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Point of Care Testing
Presentation · July 2018
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Klaus Görlinger
TEM Innovations GmbH, Munich
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Point of Care Testing
10th Biennial Conference on Cardiopulmonary Bypass,
Kuantan, Malaysia, 5th to 8th July 2018
Klaus Görlinger, MD
Munich, Germany
Disclosure
• Dec 1986 - June 2012: Senior Consultant at the Department of
Anesthesiology and Intensive Care Medicine, University Hospital
Essen, Germany
• 2010 - 2012: Chair of the DIVI Section Clinical Haemotherapy and
Haemostasis Management of the German Interdisciplinary
Association of Critical Care and Emergency Medicine
• 2010 - 2012: Member of the ESA Scientific Subcommittee
Transfusion and Haemostasis and the Task Force / co-author of
the ESA Guidelines on the Management of Severe Perioperative
Bleeding
• Honoraria for Scientific Lectures from CSL Behring GmbH,
Marburg, Germany, Octapharma AG, Lachen, Switzerland, Tem
International GmbH, Munich, Germany, and Verum Diagnostica
GmbH, Munich, Germany
• Since July 2012, Medical Director of Tem Innovations GmbH,
Munich, Germany
What is the issue?
Inappropriate blood transfusion increases
morbidity, mortality and hospital costs!
Ann Thorac Surg 2013 Aug;96(2):478-85.
MAIN RESULTS
Transfusion with FFP was inferior to control for preventing
patients receiving any red cell transfusion (OR) 2.57 (95%
CI 1.30 to 5.08; moderate quality evidence). There was
no difference in the risk of returning to theatre for
reoperation (eight trials with 398 patients; moderate
quality evidence): Peto OR 0.81 (95% CI 0.26 to 2.57).
Patients who had FFP received significantly more red
blood cells, suggesting that FFP may not be effective in this
setting (moderate quality evidence).
66%
TRANSFUSION
DOESN‘T STOP BLEEDING AND
IMPROVE OUTCOMES IN SEVERE
TRAUMA AND CARDIAC SURGERY!
Why does this patient bleed ?
„The Individualist“
„The Standard-of-Care“
ROTEM® delta and platelet
ROTEM® sigma
Coagulation factors,
anticoagulants, FDPs,
tissue factor expression
Platelets,
fibrinogen,
F XIII, colloids
Fibrinolytic enzymes,
fibrinolysis inhibitors,
F XIII
Clot Firmness [mm]
alpha-angle
Maximum Clot Firmness (MCF) [mm]
Maximum Lysis (ML) [%]
Clot Lysis Index 30 or 60
(CLI30; CLI60) [%]
A5, A10 = Amplitude 5 / 10 min after CT [mm]
Coagulation Time (CT) [s]
Clot Formation Time (CFT) [s]
Run Time [min]
CaCl2 + Tissue Factor + Polybrene
CaCl2 + Ellagic Acid
APTEM = EXTEM + Aprotinin / TXA
29
12
38
88
EXTEM + Cytochalasin D
INTEM + Heparinase
ECATEM = CaCl2 + Ecarin
87
9
27
10
73
29
38
8
92
Concept of ROTEM-guided PBM
Administer
• the right hemostatic drug/intervention
• in the right dose
• at the right time
• and in the right sequence
Concept of ROTEM-guided PBM
• Avoid any inappropriate transfusion/
hemostatic intervention
• Use the high negative predictive value of
viscoelastic and platelet function testing
in ROTEM algorithms (excludes reasons
for bleeding)
• Don’t treat numbers (low positive
predictive value of viscoelastic and
platelet function testing)
Anaesthesia.
2016 Jun;71(6):636-47.
Article
first published
online: 13 JAN 2016
Summary
• Results after protamine administration demonstrated the best
correlation with postoperative chest tube drainage.
• Both devices provided similar predictability for postoperative
chest tube drainage and red blood cell transfusion requirements.
• The latter was associated with the degree of platelet inhibition
and the number of pathways inhibited below determined
respective cut-off values.
Understand ROTEM-Algorithms
as “Not-to-Do”-Algorithms
(Avoid What is NOT Needed)
Evidence-based Cardiovascular A5-Algorithm
Clinical Situation
(Hyper)fibrinolysis
Heparin-Protamine-Management
Clot Firmness
Thrombin Generation
Clinical / POC Re-assessment
Heparin / Protamine Management
Bleeding and CTIN > 240 s  HEPTEM®
Bleeding and CTIN > 240 s and CTIN/CTHEP  1.25 
Administration of Protamine
The thromboelastometric
variable, INTEM-CT:HEPTEM-CT
ratio, correlated with heparin
concentration (r = 0.72), but
ACT (r = -0.12), APTT (r = 0.36),
and whole blood heparin
concentration, determined using
the Hepcon HMS, did not.
Peak heparin concentration
(0.18 ± 0.07 U/ml) at 4 hours
was not correlated with
mediastinal blood loss.
Differential Diagnosis of prolonged ACT
ACT
INTEM/HEPTEM CT-ratio Other ROTEM
results
Pathology
> 1.25
EXTEM CT normal
Heparin effect
( 0.2 anti-Xa IU)
 1.0
INTEM and HEPTEM > 280 s
EXTEM CT N/()
Protamine effect
Pro0.8-1.25
EXTEM CT normal (Acq.) hemophilia
longed INTEM and HEPTEM CT > 280 s FIBTEM A5  8 mm or factor deficiency
(x 1.25)
(intrinsic pathway)
0.8-1.25
INTEM and HEPTEM CT N/()
EXTEM CT N/()
FIBTEM A5 < 8mm
Low fibrinogen/
hemodilution
0.8-1.25
INTEM and HEPTEM CT 
EXTEM CT  
INTEM CT 
Direct Thrombin
Inhibitor (DTI)
0.8-1.25
EXTEM CT 
INTEM and HEPTEM CT normal
VKA or factor
deficiency
(extrinsic pathway)
Cardiac surgery after weaning from CPB and heparin reversal
Protamine overdose
?
Woman with Metastatic Breast Cancer and
unexplained “Bleeding from Everywhere“ (Hb dropped to 4 g/dL)
?
Acquired Hemophilia to be
treated with aPCC or rFVIIa
Thorac Cardiovasc Surg 2015
Clot Firmness Management: Fibrinogen
Bleeding and A5EX < 30 mm and A5FIB < 9 mm
 Administration of fibrinogen concentrate (or cryo)
34 min
A5: 22mm
A5:
2mm
A5: 31mm
Targeted increase
in A5FIB = 8 mm
50 mg/kg x 80 kg =
A5:
9mm
4 g Fibrinogen
A5: 20mm
A5: 20mm
Alternative:
20 U Cryo (300 mL)
or
16 U FFP (3.2 L)
?
A5: 29mm
A5: 28mm
post-CPB
Measurements and Main Results: The study included 1,077
patients. Clauss fibrinogen was correlated strongly with FIBTEM
amplitude (r = 0.78 for MCF and A10; P < 0.01). The area under
the receiver operating characteristic (ROC) curve was 0.95; the
optimal FIBTEM A10 cutoff for diagnosis of a fibrinogen
concentration of < 1.5 g/L was  8 mm.
Conclusions: The FIBTEM was a valid point-of-care method for
estimating the fibrinogen concentration during cardiopulmonary
bypass and may be used for prediction of hypofibrinogenemia
before separation from the extracorporeal circuit.
Clot Firmness Management: Platelets
A5EX < 30 mm and A5FIB  9 mm
A5: 27mm
A5: 25mm
A5: 15mm
A5: 22mm
Thrombocytopenia (22/nL) partially compensated
by high fibrinogen level
ROTEM®
ROTEM® delta
ROTEM® platelet
• 4 Channels
• 2 Channels
viscoelastic tests
impedance aggregometry
Assays for Platelet Activation and Aggregation
TRAPtem
ADPtem
ARAtem
GPIIbIIIa receptor
(fibrinogen receptor)
expression and
activation
Normal platelet function
Aspirin effect
Clopidogrel effect
Dual antiplatelet therapy
Vorapaxar effect
GPIIbIIIa receptor antagonist
Severe platelet dysfunction
Severe thrombocytopenia
Anesth Analg 2013;116:533-40
TRAPtest
Coagulation Time (Thrombin Gen.) Management
Bleeding and normal A5 in EXTEM® and FIBTEM®
but prolonged CTEX > 80 s  PCC (or FFP)
19 min
175 cm, 110 kg
INR 2.6  1.7
Quick (PT in %)
27%  44%
(Warfarin)
2000 IU PCC
Alternative:
8 U FFP
?
Thromb Res. 2015 May;135(5):1007-11.
EXTEM
k-TEG
Thromb Res. 2015 Sep;136(3):669-72.
ROC Curve AUC = 0.998
AF, Type A Aortic Dissection, Severe Bleeding
?
Dabigatran +
after 5 mg rFVIIa
low Fibrinogen
+ 2 g Fibrinogen
Coagulation Time (Thrombin Gen.) Management
Treat with rFVIIa instead of FFP in case of acquired hemophilia
Clinical / POC Re-assessment
Bleeding or Thrombosis?
Oral anticoagulation with warfarin and i.v. heparinisation:
Quick 18%; INR 3.5; PTT 62,8 s; Fibrinogen 6.56 g/L
J Cardiothorac Vasc Anesth. 2017 Apr 27. pii: S1053-0770(17)30431-7. [Epub ahead of print]
Conclusions: This prospective observational study reports a
significant association between transfusion of blood products
in neonates and young infants undergoing cardiac surgery
and an increased incidence of thrombotic complications in
the absence of intraoperative coagulation monitoring.
Preconditions for Clinical
Effectiveness of GDT
TRANSFUSION
PRACTICE
ROTEM
10-20 min
ALGORITHM
DO YOU HAVE PROBLEMS
WITH CLEAR DECISIONS, TOO
?
YES AND NO …
OUTCOMES
‚DOUBLE BLIND STUDY‘
(thromboembolic)
ANESTESIOLOGY. 2012 Sep;117(3):531-47.
ANESTESIOLOGY. 2012 Sep;117(3):531-47.
- Patients’ Outcome Analysis
%
ANESTESIOLOGY. 2012 Sep;117(3):531-47.
- Six-month Mortality (in %)
4%
20%
Conclusions. Rotational thromboelastometry-guided
early haemostatic intervention by rapid intraoperative
correction of EXTEM-A10 and FIBTEM-A10 reduced blood
loss (16 to 9 ml kg-1, P<0.001) and red cell transfusion
requirements (23 to 11 ml kg-1, P=0.005) after CPB, and
reduced critical care duration (71 to 60 h, P=0.014) in
paediatric surgical patients.
ANESTHESIOLOGY 2015 Mar; 122 (3): 560-70.
ROTEM® + Plateletworks®
2,481 patients
Post-algorithm odds ratio (95% CI)
for erythrocyte transfusion was 0.50 (0.32-0.77),
for platelet transfusion 0.22 (0.13-0.37) and
for plasma transfusion 0.20 (0.12-0.34).
No indication that the POC algorithm worsened any of
the measured processes of care or outcomes
Thromboelastography (TEG) or thromboelastometry
(ROTEM) to monitor haemostatic treatment versus
usual care in adults or children with bleeding
Cochrane Database Syst Rev. Issue 8, 2016. [Planned date of publication: 22/08/2016 22:02 GMT]
Wikkelsø A, Wetterslev J, Møller AM, Afshari A
UPDATE 2016
Mortality longest follow-up
Proportion of patients in need of dialysis
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