abdominal Aortic Tourniquet Package Insert. Retrieved 2009 Israel Defense Force experience in the Gaza Strip– 10 August 2013 from: http://www.speeroptech.com a preliminary report of 14 cases. Prehosp Disaster Med. /resources/AAT_Package_Insert1.pdf. 2010;25:584–588. 14. Food and Drug Administration, Department of Health 30. Tricoci P, Allen JM, Kramer JM, et al. Scientific evidence and Human Services. U.S. FDA 510(k) Number: K130482; underlying the ACC/AHA clinical practice guidelines. device name: Combat Ready Clamp (CRoC). Letter to JAMA. 2009;301:831–841. Combat Medical Systems dated 29 April 2013. 15. Kragh JF Jr, Murphy C, Steinbaugh J, et al. Prehospital emergency inguinal clamp controls hemorrhage in ca- daver model. Mil Med. 2013;78:799–805. COL Kotwal, MC, USA, is a family medicine and aerospace 16. Kheirabadi BS, Terrazas IB, Hanson MA, et al. In vivo medicine physician. He is a former Command Surgeon for assessment of the Combat Ready Clamp to control the 75th Ranger Regiment and a former Deputy Command 92 Journal of Special Operations Medicine Volume 13, Edition 4/Winter 2013 Surgeon for the U.S. Army Special Operations Command. He Dr. Dubick is a senior research pharmacologist at the U.S. is currently the director for Trauma Care Delivery at the Joint Army Institute of Surgical Research. He currently conducts Trauma System. combat casualty care research and is the program manager for Damage Control Resuscitation Research. CAPT Butler, MC, USN (ret), is an ophthalmologist and former Navy SEAL Platoon Commander. He was previously Col Rasmussen, MC, USAF, is a vascular surgeon. He was the U.S. Special Operations Command Surgeon and he is now previously the Deputy Commander for the U.S. Army Institute the chairman of the DoD Committee on Tactical Combat Ca- of Surgical Research and he is currently the deputy director sualty Care at the Joint Trauma System. for Combat Casualty Care Research program at the U.S. Army Medical Research and Materiel Command. COL Gross, MC, USA, is a trauma surgeon with prior expe- riences with the U.S. Special Operations Command and combat COL Weber, MC, USA, is a vascular surgeon with prior deployed forward surgical teams. He is currently the director experience with combat deployed forward surgical teams. He for Performance Improvement at the Joint Trauma System and is currently the Commander of the U.S. Army Institute of Sur- the Trauma Consultant to the Army Surgeon General. gical Research. Dr. Kheirabadi is a senior research physiologist at the U.S. Col Bailey, MC, USAF, is a trauma surgeon. He is currently Army Institute of Surgical Research. He currently conducts the director of the Joint Trauma System as well as the deployed combat casualty care research and is a subject matter expert in director for the CENTCOM Joint Theater Trauma System. hemorrhage control and hemostatic agents. Col Bailey was previously the head of the Air Force Center for Sustainment of Trauma and Readiness Skills at St. Louis Dr. Baer is a senior research physiologist and the current di- University Medical Center. rector of the Office of Research at the U.S. Army Institute of Surgical Research. He was previously the program manager for the Bone and Soft Tissue Trauma Research. PORTABLE RADIOGRAPHIC IMAGING SOLUTIONS From the most trusted name in portable x-ray imaging • Battlefi eld Proven • Digital Upgrade Kits Available for MinXray Units • Lightweight & Compact • DR and CR Systems • Reliable & Rugged MinXray_JSOM_HalfPg_2013Winter.indd 1 10/15/13 1:21 PM Management of Junctional Hemorrhage in Tactical Combat Casualty Care 93