Disclosures. Thromboelastography. TEG Methodology. TEG Output. Thromboelastography (TEG): Basics & Clinical Applications
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1 Thromboelastography (TEG): Basics & Clinical Applications Paula J. Santrach MD Associate Professor, Laboratory Medicine Mayo Clinic Rochester, MN Disclosures Relevant financial relationships NONE Off label usage ROTEM device not FDA cleared for clinical use Thromboelastography Known as viscoelastic tests of clot formation Physical properties of in vitro clot formation Time to onset Kinetics Strength Dissolution Contribution of various components of the coagulation system Factors / fibrinogen Platelets Fibrinolysis Anticoagulants Viscoelastic Tests of Clot Formation Thromboelastograph (TEG) Haemoscope ( ROTEM Pentapharm ( Not FDA cleared for clinical use in the US clearance currently being sought Sonoclot Sienco ( TEG Methodology TEG Output Vibration sensitive 1
2 ROTEM Methodology ROTEM Output Vibration insensitive Sonoclot Methodology Sonoclot Output Sample Types Reagent Types Fresh whole blood Citrated blood No additives (native) Activators Celite, kaolin, tissue factor Heparinase Platelet inhibitors Cytochalasin D, abciximab Aprotinin Impact of Reagent Types Anesth Analg 90:1324,
3 ROTEM Basic Tests ROTEM Basic Tests Interpretation Normal Pattern recognition Measured values Combination of results Heparin Administration Platelet Dysfunction 3
4 Fibrinolysis Quality Issues Vibration or other mechanical disturbances, sometimes instrument related Time delay to application of fresh whole blood Quality control challenges in terms of simulating patient samples and frequency of testing Testing volume, particularly in a laboratory setting Viewing and reporting of results Graph Parameters Interpretation Quality Control - TEG Clinical Applications R K Angle MA Level 1 Target (mm) CV (%) Target (mm) Level 2 CV (%) Peri-procedural hemostasis monitoring & transfusion decisionmaking Liver transplantation Cardiopulmonary bypass (CPB) Extracorporeal membrane oxygenation (ECMO) Assessment of pro-thrombotic states and anti-platelet therapy Mayo data, 2007 Intraop Transfusion Algorithm R > 15 min MA < 40 mm Angle < 45 o No improvement after initial Rx 2 U FFP 10 U platelets 6 U cryo 6 U cryo No platelets or FFP given during venovenous bypass to avoid thromboembolism Haemoscope Corp., 2003 Anesth Analg 64:888,1985 4
5 Intraop Transfusion Algorithm TEG monitored Unmonitored N Red blood cells (U) 17.0 ± 12.9* 26.7 ± 23.8 Fresh frozen plasma (U) 18.3 ± 12.5* 26.7 ± 24.1 Platelets (U) 20.8 ± 12.8* 14.1 ± 13.7 Cryoprecipitate (U) 12.2 ± 14.2* 3.9 ± 12.9 Total blood products (U) 67.9 ± ± 63.4 Crystalloid (L) 10.2 ± 4.5* 17.2 ± 8.5 Total volume infused (L) 20.2 ± 11.2* 31.4 ± 19.2 Transfusion Therapy After Conventional TEG PT >18 s (2 U FFP) R >35 mm (2 U FFP) APTT >55 s (2 U FFP) R+K >47 mm (2 U FFP) Fibrinogen <120 mg/dl (6 U cryo) MA <33 mm (6 U plts) Platelets <30,000/mL (6 U plts) Repeat MA <33 mm (6 U cryo) *p<0.05 Anesth Analg 64:888,1985 Plevak D, et al. Transplant Proc 25:1838, 1993 Transfusion Therapy After Conventional TEG N RBC transfused (U) 3.06 ± ± 0.46 FFP transfused (U) 0.78 ± 0.24* 0.11 ± 0.11 Platelets transfused (U) 2.67 ± ± 0.69 Cryo transfused (U) 1.67 ± 0.65* 0 Donor exposures (no.) 8.17 ± 1.61* 2.53 ± 0.83 Cost ($) * * p<0.05 Plevak D, et al. Transplant Proc 25:1838, 1993 Compared TEG, ROTEM, and conventional coagulation tests in light of transfusion decisions (20 patients) Moderate agreement (κ=0.42) Cryoprecipitate: FIBTEM & Clauss fibrinogen Fresh frozen plasma: INTEM & prothrombin time Fair agreement (κ<0.35) Platelets: INTEM & kaolin heparinase TEG Transfusion practice likely to differ according to the method of coagulation monitoring used J Cardiothorac Vasc Anesth 20:548, 2006 Cardiopulmonary Bypass Shore-Lesserson Transfusion Algorithm Haemoscope Corp., 2003 Shore-Lesserson L et al: Anesth Analg 88:312,
6 Shore-Lesserson Transfusion Algorithm Shore-Lesserson Transfusion Algorithm - Effectiveness TEG Control P Packed red blood cells (ml) 354 ± ± Fresh-frozen plasma (ml) 36 ± ± 463 <0.04 Platelet concentrates (ml) 34 ± ± Packed red blood cells 22/53 31/ Fresh frozen plasma 4/53 16/ Platelet concentrates 7/53 15/52 <0.05 Shore-Lesserson L et al: Anesth Analg 88:312, 1999 Shore-Lesserson L et al: Anesth Analg 88:312, 1999 TEG-Based Transfusion Algorithm TEG-Based Transfusion Algorithm Effectiveness Intraop TEG variable R >14 & <21 mm R >21 & <28 mm R >28 mm MA <48 mm MA <40 mm Lys30 >7.5% Implication clotting factors clotting factors clotting factors platelet no/fxn platelet no/fxn Increased lysis Therapy 1 FFP 2 FFP 4 FFP 1 plt pool 2 plt pools Aprotinin Control Algorithm Patients (no.) Patients transfused (no.) 10 (33%) 5 (17%) FFP transfused (units) 16 5 P<0.005 compared Platelets trans- to control fused (pools) 9 1 Median blood loss postop (ml) Royston et al: Br J Anaesth 86:575, 2001 Royston et al: Br J Anaesth 86:575, 2001 Anderson Transfusion Algorithm Retrospective audit of transfusion practices before and after introduction of ROTEM thromboelastometer (Pentapharm, Germany) Cardiac surgery intensive care unit 488 patients before & 502 patients after Testing only performed postoperatively on patients with excessive bleeding or at physician request Transfusion Medicine 16:31, 2006 Anderson transfusion algorithm based on ROTEM results Transfusion Medicine 16:31,
7 ROTEM in Cardiac Surgery ICU ECMO Patients transfused with CRCs (n) CRCs transfused (units) Patients transfused with FFP (n) FFP transfused (units) Patients transfused with platelets (n) Platelets transfused (units) 77/488 (16%) 96, 0 (0) CRC, concentrated red cell; FFP, fresh frozen plasma. Transfusion Medicine 16:31, 2006 Before introduction of ROTEM 294/488 (60%) 1094, 2 (3) 81/488 (17%) 343, 0 (0) After introduction of ROTEM 270/502 (53%) 931, 1 (2) 60/502 (12%) 271, 0 (0) 56/502 (11%) 75, 0 (0) P- value neonatal patients, heparinase TEG Overall, 57/101 (46.5%) of TEG profiles abnormal Most common problem related to platelet dysfunction 12 patients in hemorrhagic group (>1.0 ml/kg/ecmo hour RBC transfusion requirement 24/60 (40%) normal TEG profiles 5 patients in non-hemorrhagic group 30/41 (73.2%) normal TEG profiles J Extra Corpor Technol 27:137, 1995 Assessment of Pro- Thrombotic States Assessment of Anti-Platelet Therapy TEG Platelet Mapping MA thrombin MA fibrin MA ADP MA AA Kaolin Heparin ActivatorF (reptilase & FXIII) ADP Arachadonic Acid (AA) Haemoscope, 2004 TEG Platelet Mapping TEG Platelet Mapping Aspirin Effect Haemoscope, 2004 J Lab Clin Med 143:301,
8 Anti-Platelet Therapy Platelet Mapping Data Anti-Platelet Therapy Platelet Mapping Data AA agonist MA prior to dosing MA at 2 hours MA at 6 hours 300 mg ASA 60.3 ± ± ± mg ASA mg clopidogrel ± ± ± mg clopidogrel No significant differences (p>0.02) ADP agonist MA prior to dosing MA at 2 hours MA at 6 hours 600 mg clopidogrel 59.4 ± ± 7.0 (p<0.002) 39.1 ± 7.7 (p<0.002) 300 mg ASA mg clopidogrel 54.3 ± ± 5.9 (p<0.002) 28.4 ± mg ASA No significant differences (p>0.1) MA at 24 hours 23.1 ± 4.0 (p<0.002) 8.2 ± 1.2 MA at 24 hours 41.7 ± ± 5.4 Platelets 17:385, 2006 Platelets 17:385, 2006 Conclusions Viscoelastic tests of clot formation can provide information about various aspects of the coagulation system Clinical utility in guidance of transfusion therapy has been demonstrated in selected areas Role in anti-platelet therapy has yet to be determined 8
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