Strategies to Decrease Blood Utilization and Improve Safety

1. Strategies to Decrease Blood Utilization and Improve Safety Presented by Paul McLoone, M.D. April 17, 2012

2. History of RBC transfusion “triggers” • To mid-1980s: 10 g/dL hemoglobin • Conservative trend in 1980s and ff. • TTDs (HIV and NANB hepatitis (HCV)) • Shortages • Evidence that anemia is well tolerated • Non-infectious serious hazards • Threats from emerging infections

3. Guidelines and systematic reviews Few RCTs (garbage in, garbage out) Observational cohorts, case series, expert opinion Unstudied populations affect generalizability Key functional outcomes generally not available How are triggers “set”?

4. ~16 million RBCs transfused annually Why? • Prevent/reverse tissue ischemia • Preserve aerobic metabolism • Decrease cardiac effects of anemia • Decrease symptoms of anemia • “Anemia is bad” • “May help, will not hurt”

5. ~16 million RBCs transfused annually • Why not ???? • TRALI (transfusion-related acute lung injury) • TACO (circulatory overload) • TRIM (immunomodulation) • Vasoregulatory abnormalities • Immunohematological events • TTIs: Known and emerging • TA-GVHD (graft v. host disease) • Dollar costs

7. “Recognized” risks of transfusion -8 -6 -5 -4 -3 -2 -1 0 -7 10 10 10 10 10 10 10 10 10 HIV Death from general anesthesia Death from medical error HCV HBV Death from hosp. infect. Bacteria in platelets Mistransfusion Modified from S. Dzik, MD Blood Transfusion Service MGH, Boston. Zilberberg, M. BMC Health Services Res. 2007. GVHD TRALI TACO (CHF) TSACs/unit RBC/US ICUs

8. Global Red Cell Utilization Rates: 2008-09 Source: D Devine et al.: International Forum/Inventory Management, Vox Sanguinis 2009

9. Costs of surgical RBC transfusion Shander et al. Transfusion. 2010.

10. Paradox: anemic patients may do better without transfusion: TRICC* • Multicenter, randomized trial in >800 patients with <9 gram Hgb within 72 h. of ICU admit • Liberal vs. restrictive PRBC triggers • Restrictive = <7 gm, Liberal = <10 gm • Mortality endpoints and severity of organ dysfunction *Transfusion Requirements In Critical Care. Hebert et al. NEJM. 1999.

11. TRICC: Primum non nocere?

12. TRICC: Post hoc analysis of pts. with cardiovascular disease Hebert, P et al. Crit. Care Med. 2001

13. TRICC: Post hoc analysis of ventilated pts. Hebert, P et al. Chest. 2001

14. FOCUS*: Surgery for hip fracture • RCT: 2016 patients: liberal (10 g) vs. conservative (<8 g or symptoms) RBC trigger • Heart disease or risk for heart disease (CAD, CHF, PVD, CVA, DM,  BP,  lipids, or CRF) • 1 outcomes: Death or inability to cross room unassisted at 60 d. • 2 outcomes: 60 d. mortality, fatigues, falls, readmission, functional status *Functional Outcomes in Cardiovascular patients Undergoing Surgical hip fracture repair (clinicaltrials.gov NCT00071032 )

16. Why are restrictive triggers appropriate?primum non nocere • SHOTs woefully under-reported • Description of putative “new” serious hazards • Pro-inflammatory • Immunosuppressive • Large prospective trials (TRICC, TRIPICU, PINT, FOCUS, TRACS) demonstrate outcomes at least as good using restrictive triggers • Positive impact of liberal triggers on functional outcomes not demonstrated in (FOCUS) • Activity costs of transfusion

17. Changing Physician Practice • Continue Education Event: Dr. Katz MVRBC Medical Director • Medical Staff Performance Improvement Committee ( ownership of process) • Metrics, as close to real time as possible • Order set development • Medical Executive Committee • Ongoing presentations to multiple groups

18. Caveat emptor • Retrospective nature of project • Data are as reliable as our ability to find information in the medical record • Confounders (e.g. cardio-respiratory compromise, severity of illness were not systematically sought) • Acuity of operative bleeding not readily assessed • DRG and many ICD-9 numbers too small for meaningful analysis • Denominators vary from year to year

19. Trinity RBC audits • Descriptive manual chart audit of RBC units given during 1st quarter of 2009 and 2011 • Recorded ordering physician and specialty • Hemoglobin on admission, at time of 1st order (i.e. “transfusion trigger”) and after transfusion • Documentation of bleeding in medical record • Initial data presented to various constituencies after intial audit with recommendations • Trinity ongoing intervention (Marvis et al)

26. Transfusion in total hip arthroplastyMVRBC blood management programtotals for audited quarter

27. Transfusion in total knee arthroplastyMVRBC blood management programtotals for audited quarter

28. Transfusion rates in orthopedics

30. Conclusions • Non-bleeding patients still receiving 1st units at well above “TRICC-validated” thresholds, but appear to have improved • Operative bleeding is transfused above FOCUS thresholds • Single unit transfusions should be encouraged • Probably requires “rules” • Concurrent analysis of non-bleeding patients and patients with operative bleeding may reduce transfusion of RBCs • Establish clinical guidelines for broad clinical groups • Medical staff buy in is an ongoing effort in multiple settings over time • Enlist clinical champions for that process and for the remedial efforts • Close to real time analysis of outliers • Frequent reports comparing apples to apples