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Klaus Görlinger, MD
University Hospital Essen, Germany
klaus@goerlinger.net
Point-of-Care Testing Efficacy
ANEMO14, Strategie di Risparmio del Sangue,
Policlinico San Donato Milanese, 7-8 Marzo 2014
Conflicts of interest
• 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 International GmbH,
Munich, Germany
Perioperative Bleeding Management
Cost
effectiveness
Efficacy Safety
Transfusion strategies
• Formula driven (1:1:1-concept):
PRBC - FFP - Platelets - rFVIIa
• Lab-driven protocol
• Individualized POC-driven:
Fibrinogen/Cryo - Plt - PCC/FFP
EXTEM A5
Lactate
clearance
Results: ... Patients arrived in the ICU 6.8 ± 0.3
hours after admission. Coagulopathy, present at
hospital admission (pre-ICU INR, 1.8 ± 0.2)
persisted at ICU admission (initial ICU INR, 1.6 ±
0.1). ... In the ICU during resuscitation mean INR
decreased to 1.4 ± 0.03 within 8 hours, indicating
moderate coagulopathy. ... The ratio of FFP:PRBC
was 1:1. ... Statistical analysis found severity of
coagulopathy (INR) at ICU admission associated
with survival outcome (p = 0.02).
1:1 → 14.8 hours to achieve an INR < 1.5 !
CONCLUSION: MTP (massive transfusion protocol
with 1:1:1 ratio) therapy worsened mortality in
penetrating MOI (mechanism of injury) patients
receiving 10U or more RBC, indicating a continued need
for TEG-directed therapy. A 1:1:1 strategy may not be
adequate in all patients.
ROTEM®
analysis enables rapid detection of
most coagulation disorders; this study
demonstrates the additional benefit of MT
risk stratification using results available within
10 minutes after CT (FIBTEM®
A10).
Avoid FFP transfusion
(potential harmful)!
Treat trauma-induced
coagulopathy early!
Why does the patient bleed ?
Standard coagulation test results were available
after a median of 53 min [inter-quartile range
(IQR): 45–63 min], whereas 10 min values of
ROTEM results were available online after 23 min
(IQR: 21–24 min).
Further time saving was 11 minutes (8-16
minutes) if ROTEM® measurements were
performed bedside (p<0.001).
Fibrinogen
deficiency
Thrombocyto-
penia
Fibrinolysis
sensitive to
aprotinin /
TXA
CF deficiency
intrinsic pw
CF deficiency
extrinsic pw
Heparin
effect
Fibrinogen /
Cryoprecipitate
Platelet
concentrate
Tranexamic
acid
PCC
Protamine
FFP
EXTEM cut-off
(Sens/Spec):
CFT < 51 s (89/94)
MCF > 68 mm (94/94)
TPI > 3.5 (100/93)
FIBTEM cut-off
(Sens/Spec): MCF > 24
mm (77/88)
ROTEM®
delta
• 4 Channels
viscoelastic tests
ROTEM®
platelet
• 2 Channels
impedance aggrego-
metry
ROTEM®
(all-in-one)
30-day incidence of ST and
major bleeding
hyper normal low
ADPtest 31 – 46 AU (patients with DES)
EXTEMMCF45-68mm
FIBTEMMCF8-24mm
EXTEMCT40-80s
Platelet function?
Tranexamic acid
Preconditions
Bleeding patient !
Order Fibrinogen /
Cryo or Platelets ?
Protamine
Fibrinogen (Cryo)
4F-PCC (or FFP)
Platelets
FXIII or rFVIIa ?
Fibrinogen ↑
Surgical bleeding?
1718 2147
(thromboembolic)
• Primary outcome parameter (CON vs. POC):
– PRBC: 5(4/9) vs. 3(2/6); p < 0.001
• Secondary outcome parameter:
– FFP: 5(3/8) vs. 0(0/3); p < 0.001
– PC: 2(0/5) vs. 2(0/2); p = 0.010
– rFVIIa: 0(0/0) vs. 0(0/0); p = 0.001
16
24
16
75
16
2 2
10
20
56
0
20
40
60
80
100
Massive
Transfusion
rFVIIa Rescue
Therapy
Re-exploration Coagulopathy Extubation
within 6 h
CON
POC
p = 0.031
p = 0.002
p = 0.071
p = 0.112
p < 0.001
Incidence of MT, RT, Re-Exploration and Outcomes
20
14
4
0
38
6
2
0 0
8
0
5
10
15
20
25
30
35
40
ARF Sepsis TAE Allergy CAE
CON
POC
p = 0.071
p = 0.059
p = 0.495
p < 0.001
Incidence of adverse events
4%
20%
Pre-program
(2012; n = 1390)
Post-program
(2013; n = 239)
P-value
RBC % 51% 37% < 0.0001
RBC Units 1 (0, 3) 0 (0, 1) < 0.0001
Platelets % 33% 18% < 0.0001
Platelets Units 0 (0, 5) 0 (0, 0) < 0.0001
Plasma % 33% 14% < 0.0001
Plasma Units 0 (0, 2) 0 (0, 0) < 0.0001
Cryo % 4% 2% 0.1
CT drainage (1 hr) 75 (45, 140) 60 (35, 110) 0.001
CT drainage (24 hrs) 460 (350, 640) 410 (315, 565) 0.0006
Discharge Hb 98 (91, 107) 98 (93, 106) 0.5
Keyvan Karkouti, Toronto General, Canada:
Improving Outcomes with Point-of-Care Hemostasis
Testing in Cardiac Surgery: A Pilotstudy
Pre-program
(2012; n = 1390)
Post-program
(2013; n = 239)
P-value
Re-exploration 6.5% 2.5% 0.01
Large-volume RBC
Transfusion (≥ 5 units)
13.2% 5.4% 0.0007
Low output syndrome 2.8% 1.7% 0.3
Renal failure (new-dial.) 1.9% 0.4% 0.1
Atrial fibrillation 34% 39% 0.1
Stroke 2.2% 1.7% 0.6
Sternal infection 1.7% 1.3% 0.6
Death 2.4% 2.1% 0.8
Ventilation time 6.3 (4.7, 12.0) 6.2 (4.4, 10.6) 0.2
ICU LOS 2 (1, 3) 2 (1, 3) 0.6
Hospital LOS 7 (6, 10) 7 (6, 9) 0.2
Keyvan Karkouti, Toronto General, Canada:
Improving Outcomes with Point-of-Care Hemostasis
Testing in Cardiac Surgery: A Pilotstudy
POCT using ROTEM® can assist clinicians in making appropriate
and timely decisions regarding the treatment of bleeding in cardiac
surgery patients.
This allows for more targeted use of blood products, and whether
the decision to transfuse in the first place is warranted.
At The Prince Charles Hosiptal, Brisbane, the use of ROTEM® as
an element in a multi-factorial approach to patient blood
management, has resulted in a decrease in the amount of blood
products transfused during cardiac surgery.
- 39.2%
- 48.3%
$ 928,998
45.4% reduction in in-hospital mortality, 50% reduction in 24h mortality,
and 45.6% reduction in multiple organ failure within 1 year
TRAUMA MANAGEMENT
1B
1A
1C
2C
Cost-effectiveness of ROTEM®-guided
bleeding management
COSTS
OUTCOMES
Increased
costs and
worse
outcomes
Reduced
costs and
worse
outcomes
Increased
costs and
improved
outcomes
Reduced
costs and
improved
outcomes

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Anemo 2014 - Görlinger - Point-Of-Care Testing Efficacy

  • 1. Klaus Görlinger, MD University Hospital Essen, Germany klaus@goerlinger.net Point-of-Care Testing Efficacy ANEMO14, Strategie di Risparmio del Sangue, Policlinico San Donato Milanese, 7-8 Marzo 2014
  • 2. Conflicts of interest • 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 International GmbH, Munich, Germany
  • 4. Transfusion strategies • Formula driven (1:1:1-concept): PRBC - FFP - Platelets - rFVIIa • Lab-driven protocol • Individualized POC-driven: Fibrinogen/Cryo - Plt - PCC/FFP
  • 7.
  • 8. Results: ... Patients arrived in the ICU 6.8 ± 0.3 hours after admission. Coagulopathy, present at hospital admission (pre-ICU INR, 1.8 ± 0.2) persisted at ICU admission (initial ICU INR, 1.6 ± 0.1). ... In the ICU during resuscitation mean INR decreased to 1.4 ± 0.03 within 8 hours, indicating moderate coagulopathy. ... The ratio of FFP:PRBC was 1:1. ... Statistical analysis found severity of coagulopathy (INR) at ICU admission associated with survival outcome (p = 0.02). 1:1 → 14.8 hours to achieve an INR < 1.5 !
  • 9. CONCLUSION: MTP (massive transfusion protocol with 1:1:1 ratio) therapy worsened mortality in penetrating MOI (mechanism of injury) patients receiving 10U or more RBC, indicating a continued need for TEG-directed therapy. A 1:1:1 strategy may not be adequate in all patients.
  • 10.
  • 11. ROTEM® analysis enables rapid detection of most coagulation disorders; this study demonstrates the additional benefit of MT risk stratification using results available within 10 minutes after CT (FIBTEM® A10).
  • 12. Avoid FFP transfusion (potential harmful)! Treat trauma-induced coagulopathy early!
  • 13.
  • 14.
  • 15. Why does the patient bleed ?
  • 16.
  • 17. Standard coagulation test results were available after a median of 53 min [inter-quartile range (IQR): 45–63 min], whereas 10 min values of ROTEM results were available online after 23 min (IQR: 21–24 min). Further time saving was 11 minutes (8-16 minutes) if ROTEM® measurements were performed bedside (p<0.001).
  • 18.
  • 19.
  • 20. Fibrinogen deficiency Thrombocyto- penia Fibrinolysis sensitive to aprotinin / TXA CF deficiency intrinsic pw CF deficiency extrinsic pw Heparin effect Fibrinogen / Cryoprecipitate Platelet concentrate Tranexamic acid PCC Protamine FFP
  • 21. EXTEM cut-off (Sens/Spec): CFT < 51 s (89/94) MCF > 68 mm (94/94) TPI > 3.5 (100/93) FIBTEM cut-off (Sens/Spec): MCF > 24 mm (77/88)
  • 22. ROTEM® delta • 4 Channels viscoelastic tests ROTEM® platelet • 2 Channels impedance aggrego- metry ROTEM® (all-in-one)
  • 23. 30-day incidence of ST and major bleeding hyper normal low
  • 24. ADPtest 31 – 46 AU (patients with DES) EXTEMMCF45-68mm FIBTEMMCF8-24mm EXTEMCT40-80s
  • 25.
  • 26. Platelet function? Tranexamic acid Preconditions Bleeding patient ! Order Fibrinogen / Cryo or Platelets ? Protamine Fibrinogen (Cryo) 4F-PCC (or FFP) Platelets FXIII or rFVIIa ? Fibrinogen ↑ Surgical bleeding?
  • 29.
  • 30. • Primary outcome parameter (CON vs. POC): – PRBC: 5(4/9) vs. 3(2/6); p < 0.001 • Secondary outcome parameter: – FFP: 5(3/8) vs. 0(0/3); p < 0.001 – PC: 2(0/5) vs. 2(0/2); p = 0.010 – rFVIIa: 0(0/0) vs. 0(0/0); p = 0.001
  • 31. 16 24 16 75 16 2 2 10 20 56 0 20 40 60 80 100 Massive Transfusion rFVIIa Rescue Therapy Re-exploration Coagulopathy Extubation within 6 h CON POC p = 0.031 p = 0.002 p = 0.071 p = 0.112 p < 0.001 Incidence of MT, RT, Re-Exploration and Outcomes
  • 32. 20 14 4 0 38 6 2 0 0 8 0 5 10 15 20 25 30 35 40 ARF Sepsis TAE Allergy CAE CON POC p = 0.071 p = 0.059 p = 0.495 p < 0.001 Incidence of adverse events
  • 34.
  • 35. Pre-program (2012; n = 1390) Post-program (2013; n = 239) P-value RBC % 51% 37% < 0.0001 RBC Units 1 (0, 3) 0 (0, 1) < 0.0001 Platelets % 33% 18% < 0.0001 Platelets Units 0 (0, 5) 0 (0, 0) < 0.0001 Plasma % 33% 14% < 0.0001 Plasma Units 0 (0, 2) 0 (0, 0) < 0.0001 Cryo % 4% 2% 0.1 CT drainage (1 hr) 75 (45, 140) 60 (35, 110) 0.001 CT drainage (24 hrs) 460 (350, 640) 410 (315, 565) 0.0006 Discharge Hb 98 (91, 107) 98 (93, 106) 0.5 Keyvan Karkouti, Toronto General, Canada: Improving Outcomes with Point-of-Care Hemostasis Testing in Cardiac Surgery: A Pilotstudy
  • 36. Pre-program (2012; n = 1390) Post-program (2013; n = 239) P-value Re-exploration 6.5% 2.5% 0.01 Large-volume RBC Transfusion (≥ 5 units) 13.2% 5.4% 0.0007 Low output syndrome 2.8% 1.7% 0.3 Renal failure (new-dial.) 1.9% 0.4% 0.1 Atrial fibrillation 34% 39% 0.1 Stroke 2.2% 1.7% 0.6 Sternal infection 1.7% 1.3% 0.6 Death 2.4% 2.1% 0.8 Ventilation time 6.3 (4.7, 12.0) 6.2 (4.4, 10.6) 0.2 ICU LOS 2 (1, 3) 2 (1, 3) 0.6 Hospital LOS 7 (6, 10) 7 (6, 9) 0.2 Keyvan Karkouti, Toronto General, Canada: Improving Outcomes with Point-of-Care Hemostasis Testing in Cardiac Surgery: A Pilotstudy
  • 37. POCT using ROTEM® can assist clinicians in making appropriate and timely decisions regarding the treatment of bleeding in cardiac surgery patients. This allows for more targeted use of blood products, and whether the decision to transfuse in the first place is warranted. At The Prince Charles Hosiptal, Brisbane, the use of ROTEM® as an element in a multi-factorial approach to patient blood management, has resulted in a decrease in the amount of blood products transfused during cardiac surgery.
  • 38. - 39.2% - 48.3% $ 928,998
  • 39.
  • 40.
  • 41.
  • 42. 45.4% reduction in in-hospital mortality, 50% reduction in 24h mortality, and 45.6% reduction in multiple organ failure within 1 year TRAUMA MANAGEMENT
  • 43.
  • 45. Cost-effectiveness of ROTEM®-guided bleeding management COSTS OUTCOMES Increased costs and worse outcomes Reduced costs and worse outcomes Increased costs and improved outcomes Reduced costs and improved outcomes