1. Presentation given by Louise Phillips at Transfusion Update, May 2011

2. Haemostasis Registry VTE Cohort Study A registry to collect information about the use of rFVIIa in Australia and New Zealand Department of Epidemiology and Preventive Medicine

3. transfusionoutcomes research collaborative Department of Epidemiology and Preventive Medicine

4. A partnership between Monash University and the Blood Service Aim: To improve understanding of blood product usage and the influence of transfusion practice on patient outcomes Established 2008 Department of Epidemiology and Preventive Medicine TTP Registry NAIT Registry Aplastic Anaemia Registry

5. TTP, NAIT, Aplastic Anaemia: Why Registries? Uncommon diseases even major centres encounter few cases associated with significant morbidity and mortality difficult to establish optimal management significant variation in practice disease rarity hampers definitive studies (eg clinical trials)

6. TTP, NAIT, Aplastic Anaemia: Why Registries? Registries collect common experience allow recognition of patterns in care and outcome are hypothesis generating provide baseline data and platform for further studies

7. Thrombotic Thrombocytopenic Purpura (TTP) Registry Estimate approx 35-40 hospitals in Australia treating TTP 100 cases per year Steering Committee Shlomo Cohney (chair) Paul Cannell Claire Davies Sunelle Engelbrecht Danny Hsu Zoe McQuilten Stephen Opat Louise Phillips David Roxby Erica Wood

8. NZ *Auckland Progress 31 Hospitals participating 32 cases to date Plans to extend registry to include aHUS VIC ALF AUS Geelong MMC Northern RMH St Vincent’s *Western TAS LGH RHH ACT *TCH NSW Concord *Liverpool Nepean PWH RNS RPA St Vincent’s *Westmead Wollongong QLD *Gold Coast *PAH RBWH *Townsville SA FMC QEH *RAH WA Fremantle RPH *SCGH Thrombotic Thrombocytopenic Purpura (TTP) Registry *ethics or site governance in process

9. Neonatal Alloimmune Thrombocytopenia (NAIT) Registry Estimate approx 25 hospitals in Australia treating NAIT <50 cases per year Steering Committee Helen Savoia (chair) Stephen Cole Mark Davies Rhonda Holdsworth Zoe McQuilten Louise Phillips Shelly Rowland Ben Saxon Bronwyn Williams Erica Wood

10. VIC Mercy MMC RCH RWH TAS RHH ACT TCH NSW *CHW *John Hunter Nepean *RHW RNS RPA *Westmead Wollongong QLD Mater Mother’s RBWH *RCHQ SA FMC WCH WA KEMH RPH Progress 21 Hospitals participating 11 cases to date also collecting retrospective cases *ethics or site governance in process Neonatal Alloimmune Thrombocytopenia (NAIT) Registry

11. Aplastic Anaemia Registry few clinicians with a specific interest in aplastic anaemia but potentially treated at all major metropolitan hospitals including children’s and some private estimate approx 100 cases per year Current Status forming Steering Committee developing data dictionary talking to funders (Genzyme & Alexion) expect “go live” late 2011

12. TTP Registry NAIT Registry Aplastic Anaemia Registry Early Coagulopathy of Trauma

13. Early Coagulopathy of Trauma Project Lead: Dr Dev Mitra, PhD Student & Emergency Physician Markers of coagulopathy in trauma patients? – common tests and less-common tests When does coagulopathy establish? – coagulopathy testing at scene of trauma Can we recognise it when it begins? – possible use of point-of-care testing equipment Can we intervene in the pre-hospital phase? – potential trial of early treatment either on arrival at ED or in pre-hospital

14. TTP Registry NAIT Registry Aplastic Anaemia Registry Early Coagulopathy of Trauma Pandemic Project

15. Australia’s blood supply in a major disaster or pandemic: How will we meet clinical demand? Department of Epidemiology and Preventive Medicine Transfusion Outcomes Research Collaborative Epidemiological Modelling Unit Infectious Diseases Unit

16. Pandemic project Limited data on recipients of blood products indication for transfusion urgency of requirement consequences of with-holding transfusion RBC, platelets and FFP No robust model of clinical demand impact of pandemic on clinical demand impact of pandemic or other disaster on supply how can demand be made to match supply? Planning for circumstances of shortage need a model to assist in developing or evaluating the impact of different triage approaches if blood supply limited

17. Modelling Demand for Blood Transfusions Transfusion Required Non-urgent (> 1 wk) Transfusion Required Semi-urgent (24 hrs - 1 wk) Transfusion Required Urgent (1 - 24 hrs) Transfusion Required Acute (<1 hr) Not requiring transfusion Under “normal” circumstances:

18. Modelling Demand for Blood Transfusions Transfusion Required Non-urgent (> 1 wk) Transfusion Required Semi-urgent (24 hrs - 1 wk) Transfusion Required Urgent (1 - 24 hrs) Transfusion Required Acute (<1 hr) Not requiring transfusion Death If no blood is available: 4 possible outcomes at each urgency level Outcomes more or less likely depending on disease Identified 14 disease groups Total of 56 disease/urgency combinations Estimate likelihood of the outcomes for each Use this information with volume of transfusion in each category to create model

19. Modelling Demand for Blood Transfusions Transfusion Required Non-urgent (> 1 wk) Transfusion Required Semi-urgent (24 hrs - 1 wk) Transfusion Required Urgent (1 - 24 hrs) Transfusion Required Acute (<1 hr) Not requiring transfusion Death Once model is developed: able to project impact of different strategies of restriction eg with-hold transfusion from particular disease group or urgency level - how much is saved? model impact of pandemic on demand eg likely increase in demand from group (such as more ECMO) due to effect of pandemic

20. TTP Registry NAIT Registry Aplastic Anaemia Registry Early Coagulopathy of Trauma Pandemic Project Massive Transfusion Registry

21. MTR Demographic Information Clinical Coding ICD-10 AR-DRG Transfusion History Laboratory Results ?Pharmacy National or Local Databases/ Registries ANZICS ASCTS Trauma all patients receiving ≥5 units RBC in 4 hours any time in hospital admission any context of bleeding (trauma, surgical, obstetric, etc) all data collection electronic

22. MTR Demographic Information Clinical Coding ICD-10 AR-DRG Transfusion History Laboratory Results ?Pharmacy National or Local Databases/ Registries ANZICS ASCTS Trauma Progress recent scoping exercise identified 8 pilot hospital sites in four states negotiating details, ethics, costs involved expect “go live” September 2011 hope to expand to more hospitals in 2012

23. TTP Registry NAIT Registry Aplastic Anaemia Registry Early Coagulopathy of Trauma Pandemic Project Massive Transfusion Registry TRANSFUSION RESEARCH: IMPROVING OUTCOMES (TRIO)

24. TTP Registry NAIT Registry Aplastic Anaemia Registry Early Coagulopathy of Trauma Pandemic Project Massive Transfusion Registry TRANSFUSION RESEARCH: IMPROVING OUTCOMES (TRIO) NHMRC Partnership Project Grant 2010-2012

25. Stream 3 Human Factors Stream 2 Modelling & Monitoring Stream 1 Registry Data TRANSFUSION RESEARCH: IMPROVING OUTCOMES (TRIO) Stream 1: Registry Data Project Lead: Dr Zoe McQuilten, PhD Student & Clinical Fellow Clinical Registries exist and collect good quality data including risk adjustment and outcomes Data about transfusion is not included but is available from hospital laboratory information systems Stream 1 Registry Data

26. Stream 1: Registry Data Clinical Registries exist and collect good quality data including risk adjustment and outcomes Data about transfusion is not included but is available from hospital laboratory information systems Alfred Hospital Austin Hospital Geelong Hospital Monash Medical Centre Royal Melbourne Hospital St Vincent’s Hospital VSTORM (Trauma) ASCTS (Cardiac Surgery) ANZICS-APD (Intensive Care)

27. Stream 3 Human Factors Stream 1 Registry Data Stream 2 Modelling & Monitoring TRANSFUSION RESEARCH: IMPROVING OUTCOMES (TRIO) Stream 1 Registry Data Stream 1: Registry Data Stream 2 Stream 2: Modelling & Monitoring Monitoring Modelling & Monitoring Statistical Control Chart (VLAD) methodology Transfusion Rate in Cardiac Surgery Transfusion above predicted rate Modelling following on from Pandemic Project projections of future clinical demand for transfusion ageing other changes in population demographics changes in transfusion dependency with new medications

28. Stream 1 Registry Data TRANSFUSION RESEARCH: IMPROVING OUTCOMES (TRIO) Stream 3 Human Factors Stream 2: Modelling & Monitoring Stream 2 Modelling & Monitoring Stream 2 Monitoring Modelling & Stream 3 Human Factors Stream 3: Human Factors Project Lead: Dr Shelly Jeffcott Investigating aspects of clinical decision making in transfusion

29. Stream 1 Registry Data Stream 2 Modelling & Monitoring TRANSFUSION RESEARCH: IMPROVING OUTCOMES (TRIO) Stream 3: Human Factors Stream 3 Human Factors Stream 3 Human Factors

30. TTP Registry NAIT Registry Aplastic Anaemia Registry Early Coagulopathy of Trauma Pandemic Project Massive Transfusion Registry TRANSFUSION RESEARCH: IMPROVING OUTCOMES Stream 1 Registry Data Stream 2 Modelling & Monitoring Stream 3 Human Factors Stream 2 Modelling & Monitoring Stream 3 Human Factors Stream 1 Registry Data TRANSFUSION RESEARCH: IMPROVING OUTCOMES (TRIO) Obstetric Haemorrhage Study PROJECTS IN DEVELOPMENT

31. Obstetric Haemorrhage Study (in development) AMOSS surveillance system covers 94% births in Australasia Epidemiology of obstetric haemorrhage requiring blood transfusion Factors influencing variation in transfusion practice and outcomes Planned case control study of severe PPH

32. Obstetric Haemorrhage Study TTP Registry NAIT Registry Aplastic Anaemia Registry Early Coagulopathy of Trauma Pandemic Project Massive Transfusion Registry TRANSFUSION RESEARCH: IMPROVING OUTCOMES Stream 1 Registry Data Stream 2 Modelling & Monitoring Stream 3 Human Factors Age of Blood (TRANSFUSE-RCT) (INFORM-RCT) PROJECTS IN DEVELOPMENT

33. INFORM-RCT (funding application submitted) pragmatic RCT in Canada and Australia (~10 sites in Aust) age of RBC: freshest available vs standard care all in-hospital transfusions randomised in Hospital Blood Bank all data collection electronic CIHR application submitted - requested $50 per patient mid-2011 to mid-2012

34. TRANSFUSE-RCT (funding application submitted) RCT in Australia & New Zealand ICUs (>50 sites) Age of RBC: freshest available vs standard care ICU patients, excluding cardiac surgery Randomised in ICU, flagged at Hospital Blood Bank Data collection in ICU NHMRC application submitted Mid 2012-2014

35. Obstetric Haemorrhage Study Age of Blood (TRANSFUSE-RCT) (INFORM-RCT) TTP Registry NAIT Registry Aplastic Anaemia Registry Department of Epidemiology and Preventive Medicine Early Coagulopathy of Trauma Pandemic Project Massive Transfusion Registry TRANSFUSION RESEARCH: IMPROVING OUTCOMES Stream 1 Registry Data Stream 2 Modelling & Monitoring Stream 3 Human Factors Wrong Blood in Tube

36. TORC Seminars November 2008 Transfusion Safety: Tackling the ‘Real’ Risks August 2009 Patient Consent in Blood Transfusion November 2010 Critical Bleeding and Massive Transfusion Perioperative Blood Management 9 September 2011 (watch this space ) www.torc.org.au