Junctional Tourniquet

1. Junctional Tourniquet MSG Montgomery 02 August 2011

2. Term: Junctional* • Term used to include: • Groin proximal to inguinal ligament • Buttocks • Gluteal and pelvic areas • Perineum • Axilla and shoulder girdle • Base of Neck *terminology as established by Kraugh/Walters/Baer. Et al, J Trauma 2008 / Ann Surg 2009

3. Hemorrhage- A Look Back: Mogadishu, 1993 • CPL Jamie Smith injury – exsanguination from groin injury too proximal for a tourniquet. • An injury pattern we have since been attempting to solve for TCCC

4. Recent Injury Examples -excerpt of a health care record of a case submitted by COL Kragh

5. Preventable Death “With the success of regular tourniquets in the current war, isolated limb exsanguination is no longer the most common cause of death on the battlefield; hemorrhage amenable to truncal tourniquets now is most common.” -Kraugh/Walters/Baer. Et al J Trauma 2008 / Ann Surg 2009

6. Preventable Death “In 6 months there were over 1000 IEDs found in the Sangin area by 3/5 Marines. Additionally, 3/5 Marines suffered over 200 casualties and 29 KIA in the same time. Many of these Marines had severe amputations that may have benefitted from proximal hemorrhage control. ” Keith S. Gates, M.D. LT (FMF/DV/FPJ), MC, USNR Assistant Battalion Surgeon 1/23 Marines (FWD) FOB Delaram, Afghanistan

7. Preventable Death “Groin Hemorrhage is the most common type of junctional bleeding where regular tourniquets cannot work.” -Kelly JF, et al. J Trauma. 2008; 64(suppl 2)

8. Requirement • USAMRMC posted request for information for device ideas that could potentially stop bleeding at compressible sites where regular tourniquets cannot be applied. • W81XWH-RFI-003, 03 MAR 2009 • Will be able to occlude deep bleeding from intracavitary hemorrhage, including parenchymal injuries. As a minimum, the device should stop bleeding at compressible sites where standard tourniquets cannot be applied; • Can be applied easily in a tactical environment with a minimum level of familiarization; • Must not slip during tightening or following application; • Be capable of easy release and re-application; • Be of light weight; • Have long shelf life, low cost and low cube.

9. Junctional Hemorrhage Control Devices FemoStop -developed by St Jude Medical Circa: 1990s Lister Abdominal Tourniquet -developed by Dr Joseph Lister Circa: American Civil War

10. Key Premise If we are going to ask a medic or corpsman to perform a medical intervention on the battlefield, we want to be very confident that it will benefit the casualty. Anything we ask a medic or corpsman to perform must be have a training and equipping solution that is relatively easy to implement.

11. Combat Ready Clamp

13. FDA Approved • Indication: Difficult inguinal bleeds on the battlefield

14. Specifications Unit Weight: 1.5lbs Unit Dimensions stored: 3.5"H x 11.5"W x 1.5" D Unit Cube stored: .035 FDA 510(k) Approved Trade Compliant Made in USA • Vendor: Combat Medical Systems NSN: 6515-01-589-9135 Cost: $445.00 Each

15. Manufacturer’s Guidelines DETERMINING IF A CLAMP IS NEEDED. A Combat Ready Clamp (CRoC™) is placed in the inguinal area to stop circulation to the pelvic and femoral region when a casualty is in danger of bleeding to death from wounds that cannot be controlled by traditional bandages or tourniquets. A clamp is only used when a casualty is in danger of bleeding to death from an inguinal wound. Use of prior devices does not preclude clamp use. WARNING: This device is not to be used for wounds to the head, neck, abdomen and chest.

16. FDA Approved Target Application Points • INGUINAL: Direct pressure over packed inguinal injury site. • PELVIC: Pressure point midway between anterior superior iliac spine and pubic tubercle (occludes external iliac artery). • Recommend using pubic symphysis instead of tubercle.

17. Unapproved Target Application Points • ABDOMINAL: Pressure point at or just below umbilicus (occludes both internal and external iliac arteries bilaterally) • AXILLARY: Concept pending

18. Testing Conducted • Massive bleeding (perfused) models in fresh human cadavers at Wake Forest University School of Medicine • Publication Pending: Emergency Inguinal Clamp Controls Prehospital Hemorrhage in Cadaver Model, Kragh, et al

19. Proposed Testing • Effectiveness of a junctional hemorrhage control device as applied by military personnel trained in a combat zone. • Principal Investigators: • LT Keith S. Gates, MD, USNR • Col Edward L. Fieg, MD, USAF • A prospective, randomized, crossover, observational study of the application of device in a controlled setting. • Each individual will apply device on 5 male test subjects. Blood flow evaluated by color doppler ultrasound and palpable pulses.

20. Human Use • 1 reported use on an EPW with no follow-on survival or outcome data.

21. Equipping & Carrying • Medic/Corpsman carried device • Aidbag-based • Partially broken-down • 1.5 lbs

22. Training Methods • Troop on Troop procedural muscle memory • Bleeding Simulator • Perfused Cadaver • NOT amendable to traditional LTT

23. Procedure per Manufacturer 1. Remove CRoC™ from pouch. 2. Assemble CRoC™ (as shown in Figure 3). a. Rotate vertical arm up from base plate. b. Lift the horizontal arm locking pin and insert horizontal arm. c. Insert T-handle into horizontal arm head and rotate clock wise until seated. d. Attach the pressure disc head to T-handle. e. Depress the vertical arm locking pin and extend the vertical arm to desired height (Note this will be depend on patient girth).

24. Procedure cont’ This method is used to apply pressure to control hemorrhage directly over inguinal area that is not being controlled by traditional methods. a. Position the base plate under the patient beneath the desired pressure point. Ensure the vertical arm is in contact with thpatient on wounded side in close proximity to wound location. b. Adjust the horizontal arm to position the disc head over the desired pressure point. (The horizontal arm is adjusted by lifting the horizontal arm locking pin and sliding the arm to desired position then reengage pin.) C . Adjust the vertical arm downward to ensure the disc head contacts the patient. (The vertical arm is adjusted by depressing the vertical locking pin and adjusting the arm downward and reengaging pin.) d. Apply pressure by turning the T-handle clockwise until the bleeding stops. e. Attach securing strap. Write the time of application on the label. Reasses patient as needed.

25. Procedure cont’ Positioning of Casualty on a litter with CRoC™ applied. Care should be taken when moving the casualty in a tactical environment in order to avoid loosening or displacement of disc head from the desired pressure point. The CRoC™ should be reassessed after each patient movement. a. Role the patient onto the unaffected side. b. Position the litter beside the patient. c. Roll patient onto litter. d. Patient should be transported on unaffected side or place padding beside the clamp to create a gap between clamp and litter. e. Reassess the patient.

27. Issues • Stabilization during transport • Device Impact with Pelvic Fracture • Clinical decision-making on the right time and place to apply device • NOT exclusive to this device!!!! • Applies to virtually ALL TCCC concepts.

28. Current Fielding & Use • SOF • US Army SMU • 75th Ranger Regiment • US Navy SMU • Houston Memorial Hospital LifeFlight

29. Bleeding Control Tactical Field Care - Current 4. Bleeding a. Assess for unrecognized hemorrhage and control all sources of bleeding. If not already done, use a CoTCCC-recommended tourniquet to control life-threatening external hemorrhage that is anatomically amenable to tourniquet application or for any traumatic amputation. Apply directly to the skin 2-3 inches above wound. b. For compressible hemorrhage not amenable to tourniquet use or as an adjunct to tourniquet removal (if evacuation time is anticipated to be longer than two hours), use Combat Gauze as the hemostatic agent of choice. Combat Gauze should be applied with at least 3 minutes of direct pressure. Before releasing any tourniquet on a casualty who has been resuscitated for hemorrhagic shock, ensure a positive response to resuscitation efforts (i.e., a peripheral pulse normal in character and normal mentation if there is no traumatic brain injury (TBI). c. Reassess prior tourniquet application. Expose wound and determine if tourniquet is needed. If so, move tourniquet from over uniform and

30. Bleeding Control Tactical Field Care - Proposed 4. Bleeding a. Assess for unrecognized hemorrhage and control all sources of bleeding. If not already done, use a CoTCCC-recommended tourniquet to control life-threatening external hemorrhage that is anatomically amenable to tourniquet application or for any traumatic amputation. Apply directly to the skin 2-3 inches above wound. b. For compressible hemorrhage not amenable to tourniquet use or as an adjunct to tourniquet removal (if evacuation time is anticipated to be longer than two hours), use Combat Gauze as the hemostatic agent of choice. Combat Gauze should be applied with at least 3 minutes of direct pressure. Before releasing any tourniquet on a casualty who has been resuscitated for hemorrhagic shock, ensure a positive response to resuscitation efforts (i.e., a peripheral pulse normal in character and normal mentation if there is no traumatic brain injury (TBI). If inguinal wound location is not amendable to tourniquet application and cannot be controlled by hemostatics / dressings, consider immediate application of Combat Ready Tourniquet (CRoC). Apply CRoC either utilizing direct pressure on the dressing packed wound site or proximally at pressure point midway between anterior superior iliac spine and pubic symphysis (occluding external iliac artery).

31. Bleeding Control Tactical Evac Care - Proposed 3. Bleeding a. Assess for unrecognized hemorrhage and control all sources of bleeding. If not already done, use a CoTCCC-recommended tourniquet to control life-threatening external hemorrhage that is anatomically amenable to tourniquet application or for any traumatic amputation. Apply directly to the skin 2-3 inches above wound. b. For compressible hemorrhage not amenable to tourniquet use or as an adjunct to tourniquet removal (if evacuation time is anticipated to be longer than two hours), use Combat Gauze as the hemostatic agent of choice. Combat Gauze should be applied with at least 3 minutes of direct pressure. Before releasing any tourniquet on a casualty who has been resuscitated for hemorrhagic shock, ensure a positive response to resuscitation efforts (i.e., a peripheral pulse normal in character and normal mentation if there is no traumatic brain injury (TBI). If inguinal wound location is not amendable to tourniquet application and cannot be controlled by hemostatics / dressings, consider immediate application of Combat Ready Tourniquet (CRoC). Apply CRoC either utilizing direct pressure on the dressing packed wound site or proximally at pressure point midway between anterior superior iliac spine and pubic symphysis (occluding external iliac artery).

32. Questions? 32