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Presentation given by Louise Phillips at Transfusion Update , May 2011

Presentation given by Louise Phillips at Transfusion Update , May 2011. Department of Epidemiology and Preventive Medicine. VTE Cohort Study. Haemostasis Registry. A registry to collect information about the use of rFVIIa in Australia and New Zealand. Department of Epidemiology

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Presentation given by Louise Phillips at Transfusion Update , May 2011

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

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

  3. Department of Epidemiology and Preventive Medicine transfusionoutcomes research collaborative

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

  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. Thrombotic Thrombocytopenic Purpura (TTP) Registry QLD *Gold Coast *PAH RBWH *Townsville Progress • 31 Hospitals participating • 32 cases to date • Plans to extend registry to include aHUS NSW Concord *Liverpool Nepean PWH RNS RPA St Vincent’s *Westmead Wollongong SA FMC QEH *RAH ACT *TCH WA Fremantle RPH *SCGH VIC ALF AUS Geelong MMC Northern RMH St Vincent’s *Western TAS LGH RHH NZ *Auckland *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. Neonatal Alloimmune Thrombocytopenia (NAIT) Registry Progress • 21 Hospitals participating • 11 cases to date • also collecting retrospective cases QLD Mater Mother’s RBWH *RCHQ NSW *CHW *John Hunter Nepean *RHW RNS RPA *Westmead Wollongong SA FMC WCH WA KEMH RPH VIC Mercy MMC RCH RWH ACT TCH TAS RHH *ethics or site governance in process

  11. Aplastic Anaemia Registry • few clinicians with a specific interest inaplastic 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. Aplastic Anaemia Registry NAIT Registry TTP Registry Early Coagulopathy of Trauma

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

  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 Under “normal” circumstances: Transfusion Required Acute (<1 hr) Transfusion Required Urgent (1 - 24 hrs) Transfusion Required Semi-urgent (24 hrs - 1 wk) Transfusion Required Non-urgent (> 1 wk) Not requiring transfusion

  18. Modelling Demand for Blood Transfusions 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 Transfusion Required Acute (<1 hr) Transfusion Required Urgent (1 - 24 hrs) Transfusion Required Semi-urgent (24 hrs - 1 wk) Transfusion Required Non-urgent (> 1 wk) Not requiring transfusion

  19. Modelling Demand for Blood Transfusions 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 Transfusion Required Acute (<1 hr) Transfusion Required Urgent (1 - 24 hrs) Transfusion Required Semi-urgent (24 hrs - 1 wk) Transfusion Required Non-urgent (> 1 wk) Not requiring transfusion

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

  21. Transfusion • History • Laboratory • Results • Clinical Coding • ICD-10 • AR-DRG • ?Pharmacy • 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 • National • or LocalDatabases/ Registries • ANZICS • ASCTS • Trauma MTR • Demographic • Information

  22. Transfusion • History • Laboratory • Results • 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 • Clinical Coding • ICD-10 • AR-DRG • ?Pharmacy • National • or LocalDatabases/ Registries • ANZICS • ASCTS • Trauma MTR • Demographic • Information

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

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

  25. Stream 1 TRANSFUSION RESEARCH: IMPROVING OUTCOMES (TRIO) Stream 1: Registry Data • Project Lead: Dr Zoe McQuilten, PhD Student & Clinical Fellow Registry Stream 1 Registry Data 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 Stream 2 Modelling & Monitoring Stream 3 Human Factors

  26. Stream 1: Registry Data Alfred Hospital Austin Hospital Geelong Hospital Monash Medical Centre Royal Melbourne Hospital St Vincent’s Hospital 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 VSTORM (Trauma) ASCTS (Cardiac Surgery) ANZICS-APD (Intensive Care)

  27. Stream 1 TRANSFUSION RESEARCH: IMPROVING OUTCOMES (TRIO) Stream 2: Modelling & Monitoring Stream 1: Registry Data Registry Stream 1 Registry Data Data Monitoring • Statistical Control Chart (VLAD) methodology 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 Transfusion Rate in Cardiac Surgery Stream 2 Stream 2 Modelling & Monitoring Stream 3 Human Factors Modelling & Monitoring Transfusion above predicted rate

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

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

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

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

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

  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

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