Plumbing 101:! TXA and EMS! Jay H. Reich, MD FACEP! EMS Medical Director! City of Kansas City, Missouri/Kansas City Fire Department!

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1 Plumbing 101:! TXA and EMS! Jay H. Reich, MD FACEP! EMS Medical Director! City of Kansas City, Missouri/Kansas City Fire Department! EMS Section Chief! Department of Emergency Medicine! University of Missouri-Kansas City School of Medicine!

2 No financial disclosures! No product endorsements!

3 City of Kansas City! Area: 320 sq. miles! Population: 470,000 (2,000,000 in metro area)! 125,000 runs/year! 75,000 transports! 5-10 min. Average Transport Time to a Trauma Center!

4

5

6 Clotting!

7 Acute Coagulopathy of Trauma!

8 Acute Coagulopathy of Trauma! Tissue injury shuts down fibrinolysis! Shock promotes fibrinolysis!

9 Acute Coagulopathy of Trauma! Risk of death in trauma correlates with fibrinolysis! Severe Trauma + Hyperfibrinolysis = High Mortality (70-100%)!

10

11 What is TXA?! Synthetic derivative of the amino acid Lysine! Antifibrinolytic! Anti Clot buster! Clot stabilizer (inhibits clot breakdown)! Anti-inflammatory modulator?!

12 TXA!

13 TXA! Written about 40+ years ago! Used in cardiovascular surgery, uterine bleeding, hemophilia for more than 20 years! Seizures s/p CABG (binds GABA receptor)! Acute Kidney Injury!

14 TXA! Rediscovered for use by Trauma and EMS! IO! Tourniquets!

15

16 CRASH-2! Clinical Randomization of an Antifibrinolytic! in Significant Hemorrhage! Lancet Jul 3;376(9734):23-32!

17 CRASH-2: Study Design! Prospective civilian trauma patients! Randomized, placebo-controlled trial! 274 hospitals in 40 countries! 20,211 adult trauma patients! With significant bleeding or risk of significant bleeding! HR >110, SBP <90 mmhg, clinical judgment! Treatment within 8 hours of injury! TXA or placebo!

18 CRASH-2: Outcome Measures! Death in hospital within 4 weeks of injury! Bleeding! Vascular occlusion (MI, stroke, PE)! Multi-organ failure! Head injury! Other! Vascular occlusive events! Need for blood transfusion/surgery!

19 CRASH-2: Results! All cause mortality (TXA)! 14.5% vs. 16.0% (approx. 10% reduction)! 95% CI ! p = ! Death due to bleeding (TXA)! 4.9% vs. 5.7% (approx. 15% reduction)! 95% CI ! p = !

20 CRASH-2: Results! Number Needed to Treat = 67 patients!

21 CRASH-2: Results! What about harm?! No difference in rate of MI/Stroke/DVT/PE! 1.7% vs. 2.0% (168 vs. 201)! p = 0.084!

22 CRASH-2: Conclusions! Didn't reduce the need for blood transfusion! Didn't reduce the need for surgery! Did increase overall survival!

23 CRASH-2: Subgroup Analysis! Early vs. Late Administration! < 1 hr, 1-3 hrs, >3 hrs from injury! <1 hr associated with greatest reduction in death by hemorrhage! >3 hrs associated with increased risk of death by hemorrhage!

24 MATTERS! Military Application of Tranexamic Acid in Trauma Emergency Resuscitation Study! Arch Surg Feb;147(2):113-9.!

25 MATTERS: Study Design! Retrospective review of combat casualties! British physicians in Afghanistan! TXA vs. No TXA! Receiving 1+ units of PRBC s! Subgroup receiving a massive transfusion! 10+ units! 896 consecutive admissions of which 293 received TXA!

26 MATTERS: Outcome Measures! Characterize TXA use in combat injury care! Effect of TXA on:! Total blood product use! Thromboembolic complications! Mortality (24 hr, 48 hr, 30 days)!

27 MATTERS: Results! TXA lower mortality - overall! 17.4% vs 23.9% (p = 0.03)! Mean ISS higher in TXA group! TXA lower mortality massive transfusion! 14.4% vs. 28.1% (p = 0.004)!

28 MATTERS: Results! Number Needed to Treat=7 patients!

29 MATTERS: Results! What about harm?! DVT Overall! TXA 7 (2.4%) v no TXA 1 (0.2%)! p=.001! DVT Massive Transfusion! TXA 2 (1.6%) v no TXA 1 (0.5%)! no sig difference!

30 MATTERS: Results! What about harm?! PE Overall! TXA 8 (2.7%) vs. no TXA 2 (0.3%)! p =.001! PE Massive Transfusion! TXA 4 (3.2%) vs. no TXA 0 (0.0%)! p=.01!

31 MATTERS: Results! What about harm?! After correcting for severity if injury, there was no association of TXA with an increased risk of DVT or PE!

32 MATTERS: Limitations! TXA Group had a higher injury burden! More thrombotic events?! Military theater! More penetrating and orthopedic trauma! Does better survival allow more time for DVT/PE to be diagnosed?! DVT/PE clinical significance! Retrospective design! Screening/diagnostic approach!

33 MATTERS: Conclusions! Survival benefit to any patient getting blood! Massive transfusion (10+ units PRBC)! Receiving TXA independent predictor of survival! Most benefit shown at 48+ hrs! Can t solely be clot function! Anti-inflammatory component?! The earlier the better... first hour post trauma!!

34 Other Studies! Do all trauma patients benefit from Tranexamic acid?! Journal of Trauma and Acute Care Surgery! 2014 Jun 76(6):1373-8! For the highest injury acuity patients, TXA was associated with increased, rather than reduced, mortality, no matter what time it was administered. This lack of benefit can probably be attributed to the rapid availability of fluids and emergency OR at this trauma center.!

35 Other Studies in Progress! Univ. Texas-Houston! No survival benefit?! US Army! No benefit, increased risk of PE?! Mayo Clinic! No benefit, increased risk of PE?!

36 Who should get?! Selective use! Right patient, right time!

37 Who should get?! Serious trauma! Not isolated head injury! Likely to need massive transfusion! i.e. signs of ongoing bleeding! Sustained tachycardia! HR >110! Sustained hypotension! SBP < 90 mm Hg!

38 How do we give it?! First Dose! 1 gram in 100 ml of Normal Saline over 10 mins! First dose must be within 3 hours of injury! Best within 1 hour of injury! Second dose! 1 gram over 8 hours IVPB!

39 Cost Factor! Military $1.50 a dose! $10 - $100 per life saved! Civilian $55 a dose! $385 $3,685 per life saved!

40 Cost Factor Considerations! Kansas City! $55 per dose x 500 critical traumas per year = $27,500! 55 units x 3 doses x $55 = $9,075!

41 Transport Time Considerations! Kansas City! 5-10 min. average transport time to Level 1 Trauma Center! Is it going to be a treatment priority in Kansas City? Not yet! For other systems with longer transport times, it might be!

42 Final Thoughts! Currently, no EMS answer for all bleeding! Should EMS administer TXA?! Good clinical benefit shown in evidence based medicine! Good safety profile! Limited vaso-occlusive events! Must administer early. Within 3 hrs of injury, ideally < 1 hr! Does it fit in operational/fiscal realities?! Discussion with trauma surgeons essential!

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