thromboelastometry in the bleeding patient...clotting time •clotting time is a measure of how well...
TRANSCRIPT
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B E N D E A T O N , M D
THROMBOELASTOMETRY IN THE BLEEDING PATIENT
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DISCLOSURES
• None
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BACKGROUND
• Bleeding and coagulopathy in critical care
environments can be a source of significant
morbidity and mortality
• Coagulopathy complex
• Exposure to allogenic blood products carry
important associated morbidity.
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COAGULOPATHY
• Can result from numerous conditions • Liver failure
• Sepsis
• Trauma
• Transfusions themselves
• Hypothermia
• Strategies to evaluate and correct coagulopathy are
evolving
• One such strategy has been the increasing use of TEG and
ROTEM
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TEG? ROTEM?
• What is TEG?
• Thromboelastography
• What is ROTEM?
• Thromboelastogram
• Viscoelastic coagulation testing
• Sometimes called VHAs (Viscoelastic Hemostatic Assays)
• Developed in 1948 By Dr. Hartert in Germany
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ROTEM SCHEMATIC
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cerca 1995
TEG system
wired to
monitors in
the OR, ICU,
and Lab.
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REPORTED BENEFITS
• Purported benefits of TEG and ROTEM over routine
screening coagulation?
• RSCTs are performed in plasma
• TEG/ROTEM performed in whole blood with cellular
components (particularly platelets)
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LIMITATIONS OF STANDARD COAGS
• INR
• Fibrinogen concentration
• aPTT
• ACT
• Platelet count
• Bleeding time
• Platelet function assay
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BENEFITS
• The idea is TEG/ROTEM can/will:
• Diagnose/assess coagulopathy in bleeding patient
• Including hypercoagulability and hyperfibrinolysis
• Guide transfusion strategy
• Prediction and/or Reduction in mortality
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OTHER BENEFITS
• Other benefits:
• Rapid turnaround time
• Reduced Factor concentrates, fresh frozen plasma,
cryoprecipitate, platelet concentrates
• Antifibrinolytic drugs, other drugs
• Surgery time and patient time in the ICU
• Total time in the hospital and for recovery
• What it is not:
• Pre-procedure coagulation testing
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BRIEF REVIEW OF HEMOSTASIS
• Primary hemostasis – damage to vascular wall
exposure of injured collagen binding of vWF
plt plug formation
• Secondary hemostasis – Coagulation cascade and
fibrin mesh
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BRIEF REVIEW OF PLATELETS
Singh D, et al. Anticoag and AntiPlt Therapy
in ACS. Cleveland Clinic J Med. 2014 Feb.
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ROTEM PARAMETERS
• There are MANY!
• It is difficult to try to understand them all.
• Review a practical guide to using ROTEM in a
bleeding patient.
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ROTEM PARAMETERS
• CT = Clotting Time
• CFT = Clot Formation Time
• ∝-Angle
• MCF = Maximum Clot Firmness
• A10 = Amplitude at 10 min
• LI30 = Lysis Index at 30 min
• ML = Maximum lysis
• NOTE: A sample algorithm will be used for general principles in this presentation. However, normal values can vary between institutions and machines. Please use appropriate local values and algorithms for clinical use.
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CLOTTING TIME
• Clotting Time is a measure of how well the clotting
cascade is working.
• Measured in Seconds
• CTEXTEM ≤ 85s is normal
• If CTEXTEM > 85s, give Plasma
• Or consider PCC when wishing to restrict volume infusion.
• PCC = Prothrombin Complex Concentrate, aka K-Centra
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A10
• Next look at the A10EXTEM
• A10 = Amplitude @ 10minutes
• A10 = CT + 10 min
• We expect A10EXTEM ≥ 45mm
• If A10EXTEM < 45mm suggests a problem with
fibrinogen or platelet function.
• We need to distinguish which so that we can give the
correct product (either cryoprecipitate, platelets or both.)
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A10
• Assume A10EXTEM < 45mm
• Now look at A10FIBTEM
• When enough Fibrinogen is present, A10FIBTEM ≥ 10mm
• So, if A10EXTEM<45mm and A10FIBTEM≥10mm
• Give platelets
• Or, if A10EXTEM<45mm and A10FIBTEM<10mm
• Give cryoprecipitate
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HYPERFIBRINOLYSIS
• Who gets hyperfibrinolysis?
• Trauma patients
• CT surg patients
• tPA
• Malignancy
• Labor
• Evidence of Hyperfibrinolysis on ROTEM
• ML = Maximum Lysis (at any given point in time)
• Percentage of clot lost in relation to MCF
• ML ≥ 15% is consistent with hyperfibrinolysis
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EXTEM Graph above;
INTEM, FIBTEM, APTEM all below
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FIBRINOLYSIS
• If evidence of fibrinolysis
• Tranexamic Acid
• Amicar (Aminocaproic Acid)
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ONGOING BLEEDING?
• Draw another ROTEM in 10-15 minutes
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TYPICAL BLOOD PRODUCTS
• FFP
• Clotting factors
• Protein C, S, Z
• vWF
• RBCs
• All at UNM are leukoreduced
• Most pts should get non-irradiated cells
• Some immunocompromised pts should get irradiated to
reduce the risk of GvH disease (graft vs host.)
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CRYOPRECIPITATE
• Fibrinogen
• Factor XIII (aka fibrin stabilizing factor)
• Factor XIIIa is a primary component for cross linking fibrin.
• Note: Factor XIIIa requires Ca2+ as a co-factor
• Factor VIII
• von Willebrand Factor
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PCC (aka K-CENTRA)
• Trade name for PCC • PCC = Prothrombin Complex Concentrate
• Contains II, VII, IX, X, protein C, protein S
• Contraindications: • Heparin-Induced Thrombocytopenia (HIT)
• Disseminated Intravascular Coagulaiton (DIC)
• Adverse Reactions: • MI, VTE, arterial thrombosis, DIC
• Higher thromboembolic risk than plasma
• Pt’s with VTE, MI, CVA, TIA in last 3 months were excluded from trials.
• http://www.kcentra.com/professional/presentations/dr-blinder.aspx (video 22:33)
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WHAT’S THE EVIDENCE?
• Well…..
• Justify the cost of replacing in-place technology
• Let’s take a look
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TURN AROUND TIME
• Haas T, et al. Brit J Anaesth. 2012; 108: 36-41.
• 50 surgical pediatric patients
• Timing of Results of Standard Coags vs ROTEM A10
• Median 53 min (IQR 45–63min) vs 23 min (IQR 21–24min)
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REDUCED TRANSFUSIONS
• Spiess et al, J Cardiothorac Vasc Anesth, 1995
• Retrospective Analysis
• Before and After Institution of TEG-based Transfusion
Algorithm
• 1079 sequential patients undergoing major cardiac
surgery (CABG ± open ventricular procedures)
• Group1 – 488 patients
• Group 2 – 591 patients
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REDUCED TRANSFUSIONS
• Significantly lower incidence of transfusions
• 78.5% vs 86.3%, during hospitalization, p=0.001
• Lower median donor exposure
• 6 (IQR 11) in Group 2 vs. 8 (IQR 15) in Group 1, p=0.001
• Mediastinal re-exploration
• 1.5% in Group 2 vs. 5.7% in Group 1, p=0.0001
• Use of TEG monitoring before re-exploration has
decreased the cost and potential risk for patients
undergoing CABG surgery.
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RCT OF ROTEM IN CARDIAC SURG
• Weber, et al. 2012
• RCT of 100 cardiac surg patients
• Randomized to monitor Conventional Coags vs
POC ROTEM
• Used algorithm for transfusion strategies
• Primary outcomes were blood loss and transfusion
requirements
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RCT OF ROTEM IN CARDIAC SURG - 2012
• Weber, et al. 2012
• Trial stopped early
• Conventional 5un RBC (IQR 4-9) vs POC 3un RBC
(IQR 2-6), p<0.001
• Reduced plasma and plt exposure
• Reduced post-op mechanical ventilation
• Decreased ICU LOS
• Decreased hemostatic therapy costs
• Decreased 6-month mortality
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MORTALITY IN TRAUMA
• Rourke, et al. 2012
• Prospective cohort trial
• 517 major trauma patients
• What about fibrinogen?
• Low fibrinogen was independent predictor of 24h
and 28d mortality
• Administration of high dose Cryo improved survival
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SYSTEMATIC REVIEW TRAUMA - 2014
• Da Luz, et al. Critical Care Medicine. 2014.
• TEG/ROTEM in coagulopathy, transfusion and mortality in trauma
• 55 studies (12,489 patients) • TEG/ROTEM were SN and SP for early detection/prediction of:
• Hypocoagulability • Transfusion needs • Mortality
• 1 observational study suggested ROTEM-based algorithm reduces transfusion needs
• No clear mortality reduction
• Evidence is low quality • No RCTs
• Limited observational data
• More research needed
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COCHRANE REVIEW SURGERY - 2011
• No clear evidence that TEG or ROTEM improve
survival in adult cardiac surg and liver transplant
patients .
• However, reduced bleeding and fewer patients
requiring both Plt and FFP.
• More research needed
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COCHRANE REVIEW TRAUMA - 2015
• Hunt H, et al. The Cochrane Library. 2015
• Primarily focused on A5, A10, A15 for diagnosis of
TIC.
• Only 3 studies major limitation of this review.
• More research needed
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LIMITATIONS OF TEG TESTING
• Warfarin not detected with TEG
• No data on Warfarin detection with ROTEM
• Direct oral anticoagulants (DOACs)
• No data for either TEG or ROTEM
• Nascimento B, et al. Transfusion. 2012.
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CT VS CFT FOR PT/PTT
• CT often used as a marker of clotting cascade
function with success
• Similar to PT or PTT
• Our algorithm, Teaching from TEM intl, Algorithm in Cardiac
surgery stdy (Weber, et al.)
• However some studies suggest CFT or ∝-Angle may
be better
• Haas, et al. 2012
• 50 Ped Surg patients
• Stancheva A, et al. Clin Lab. 2011.
• 30 pts undergoing orthotopic liver transplant
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MEASURE OF FIBRINOGEN
• A10FIBTEM is a good test for fibrin activity as
compared to Fibrinogen level determined by Clauss
method.
• Haas T et al. Brit J Anaesth. 2012.
• Rourke, et al. Int’l Soc Thromb and Haemostaasis. 2012. A5FIBTEM
• Stancheva A, et al. Clin Lab. 2011.
• In trauma, low fibrinogen correlated with mortality
• And, reversal with improved survival
• Rourke, et al. Int’l Soc Thromb and Haemostaasis. 2012.
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OTHER TOPICS NOT DISCUSSED
• Response to blood products
• GI bleeding
• Coagulopathic pts in sepsis/septic shock
• Pre-operative coagulation status
• Hemolytic conditions (DIC, TTP, etc.)
• Use in obstetrics
• Hypercoagulability
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ADVANTAGES
• Advantages
• Faster turnaround time
• All steps of coagulation, clot growth, and fibrinolysis
• Hypofibrinogenemia and when to treat
• Hyperfibrinolysis
• Reduced bleeding and transfusion (cardiac surgery)
• Likely appropriate for response to blood product therapy
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DISADVANTAGES
• Disavantages
• Interdependent values and variability
• Lack of standardization & data
• Variability of reagents
• Variability between machines
• Variable algorithms
• Mostly low quality evidence,
• Mostly observation data with lack of controls and small studies
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BOTTOM LINE
• Surgical evidence has shown some benefits
• Less bleeding and less transfusion
• Best RCT thus far also showed improved outcomes
• But only 1, and only 100 pts. Ties to TEM Intl.
• Level of evidence
• Moderate in cardiac surgery
• Low quality in liver transplantation and trauma
• Poor or none in other areas (sepsis, GI bleeding, obstetrics,
etc.)
• In contrast, no significant evidence that standard
tests improve important clinical outcomes either.
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REFERENCES
• Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH,
Zacharowski K. A Prospective Randomized Clinical Trial of Efficacy of
Coagulopathic Cardiac Surgical Patients. Anesthesiology. Sept 2012.; 118 (3): 531-
47.
• Haas T, Spielmann N, Mauch J Madjdpour C, Speer O, Schmugge M, Weiss M.
Comparison of Thromboelastometry (ROTEM®) with Standard Plasmatic
Coagulation Testing in Paediatric Surgery. British Journal of Anaesthesia. 2012;
108 (1):36-41.
• Singh D, et al. Anticoagulation and Antiplatelet Therapy in ACS. Cleveland Clinic J
Med. Feb 2014.
• Spiess BD, Gillies BSA, Chandler W, Verrier E. Changes in Transfusion Therapy and
Re-exploration Rate After Institution of a Blood Management Program in Cardiac
Surgery Patients. J Cardiothorac Vasc Anesth. April 1995; 9 (2):168-73.
• Rourke C, Curry N, Khan S, Taylor R, Raza I, Davenport R, Stanworth S, Brohi K.
Fibrinogen Levels During Trauma Hemorrhage, Response to Replacement
Therapy, and Association with Patient Outcomes. J of Thrombosis and
Haemostasis. 2012; 10:1342-51.
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REFERENCES
• Hunt H, Stanworth S, Curry N, Woolley, Cooper C, Ukoumunne O, Zhelev Z, Hyde C.
Thromboelastography (TEG) and Rotational Thromboelastometry (ROTEM®) for
Trauma Induced Coagulopathy in Adult Trauma Patients with Bleeding (Review.)
The Cochrane Library. 2015. Issue 2.
• Afshari A, Wikkelso A, Brok J, Moller AM, Wetterslev J. Thromboelastography (TEG)
and Rotational Thromboelastometry (ROTEM®) to Monitor Haemotherapy Versus
Usual Care in Patients with Massive Transfusion. The Cochrane Library. 2011.
Issue 3.
• Da Luz LT, Nascimento B, Shankarakutty AK, Rizoli S, Adhikari NKJ. Effect to
Thromboelastography (TEG) and Rotational Thromboelastometry (ROTEM®) on
Diagnosis of Coagulopathy, Transfusion Guidance, and Mortality in Trauma: A
Descriptive Systematic Review. Critical Care. 2014; 18:518.
• Latour C. Thromboelastometry. Canadian Blood Services Seminars. Oral
Presentation. 8 Sept 2015.
• Nascimento B, Mahoos MA, Callum J, Capone A, Pacher J, Tien H, Rizoli S. Vitamin
K-dependent Coagulation Factor Deficiency in Trauma: A Comparative Analysis
Between International Normalized Ratio and Thromboelastography. Transfusion.
2012;52:7-13.