1 Hemostasis and TEG® Technology Copyright © 2001-2003 Haemoscope Corporation

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Hemostasis and TEG® Technology

www.haemoscope.comCopyright © 2001-2003 Haemoscope Corporation

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Hemostasis Issues Facing Clinicians

• Before surgery– Is there a coagulopathy present and how should it be treated– Prophylactic treatment / Autologous platelet plasmapheresis

• During surgery– What coagulopathy is developing

• After surgery– If the patient is bleeding, is it due to

• Surgical• Excess of heparin• Coagulopathy and how it should be treated

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Normal Hemostasis…

… is controlled activation of clot formation and clot lysis that stops hemorrhage without permitting inappropriate clotting (thrombosis).

Laposata et al. University of Pennsylvania Medical School/Mass.General Hospital

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Hemostasis Components

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The Procoagulant

Cascade

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The Hemostasis

Process

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The Clot

• The only end result of the activated coagulation protein is the fibrin strand which, together with activated platelets, forms fibrin-platelet bonding to produce the final clot.

• The strength and stability of the clot, that is its physical properties, determine its ability to do the work of hemostasis, which is to mechanically impede hemorrhage.

• The clot is in essence a damage control device, a temporary stopper, which gradually dissolves during vascular recovery.

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TEG® Technology

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Clot Kinetics

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TEG® Data Related to Pathways

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Formal Definition of TEG® Parameters

R R is the time of latency from the time that the blood was placed in the TEG® analyzer until the initial fibrin formation.

The value measures the rapidity (kinetics) of fibrin build-up and cross-linking, that is, the speed of clot strengthening.

K K time is a measure of the rapidity to reach a certain level of clot strength

MA MA, or Maximum Amplitude, is a direct function of the maximum dynamic properties of fibrin and platelet bonding via GPIIb/IIIa and represents the ultimate strength of the fibrin clot.

CI Coagulation Index is linear combination of the above parameters.

LY30 LY30 measures the rate of amplitude reduction 30 minutes after MA. This measurement gives an indication of the stability of the clot.

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Pattern Recognitio

n

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Recombinant Factor VIIa - before

R K MA

3—8 1—3 51—69

19.4 5.6 9.4

“Normalization of TEG® tracing and cessation of bleeding after infusion of recombinant Factor VIIa in a child with pulmonary hemorrhage and complex coagulopathy post tissue plasminogen activator infusion”Boshkov et al, abstract presented at Am Soc Hem Dec 2002

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Recombinant Factor VIIa - after

R K MA

3—8 1—3 51—69

8.0 2.1 55.4

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Recombinant Factor VIIa - superimposed

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Sepsis

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Sepsis - after

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Sepsis (superimposed before and after)

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Extreme Hypercoagulability

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Clot Breakdown with Urokinase

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Amicar and Urokinase Combined

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ReoPro Effect

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AMI – before treatment

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AMI – immediately post treatment

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AMI – during recovery

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Mitral Valve Replacement(Complicated history with numerous conditions)

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Mitral Valve Replacement (2)

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Marfan Syndrome/Aneurism

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Marfan Syndrome/Aneurism (2)

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2 mo old baby/Fontan heart surgery -1

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High contractility - 1

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Monitoring Hirudin with TEG® Analysis

0

1

2

3

4

0 2 4

Hirudin (ug/ml)

R (

min

)

y= 0.78x + 0.56

r-square = 0.99

Von Kier, Wade, and Royston, Royal Brompton and Harefield NHS Trust, Harefield, UK

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Monitoring Anti-Xa with TEG® Analysis

Klein, et al. Duke University Medical Center

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TEG® Tracing

Schematic

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Standard Protocol for Cardiovascular

Applications

• Baseline tracing on induction– 1 sample with kaolin and heparinase (heparinase in case of

heparin presence or contamination)• At rewarming (approx 36°) on CPB

– 1 sample with kaolin and heparinase • *10 min post protamine, 2 TEG® columns needed

– 1 sample with kaolin and heparinase– 1 sample with kaolin only

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Post Protamine

• Looking at only the R parameter, if the samples with and without heparinase are the same, the patient has received enough protamine to reverse heparin.

• If both tracings are normal and the patient is bleeding, the reason is surgical.

• If the R without heparinase is elongated and the heparinase tracing is normal and the patient is bleeding, the bleeding is due to excess of heparin.

• If the tracing with heparinase shows a coagulopathy, the patient is treated accordingly. Most likely coagulopathies will be consistent with those observed during monitoring while the patient is on the pump.

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Suggested Therapy Algorithm

Copyright © 2002 Haemoscope Corp.

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Sampling Protocol (Cardiovascular)

Sampling Protocol — All samples are Kaolin activated

Sample #

When Cup type

1 On induction Heparinase bonded (blue) cup and pin

2 At rewarming (approx 36°C) on CPB Heparinase bonded (blue) cup and pin

3 & 4 10 min post protamine Split sample:Heparinase bonded (blue) cup and pinPlain (clear) cup and pin

5 & 6 Post op Split sample:Heparinase bonded (blue) cup and pinPlain (clear) cup and pin


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Interpretation

TEG® Results Interpretation (If HIT, treat with Hirudin)

Sample # Measures If Suggested Treatment

1 Baseline hemostasis profile Prothrombotic state: AT III deficiency or others

(To test for AT III deficiency, see AT III protocol)

AT III or FFP Antifibrinolytic drugs are contraindicated unless

patient treated with Plavix, ReoPro, Aggrastat, or Integrilin, in which case Aprotinin is recommended.

2 Coagulopathy, if any, developed during bypass phase

Coagulopathy Treat hyperfibrinolysis. See protocol below. Order blood product. See protocol below.

3 & 4 Post-CPB hemostasis profile

Heparin reversal

Heparinase R and Plain R are within normal limits, heparin is effectively reversed

None

Heparinase R normal, Plain R above normal limits, heparin is not completely reversed

Protamine

Coagulopathy See protocol below

5 & 6 Post-op hemostasis profile Normal None

Coagulopathy / heparin rebound See protocol below


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Suggested Treatment

Treatment protocol

TEG® value Clinical cause Suggested Treatment

R between 7 - 10 min clotting factors x 1 FFP or 4 ml/kg

R between 11-14 min clotting factors x 2 FFP or 8 ml/kg

R greater than 14 min clotting factors x 4 FFP or 16 ml/kg

MA between 49 -54 mm platelet function 0.3mcg/kg DDAVP

MA between 41 -48 mm platelet function x5 platelet units

MA at 40 mm or less platelet function x10 platelet units

less than 45° fibrinogen level .06 u/kg cryo

LY30 at 7.5% or greater, C.I. less than 3.0 Primary fibrinolysis antifibrinolytic of choice

LY30 at 7.5% or greater, C.I. greater than 3.0 Secondary fibrinolysis anticoagulant of choice

LY30 less than 7.5%, C.I. greater than 3.0 Prothrombotic state anticoagulant of choice


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Plavix Monitoring with TEG® Analysis

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Aspirin Monitoring with TEG® Analysis

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Reduced Hemostatic Factor Transfusion Using Heparinase-

modified [TEG® Analysis] During Cardiopulmonary Bypass (CPB)

Stephen von Kier and David Royston

GroupActual Predicted

C(n=30)

DT(n=30)

C(TEG®)

DT(lab)

Pts transfused 10 5 2 12

FFP 16 5 1 22

Platelets 9 1 1 8

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Benefit of Intraoperative TEG® Algorithm to Reduce Platelet Transfusion Associated

Adverse Outcome in Higher Risk Cardiac Surgery Patients

Mortality Rate

With platelets 6/21 patients 28%

Without platelets 1/16 patients 6%


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Benefit of Intraoperative TEG® Algorithm to Reduce Platelet Transfusion Associated

Adverse Outcome in Higher Risk Cardiac Surgery Patients

Hospital Stay

With platelets 17.6 2.9 days

Without platelets 8.8 .6 days


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[TEG® Analysis] Decreases Transfusion Requirement After

Cardiac Surgery

Linda Shore-Lesserson MD et al

RBCintra

RBCpost

Non-RBCintra

Non-RBCpost

CTD(ml)

TEG® analysis

17/53 10/53 5/53 3/53 577 ± 412

Control 23/52 12/52 8/52 13/52** 659 ± 429

** p < 0.006 TEG® sample vs control

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TEG® Applications

• Liver transplantation• Cardiovascular surgery• Heart assist device• Percutaneous Transluminal

Coronary Angioplasty (PTCA)

• Trauma• Obstetrics• ICU• Orthopedics

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TEG® System

TEG® Analytical Software• Software-assisted diagnosis• Early projected values• Full report capability• Automated QC management• Additional data entry• Full peer-to-peer network

support• Standard Windows interface• Touch screen and barcode• Smoothing algorithm

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Connectivity

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TEG® Analyzer

5000 Series

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Documents

1 Hemostasis and TEG® Technology Copyright © 2001-2003 Haemoscope Corporation