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 -28 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 Background • Disappoint ing MonthUnits I ssued (2005) result s NBS nat ional audit February 1647 2001 March 1698 • Failure t o April 1939 implement BCSH May 2177 guidelines 2004 J une 1914 • J uly 1412 regional FFP issues 2005
Frozen Component issues 2004/ 2005 - 2006/ 2007 Frozen Components Average Weekday Issues By Month - April 2004 onwards Data to 18th Mar 2007 Average Weekday Issues 1500 1450 1400 1350 1300 1250 1200 Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Month 2004/05 2005/06 2006/07 Plan
• of 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) 5% 16% 16% 1 3 Yes 15 No NR 79%
Fig. 3 Patient Age (n=302) 100 Number of patients 78 80 62 60 44 44 40 29 27 10 20 5 3 0 <16 16-29 30-39 40-49 50-59 60-69 70-79 Over NR 80 Age (Years) Mean 61 yrs, range 2 days -93 years 5 children (age 2 days - 1 year
Weight of pat ient s: Fig. 4 Weight (n=302) 160 Number of patients 140 120 100 80 60 40 20 0 1-40 kgs 41-60 kgs 61-80 kgs 81-100 Over 100 NR kgs kgs Weight (kg) Mean: 75kgs Range 2-134 kgs NR=44% mean 75 kg; range 2-4 kg; 14% >100 kg
Locat ion in hospit al Fig. 5 Location of patient 47 50 45 Percentage of patients 40 35 27 30 25 20 15 9 7 10 5 2 2 5 1 0 A &E HDU ITU Other Out- Theatre Ward Not patients recorded Locations
Fig. 6 Broad Speciality (n=302) 45 41% 42% 40 Haematology/Medical Oncology 35 Medicine 30 % Patients Obstetrics 25 20 Paediatrics 15 Surgery 9% 10 Other/NR 4% 5 2% 2% 0
Medicat ion wit hin 24 hours prior t o M edication % Alone/ in P atients combination V itam inK 52 18 W arfarin 36 12 • H eparin 21 7 A nti-platelet 14 5 61* (21%) A nti-fibrinolytics 0 0 V itam inK&W arfarin 20 7 • Heparin V itam inK&H eparin 4 1 V itam inK&A nti-platelet 3 1 32 (11%) V itam inK&W arfarin&A nti-platelet 1 0.3 • Vit amin K V itam inK&W arfarin&H eparin&A nti-platelet 1 0.3 W arfarin&H eparin 1 0.3 81 (28%) W arfarinandA nti-platelet 2 1 H eparin&A nti-platelet 5 2 N one 131 45 * This no. dif f ers f rom no. t reat ed f or indicat ion F2
Fig. 8aPre-T ransfusionClottingResults(n=291) N one •No dat a in All F ib 10% pre- and APT T 15% post - PT /IN R 0 1 0 20 30 40 50 60 70 80 90 t ransf usion %Patients •Furt her analysis of Fig. 8b Post Transfusion Clotting Results(n=291) t iming and degree of None All correct ion Fib required APTT PT/INR 0 1 0 20 30 40 50 60 70 80 %Patients
How many unit s of FFP were t r ansf used? Fig. 7 Units Transfused (n=1018) 95% Transfused Not Transfused • 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 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) 0 - 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 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
Final panel consensus Figure 11. Panel Review including 4th Consultant (291) 140 Number of patients 40% 37% 120 100 80 19% 60 40 4% 20 0 Appropriate Inappropriate Split clinical Not enough transfusion transfusion panel decision information to form clinical decision Clinical Decisions
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 0 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 No. Inappropriate No. Split patients appropriate units F6ableeding 21 19 2 0 69 F6anot bleeding 7 3 2 2 25 F6ableedingstatusnot known 3 2 0 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
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