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Thrombelastograph® (TEG®)
Coagulation Analyser
Phillip Gray
25 January 2016
The TEG® System is indicated for use with adult patients when an evaluation of their blood hemostatic properties is desired. Results from the TEG analyser should not be the
sole basis for a patient diagnosis; TEG results should be considered along with a clinical assessment of the patient’s condition and other coagulation laboratory tests. For
Professional Use Only.
Haemonetics, TEG, and Thrombelastograph are trademarks or registered trademarks of Haemonetics Corporation in the USA, other countries, or both. PlateletMapping is a
registered trademark of Coramed Technologies, LLC. Effient is a registered trademark of Eli Lilly and Company. Plavix is a trademark of Bristol-Myers Squibb/Sanofi
Pharmaceuticals Partnership.
Please refer to the manuals for Indications for Use, Contraindications, Warnings, Precautions, and Potential Adverse Events.
Individual Goal Directed
Coagulation Management
TEG 6s
“Making the Complex Simple”
2
© Haemonetics Corporation
What is TEG®?
 A real time analyser of whole blood allowing for
individualised goal-directed therapy.
 Measures the viscoelastic properties of the
haemostasis process functionally, with the endresult being a haemostatic plug, or clot.
3
© Haemonetics Corporation
Clinical Practice: A Constant Struggle…
4
© Haemonetics Corporation
Upsetting the balance
Natural processes






Injury
Disease
Aging Process
Cholesterol
Hardening of Arteries
Vascular Constriction
and Breakdown
 Blood Activation by
Turbulence
5
© Haemonetics Corporation
Upsetting the balance
Human intervention
 Surgery
 Devices – LVADs,
CPB, ECMO




Trauma
Drugs
Stents
Airplane Flights –
DVT
 Smoking
6
© Haemonetics Corporation
Complexity of haemostasis
 Multiple systems
 Cells
 56+ proteins
 Dynamic
 Interactive
7
© Haemonetics Corporation
The Coagulation Cascade
Intrinsic Pathway
Extrinsic Pathway
Surface Contact
Collagen
FXII activator
F XII
Tissue/Cell Defect
F XIIa
F XI
F IXa
Ca2+
F VII
F III (Tissue
Thromboplastin)
F VIIIa
Platelet Factor 3
FX
Ca2+
F Xa
Ca2+
F Va
Prothrombin II
F XIIIa
Crosslinked
Fibrin Network
Ca2+
F XIa
Ca2+
F IX
F VIII
F VIIa
Ca2+
FV
Thrombin IIa
F XIII
Fibrin
polymers
Fibrin
monomers
Copyright © 2011 Haemonetics Corp.
FX
Fibrinogen
Yellow lines
indicate
positive
feedback
loops lost in
isolated tests
Traditional haemostasis monitoring
D-Dimer
Traditional
Hemostasis
Tests
9
© Haemonetics Corporation
Do not define the overall process, just provide
pieces of the process!
Cell-Based Model
•
•
•
Tissue factor
bearing cells
Reflects in vivo
 Occurring on cell surfaces
 Tissue factor bearing cells
 Platelets
 Overlapping phases:
 Initiation (TF bearing cells)
 Amplification (platelets)
 Propagation (platelets)
1. Initiation
IIa
2. Amplification
Platelets
The coagulation cascades are still
important, but are cell-based
3. Propagation
 extrinsic pathway: surface of tissue
factor bearing cells
 intrinsic pathway: surface of
platelets
Routine coagulation tests do not
represent the cell-based model of
hemostasis
IIa
Activated
platelets
[Monroe,
DM. et al. Arterioscler Thromb Vasc Biol. 2002;22:1381]
10
TEG Technology
11
© Haemonetics Corporation
Haemostasis made simple with TEG
1- INITIATION
Reaction
INITIATION
1
12
© Haemonetics Corporation
Haemostasis made simple with TEG (2/3)
1- INITIATION 2- STRENGTH
Reaction
INITIATION
1
13
© Haemonetics Corporation
Maximum clot
STRENGTH
2
Haemostasis made simple with TEG (3/3)
1- INITIATION 2- STRENGTH 3- STABILITY
Reaction
INITIATION
1
14
© Haemonetics Corporation
Maximum clot
STRENGTH
2
Clot degradation
STABILITY
3
TEG® Core Assessment
1. INITIATION
1
2. STRENGTH
INITIATION
3. STABILITY
2
15
STRENGTH
© Haemonetics Corporation
3
STABILITY
TEG® Trace – Diagnostic Complex
16
© Haemonetics Corporation
Heparin/Enoxaparin Effect
Heparinase cup
Plain cup
5.8
17
2.2
© Haemonetics Corporation
59.1
0.0
56.2
6.4
Functional Fibrinogen TEG ®
18
© Haemonetics Corporation
Fibrinogen/Platelet Ratio
19
© Haemonetics Corporation
Fibrinogen/Platelet Ratio
20
© Haemonetics Corporation
RapidTEG® Assay
 Tissue Factor and Kaolin Activation –
 RAPID test of CLOT STRENGTH and any FIBRINOLYSIS
 Also provides RAPID TEG® ACT Result
21
© Haemonetics Corporation
Rapid TEG
22
© Haemonetics Corporation
4 TEST CONCEPT
Kaolin Activated
Heparinase
Functional Fibrinogen
Rapid TEG
23
© Haemonetics Corporation
4 TEST CONCEPT - Combination TEST
Fast…Global…Sensitivity to All Phases…
Rapid TEG
Kaolin Activated
Functional Fibrinogen
Early Diagnosis ~10 Min
24
© Haemonetics Corporation
The TEG5000 Today
25
© Haemonetics Corporation
The TEG5000 Software Today
26
© Haemonetics Corporation
The TEG6s………. TOMORROW
27
© Haemonetics Corporation
TEG 6s
“Making the Complex Simple!
28
© Haemonetics Corporation
TEG 6s Test Procedure
Patient Test Procedure
30
© Haemonetics Corporation
TEG 6s Stand-Alone Device
31
© Haemonetics Corporation
TEG 6s
Complex Technology
Resonance-frequency viscoelasticity measurements and
disposable multi-channel microfluidic cartridges
32
© Haemonetics Corporation
Sample Testing
 Sample ring subjected to external vibration
33
© Haemonetics Corporation
Measurement
 Harmonic motion of sample measured optically
Optical detection
34
© Haemonetics Corporation
Sample Testing Animation
Click to play
35
© Haemonetics Corporation
Measurement
 As sample transitions from liquid to gel state,
measurements are plotted: Clot strength vs. Time
Clot
strength
Gel
state
Liquid
state
Time
36
© Haemonetics Corporation
TEG 6s
Tests
1. Global hemostasis cartridge (citrated tube - blue top)
Kaolin TEG
Contact activator in routine use
Heparinase cups
Neutralises heparin to allow you to see patients underlying
haemostatic profile
RapidTEG®
Tissue Factor and Kaolin Activation – for rapid testing of clot strength
and also provides TEG® ACT Result
Functional
Fibrinogen
Functional fibrinogen reagent provides a functional measurement of
patient fibrinogen level
2. PlateletMapping cartridge (heparin tube – green top)
PlateletMapping®
Gives personalised antiplatelet therapy for both haemorrhagic and
thrombotic condition
3. QC cartridges
Biological QC
37
© Haemonetics Corporation
Level I and II
The TEG 6s
Making the Complex Simple
Simplicity in Facilitating the Science of the Cell Based Model
38
© Haemonetics Corporation
TEG 6s
Advances the TEG 5000 legacy through simple,
smart and reliable design
Same
Simple
Assess same physical property/results
Smart
39
© Haemonetics Corporation
Reliable
Global Haemostasis Assessment
Kaolin TEG
Heparinase
effect
Rapid TEG
Functional
Fibrinogen
TEG
40
© Haemonetics Corporation
TEG 6s COMBINATION TEST CONCEPT
Global Impact: Fast and Specific Sensitivity
Global Haemostasis
Rapid TEG
Kaolin Activated
Functional Fibrinogen
Early Diagnosis ~10 Min
41
© Haemonetics Corporation
1/17/2014
11:21 AM
ID: patientID1
CM Citrated K,KH,RT,FF
baseline
1/16/2014
11:21
80
CK
60
40
20
0
0
CRT
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
(min)
CKH
CFF
results
42
next tracing
device 1
User 1
1/17/2014
11:21 AM
ID: patientID1
CM Citrated K,KH,RT,FF
1/16/2014
11:21
R
K
Angle
(min)
(min)
(deg)
5.8
1.3
73.4
58.5
2.3
4.6-9.1
0.8-2.1
63-78
52-69
0-2.6
0.3
1.6
73.4
59.7
1.5
0.3-1.1
0.8-2.7
60-78
52-70
0-2.2
CK
CRT
MA
LY30
(mm)
(%)
TEG-ACT
(sec)
78.6 !
82-152
5.5
1.2
74.9
58.5
4.3-8.3
0.8-1.9
64.3-77.1
52.3-68.9
FLEV
19.8-
361.3
15-32
278-581
CKH
CFF
done
43
baseline
print
(mg/dl)
tracings
1/17/2014
11:21 AM
ID: patientID1
CM Citrated K,KH,RT,FF
baseline
1/16/2014
11:21
CK
CRT
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
CKH
CFF
results
44
next tracing
1/17/2014
11:21 AM
ID: patientID1
CM Citrated K,KH,RT,FF
baseline
1/16/2014
11:21
CK
80
60
5.8
4.6-9.1
K
40
20
0
0
R
(min)
(min)
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
Angle
85
(deg)
(min)
MA
58.5
52-69
(%)
45
73.4
63-78
(mm)
LY30
results
1.3
0.8-2.1
2.3
0-2.6
next tracing
1/17/2014
11:21 AM
ID: patientID1
CM Citrated K,KH,RT,FF
baseline
1/16/2014
11:21
CKH
R
80
(min)
60
40
20
0
0
5
10
15
20
30
35
40
45
50
55
60
65
70
75
80
K
1.2
(min)
0.8-1.9
Angle
85
(deg)
(min)
results
46
25
5.5
4.3-8.3
74.9
64.3-77.1
MA
58.5
(mm)
52.3-68.9
next tracing
1/17/2014
11:21 AM
ID: patientID1
CM Citrated K,KH,RT,FF
baseline
1/16/2014
11:21
CRT
80
60
40
20
0
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
(min)
R
0.3
(min)
0.3-1.1
K
1.6
(min)
0.8-2.7
Angle
73.4
(deg)
60-78
MA
59.7
(mm)
52-70
LY30
1.5
(%)
0-2.2
TEG-ACT 78.6
(sec)
results
47
82-152
next tracing
1/17/2014
11:21 AM
ID: patientID1
CM Citrated K,KH,RT,FF
baseline
1/16/2014
11:21
CFF
80
60
40
20
0
0
5
10
15
20
30
35
40
45
50
55
60
65
70
75
80
85
(min)
results
48
25
MA
19.8
(mm)
15-32
FLEV
361.3
(mg/dl)
278-581
next tracing
49
device 1
User 1
1/17/2014
11:21 AM
ID: patientID2
CM Citrated K,KH,RT,FF
1/16/2014
11:21
R
K
Angle
(min)
(min)
(deg)
5.8
1.3
73.4
58.5
2.3
4.6-9.1
0.8-2.1
63-78
52-69
0-2.6
0.3
1.6
73.4
59.7
1.5
0.3-1.1
0.8-2.7
60-78
52-70
0-2.2
CK
CRT
MA
LY30
(mm)
(%)
TEG-ACT
(sec)
78.6 !
82-152
5.5
1.2
74.9
58.5
4.3-8.3
0.8-1.9
64.3-77.1
52.3-68.9
FLEV
19.8-
361.3
15-32
278-581
CKH
CFF
done
50
baseline
print
(mg/dl)
tracings
TEG 6s Case Studies
51
© Haemonetics Corporation
Case Study 1: Re-warm sample
pre-op INR 2.6
Case Study 1: Re-warm sample
pre-op INR 2.6
Case Study 1:
Post-protamine
Case Study 1:
Post-protamine
Case Study 1: Post-protamine #2
Post-transfusion 1 x plasma, 1 x thrombocyte,
additional protamine
Case Study 1: Post-protamine #2
Post-transfusion 1 x plasma, 1 x thrombocyte,
additional protamine
Case Study 2: Post-protamine
Case Study 2: Post-protamine
Aorte Ascendante Post-0p (Dr. Braunberger)
60
© Haemonetics Corporation
Aorte Ascendante Post 1,5 g Fibrinogene
61
© Haemonetics Corporation
Platelet Mapping:
Measuring the potential impact of ant-Platelet therapy
Measures Individualized response to drugs!
INDIVIDUAL haemostatic baseline
Individually affected by ANTI-PLATELET DRUGS
62
© Haemonetics Corporation
PlateletMapping®
What drugs are monitored?
Antiplatelet drugs
 ADP receptor inhibitors
Examples: clopidogrel (Plavix®), ticlopidine (Ticlid®)
prasugrel (Effient®), ticagrelor (Brilinta®)
 Thromboxane pathway inhibitors
Example: aspirin
 GPIIb/IIIa inhibitors
Examples: abciximab (Reopro®), tirofiban
(Aggrastat®),
eptifibatide (Integrilin®)
63
© Haemonetics Corporation
Platelet Mapping – Combination Test
Maximum
(100% Aggregation)
Platelet
Function
ZERO
(0% Aggregation)
Drug affect
(60% Inhibition)
64
© Haemonetics Corporation
Why PlateletMapping® Assay?
Personalized Platelet Therapy
What if they are all treated the same? (50% inhibition)
65
© Haemonetics Corporation
Why PlateletMapping® Assay?
Personalized Platelet Therapy
All 50% Inhibition
66
© Haemonetics Corporation
1/17/2014
11:21 AM
ID: patientID1
PM Platelet Mapping
baseline
1/16/2014
11:21
80
HKH
60
40
20
0
0
ActF
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
(min)
ADP
AA
results
67
next tracing
device 1
user 1
1/17/2014
11:21 AM
ID: patientID1
PM Platelet Mapping
baseline
1/16/2014
11:21
R
K
Angle
(min)
(min)
(deg)
HKH
6.6
1.7
68.2
1-2.96
57-75
4.2-9.8
MA
LY30
Inhibition
(mm)
(%)
(%)
61.8
---
54-70
0-2.4
ADP
AA
7.6
ActF
2-19
AA
68
(%)
44-69
ADP
95.9
61.9
AA
100
37-71
done
0
Aggregation
59.6
ADP
4.1
print
tracings
1/17/2014
11:21 AM
ID: patientID1
PM Platelet Mapping
baseline
1/16/2014
11:21
HKH
R
80
(min)
60
K
40
20
0
0
(min)
5
10
15
20
30
35
40
45
50
55
60
65
70
75
80
85
(min)
results
69
25
6.6
4.2- 9.8
1.7
1- 2.9
Angle
68.2
(deg)
57- 75
MA
61.8
(mm)
54- 70
LY30
---
(%)
0-2.4
next tracing
1/17/2014
11:21 AM
ID: patientID1
PM Platelet Mapping
baseline
1/16/2014
11:21
ActF
80
60
40
20
0
0
5
10
15
20
30
35
40
45
50
55
60
65
70
75
80
85
(min)
results
70
25
MA
7.6
(mm)
2-19
next tracing
1/17/2014
11:21 AM
ID: patientID1
PM Platelet Mapping
baseline
1/16/2014
11:21
ADP
80
60
40
20
0
0
5
10
15
20
30
35
40
45
50
55
60
65
70
75
80
85
(min)
results
71
25
MA
59.6
(mm)
44-69
next tracing
1/17/2014
11:21 AM
ID: patientID1
PM Platelet Mapping
baseline
1/16/2014
11:21
AA
80
60
40
20
0
0
5
10
15
20
30
35
40
45
50
55
60
65
70
75
80
85
(min)
results
72
25
MA
61.9
(mm)
37- 71
next tracing
TEG 6s COMBINATION TEST CONCEPT
Global Impact: Fast and Specific Sensitivity
Global Haemostasis
Rapid TEG
Kaolin Activated
Functional Fibrinogen
Platelet Function
Maximum
(100%
Aggregation)
Early Diagnosis ~10 Min
ZERO
(0%
Aggregation)
Drug affect
(60% Inhibition)
73
© Haemonetics Corporation
TEGManager
TEG Viewer
+
Device Manager
74
© Haemonetics Corporation
= TEG Manager
TEG Viewer
75
© Haemonetics Corporation

View real-time and
historical TEG tests on
remote monitors

View multiple TEG
tests per patient

Color-coded by
cartridge

“Share” a view with
others

10 languages to start
TEGManager = Two applications
 TEG Viewer
TEGViewer:








TEGManager leverages the TEG 6s data
One way communications pull from the
device
Stores clinical test results from a fleet of TEG
devices
Displays active and historical TEG test results
Provides patient trending data across multiple
TEG devices
Available on various screen sizes from iPad
to large screen monitor
Provides clinical and research reports
Allows viewing of active and historical results
on multiple screens & View status of all
TEG 6s devices in the institution (operation,
calibration, status, logs, firmware, cartridge
configuration
TEG Viewer + Device Manager = TEG Manager
TEG Viewer Main Screen
TEGManager = Two applications
 Device Manager
Device Manager:







Manages:
 User credentials & different level of
access
 Network connectivity
Bi-directional connectivity to devices
Connectivity to middleware for Patient
Identification
Device-specific reports (i.e., uptime, error
logs, etc.)
Aggregates TEG data from several
Analyzers into a centralized data repository
Provides centralized administration (i.e.,
User IDs)
Connectivity between devices and
middleware (HaemoCommunicator)
TEG Viewer + Device Manager = TEG Manager
TEG Device Manager



View status of all TEG 6s
devices in the institution
(operation, calibration,
status, logs, firmware,
cartridge configuration)
Manage users on devices,
their permissions, full data
access reporting
Model for managing
Haemonetics devices
moving forward
TEG : IT Architecture in Hospital
Emergency
Operating room
Satellite Lab
Etc.
Hospital Network
Operating room
Biologist’s Office
WEB Access anywhere
Everywhere…
Doctor’s office
from any PC or tablet connect on the network
 With one of the following browser
Or higher
 IT SERVICES
Unrivalled performance with TEG6s
Protocols
When to Sample?
How to Treat?
Cardiac Surgery TEG Protocol
TEG Protocol
When
Global Haemostasis
or
 Either Day before or on induction:
Prior to heparin and hemodilution
Platelet
Mapping
Re-warm
Post-Protamine
Post Op
83
 Blood Temperature 35-36 Degrees
C (20 minutes prior to coming off
bypass)
 Ten Minutes post protamine (Same
time ACT drawn)
 Two Hour Post protamine (ICU
sample) or upon bleeding
Tube
 Blue Top: Patient Label and
time sample drawn.
 Green Top: Patient Label and
time sample drawn
 Blue Top: Patient Label and
time sample drawn.
 Blue Top: Patient Label and
time sample drawn.
 Blue Top: Patient Label and
time sample drawn
TEG-guided
hemostasis
algorithm in CV
surgery
Pre-Bypass Platelet Function Testing TEG® PlateletMapping
Pre-Bypass Kaolin TEG®
Pre-Bypass Functional Fibrionogen TEG®
Operative Procedure
– Liverpool Heart and
Chest Hospital
Liverpool, UK
Post-Protamine Kaolin and Heparinase TEG®
Post-Protamine Functional Fibrionogen TEG®
Yes
No
Is the patient suffering from postoperative micro-vascular bleeding
Check Pre-Bypass
Platelet Function Test
Resume standard care
Check Kaolin and Heparinase TEG®
Check Functional Fibrinogen TEG® **
Is the FLEV < 1g/l?
No
Is
PLM ADP Inhibition
>60%?
No
Yes
Transfuse 1 pool
platelets
No
Is
PLM ADP Inhibition
>70%?
Is the
Kaolin R time
>2 Heparinase
R time?
Yes
Yes
Transfuse 2 pools
platelets
Administer 50mg
Protamine
No
Is the
R time ≥10 and
< 14 min?
Yes
Transfuse 8ml/kg
FFP
No
Is the R time
> 14 min?
Is MA <40 and
≥25mm?
Yes
Yes
Transfuse 16ml/kg
FFP
Transfuse 1 pool
platelets*
No
Is MA <25mm?
Yes
Yes
Transfuse 1 pool
platelets*
Transfuse 10 units
Cryoprecipitate
No
* If not already receiving platelet transfusion from TEG® PlateletMapping (PLM)
** Reverted to Clauss firbrinogen values after first 100 patients
Adapted from: Agarwal S et al. J Cardiothorac Vasc Anesth. 2014
84
© Haemonetics Corporation
If bleeding continues
consider resternotomy
No
No
ECLS et TEG
85
© Haemonetics Corporation
COL-COPY-000864-IE(AA)
TEG et CIVD
86
© Haemonetics Corporation
COL-COPY-000864-IE(AA)
Septic Patient – DIC?
• Patient presented in ED with suspected Meningitis.
• TEG shows classic Stage 1 DIC tracing
Septic Patient – DIC?
• 2 hours after administration of heparin 10u/kg iv followed
by 10u/kg/hr drip. Note that the patient is no longer
hypercoagulable under heparin, but when heparin is
removed with heparinase, condition reverts (red tracing).
Septic Patient – DIC?
• 12 hours later the heparin effect is more pronounced
(extended R) and normal values on heparinase tracing
(red). Heparin dose can now be reduced.
Septic Patient – DIC?
• 36 hours after treatment with heparin begun. Dose has
been reduced to 5u/kg/hr. Note no reversion to
hypercoagulable values in heparinase (red tracing).
Condition resolved. Patient subsequently extubated and
transferred to the floor.
Questions?
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