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Current Concepts in Blood Utilization

Current Concepts in Blood Utilization. Lawrence Tim Goodnough, MD Professor of Pathology and Medicine Stanford University Director, Transfusion Services Stanford University Medical Center Stanford, CA. Objectives. U nderstand blood risks and principles of Patient Blood Management

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Current Concepts in Blood Utilization

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  1. Current Concepts in Blood Utilization Lawrence Tim Goodnough, MD Professor of Pathology and Medicine Stanford University Director, Transfusion Services Stanford University Medical Center Stanford, CA

  2. Objectives • Understand blood risks and principles of Patient Blood Management • Review published clinical practice guidelines for blood transfusions • Know current Level 1 evidence for blood transfusion practices • Understand need for improved indicators for blood utilization

  3. Perkins H, Busch M. Transfusion 2010;50:2080-2099.

  4. Potential risks of blood transfusion 1. Infectious Agents 2. Transfusion Reactions a. Alloimmunization b. Febrile c. Allergic 3. Medical Errors: (wrong blood to patient due to mislabeled specimen or patient misidentification) 4. Transfusion Associated Acute Lung Injury (TRALI) 5. Transfusion Associated Circulatory Overload (TACO) 6. Iron Overload 7. Immunomodulation 8. Storage Lesions: Age of Blood Goodnough, Levy, Murphy. Lancet 2013;381:1852-3.

  5. Some Definitions • Blood Conservation (1970’s): driven historically by blood risks, blood supply, and blood costs • Blood Management (2003): The appropriate use of blood and blood components, with a goal of minimizing their use* • Patient Blood Management** (2011): Patient-centered, evidence-based, coordinated approach • Develop preventative strategies and workflows • Detect, evaluate and manage anemia • Identify coagulopathy and optimize hemostasis • Restrictive blood utilization/transfusion practices *Society for Advancement of Blood Management (SABM) http://www.sabm.org/public/ **Goodnough LT, Shander AS. Patient Blood Management. Anesthesiology 2012; 116: 1367-1376

  6. Patient Blood Management Optimize erythropoiesis Minimize blood loss Manage anemia • Identify, evaluate, and treat underlying anemia • Preoperative autologous blood donation • Consider erythropoiesis stimulating agents (ESA) if nutritional anemias ruled out/treated • Refer for further evaluation if necessary • Identify and manage bleeding risk (past/family history) • Review medications (antiplatelet, anticoagulation therapy) • Minimize iatrogenic blood loss • Procedure planning and rehearsal • Compare estimated blood loss with patient-specific tolerable blood loss • Assess/optimize patient’s physiological reserve (eg, pulmonary and cardiac function) • Formulate patient-specific management plan using appropriate blood conservation modalities to manage anemia Preoperative Intraoperative • Time surgery with optimization of red blood cell mass (note: unmanaged anemia is a contraindication for elective surgery) • Meticulous hemostasis and surgical techniques • Blood-sparing surgical techniques • Anesthetic blood conserving strategies • Acute normovolemichemodilution • Cell salvage/reinfusion • Pharmacological/haemostatic agents • Optimize cardiac output • Optimize ventilation and oxygenation • EVIDENCE-BASED TRANSFUSION STRATEGIES • Manage nutritional/correctable anemia (e.g. avoid folate deficiency, iron-restricted erythropoiesis) • ESA therapy if appropriate • Be aware of drug interactions that can cause anemia (e.g. ACE inhibitor) • Monitor and manage bleeding • Maintain normothermia (unless hypothermia indicated) • Autologous blood salvage • Minimize iatrogenic blood loss • Hemostasis/anticoagulation management • Be aware of adverse effects of medications (e.g. acquired Vit K deficiency) • Maximize oxygen delivery • Minimize oxygen consumption • Avoid/treat infections promptly • EVIDENCE-BASED TRANSFUSION STRATEGIES Postoperative From Goodnough, Shander. Patient Blood Management. Anesthesiology 2012;116:1367-76.

  7. Objectives • Understand blood risks and principles of Patient Blood Management • Review published clinical practice guidelines for blood transfusions • Know current Level 1 evidence for blood transfusion practices • Understand need for improved indicators for blood utilization

  8. Effect of Anemia on Cardiac Index and DPG Finch CA et al. N Engl J Med 1972;286:407-15.

  9. Perioperative Red Blood Cell Transfusion Hgb ≥ 100 g/L rarely require transfusion Hgb < 70 g/L frequently require transfusion NIH Consensus Conference. JAMA 1988;260:2700-2703.

  10. Practice Strategies for Elective Red Blood Cell Transfusion • A traditional concept: Blood transfusion is an effective therapeutic intervention • A new paradigm: Blood transfusion is an undesirable outcome Audet, Goodnough Ann Int Med 1992;116:403-406. American College of Physicians

  11. Principles of Transfusion Practice • “No blood transfusion” is an alternative. • Single unit transfusion events are desirable. • Patients should be re-assessed between transfusion events. Audet, Goodnough. Ann Int Med 1992;116:403-406. American College of Physicians

  12. ASA Guidelines for Red Cell Transfusion • Hgb level > 10 g/dL Rarely indicated • <6 g/dL Almost always indicated • 6-10 g/dL Based on patient’s risk for complications of inadequate oxygenation Anesth 1996;84:732-747. American Society of Anesthesiology Updated Anesth 2006;105:198-208 • “Literature is insufficient to define a transfusion trigger in surgical patients with substantial blood loss”

  13. Adjusted odds ratio for mortality by cardiovascular disease and preoperative haemoglobin Carson JL, et al. Lancet 1996;348:1055-60.

  14. Guidelines for Red Blood Cell Transfusion • “In patients not at risk for coronary artery disease…transfusion is unlikely to be of benefit for Hgb > 80 g/L” • “The presence of coronary artery disease likely constitutes an important factor in determining a patient’s tolerance to low Hgb” • Can Med Assoc J 1997;156:S1-S23 • Updated J Emerg Med 1998;16:129-31 • No explicit recommendation for a threshold Hgb concentration

  15. Guidelines for the use of red cell transfusions • The cause for anemia should be established and blood should not be given where effective alternatives exist • There is no universal ‘trigger’ for blood transfusions • Clinical judgment plays a vital role in decision to transfuse or not • The reason for transfusion should be documented in the patients’ medical records British Committee for Standards in Haematology Murphy MF, Wallington TB, et al.Br J Haematol2001;113:24-31.

  16. Medical Society Guidelines/Recommendations Goodnough LT, Levy JH, Murphy MF. Lancet 2013;381:1845-54

  17. Objectives • Understand blood risks and principles of Patient Blood Management • Review published clinical practice guidelines for blood transfusions • Know current Level 1 evidence for blood transfusion practices • Understand need for improved indicators for blood utilization

  18. A Multicenter, Randomized, Controlled Clinical Trial of Transfusion Requirements in Critical Care (TRICC Study) • 838 critical care adult patients in 25 ICU. • 2039 eligible: 838 (41%) consented. • A restrictive strategy of RBC transfusion was at least as effective as a liberal strategy: 30 day mortality was 18.7% vs. 23.3%, respectively. Herbert, et al. N Engl J Med 1999;340:409

  19. Transfusion Requirements in Critical Care (TRICC) Herbert et al. N Engl J Med 1999;340:409-417 N Engl J Med 1999;340:409

  20. Kaplan-Meier Estimates of 30-Day Survival by Transfusion Strategy All Patients 100 90 Restrictive strategy 80 Liberal strategy Survival (%) 70 60 P=0.10 50 0 5 10 15 20 25 30 Days Hébert PC et al. N Engl J Med. 1999;340:409-417.

  21. Journal Supplements, Anemia Management, and Evidence-Based Medicine Parillo JE. Crit Care Med 2001;29(9 Suppl):S139-141 “…survival tended to decrease for patients with preexisting heart disease (especially those with acute MI or unstable angina) in the restrictive transfusion strategy group, suggesting that critically ill patients with heart and vascular disease may benefit from higher Hb.”

  22. Transfusion Requirements After Cardiac SurgeryThe TRACS Randomized Controlled Trial • Prospective non-inferiority trial in 512 (75%) of 681 eligible patients at one center • Liberal (HCT above 30% vs. restrictive (HCT above 24%) transfusions • 0% and 1.6%, respectively, transfused off protocol • 30 day all-cause mortality not different (10% vs. 11%, respectively) Hajjar LA, et al. JAMA 2010;14:1559-1567

  23. Mean Hemoglobin Levels During the Study According to Transfusion Strategy 16 Liberal strategy 15 Restrictive strategy 14 13 12 Mean Hemoglobin (g/dL) 11 10 9 8 7 1 2 3 4 5 6 7 Preop Intraop Days After ICU Admission Immediate Postop P<.05 between the groups at all points following preop. Error bars indicate 95% confidence intervals. ICU indicates intensive care unit. Hajjar LA et al. JAMA. 2010;14:1559-1567.

  24. Liberal or restrictive transfusion in high-risk patients after hip surgery • Patients 50 years of age or older with risk factors for cardiovascular disease • Hemoglobin levels less than 10 g/dl after hip fracture surgery • 2,016 (56%) of 3596 eligible patients participated • Liberal (hgb threshold of 10 g/dl): 97% transfused • Restrictive (symptoms of anemia or hgb less than 8 g/dl, at physician discretion): 41% transfused • 4% and 12% of transfusions were for symptoms in the liberal vs restrictive cohorts, respectively Carson JL et al. N Engl J Med 2011; 365:2453-62

  25. Lowest Daily Hemoglobin Levels 14 Liberal strategy Restrictive strategy Both strategies 13 12 11 10 Lowest Daily Hemoglobin (g/dL) 9 8 7 6 0 0 1 2 3 4 5 6 7 Days since Randomization Carson JL et al. N Engl J Med. 2011;365:2453-2462.

  26. Outcomes * At 60 days Carson JL et al. N Engl J Med 2011;365:2453-2462.

  27. Transfusion Strategies for Acute Upper Gastrointestinal Bleeding • Prospective, randomized trial of 921 patients • Liberal (Hgb >9 g/dl) vs. restrictive (Hgb < 7g/dl) • 962 eligible, 921 (95%) consented • Six week survival was higher in the restrictive vs. liberal cohort (95% vs. 91%, p=0.02) Villanueva C, et al. N Engl J Med 2013; 368:11-2

  28. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease • Pilot study in 110 patients (200 planned) with acute coronary syndromes • Randomized to Hgb >10 g/dL vs <8 g/dL • Composite primary outcome (death, myocardial infarction, or unscheduled revascularization) • RBC transfusions 1.58 vs. 0.49 units (p=0.001), respectively • Pre-transfusion Hgb 9.3 vs. 7.9 g/dL (p=0,001) • Composite outcome: 10.9 vs. 25.5% (p=0.054) • 30 day mortality: 1.8 vs. 13% (p=0.032) Carson JL, et al. Am Heart J 2013;165:964-971.

  29. Five Key Clinical Trials of Blood Transfusion in Adults *Average daily Hgb. ** NA: Not Available • Hebert PC, et al. N Engl J Med 1999;340:409-17. • Hajjar LA, et al. JAMA 2010;304:1559-67. • Carson JL, et al. N Engl J Med 2011;365:2453-62. • Villanueva C, et al. N Engl J Med 2013; 368:11-2. • Carson JL, et al. JAMA Intern Med 2013;173:139-41. Goodnough LT, Levy JH, Murphy MF. Concepts of blood transfusion in adults. Lancet 2013;381:1845-54.

  30. Transfusion Thresholds in Focus* “The decision to transfuse should be guided by an assessment of individual patients on the basis of a combination of signs, symptoms and laboratory measures, and not by a single hemoglobin level.” Barr PJ, Bailie KE. N Engl J Med 2011; 356: 2532 *Carson et al. (Hip Fracture) Focus Trial N Engl J Med 2011; 365:2453-62.

  31. Red Blood Cell Transfusion: A Clinical Practice Guideline from the AABB • Recommends adhering to a restrictive transfusion strategy (7-8 g/dl) in hospitalized, stable patients. • For patients with pre-existing cardiovascular disease, consider transfusion for patients with symptoms or a hgb less than 8 g/dl. • Cannot recommend for or against liberal vs restricted transfusions for patients with acute coronary syndrome • Suggests that transfusion decisions be influenced by symptoms as well as hemoglobin concentration. Carson JL, et al. Ann Intern Med 2012;157:49-58.

  32. Medical Society Guidelines/Recommendations (Cont.) *For patients with acute blood loss **For patients with symptoms of end organ ischemia ***Kidney Disease Improving Global Outcomes Goodnough LT, Levy JH, Murphy MF. Lancet 2013;381:1845-54.

  33. Objectives • Understand blood risks and principles of Patient Blood Management • Review published clinical practice guidelines for blood transfusions • Know current Level 1 evidence for blood transfusion practices • Understand need for improved indicators for blood utilization

  34. Blood Transfusion as a Quality Indicator in Cardiac Surgery • Persistent variability in transfusion outcomes since 1991 • Clinical practice guidelines from STS/SCA, 2007 • Restrictive vs. liberal transfusion trials published 1999 and 2010 • Blood transfusion outcomes should serve as a quality indicator in cardiac surgery Shander A, Goodnough LT. JAMA 2010;14:160-1611.

  35. EPIC Best Practice Alert (BPA): Live July 2010

  36. Blood Transfusions Administered at SHC* % RBC units transfused with Hgb ≥8 g/dl Quarterly Intervals *Stanford Hospital and Clinics BPA = Best Practice Alert Goodnough et al. Transfusion 2013, In Press

  37. Trends in red blood cell (RBC) transfusions RBC Units BPA (best practice alert) implementation: July 2010 Stanford Hospital and Clinics, 6 month intervals

  38. Trends in red blood cell (RBC) transfusions BPA RBC per 100 patient days at risk RBC= Red Blood Cell BPA (best practice alert) implementation: July 2010 Stanford Hospital and Clinics, 6 month intervals

  39. Patient Profile All in-patient discharges, Stanford Hospital & Clinics (SHC) *Total knee, total hip, or spinal fusion **Isolated coronary artery bypass or aortic valve replacement ***Heart or lung transplant

  40. Clinical Patient Outcomes *Rates/1000 discharges

  41. Patient Clinical Outcomes (SHC) Rate *** * *Length of Stay (Days) Is decreasing (p=0.003) ** Mortality rate (per 1,000 discharges is decreasing (p=0.034) ***30 day readmission rate per 1,000 discharges) is unchanged (p=0.909)

  42. RBC Distributions based on the National Blood Center Utilization Survey (NBCUS) 14.9M 48.9 RBC/1,000 13.7M 44.2 RBC/1000 13.2M 41.8 RBC/1000 RBC Transfusions (millions) 10.5M 40.0 RBC/1,000

  43. Conclusion 1. Blood Utilization • Traditional measures*: blood outdates, blood wastage, T/C ratios • Evolving quality indicators : transfusion and clinical outcomes • Improves Patient Safety • Reduces Transfusion-Related Costs • Preserves Blood Inventory 2. Endorsed by • Joint Commission: 2010-2012 Strategic Objective • World Health Alliance (WHA 63.12, Accepted 6/8/11) • Blood Products and Patient Safety Advisory Committee to the FDA, 6/9/11 • *CAP Q-tracks Arch Pathol Lab 2002;126:1036-1044.

  44. Conclusion (Cont.) • 3. Transfusion triggers should be patient-centered, rather than based only on a lab number • 4. Variability in transfusion outcomes persists, despite Level I evidence and published clinical practice guidelines • 5. Blood transfusion outcomes should be designated as a quality indicator

  45. Acknowledgements • Mentors • CWRU • Oscar Ratnoff • Hidehiko Saito • Collaborators • Washington University, St. Louis • Terry Monk • George Despotis • Stanford University • Neil Shah • Mentors/Colleagues/Collaborators • John Adamson • Aryeh Shander • Family • Mary Ellen Kleinhenz • Julia, Lucy, Henry, Bob • Administrative Support • Jason Calcagno

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