Strategies to Decrease Blood Utilization and Improve Safety

Presented byPaul McLoone, M.D.

April 17, 2012

History of RBC transfusion “triggers”

• To mid-1980s: 10 g/dL hemoglobin

• Conservative trend in 1980s and ff.– TTDs (HIV and NANB hepatitis (HCV))

–Shortages–Evidence that anemia is well tolerated–Non-infectious serious hazards–Threats from emerging infections

How are triggers “set”?• Guidelines and systematic reviews• Few RCTs (garbage in, garbage out)

–Observational cohorts, case series, expert opinion

–Unstudied populations affect generalizability–Key functional outcomes generally not

available

~16 million RBCs transfused annually

Why?– Prevent/reverse tissue ischemia

• Preserve aerobic metabolism

• Decrease cardiac effects of anemia

• Decrease symptoms of anemia

– “Anemia is bad”

– “May help, will not hurt”

~16 million RBCs transfused annually• Why not ????

– TRALI (transfusion-related acute lung injury) – TACO (circulatory overload)– TRIM (immunomodulation)– Vasoregulatory abnormalities– Immunohematological events– TTIs: Known and emerging– TA-GVHD (graft v. host disease)– Dollar costs

“Recognized” risks of transfusion010-110-210-310-4 1010-510-610-710-8

HIV

HCV

HBV

Mistransfusion

GVHD

TACO (CHF)

TSACs/unit RBC/US ICUs

Bacteria in platelets

Modified from S. Dzik, MD Blood Transfusion Service MGH, Boston.

Zilberberg, M. BMC Health Services Res. 2007.

Death from medical error

Death from general anesthesia

TRALI

Death from hosp. infect.

Global Red Cell Utilization Rates: 2008-09

Venez

uela

Brazil

South

Africa

Singap

ore

Saudi-

Arabia

Poland

Hong K

ong

New Zea

land

Canad

a CBS

Canad

a Hem

a-Que

bec

Irelan

dSpa

in

Netherl

ands

²⁾Croa

tia

France

UK NHSBT ¹

⁾

Portug

al

Austra

lia

Hunga

ryIta

ly

Norway

Japa

n

Finlan

dUSA

Sweden

Austria

Belgium

Flande

rs

German

y0

10

20

30

40

50

60

RBCs

per

1,0

00 P

opul

atio

n

Source: D Devine et al.: International Forum/Inventory Management, Vox Sanguinis 2009

Costs of surgical RBC transfusion

New Jersey

Rhode Island

Switzerland

Austria

$0 $200 $400 $600 $800 $1,000 $1,200

$248

$203

$194

$154

$1,183

$726

$611

$522 Activity-based costRBC acquisition cost

Shander et al. Transfusion. 2010.

Paradox: anemic patients may do better without transfusion: TRICC*

• Multicenter, randomized trial in >800 patients with <9 gram Hgb within 72 h. of ICU admit

• Liberal vs. restrictive PRBC triggers

– Restrictive = <7 gm, Liberal = <10 gm

• Mortality endpoints and severity of organ dysfunction

*Transfusion Requirements In Critical Care. Hebert et al. NEJM. 1999.

TRICC: Primum non nocere?Restrictive (7 gm) Liberal (10 gm)

n=418 % n=420 % p

Mortality

30 day 78 18.7 98 23.3 .11

60 day 95 22.7 111 26.5 .23

Hospital 93 22.2 118 28.1 .05

Length of stay

ICU 11.010.7 11.5 11.3 .53

Hospital 34.8 19.5 35.5 19.4 .58

“A restrictive strategy of red-cell transfusion is at least as effective as and possibly superior to a liberal transfusion strategy in critically ill patients.” Hebert et al. NEJM. 1999.

TRICC: Post hoc analysis of pts. with cardiovascular disease

Restrictive (7 gm) Liberal (10 gm)N=160 N=197

30 day mortality 23% 23%

MODS change from baseline 0.2±4.2 1.3±4.4 p<.02

Mean Hgb 8.5 ±0.62 10.3 ±0.67Mean units transfused 2.4 ±4.1 5.2 ±5.0

Hebert, P et al. Crit. Care Med. 2001

TRICC: Post hoc analysis of ventilated pts.

Restrictive (7 gm)N=357

Liberal (10 gm)N=356

Mean vent days 8.3 ±8.1 8.8 ±8.7

Mean vent free days 17.9 ±10.9 16.1 ±11.4

Successful weaning 82% 78%

Mean Hgb 8.4 ±0.62 10.4 ±0.71

Mean units transfused 2.7 ±4.0 5.5 ±5.1

Hebert, P et al. Chest. 2001

FOCUS*: Surgery for hip fracture• RCT: 2016 patients: liberal (10 g) vs. conservative

(<8 g or symptoms) RBC trigger• Heart disease or risk for heart disease (CAD, CHF,

PVD, CVA, DM, BP, lipids, or CRF)• 1 outcomes: Death or inability to cross room

unassisted at 60 d.• 2 outcomes: 60 d. mortality, fatigues, falls,

readmission, functional status*Functional Outcomes in Cardiovascular patients Undergoing Surgical hip fracture repair (clinicaltrials.gov NCT00071032 )

FOCUS results Liberal trigger(n=1008)

Restrictive trigger(n=1005)

Units transfused 1866(97% transf.)

652(41.5% transf.)

Median units 2 (IQ 1-2) 0 (IQ 0-1)

1 outcome 35% 35%

60 day mortality 7.6% 6.5%

In-hosp MI, unstab angina, death 4.3% 5.2%

Readmit, fall, fatigue, function No differences

Carson et al. AHA Scientific Session and ASH Late Breaking Abstracts. 2009.

Why are restrictive triggers appropriate?primum non nocere

• SHOTs woefully under-reported

• Description of putative “new” serious hazards

– Pro-inflammatory– Immunosuppressive

• Large prospective trials (TRICC, TRIPICU, PINT, FOCUS, TRACS) demonstrate outcomes at least as good using restrictive triggers

• Positive impact of liberal triggers on functional outcomes not demonstrated in (FOCUS)

• Activity costs of transfusion

Changing Physician Practice• Continue Education Event: Dr. Katz

MVRBC Medical Director• Medical Staff Performance Improvement

Committee ( ownership of process)• Metrics, as close to real time as possible• Order set development• Medical Executive Committee• Ongoing presentations to multiple groups

Caveat emptor• Retrospective nature of project

– Data are as reliable as our ability to find information in the medical record

– Confounders (e.g. cardio-respiratory compromise, severity of illness were not systematically sought)

– Acuity of operative bleeding not readily assessed

– DRG and many ICD-9 numbers too small for meaningful analysis

– Denominators vary from year to year

Trinity RBC audits• Descriptive manual chart audit of RBC units given

during 1st quarter of 2009 and 2011• Recorded ordering physician and specialty• Hemoglobin on admission, at time of 1st order (i.e.

“transfusion trigger”) and after transfusion• Documentation of bleeding in medical record• Initial data presented to various constituencies

after intial audit with recommendations• Trinity ongoing intervention (Marvis et al)

13121110987654321

18

16

14

12

10

8

6

4

2

0

HOSPITAL ID

Gra

ms

TRICCFocus

Hemoglobin triggers (all) by hospital

12111098765321

13

12

11

10

9

8

7

6

5

4

HOSPITAL ID

Gra

ms

FOCUS

Trigger by hospital: operative blood loss

121110987654321

15.0

12.5

10.0

7.5

5.0

HOSPITAL ID

Gra

ms

TRICC

Trigger by hospital: nonbleeding

21181512963

400

300

200

100

0

211815129631st Audit

Units 1st order

2nd audit

Units in first order

1st Audit 2nd audit

ORTSUR

CARCVSERFPGIIMOBGONC

Category

Ordering specialty

Transfusion in total hip arthroplastyMVRBC blood management program

totals for audited quarterHospital ID # THA # THA

transfused%

transfused 95% CI

1 26 15 57.7 36.9-76.6

2 52 23 44.2 30.5-58.7

7 52 20 38.5 25.3-53.0

8 26 12 46.2 26.6-66.6

10 53 21 39.6 26.4-54.02=.67 p=.96

Hospital ID # TKA # TKA transfused

% transfused 95% CI

1 77 19 24.7 15.6-35.8

2 124 31 25.0 17.7-33.6

7 105 37 35.2 26.2-45.2

8 55 25 45.5 32.0-59.5

10 139 56 40.3 32.1-48.9

2=13.2 p=0.010

Transfusion in total knee arthroplastyMVRBC blood management program

totals for audited quarter

Transfusion rates in orthopedicsReference Population Percent transfused

Hasley et al. Med Care. 1995.

Range among hospitals (THA and TKA)

THA 36-95 TKA 9-97

Carson et al. JAMA. 1998.

8787 consecutive hip fractures 42.1

Pedersen et al. BMC MS. 2010.

28087 consecutive Danish THA 1999-2007 32.3

Wong et al. Transfusion. 2007.

THA at 30 hospitals randomized UC or BCA

Usual care 26.1 BCA 16.5

Muller et al. BMJ. 2004.

425 THA & TKA before/after decision support flow sheet

Before 39.9 After 19.8

Martinez et al. BJAnes. 2007.

475 THA and TKA before/after algorithm

Total 55 to 24Allo 21 to 13

Auto 32 to 12 Allo+Auto 8 to 0

Pierson et al. JBJS. 2004.

Single surgeon 500 consec. THA/TKA on/off algorithm

On (433) 2.1 Off (67) 16.4

1211109876543

99.99

9995

80

50

20

51

0.01

Trigger hemoglobin

Per

cent

5.515

18.084

TRICC

1st Audit2nd audit

Audit burden for non-bleeding patients: Trinity

Conclusions• Non-bleeding patients still receiving 1st units at well above “TRICC-

validated” thresholds, but appear to have improved• Operative bleeding is transfused above FOCUS thresholds• Single unit transfusions should be encouraged

– Probably requires “rules”• Concurrent analysis of non-bleeding patients and patients with

operative bleeding may reduce transfusion of RBCs– Establish clinical guidelines for broad clinical groups– Medical staff buy in is an ongoing effort in multiple settings over

time– Enlist clinical champions for that process and for the remedial efforts– Close to real time analysis of outliers– Frequent reports comparing apples to apples