Concept for standardized testing of tourniquets: Information & Discussion

1. Concept for standardized testing of tourniquets:Information & Discussion JF Kragh, MD USAISR

2. Tourniquet Work • Survival with emergency tourniquet use to stop bleeding in major limb trauma. Kragh JF Jr, Walters TJ, Baer DG, Fox CJ, Wade CE, Salinas J, Holcomb JB. Ann Surg. 249(1):1-7, 2009. • Battle casualty survival with emergency tourniquet use to stop limb bleeding. Kragh JF Jr, Littrel ML, Jones JA, Walters TJ, Baer DG, Wade CE, Holcomb JB. J Emerg Med. J Emerg Med. 41(6):590-597, 2011. • Practical use of emergency tourniquets to stop bleeding in major limb trauma. Kragh JF Jr, Walters TJ, Baer DG, Fox CJ, Wade CE, Salinas J, Holcomb JB. J Trauma. 64(2 Suppl):S38-49; discussion S49-50, 2008. • Damage control resuscitation for vascular surgery in a combat support hospital. Fox CJ, Gillespie DL, Cox ED, Kragh JF Jr, Mehta SG, Salinas J, Holcomb JB. J Trauma. 65(1):1-9, 2008. • Extended (16-hour) tourniquet application after combat wounds: a case report and review of the current literature. Kragh JF Jr, Baer DG, Walters TJ. J Orthop Trauma. 21(4):274-278, 2007.

3. More Tourniquet Work • Tourniquets, Kragh JF Jr. Chapter 14 in, Combat Orthopaedic Surgery: Lessons Learned in Iraq and Afghanistan. Owens BD, Belmont PJ Jr, editors. SLACK, Thorofare, NJ. 2011. • Popliteal artery repair in massively transfused military trauma casualties: a pursuit to save life and limb. Fox CJ, Perkins JG, Kragh JF Jr, Singh NN, Patel B, Ficke JR. J Trauma. 2010 Jul;69 Suppl 1:S123-134. • Use of tourniquets and their effects on limb function in the modern combat environment. Kragh JF Jr. Foot Ankle Clinics N Am 15:23-40, 2010. • Effect of recombinant factor VIIa as an adjunctive therapy in damage control for wartime vascular injuries: a case control study. Fox CJ, Mehta SG, Cox ED, Kragh JF Jr, Salinas J, Holcomb JB.J Trauma. 66(4S):S112-119, 2009. • Influence of fiber-type composition on recovery from tourniquet-induced skeletal muscle ischemia-reperfusion injury. Walters TJ, Kragh JF, Baer DG. ApplPhysiol. 33(2):272-281, 2008. • The combined influence of hemorrhage and tourniquet application on the recovery of muscle function in rats. Walters TJ. Kragh JF. Kauvar DS. Baer DG. J Orthop Trauma. 22(1):47-51, 2008. • The effectiveness of a damage control resuscitation strategy for vascular injury in a combat support hospital. Fox CJ, Gillespie DL, Cox ED, Mehta SG, Kragh JF Jr, Salinas J, Holcomb JB. J Trauma. 64(2S):99-106, 2008.

4. Recent Tourniquet Work • Tourniquets exposed to the Afghanistan combat environment have decreased efficacy and increased breakage compared to unexposed tourniquets. Childers R, Tolentino JC, Leasiolagi J, Wiley N, Liebhardt D, Barbabella S, Kragh JF Jr. Mil Med.176(12):1400-1403, 2011. • The Military Emergency Tourniquet Program’s lessons learned with devices and designs. Kragh JF Jr, O’Neill ML, Walters TJ, Dubick MA, Baer DG, Wade CE, Holcomb JB, Blackbourne LB. Mil Med. 176(10):1144-1152, 2011. • Minor morbidity with emergency tourniquet use to stop bleeding in severe limb trauma: research, history, and reconciling advocates and abolitionists. Kragh JF, O'Neill ML, Walters TJ, Jones JA, Baer DG, Gershman LK, Wade CE, Holcomb JB. Mil Med. 176(7):817-823, 2011. • Historical review of emergency tourniquet use to stop bleeding. Kragh JF Jr, Swan KG, Smith DC, Mabry RL, Blackbourne LH. Am J Surg. 203(2):242-252, 2012. • New tourniquet device concepts for battlefield hemorrhage control. Kragh JF Jr, Murphy C, Dubick MA, Baer DG, Johnson J, Blackbourne LH. US Army Med Dep J. 38-48. Apr-Jun 2011. • Fasciotomy rates in Operations Enduring Freedom and Iraqi Freedom: association with injury severity and tourniquet use. Kragh JF Jr, Wade CE, Baer DG, Jones JA, Walters TJ, Hsu JR, Wenke JC, Blackbourne LH, Holcomb JB. J Orthop Trauma. 25(3):134-139, 2011. • Survey of the indications for use of emergency tourniquets. Kragh JF, O’Neill ML, Beebe DF, Fox CJ, Beekley AC, Cain JS, Parsons DL, Mabry RL, Blackbourne LH. J Spec Oper Med. 11(1):30-38, Winter 2011.

5. Assessment of Tourniquets • Why do we need to test tourniquets? • What is the potential gain for which we aim?(survival change, effectiveness, safety) • What is a relevant referent? (clinical, lab) • What is the setting(s) of interest? (lay, medic, clinic) • What is the minimum significant difference? • What are the parameters to test? • At what cost do we proceed? (funds, priority) • Who does it, when, order, instead of else?

6. Tourniquets to Consider • High • CAT (Combat Application Tourniquet) • SOFFT W (Special Operations Forces Tactical Tourniquet Wide) • EMT (Emergency & Military Tourniquet) • RMT CBT (Ratcheting Military Tourniquet Combat) • RMT TAC (Ratcheting Military Tourniquet Tactical) • MET (Military Emergency Tourniquet) • Low • SWAT-T (Special Weapons & Tactics Tourniquet) • LBT (London Bridge Tourniquet) • Tiger Tourniquet • NATO (North Atlantic Treaty Organization) Tourniquet • MAT (Mechanical Advantage Tourniquet) • Others • SATS, Flow stopper, Hemodyne, LRT, McMillan, QT, Q, TIAX, TK4

7. Concepts for Future Testing • Setting-based tests (Medic, ER, vs. lay) • Field vs. Laboratory tests • User test vs. Researcher test • Clinical assessment vs. Research • Consumer Report vs. Ivory Tower Say So • Junctional device test vs. regular device test • Model development (manikin, carcass, pig) • Maneuver test (manual compression, knee)

8. Information on non-limb tourniquets/clamps • CRoC (Combat Ready Clamp) FDA 11AUG10 • AAT (Abdominal Aortic Tourniquet) FDA 17OCT11 • Prototypes include NARP, SAM • Data: FDA file, cadaver, animal, manikin, human, JTTR • Problem: ‘TRL5’ to ‘TRL off the chart’ overnight • Although aware, most were unready to act on approval • CoTCCC approved 355 days later; DCDD waits • Therefore they buy time by asking for more data (time)