Thrombin Formation for Children on Lovenox. Steven Ignell, BA

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1 Thrombin Formation for Children on Lovenox Steven Ignell, BA

2 Definitions Anticoagulation Historically this refers to inhibiting thrombin formation Measured by PTT, INR, anti-xa Hypo and hypercoagulation Relates to overall hemostatic capacity Reflect increased risk of bleeding or risk of thrombosis Can be measured with global functional measures of hemostasis such as TEG/ROTEM

3 The Hemostatic Process: Interaction between Platelets Coagulation factors Fibrinolytic pathway Vascular endothelium Subendothelium Inflammatory cells and mediators

4 Anti-coagulation Goals Hypercoaglable Normocoagulable Hypocoagulable

5 Anticoagulation Goals Anticoagulation hypocoagulable Goal of anticoagulation is to prevent thrombosis by reducing thrombin formation What is optimal method to monitor therapeutics that reduce thrombin formation?

6 Measures of Hemostasis Anti-Xa levels reflect the degree of enoxaparin inhibition on Xa (direct measure of drug effect) Does not reflect actual amount of thrombin formation Inhibition of Xa is not analyzed in relation to: Baseline thrombin formation or platelet function Does not reflect global hemostatic capacity Car speed analogy

7 Measures of Hemostasis Current guidelines for anti-xa deep vein thrombosis treatment levels are 0.5 units/ml May over or under treat based upon baseline thrombin formation or platelet function

8 Measures of Hemostasis Thromboelastography (TEG) provides a global functional analysis of each hemostasis phase

9 TEG-directed Anticoagulation Unknown what goals should be No trials performed to determine Indication for use of anticoagulation Therapeutic goals for anticoagulation Makes implementation difficult. For the record no such trials for anti-xa approach either. Anti-Xa goal range, extrapolated from heparin values and PTT data in adults.

10 Direct Measures of Thrombin Formation Thrombin-antithrombin complexes Prothrombin Fragments 1&2 Thrombin generation assay Thrombinoscope

11 Study Objectives To determine if there is a correlation between anti- Xa and TEG parameters for children on enoxaparin. Hypothesize that there will be discordance between anti-xa and TEG values

12 Study Objectives To determine if anti-xa or TEG parameters correlate with measures of thrombin formation (PF1&2, TAT, TG). Hypothesize that TEG-R values correlate with measures of thrombin formation better than anti-xa values.

13 Study Objectives This preliminary data will support funding for multicenter trials to determine what values are associated with adverse events to then set up therapeutic trials of anti-xa vs TEG directed anticoagulation

14 Methods For children on enoxaparin in the PICU/CICU TEG and Anti-Xa labs were drawn simultaneously at at time when anti-xa was being drawn clinically Extra plasma can be held for PF1&2, TAT and thrombin generation testing. Exclusion Criteria Weight 3kg Unable to perform TEG testing due to device availability

15 Discordance between hemostatic parameters TEG R-Time<5 minutes and Anti-Xa 0.5 units/ml Direct discordance between measures of thrombin formation TEG G-Value>11 dynes/s 2 and Anti-Xa 0.5 units/ml Measure of reduced thrombin but still increased platelet function Still at risk of thrombotic event theoretically

16 Results 28 children were enrolled with evaluable data 23 children also had Heparinase TEG values

17 Table 1: Patient Population Table 1a N Lovenox Age (years) (0.43,15.05) Weight (kg) (5.1,56.93) Weight for age (%) (4.48,64.65) Male % (13) Hispanic % (1) Race % White (20), 17.9% Black (5), 10.7% Asian (3) Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N)

18 Table 1 Table 1b N Lovenox Chronic Cardiac disease % (14) Chronic Heme/Onc Disease % (6) Chronic Neuro Disease % (5) Chronic Pulmonary Disease % (11) Chronic Other Disease % (6) Lovenox for Prophylaxis % (14) Surgery in Past 12 Weeks % (15) Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N)

19 Table 1 Table 1c N Lovenox PELOD at Admission (10,12) PELOD Day of Blood Draw (1,11) PIM- 2 at Admission (- 4.37,- 2.91) PRISM at Admission 28 7 (3,9) Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N)

20 Table 1 Table 1d N Lovenox WBC (k/cumm) ±4.38 Hgb (g/dl) ±2.00 Hct (%) ±6.46 Plt (k/cumm) (158.5,315.5) RDW (%) ±1.82 AnZ- Xa (units/ml) ±0.27 Enoxaparin Dose (mg/kg) ±0.46 Time on Current Enoxaparin Dose at Blood Draw (Hrs) (16,107.25) Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N)

21 Outcomes Outcomes N Lovenox In- hospital Mortality % (6/28) ICU Days (15,36.75) Intubated Vent Days (5,28) Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N)

22 Results 35.7% (10/28) of children had discordant results 5 children were discordant based on R-time 8 children were discordant based on G-value 3 children discordant with both R-time and G-value

23 Scatter of R-Time 1.20 B 1.00 B 0.80 Anti-Xa (units/ml) T B B B B Discordance T=Thrombotic Event B=Bleeding Event Kaolin TEG R-Time (s)

24 Scatter of TEG G-Value 1.20 B 1.00 B 0.80 Anti-Xa (Units/mL) B B B B T Discordance T=Thrombotic Event B=Bleeding Event Kaolin TEG G-Value (Dynes/s^2)

25 R-Time Regression R 2 Linear=0.135

26 Results Table 2a Concordant N=18 Discordant N=10 p value Age (years) 0.95 (0.35,13.9) (0.55,15.88) Weight (kg) 9.25 (4.43,53.28) (5.93,57.25) Weight for age (%) 12.7 (3.68,95.8) (8.73,61.68) Male 44.4% (8) 50.0% (5) 1 Hispanic 5.6% (1) 0.0% (0) 1 Race 72.2% White, 22.2% Black, 5.6% Asian 70.0% White, 10.0% Black, 20.0% Asian Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N) 0.408

27 Results Table 2b Concordant N=18 Discordant N=10 p value Chronic Caridac disease 55.6% (10) 40.0% (4) Chronic Heme/Onc Disease 22.2% (4) 20.0% (2) 1 Chronic Neuro Disease 27.8% (5) 0.0% (0) Chronic Pulmonary Disease 50.0% (9) 20% (2) Chronic Other Disease 16.7% (3) 30% (3) ProphylacZc IndicaZon for AnZcoags 61.1% (11) 30% (3) Past Surgical History in 12 Weeks 44.4% (8) 70.0% (7) 0.254

28 Results Table 2c Concordant N=18 Discordant N=10 p value WBC (k/cumm) 9.25 (5.57,12) (9.35,14.03) Hgb (g/dl) 9.79±2.06 (14) 10.53±1.93 (7) Hct (%) 30.67±6.63 (14) 31.91±6.52 (7) Plt (k/cumm) 229 (130.5,293.5) 301 (199,395) RDW (%) 16.31±1.61 (18) 14.26±1.43 (10) Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N)

29 Results Table 2d PELOD at Admission PELOD Study Day Started PIM- 2 at Admission PRISM at Admission Concordant N=18 Discordant N=10 p value 11 (10,12) 10.5 (1,12) (1,11) 5.5 (0.25,10.75) (- 4.36,- 3.01) (- 4.63,- 2.44) (2.75,8.25) 7.5 (6,12.25) Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N)

30 Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N) Results Table 2e Concordant N=18 Discordant N=10 p value AnZ- Xa 0.56±0.29 (16) 0.72±0.2 (10) Enoxaparin Dose (mg/kg) 1.02±0.54 (18) 1.1±0.26 (10) Time at current anzcoag dose (hrs) 28 (16,137.5) (15.63,93.75) Heparin_Effect 1.3 (0.2,4.85) 0.3 (0.1,0.5) Kaolin TEG G- value 6.9 (4.68,9.97) (11.38,19.48) Kaolin TEG MA 58.7 (50.7,66.85) (69.45,79.55) Kaolin TEG R- Time 7.65 (5.78,14.45) 4.95 (4.5,6.08) Kaolin TEG Angle 63.3 (51.25,69.85) 72.4 (70.25,75.5) Kaolin TEG Delta R 0.65 (0.5,1.4) 0.5 (0.4,0.65) Kaolin TEG K 1.95 (1.28,3.2) 1.2 (1,1.38) 0.01 Kaolin TEG Ly% (0,0.4) 0 (0,1.2) 1

31 Outcomes Concordant N=18 Discordant N=10 p value In- hospital Mortality 27.8% (5) 10% (1) ICU Days 21.5 (17.25,42.5) 23.5 (10.5,45) Intubated Vent 17 (8.5,33) 6.5 (0.75,21.5) Days Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N)

32 Correlations Pearson r P value RDW vs AnZ- Xa RDW vs Kaolin TEG R- Time RDW vs Kaolin TEG G- Value

33 Limitations Small Sample Sizes Enrolling more patients to increase the sample size NEED ADDITIONAL CENTERS We can provide TEG reagents and send us plasma for thrombin measure testing. Just need you to draw blood at same time as anti-xa values and run a TEG

34 Conclusions There is a high rate of discordance between TEG parameters and anti-xa levels, indicating some patients remain hypercoagulable (increased thrombin generation and increased platelet function) despite anti-xa values.5 units/ml

35 Conclusions Cont d Decreased RDW is associated with increased measures of thrombin generation and platelet function Unknown significance or pathophysiology Larger multicenter studies are needed to assess if TEG directed Lovenox administration is more effective than an anti-xa guided approach

36 Questions?

37 Delta R Regression R 2 Linear=0.112

38 Complications 6 Children had bleeding events after the start of Lovenox 1 patient had a thrombotic event after the start of Lovenox No Complica8ons N= 21 Bleeding N=6 No Complica8ons vs Bleeding AnZ- Xa 0.62±.27 (19) 0.68±.29 (6) Kaolin TEG R- Time Kaolin TEG G- value Kaolin TEG Delta R In- Hospital Mortality ICU Days 6.9 (5,9.85) 8.3 (6.55,12.55) 6.45 (5.5.3,24.08) (3.6,17.88) (.5,1) 0.7 (.45,2.9) % (3) 50.0% (3) (16,35) 35.5 (14.75,124.25) Vent Days 13 (2.5,20.5) 28 (8.25,104.5) Results presented as Median (IQR), Mean±Standard Devia8on (N), or Percent (N)

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