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Special Lecture: Patient Blood Management EORTC 03-2015 Madrid Dr. rer. medic. Axel Hofmann, ME Visiting Professor | Institute of Anaesthesiology University Hospital Zurich - Switzerland Adjunct Associate Professor | School of Surgery Faculty of Medicine Dentistry and Health Sciences University of Western Australia Adjunct Professor | Faculty of Health Sciences Curtin University Western Australia Bangkok 10-2013

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Special Lecture:

Patient Blood Management

EORTC 03-2015 Madrid

Dr. rer. medic. Axel Hofmann, ME

Visiting Professor | Institute of Anaesthesiology

University Hospital Zurich - Switzerland

Adjunct Associate Professor | School of Surgery

Faculty of Medicine Dentistry and Health Sciences

University of Western Australia

Adjunct Professor | Faculty of Health Sciences

Curtin University Western Australia

Bangkok 10-2013

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EORTC 03-2015 Madrid

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Blood Management

Patient Blood Management

(PBM)

DonorBlood Management

EORTC 03-2015 Madrid

The rationale behind PBM is that optimal clinical outcomes can be achieved when the optimization and preservation of a patient’sown blood takes priority over the transfusion of donor blood

GGombotz, H., Hofmann Patient Blood Management – A Concept to Improve Patient Safety and Outcome in A.Gombotz, H., Zacharowski, K.,

Spahn, D. Patient Blood Management, 2nd Edition, 2015 Georg Thieme Verlag KG

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EORTC 03-2015 Madrid

BleedingAnaemiaand ID

Two Conditions of Clinical Significance

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EORTC 03-2015 Madrid

Highest prevalence of all

diseases worldwide, caused by• absolute iron deficiency (50% of

all causes)

• functional iron deficiency

• severe hemorrhage

• chemotherapy (CIA) and/or

radiation

• medication

• congenital disorders

• other

BleedingAnaemiaand ID

Two Conditions of Clinical Significance

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EORTC 03-2015 Madrid

Highest prevalence of all

diseases worldwide, caused by• absolute iron deficiency (50% of

all causes)

• functional iron deficiency

• severe hemorrhage

• chemotherapy (CIA) and/or

radiation

• medication

• congenital disorders

• other

BleedingAnaemiaand ID

Two Conditions of Clinical Significance

Very high prevalence

caused by• local surgical or vessel interruption

• therapeutic and diagnostic

interventions

• trauma

• anticoagulant drugs

• obstetric complications

• congenital disorders

• other

related

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EORTC 03-2015 Madrid

1

Problem

Anemia & ID

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Anemia Prevalence in Surgical Populations

EORTC 03-2015 Madrid

Type of surgery Prevalence of

pre-operative anaemia (%)

Elective surgery1 19–75

Cardiac surgery1,6 24-26

Non-cardiac surgery2,7 30-40

Orthopaedic surgery1,3-5 19–38

Colorectal surgery5 70

1. Gombotz H, Rehak PH, Shander A, Hofmann A. Blood use in elective surgery: the Austrian benchmark study. Transfusion 2007;47:1468–80.2. Beattie AS, Karkouti K, Wijeysundera DN, Tait G. Risk associated with pre-operative anemia in noncardiac surgery. Anesthesiology 2009;110:574–81.3. Saleh E, McClelland DBL, Hay A, Semple D, Walsh TS. Prevalence of anaemia before major joint arthroplasty and the potential impact of pre-operative

investigation and correction on peri-operative blood transfusions. Br J Anaesth 2007;99:801–8.4. Carson JL, Duff A, Berlin JA, et al. Peri-operative blood transfusion and post-operative mortality. JAMA 1998;279:199–205.5. Auerbach M, Goodnough LT, Picard D, Maniatis A. The role of intravenous iron in anemia management and transfusion avoidance. Transfusion 2008;48:988–10006. Karkouti, K., D.N. Wijeysundera, and W.S. Beattie, Risk associated with preoperative anemia in cardiac surgery: a multicenter cohort study. Circulation, 2008.

117(4): p. 478-84 7. Musallam, K.M., et al., Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet, 2011.

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Independent

Risk Factor

for

AdverseOutcomes

Anemia

& Iron

Deficiency

EORTC 03-2015 Madrid

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Independent

Risk Factor

for

AdverseOutcomes

Anemia

& Iron

Deficiency

Anaemia independently associated with increased:

• morbidity

• hospital length of stay

• Mortality

• likelihood of transfusion (2-9 fold) Mussallam KM et al. Lancet 2011

Spahn DR. Anesthesiology 2010; 113(2) 1-14

Beattie WS, et al Anesthesiology 2009; 110(3) 574-81

Dunne JR, et al J Surg Res 2002; 102: 237-44

Shander A. Am J Med 2004; 116(7A) 58S-69S

EORTC 03-2015 Madrid

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EORTC 03-2015 Madrid

2

Problem

Blood Loss & Bleeding

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Independent

Risk Factor

for

AdverseOutcomes

Blood Loss

&

Bleeding

EORTC 03-2015 Madrid

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Independent

Risk Factor

for

AdverseOutcomes

Blood Loss

&

Bleeding

Bleeding associated with increased

• Morbidity

• ICU and hospital length of stay

• Mortality

• Elective & emergency surgery ~0.1%

• Subgroups:

• Vascular 5–8%

• Up to 20% with severe bleeding

• Major organ damage 30–40%

Causes

• On average 75 – 90% local surgical interruption or vessel

interruption

• 10–25% acquired or congenital coagulopathy

Shander A. Surgery 2007

Vivacqua et al Ann Thorac Surg 2011

Christensen et al J Thorac Cardiovasc Surg 2009

Spence et al Am J Surg 1990

Stokes, M.E., et al BMC Health Serv Res, 2011

Ye, X., et al BMC Health Serv Res, 2013

Alstrom, U., et al Br J Anaesth, 2012

EORTC 03-2015 Madrid

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Independent

Risk Factor

for

AdverseOutcomes

Blood Loss

&

Bleeding

EORTC 03-2015 Madrid

Anemia

& Iron

Deficiency

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EORTC 03-2015 Madrid

For decades RED BLOOD CELL TRANSFUSION

was considered theoptimal treatment for anemia and bleeding

How to Fix Anemia and Bleeding?

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EORTC 03-2015 Madrid

How to Fix Anemia and Bleeding?

STOP and evaluateoutcome data!

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EORTC 03-2015 Madrid

Blood transfusion was the most common procedureperformed during hospitalizations in 2011 (12 percentof stays with a procedure); the rate of hospitalizationswith blood transfusion more than doubled since 1997.

http://www.hcup-us.ahrq.gov/reports/statbriefs/sb165.pdf

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EORTC 03-2015 Madrid

3

Problem

Transfusion andOutcome

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Independent

Risk Factor

for

AdverseOutcomes

Transfusion

Large observational studies show RBC txn is

independently associated in a dose-

dependent relationship with

•Morbidity

•ALOS

•Mortality

Shaw et al. Transfusion 2014

Parsons J et al. Crit Care 2013

Horvath K et al. Ann Thorac Surg 2013

Linder et al. BJU Int 2013

Al-Refaie et al Surgery 2012

Ferraris V et al. Arch Surg 2012

Paone G et al. J Thorac Cardiovasc Surg 2012

Bhaskar B et al. Ann Thorac Surg 2012

Stone GW et al. Am Heart J 2012

Xenos et al. Thromb Res 2012

Ferraris et al. Ann Thorac Surg 2011

Glance L et al. Anesthesiol 2011

Ranucci M et al. J Thorac Cardiovas Surg 2011

Haijar LA et al. JAMA 2010

Beattie et al. Anesthesiology 2009

Bernard et al. J Am Coll Surg 2009

Bursi et al. Eur J Vasc Endovasc Surg 2009

Chaiwat O et al. Anesthesiology 2009

Karkouti et al. Circulation 2009

Gauvin et al Transfusion 2008

Scott BH et al. Ann Card Anaesth 2008

Salim A et al. J Am Coll Surg 2008

Ho et al. Spine 2007

Kulier A, et al. Circulation 2007

Murphy GJ, et al. Circulation 2007

Bernard AC, et al J Am Coll Surg 2008

Banbury MK et al. J Am Coll Surg 2006

Jagoditsch et al. Dis Colon Rectum 2006

Koch et al. Ann Thorac Surg 2006

Koch et al. Crit Care Med 2006

Rogers et al. Am Heart J 2006

Surgenor SD, et al Circulation 2006

Taylor RW et al. Crit Care Med 2006

Leal-Noval et al. Anesthesiology 2003

Malone DL et al. J Trauma 2003

Chelemer et al. Ann Thorac Surg 2002

Dunne et al. J Surg Res 2002

Chang et al. Vox Sang 2000

Vignali et al. Vox Sang 1996 EORTC 03-2015 Madrid

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Independent

Risk Factor

for

AdverseOutcomes

Transfusion

Large observational studies show RBC txn is

independently associated in a dose-

dependent relationship with

•Morbidity

•ALOS

•Mortality

Shaw et al. Transfusion 2014

Parsons J et al. Crit Care 2013

Horvath K et al. Ann Thorac Surg 2013

Linder et al. BJU Int 2013

Al-Refaie et al Surgery 2012

Ferraris V et al. Arch Surg 2012

Paone G et al. J Thorac Cardiovasc Surg 2012

Bhaskar B et al. Ann Thorac Surg 2012

Stone GW et al. Am Heart J 2012

Xenos et al. Thromb Res 2012

Ferraris et al. Ann Thorac Surg 2011

Glance L et al. Anesthesiol 2011

Ranucci M et al. J Thorac Cardiovas Surg 2011

Haijar LA et al. JAMA 2010

Beattie et al. Anesthesiology 2009

Bernard et al. J Am Coll Surg 2009

Bursi et al. Eur J Vasc Endovasc Surg 2009

Chaiwat O et al. Anesthesiology 2009

Karkouti et al. Circulation 2009

Gauvin et al Transfusion 2008

Scott BH et al. Ann Card Anaesth 2008

Salim A et al. J Am Coll Surg 2008

Ho et al. Spine 2007

Kulier A, et al. Circulation 2007

Murphy GJ, et al. Circulation 2007

Bernard AC, et al J Am Coll Surg 2008

Banbury MK et al. J Am Coll Surg 2006

Jagoditsch et al. Dis Colon Rectum 2006

Koch et al. Ann Thorac Surg 2006

Koch et al. Crit Care Med 2006

Rogers et al. Am Heart J 2006

Surgenor SD, et al Circulation 2006

Taylor RW et al. Crit Care Med 2006

Leal-Noval et al. Anesthesiology 2003

Malone DL et al. J Trauma 2003

Chelemer et al. Ann Thorac Surg 2002

Dunne et al. J Surg Res 2002

Chang et al. Vox Sang 2000

Vignali et al. Vox Sang 1996 EORTC 03-2015 Madrid

RCTs and meta-analyses therof show that liberal

transfusion strategies appear to offer no benefit but result

in increased adverse patient outcomes.

Carson et al. Cochrane Review 2012

Salpeter et al. Am J Med 2014

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Triad of

Independent

Risk Factors

for

Adverse Outcomes

Anemia

& Iron

Deficiency

Blood Loss

&

Bleeding

Transfusion

Farmer SL., et al. Best Pract Res Clin Anaesthesiol, 2013. 27(1): p. 43-58Gombotz, H., Hofmann Patient Blood Management – A Concept to Improve Patient Safety and Outcome in A.Gombotz, H., Zacharowski,

K., Spahn, D. Patient Blood Management, 2nd Edition, 2015 Georg Thieme Verlag KG.

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Triad of

Independent

Risk Factors

for

Adverse Outcomes

Anemia

& Iron

Deficiency

Blood Loss

&

Bleeding

Transfusion

Farmer SL., et al. Best Pract Res Clin Anaesthesiol, 2013. 27(1): p. 43-58Gombotz, H., Hofmann Patient Blood Management – A Concept to Improve Patient Safety and Outcome in A.Gombotz, H., Zacharowski,

K., Spahn, D. Patient Blood Management, 2nd Edition, 2015 Georg Thieme Verlag KG.

Induces or

exacerbates

anemia

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Triad of

Independent

Risk Factors

for

Adverse Outcomes

Anemia

& Iron

Deficiency

Blood Loss

&

Bleeding

Transfusion

Farmer SL., et al. Best Pract Res Clin Anaesthesiol, 2013. 27(1): p. 43-58Gombotz, H., Hofmann Patient Blood Management – A Concept to Improve Patient Safety and Outcome in A.Gombotz, H., Zacharowski,

K., Spahn, D. Patient Blood Management, 2nd Edition, 2015 Georg Thieme Verlag KG.

Restellini S, AP&T 2012Hearnshaw SA, et al Aliment Pharmacol Ther 2010Blair SD, et al Br J Surg 1986

Induces or

exacerbates

anemia

Triggers

transfusion

Associated w/ increased

rebleeding

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EORTC 03-2015 Madrid

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EORTC 03-2015 Madrid

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Optimise

red cell

mass

Minimise

blood loss

& bleeding

Harness &

optimise

physio-

logical

reserve of

anaemia

Anemia,

Iron

Deficiency

Blood Loss

&

Bleeding

Transfusion

EORTC 03-2015 Madrid

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Optimise

red cell

mass

Minimise

blood loss

& bleeding

Harness &

optimise

physio-

logical

reserve of

anaemia

Blood Loss

&

Bleeding

Transfusion

EORTC 03-2015 Madrid

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Optimise

red cell

mass

Minimise

blood loss

& bleeding

Harness &

optimise

physio-

logical

reserve of

anaemia

Transfusion

EORTC 03-2015 Madrid

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Optimise

red cell

mass

Minimise

blood loss

& bleeding

Harness &

optimise

physio-

logical

reserve of

anaemia

EORTC 03-2015 Madrid

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2nd Pillar

Minimise blood loss

& bleeding

3rd Pillar

Harness & optimise

physiological

reserve of anaemia

• Optimise erythropoiesis

• Be aware of drug interactions that can

increase anaemia

• Vigilant monitoring and management of

post-operative bleeding

• Avoid secondary haemorrhage

• Rapid warming / maintain normothermia

(unless hypothermia specifically

indicated)

• Autologous blood salvage

• Minimise iatrogenic blood loss

• Haemostasis/anticoagulation

management

• Prophylaxis of upper GI haemorrhage

• Avoid/treat infections promptly

• Be aware of adverse effects of medication

• Time surgery with haematological

optimisation

• Optimise cardiac output

• Optimise ventilation and oxygenation

• Identify and manage bleeding risk

• Minimise iatrogenic blood loss

• Procedure planning and rehearsal

• Assess/optimise patient’s physiological

reserve and risk factors

• Compare estimated blood loss with

patient-specific tolerable blood loss

• Formulate patient-specific management

plan using appropriate blood

conservation modalities to minimise

blood loss, optimise red cell mass and

manage anaemia

1st Pillar

Optimise red cell mass

Perioperative multidisciplinary multimodal patient-specific team approach

PR

EO

PIN

TR

AO

PP

OS

TO

P

Hofmann et al. Current Opinions in Anaesthesiology 2012

• Detect anaemia

• Identify underlying disorder(s) causing

anaemia

• Manage disorder(s)

• Refer for further evaluation if necessary

• Treat suboptimal iron stores/iron

deficiency/anaemia of chronic

disease/iron-restricted erythropoiesis

• Treat other haematinic deficiencies

• Note: Anaemia is a contraindication for

elective surgery

• Meticulous haemostasis and surgical

techniques

• Blood-sparing surgical devices

• Anaesthetic blood conserving strategies

• Autologous blood options

• Maintain normothermia

• Pharmacological/haemostatic agents

• Optimise anaemia reserve

• Maximise oxygen delivery

• Minimise oxygen consumption

• Avoid/treat infections promptly

• Restrictive transfusion thresholds

EORTC 03-2015 Madrid

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The Rationale of Patient Blood Management

“PBM ... preempts and significantly reduces the resort to transfusions by addressing modifiable risk factorsthat may result in transfusion long before a transfusion may even be considered“

EORTC 03-2015 Madrid

Hofmann A, Shander A, Farmer S. Five Drivers Shifting the Paradigm from Product Focused Transfusion Practice to Patient Blood Management. Oncologist. 2011;16. (suppl3):3-11

BleedingAnaemiaand ID

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2008Government of Western Australia

World’s First Statewide PBM Program

EORTC 03-2015 Madrid

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“The WA PBMP is the first proposed on a jurisdictionalsystem-wide basis“

EORTC 03-2015 Madrid

Farmer SF et al. Drivers for change: Western Australia Patient Blood Management Program (WA PBMP), World HealthAssembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA). Best Pract Res Clin Anaesthesiol

2013;27(1): in press

“… the Government of Western Australia is to be congratu-lated ... to sustainably implement patient blood management. ... they are leading the world in the battle against unnecessary erythrocyte transfusions and their burden—financially and in terms of morbidity and mortality.“

Spahn et al. Patient blood management: the pragmatic solution for the problems with blood transfusions. Anesthesiology, 2008. 109(6): p. 951-3.

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15

20

25

30

35

40

45

50

2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13 2013-14

Unit

s is

sued

per

1,0

00 p

opula

tion

Financial year

RBC Issuance Comparison between Australia's Five Largest Jusrisdictions2006/07-2013/14

NSW

QLD

SA

VIC

WA

Implementation of WA PBM program

Source: National Blood Authority, 2014

EORTC 03-2015 Madrid

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0

1

2

3

4

5

6

7

8

9

10

2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13 2013-14

Un

its

issu

ed

pe

r 1

,00

0 p

op

ula

tio

n

Financial year

Platelet Issuance Comparison between Australia's Five Largest Jusrisdictions2006/07-2013/14

NSW

QLD

SA

VIC

WA

Source: National Blood Authority, 2014

Implementation of WA PBM program

EORTC 03-2015 Madrid

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0

1

2

3

4

5

6

7

8

9

10

2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13 2013-14

Un

its

issu

ed

pe

r 1

,00

0 p

op

ula

tio

n

Financial year

FFP Issuance Comparison between Australia's Five Largest Jusrisdictions2006/07-2013/14

NSW

QLD

SA

VIC

WA

Source: National Blood Authority, 2014

Implementation of WA PBM program

EORTC 03-2015 Madrid

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2010Geneva, Switzerland

World Health Assembly

EORTC 03-2015 Madrid

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EORTC 03-2015 Madrid

WHA63.12 adoptedby resolution May 21, 2010:

„Bearing in mind that patient blood management means that before surgery every reasonable measure should be taken to optimize the patient’s own blood volume, to minimize the patient’s blood loss and to harness and optimize the patient-specific physiological tolerance of anaemia following WHO’s guide for optimal clinical use (three pillars of patient blood management)“

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2011Dubai, UAE

WHO Global Forum on Patient Blood Management

EORTC 03-2015 Madrid

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EORTC 03-2015 Madrid

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2011Canberra, Australia

National Blood Authority

EORTC 03-2015 Madrid

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EORTC 03-2015 Madrid

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EORTC 03-2015 Madrid

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EORTC 03-2015 Madrid

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“The establishment of coordinated patient blood management programs will help organisations to attain accreditation against national standards such as the new Blood and Blood Products Standard developed by the Australian Commission on Safety and Quality in Health Care.”

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2014European Commission

PBM Pilot Project

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4

PBM

Results

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Transfused RBCs per Admissions in the Eight Largest Public Austrian Hospitals (Admissions w/ >0 ALOS)

0,150

0,200

0,250

0,300

0,350

0,400

0,450

0,500

0,550

2004 2005 2006 2007 2008 2009 2010 2011

RB

Cs

pe

r A

dm

issi

on

Year

A

B

C

D

E

F

G

Linz AKH (mit PBMProgramm)

Bekanntgabe der Ergebnisse der österreichischen Benchmark Studie zum Verbrauch von Blutprodukten an öffentlichen Krankenhäusern

Gombotz, H. and A. Hofmann. Patient Blood Management: three pillar strategy to improve outcome through avoidance of allogeneic blood products. Anaesthesist, 2013. 62(7): p. 519-27.

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General Hospital Linz w/ PBM Program

Publication of the results of the Austrian Benchmark Study(blood utilization in public hospitals)

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Source: National Blood Authority, 2014; Paul Ehrlich Institut, Germany

0

10

20

30

40

50

60

2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13 2013-14

Un

its

issu

ed

pe

r 1

.00

0 p

op

ula

tio

n

Year(Australia and WA finacial year 2013-14, Germany calender year 2013)

RBC Issuance Comparison between Germany, Australia and WA 2004-2013

WA

Australia

Germany

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Benefits of PBM Programs

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reduction up to 43%

reduction of composite morbidity up to 41%,and infection rate up to 80%

reduction up to 68%

reduction by 16-33%Average LOSA

AeadmissionsR

A omplicationsC

ortalityM

A ostsC reduction by 10-24%

Frank 2014; Freedman 2014; Lapar 2013; Kotze 2012; Moskowitz 2010; Reddy 2009; Brevig 2009; Ferraris 2007; Wong 2007; Ghiglione 2007; Freedman

2007; Martinez 2007; DeAnda 2006; Freedman 2005; Pierson 2004; Green 2004; Kourtzis 2004; Morgan 2004; Slappendel 2003; Van der Linden 2001;

Helm 1998

reduction by 10 - 95%ransfusionT

AeoperationR reduction up to 43%

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Safety

Mortality & Morbidity ALOS Health Care $$$

Problem:

Solution:

Benefit:

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1. Too much unnecessary care

2. Avoidable harm to patients

3. Billions of dollars wasted

4. Perverse incentives in how we pay for care

5. Lack of transparency

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All addressed by PBM