Manchest er and Lancast er Regional FFP Elizabet h Love Nort h - - PowerPoint PPT Presentation

Manchest er and Lancast er Regional FFP

Elizabet h Love Nort h West England and Nort h Wales RTC Educat ion symposium 16 April 2006

Guidelines f or t he use of f resh- cryosupernat ant

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ht t p:/ / www.bcshguidelines.com/ pdf / f reshf rozen_28

I ndicat ion codes derived f rom BCSH guidelines

F1 Single coagulat ion f act or def iciencies/ f act or concent rat e unavailable (Fact or V) F2 I mmediat e reversal of warf arin in presence of severe bleeding (not def ined) PCC pref erred. F3 Acut e DI C, bleeding, abnormal coagulat ion t est s F4 Thrombot ic t hrombocyt openic purpura (Solvent det ergent -t reat ed FFP pref erred) F5 Massive t ransf usion, guided by t imely clot t ing t est s including POCT Liver disease: prolonged PT: prevent ion of bleeding, bleeding, prophylaxis f or invasive procedure (ambiguous)

• Hypovolaemia
• Plasma exchange (except f or TTP)
• Rever sal of prolonged I NR in absence of

bleeding

Background

• Disappoint ing

result s NBS nat ional audit 2001

• Failure t o

implement BCSH guidelines 2004

• regional FFP

issues 2005

Background

MonthUnits I ssued (2005) February 1647 March 1698 April 1939 May 2177 J une 1914 J uly 1412

Frozen Component issues 2004/ 2005 - 2006/ 2007

Frozen Components Average Weekday Issues By Month - April 2004 onwards

1200 1250 1300 1350 1400 1450 1500 Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

Month

Average Weekday Issues

2004/05 2005/06 2006/07 Plan

Data to 18th Mar 2007

• f result s t o hospit als via RTC and HTC

Chairs.

• Det ermine appropriat eness of FFP

t r ansf usions.

• I dent if y pot ent ial wast age.
• Ensure coagulat ion screening is per f ormed

pre and post Tr ansf usion.

Met hod

• All hospit als served by NBS Manchest er and Lancast er

were invit ed t o part icipat e

• 31

May 2006).

• Prospect ive and ret rospect ive dat a collect ion.
• Use of FFP I ndicat ion Codes (F1-F6) derived f rom

BCSH guidelines plus – bleeding, clot t ing abnormal, ot her indicat ion – ot her

Result s

• 19/ 25 hospit als par t icipat ed
• 10-20/ hospit al)
• annual adult FFP issues in t he region

– Caveat : FFP shelf lif e is 24 mont hs so issues may not accurat ely ref lect usage but assume re-st ocking

Does your Trust have an FFP Policy?

Fig.1 Hospitals with FFP Policy (n=19)

1 3 15 Yes No NR 79% 16% 5% 16%

Mean 61 yrs, range 2 days -93 years 5 children (age 2 days - 1 year

• Fig. 3 Patient Age (n=302)

5 10 27 29 44 78 62 44 3 20 40 60 80 100 <16 16-29 30-39 40-49 50-59 60-69 70-79 Over 80 NR Age (Years) Number of patients

Weight of pat ient s:

Mean: 75kgs Range 2-134 kgs NR=44% mean 75 kg; range 2-4 kg; 14% >100 kg

• Fig. 4 Weight (n=302)

20 40 60 80 100 120 140 160 1-40 kgs 41-60 kgs 61-80 kgs 81-100 kgs Over 100 kgs NR Weight (kg)

Number of patients

Locat ion in hospit al

• Fig. 5 Location of patient

5 7 27 2 1 9 47 2 5 10 15 20 25 30 35 40 45 50

A &E HDU ITU Other Out- patients Theatre Ward Not recorded

Locations Percentage of patients

• Fig. 6 Broad Speciality (n=302)

5 10 15 20 25 30 35 40 45 % Patients

Haematology/Medical Oncology Medicine Obstetrics Paediatrics Surgery Other/NR

9% 41% 2% 2% 42% 4%

Medicat ion wit hin 24 hours prior t o

Alone/ in combination

• 61* (21%)
• Heparin

32 (11%)

• Vit amin K

81 (28%)

M edication P atients % V itam inK 52 18 W arfarin 36 12 H eparin 21 7 A nti-platelet 14 5 A nti-fibrinolytics V itam inK&W arfarin V itam inK&H eparin V itam inK&A nti-platelet V itam inK&W arfarin&A nti-platelet V itam inK&W arfarin&H eparin&A nti-platelet W arfarin&H eparin W arfarinandA nti-platelet H eparin&A nti-platelet N

• ne

20 4 3 1 1 1 2 5 131 7 1 1 0.3 0.3 0.3 1 2 45

* This no. dif f ers f rom no. t reat ed f or indicat ion F2

• No dat a in

10% pre- and 15% post - t ransf usion

• Furt her

analysis of t iming and degree of correct ion required

• Fig. 8aPre-T

ransfusionClottingResults(n=291)

1 20 30 40 50 60 70 80 90 %Patients N

• ne

All F ib APT T PT /IN R

• Fig. 8b Post Transfusion Clotting Results(n=291)

1 20 30 40 50 60 70 80 %Patients None All Fib APTT PT/INR

How many unit s of FFP were t r ansf used?

• Fig. 7 Units Transfused (n=1018)

Transfused Not Transfused 95%

• init ial int ent ion t o t reat
• 49 (5%) unit s not t ransf used, presumed wast ed

FFP units requested/ transf used per hospital

HospID Units Requested Units Transfused % Transfused 1 64 52 81 2 77 77 100 3 63 60 95 4 61 60 98 5 54 53 98 6 26 26 100 7 65 61 94 8 67 63 94 9 57 57 100 10 37 37 100 11 82 78 95 12 66 65 99 13 28 28 100 14 30 26 87 15 84 80 95 16 33 33 100 17 25 25 100 18 63 60 95 19 36 28 67 Total 1018 969 95

Clinical indicat ions recorded

I n some cases >1 indicat ion was select ed. We have made a j udgement , f rom t he dat a provided, about t he predominant code

IndicationCode Number % F1 Replacement of SpecificCoagulationFactor Deficiencies 11 4 F2 Reversal of WarfarinEffect 64 22 F3 DisseminatedIntravascular Coagulation(DIC) 23 8 F4 ThromboticThrombocytopenic Purpura(TTP)

• F5

M assiveTransfusion(1.5xbloodvolume) 45 15 F6a Liver Disease 31 11 F6b Liver Disease–tocover invasiveprocedure(biopsy/surgery) 27 9 BCO Bleeding, clottingabnormal, other reason 54 19 Other AnyOther Indication 32 11 NoIndicationRecorded 4 1 Total 291 100

Final panel consensus

Figure 11. Panel Review including 4th Consultant (291) 20 40 60 80 100 120 140 Appropriate transfusion Inappropriate transfusion Split clinical panel decision Not enough information to form clinical decision Clinical Decisions Number of patients

40% 37% 4% 19%

Panel consensus according t o indicat ion code

I ndicat ion Tot al

• App. (no)
• App. (%)

F1 11 6 54 F2 64 2 3 F3 23 21 91 F4 F5 45 No decision F6 58 45 76 Ot her 86 42 49 Not recorded 4 1

Was t he dose of FFP appropriat e?

Assumpt ions

• 15 mg/ kg (or more if

clinical circumst ances dict at e)

• Aver age vol/ bag (adult ) = 250 ml

– 268 ml (r ange 186-339 ml)

• An init ial dose of 4 bags (~1000ml) is

kg in t he audit ) – 67 - 100 kg @ 15 - 10 ml/ kg respect ively

Adequacy of FFP dosage f or appropriat e indicat ions (n=113 adult s)

Number % Patients with current weight recorded 73 10 ml/kg dose achieved 49 67 15 ml/kg dose achieved 14 19 Patients without current weight recorded 40 4 units FFP achieved 28 70

• No weight recorded in 40/ 113 (35%)
• 31/ 113 (27%) given 2 unit s (adequat e in only 2)
• 4/ 113 (3%) given 3 unit s (adequat e in 2)

Ef f icacy of t r ansf usion f or appropr iat e indicat ions (n=117)

Number of patients Appropriate indications 117 Pre-&post- treatment test results available 103 Post-test = 12 hours after pre-test 40 C 2 P 11 N 26 X 1

• Only 34% (40/ 117) could be assessed
• Correct ion/ part ial correct ion in 13 (32%)
• No at t empt t o correlat e wit h dose
• J udged on all/ any t est s
• Too many unknowns t heref ore of limit ed value

Adverse react ions

• One adverse r eact ion was r eport ed in

– – 1/ 969 unit s of FFP (0.1%)

Replacement of single coagulat ion f act or def iciencies wher e a specif ic concent r at e is not available e.g. f act or V – 11 pat ient s: ? mis-int erpret ed. No f urt her inf ormat ion available.

Comment s about clinical indicat ions: F2

I mmediat e rever sal of war f ar in in presence of lif e-t hreat ening haemorrhage.

• 201 (21%) of FFP unit s t r ansf used
• 2 (3%) indicat ed; 5 possibly indicat ed (panel

split )

• bleeding - could not ascert ain sever it y

Prot hrombin Complex Concent r at e is t he in addit ion t o I I , I X, X * 1 pat ient = insuf f icient inf ormat ion t o decide

Comment s about clinical indicat ions: F5

Massive t r ansf usion: t he use of FFP should be guided by t imely t est s of coagulat ion including near pat ient t est ing

The panel could not decide on t his group of pat ient s: – I nsuf f icient inf ormat ion – Unwilling t o “give t he benef it of t he doubt ” – There is a need t o review how guidelines on t he management of massive t ransf usion work in pract ice. More lat er!

Indication Num ber of patients No. appropriate Inappropriate Split No. units F6ableeding 21 19 2 69 F6anot bleeding 7 3 2 2 25 F6ableedingstatusnot known 3 2 1 10 F6bpre-invasiveprocedure 27 21 5 1 84 Total 58 45 9 4 188

• 20% of all t reat ed pat ient s
• 19% of all FFP unit s
• 78% appropriat e - lenient assessment !
• Ef f icacy of t reat ment unclear

Comment s about clinical indicat ions: F6

Liver disease: what t he BCSH guidelines say

• FFP advocat ed by some f or prevent ion of bleeding

when PT is prolonged

• Response may be unpredict able
• Complet e normalisat ion of haemost at ic def ect may

not occur

• Coagulat ion t est s should be repeat ed post -inf usion

t o guide decision-making

• No evidence t o subst ant iat e pract ice of only doing

liver biopsy if PT is wit hin 4 secs of cont rol (grade C, level I V evidence) The guidelines are vague and evidence lacking

FFP administ ered out side indicat ion codes

Location Other Indication Bleeding, clotting abnormal other indication Total (%) Ward 16 20 36 (42) Theatre 2 5 7 (8) ITU 10 24 34 (40) HDU 2 5 7 (8) A&E 2 2 (2) Total patients 32 54 86 Total FFP used 108 172 280

• 29% of FFP t ransf used
• 49% appropriat e as j udged by diagnosis and clot t ing

t est s

Indication code Number of patients Number of FFP units F1 Replacement of Specific Coagulation Factor Deficiencies 8 22 F2 Reversal of Warfarin Effect 9 23 F3 Disseminated Intravascular Coagulation (DIC) 4 16 F4 Thrombotic Thrombocytopenic Purpura (TTP) F5 Massive Transfusion (1.5 x blood volume) 15 53 F6 Liver Disease 7 28 Bleeding Clotting Abnormal Other (BCO) 24 78 Any Other Indication (Other) 10 36 Not Recorded 2 8 Total 79 264

27% of pat ient s; 27% of FFP 43% of episodes out side recognised indicat ion codes

Key observat ions (1)

Audit criterion %expected % compliance Transfusionappropriateaccordingtoguidelines 100 40 Transfusionappropriatebut dosageinappropriate 30* FFPrequestedandusednot wasted 100 95 Coagulationscreenperformedpre-transfusion 100 89 Coagulationscreenperformedpost-transfusion 100 87

* dependent on which dosage crit eria used

Key observat ions (2)

• High level of part icipat ion and

represent at ive of ~ 94% FFP issues

• Decisions not always easy - a panel of

haemat ologist s could not agree on some cases, not ably massive t r ansf usion

• Fact or s which af f ect ed assessment :

– lack of dat a: is t his a ref lect ion of lack

• f document at ion/ f ailure t o f ollow

guidelines/ design of audit ? – mis-underst anding of F codes (F1)

Key observat ions (3)

• Management of warf arin rever sal poorly

underst ood and must be improved

• Suspicion t hat FFP is being used t o t reat

haemost at ic def ect s associat ed wit h t he use of hepar in

• Massive t r ansf usion management - not

wrong but not enough inf or mat ion t o make an assessment against t he guidelines

– audit not suf f icient ly well-designed f or t his purpose

• Liver disease and FFP - are we achieving

anyt hing?

• dit t o
• “Ot her indicat ions”: large group, I TU

pat ient s prominent - dit t o

• Dosage - does t his need t o be reviewed?
• What t est s should be used t o measure

ef f icacy?

Key observat ions (5)

Overall inappropriat e use 37%

• pot ent ial f or savings @ £ 31.89/ unit

adult FFP

• pot ent ial f or reduct ion of risk
• but cost of under-dosing/ alt ernat ive

t reat ment must be t aken int o account

• General: t he RTC should develop a programme of

act ion based on – educat ion about appropriat e use of FFP – measures t o reduce inappropriat e use – promot ing f urt her audit of specif ic areas

• Warf arin:

– t he RTC should develop a specif ic – BCSH guidelines should be updat ed t o ref lect t he role of PCC

Recommendat ions (2)

• Massive t ransf usion

– t he RTC could act as a f ocus f or developing an agreed regional prot ocol – det ailed audit of massive t ransf usion management is needed

• Liver disease

– det ailed audit is needed (SHI Pst udy may help) – BCSH guidelines should be reviewed wit h t he aim of providing more specif ic recommendat ions

• I TU pat ient s

– t he RTC should not e t he f indings (when wit h I TU net works t o disseminat e best pract ice

Gordon Hodgson Anna Barclay Barbara St earn Rebecca Gerrard Vikki Sandland Paula Bolt on-Maggs David Alderson Mark Grey Expert panel Hospit al Transf usion Teams