HB TRIGGER & SINGLE UNITS

Transcription

1 HB TRIGGER & SINGLE UNITS

2 Conflict of Interest Disclosure I hereby declare the following potential conflicts of interest concerning my presentation: Consultancy: none Research Funding: 2 RCTs funded by unrestricted grants from Pharmacosmos to my hospital department (none personally) Honoraria: none Patents and Royalties: none Membership on an Entity s Board of Directors or Advisory Committees: none Discussion of off-label drug use: none

3 CAVEAT The bleeding emergency: Hypoxia Exsanguination Death Hb triggers & Single-unit transfusions do NOT apply to Massive bleeding / Unstable bleeding patients

4 Cochrane 2015 transfusion RCT review

5 Cochrane 2016 transfusion RCT review Transfusion rate Liberal 84% vs Restrictive 48% I 2 = 97%

6 Cochrane 2016 transfusion RCT review

7 Cochrane 2016 transfusion RCT review We have no solid evidence for transfusion triggers in bone marrow failure & haematological malignancies

8 Some ongoing studies TRIST: Transfusion of red cells in hematologic stem cell transplantation (n=300), Tay et al. Trials, Completed. Trigger 7 vs 9 g/dl TRICS III: Transfusion thresholds in cardiac surgery Trigger 7.5 vs 9.5 g/dl (n=4500) REALITY: Acute myocardial infarction, cost-effectiveness of liberal vs restrictive transfusion strategy (n=630) Trigger 8 vs 10 g/dl

9 Hb trigger evidence base (PICO principle / GRADE) Population Intervention Comparator Outcome Evidence Base Reference Mixed +children Restrictive 7-8 g/dl OR Symptoms Liberal 9-10 g/dl NS for mortality, overall morbidity, myocardial infarction Restrictive infection rate 31 RCT meta-analysis n=9,813 Holst et al., BMJ 2015 Septic shock Restrictive 7 g/dl Liberal 9 g/dl NS for mortality, ischemic events, adverse event, life support Multicenter RCT n = 1005 Holst et al., NEJM 2014 Hip fracture Restrictive 8 g/dl Liberal 10 g/dl NS for mortality, functional recovery, postop morbidity 6 RCT meta-analysis n=2722 Brunskill et al. Cochrane 2015 Cardiac surgery Restrictive 7.5 g/dl Liberal 9 g/dl NS for [infection /ischemic event] Restrictive 90 day mortality Multicenter RCT n = 2007 Murphy et al. NEJM 2015 Critical illness OR bleeding Restrictive 7 g/dl Liberal 9-10 g/dl Restrictive cardiac events Restrictive infection rate Restrictive mortality 3 RCT meta-analysis n=2,364 Salpeter et al. Am J Med 2014 Cardiovasc disease Restrictive 7-8 (9) g/dl Liberal 910 (11) g/dl NS Mortality Liberal Cardiac events 11 RCT metaanalysis n=3,033 Docherty et al., BMJ 2016 Mixed Restrictive 7-8 g/dl Liberal 9-10 g/dl Restrictive infection rate for orthopedic surgery and sepsis 18 RCT meta-analysis n=7,593 Rohde et al. JAMA 2014 Upper IG bleeding Restrictive Liberal Restrictive death Restrictive LOS 4 RCT meta-analysis n=982 Wang et al. WJG 2013 Mixed Restrictive Liberal NS for mortality, AMI, heart failure, pneumonia, rebleeding, stroke 31 RCT meta-analysis n=12,587 Carson et al. Cochrane 2016

10 Singe unit evidence base (PICO principle / GRADE) Population Intervention Comparator Outcome Evidence Base Reference Mixed +children Restrictive 7-8 g/dl OR Symptoms Liberal 9-10 g/dl NS for mortality, overall morbidity, myocardial infarction Restrictive infection rate 31 RCT meta-analysis n=9,813 Holst et al., BMJ 2015 Septic shock Restrictive 7 g/dl Liberal 9 g/dl NS for mortality, ischemic events, adverse event, life support Multicenter RCT n = 1005 Holst et al., NEJM 2014 Hip fracture Restrictive 8 g/dl Liberal 10 g/dl NS for mortality, functional recovery, postop morbidity 6 RCT meta-analysis n=2722 Brunskill et al. Cochrane 2015 Cardiac surgery Restrictive 7.5 g/dl Liberal 9 g/dl NS for [infection /ischemic event] Restrictive 90 day mortality Multicenter RCT n = 2007 Murphy et al. NEJM 2015 Critical illness OR bleeding Restrictive 7 g/dl Liberal 9-10 g/dl Restrictive cardiac events Restrictive infection rate Restrictive mortality 3 RCT meta-analysis n=2,364 Salpeter et al. Am J Med 2014 Cardiovasc disease Restrictive 7-8 (9) g/dl Liberal 910 (11) g/dl NS Mortality Liberal Cardiac events 11 RCT metaanalysis n=3,033 Docherty et al., BMJ 2016 Mixed Restrictive 7-8 g/dl Liberal 9-10 g/dl Restrictive infection rate for orthopedic surgery and sepsis 18 RCT meta-analysis n=7,593 Rohde et al. JAMA 2014 Upper IG bleeding Restrictive Liberal Restrictive death Restrictive LOS 4 RCT meta-analysis n=982 Wang et al. WJG 2013 Mixed Restrictive Liberal NS for mortality, AMI, heart failure, pneumonia, rebleeding, stroke 31 RCT meta-analysis n=12,587 Carson et al. Cochrane 2016

11 Single unit evidence base I RCTs comparing restrictive with liberal triggers generally use a standard dose of 1 unit of RBC

12 Single unit evidence base II Studies which had TACO (transfusion associated circulatory overload) as an outcome.. RCT (Carson et al, NEJM 2011 and Villanueva et al., NEJM 2013) Meta-analysis of RCTs (Salpeter et al., Am J Med 2014) Showed that..even with a single-unit dose, a liberal transfusion trigger is associated with higher frequency of TACO (transfusion associated circulatory overload)

13 Single unit evidence base III TACO frequency in clinical studies 2-12% (average 4%) Risk of TACO increases significantly (observational data) with: Age Female gender Number of units transfused Kidney failure Congestive heart failure Vascular, thoracic and transplant surgery Fluid overload Faster transfusion rate Clifford et al., Anaesthesiology 2015 Menis et al., Vox Sang 2014 Lieberman et al., Transfus Med Rev 2013 Murphy et al., Am J Med 2013 Li et al., Transfusion 2011

14 PBM definitions ISBT: Patient Blood Management Multidisciplinary Evidence-based Approach aimed at optimising the care of patients who might need transfusion WHO: Patient Blood Management Improve patient outcome Multidisciplinary Evidence-based Systematic approach Implement, monitor and study the effect PBM Subject to copyright

15 The Capital Region of Copenhagen 1.8 mio inhabitants -10 hospitals doctors & nurses

16 The Capital Region of Copenhagen 1.8 mio inhabitants -10 hospitals doctors & nurses 300,000 admissions/year 400,000 surgeries/year 75,000 RBC units/year

17 Liberal transfusion in Copenhagen 2008 > 40% of surgical transfusions at Hb 10g/dL or higher Mostly double-units RBC utilization >60 per 1000 inhabitants Now < 40 & close to European median rate Varying transfusion practice (10-fold)

18 Source data & linkage

19 Pre-transfusion Hb & volume Pre-transfusion Hb Pre-transfusion Hb Hb-linked volume Norgaard et al., Blood Transfus 2014

20 CPH PBM Transfusion optimization Periop Bleeding Management Preop Anaemia management

21 Aim of Copenhagen PBM Goal: To improve the quality of transfusion treatment in non-massively bleeding patients (Massive haemorrhage protocol was implemented in ) Vision: All patients to receive optimal transfusion treatment by end of 2015

22 Choosing departments for PBM 1. Evidence supporting restrictive transfusion practice 2. Data: liberal, inappropriate transfusion practice 3. Transfusing > 5% of patients Orthopedic surgery: PBM Intensive care unit: PBM Haematology: 3 no intervention Oncology: 3 no intervention

23 Orthopedic department Hb mmol/l 7,0 6,5 6,0 9 g/dl 5,5 8 g/dl 5,0 4,5 7 g/dl 4,0 Hb-trigger for transfusion % single-unit transfusion events. 3,5 30 3,0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Ortopædkirur. Orhtopedic dept mean trigger Transf. Restrictive bør Hbovervejes trigger Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q goal

24 Orthopedic transfusion rates % surgeries with RBC transfusion Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Hip fracture Primary Hip Primary knee Prim. Hof. Prim. Knæ Hoftefraktur Hoftefraktur Prim. Hof. Prim. Knæ

25 Haematology triggers? Hb mean trigger 8.2 g/dl Single unit transfusions = 82% 10% inappropriate (liberal) Transfusion rate 38 % No PBM-intervention in our haematology dept. No RCT evidence for Hb triggers Guideline: Individual, clinical symptoms Best practice, week recommendation (GRADE)

26 Hb trigger hospital level Distribution of Hb trigger vs guideline (lower/upper) Percentage of single-unit transfusions 40% % % 10% < <= >=6.0 > % Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 0 Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q portion 2 portioner

27 CPH regional pre-transfusion Hb (10 hosp) Compliance with guidelines 35% Hb trigger for transfusion vs Restrictive trigger (recommended) & Liberal trigger (upper limit) 30% 25% 20% 15% 10% 5% < <= >=6.0 > 9.7 0% q1 q2 q3 q4 q1 q2 q3 q4 q1 q2 q3 q4 q1 q2 q3 q4 q1 q2 q3 q Region

28 CPH regional single unit transfusions 80 Percentage Andel enkelt of single og dobbelt unit transfusioner transfusions % of transfusion events unit units 1 portion 2 portioner 0 q1 q2 q3 q4 q1 q2 q3 q4 q1 q2 q3 q4 q1 q2 q3 q4 q1 q2 q3 q Region

29 Thanks to colleagues & coworkers The Patient Blood Management team T. H. de Lichtenberg L. Sundstrup J. Nielsen J. Seeberg The Copenhagen Region Hospital s Quality & Patient Safety Unit B.H. Sparsoe A.M. Hellebek The Copenhagen PBM Steering Committee The Hospital PBM Steering Committees Managers and staff at the clinical departments Capital Region Bloodbank & Section for Transfusion Medicine

30 Thank you for your attention!