Blood Conservation Program

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A Blood Conservation Program for Santa Clara (and Region?):

A Blood Conservation Program for Santa Clara (and Region?) Jason D. Lee, M.D. Department of Pathology Kaiser Santa Clara

Goals:

Goals Transfusion guidelines “shop-talk”. Critical review of red cell transfusion guidelines for Hb 7-10 g/dL. Randomized trials vs. observational studies Cardiac ischemic patients Describe blood conservation goals and approaches for Kaiser Santa Clara (and Region?).

Blood use at Kaiser Santa Clara:

Blood use at Kaiser Santa Clara Santa Clara Blood Bank records Total Number of Patients Transfused Red Cells 0 500 1000 1500 2000 2500 3000 3500 4000 4500 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year 1991-2008 Number of Patients

Who cares about blood use?:

Who cares about blood use? AABB The Joint Commission http://www.jointcommission.org/patient_blood_management_performance_measures_project/ Society for Thoracic Surgeons http://www.sts.org/sites/default/files/documents/pdf/guidelines/BloodConservationUpdate0311.pdf American Red Cross http://www.redcrossblood.org/sites/arc/files/pdf/Practice-Guidelines-Nov2010-Final.pdf Academic and community hospitals

Blood conservation principles:

Blood conservation principles Blood transfusion is potentially life-saving when applied to the population most likely to benefit from therapy. The benefit of transfusion has not been proven in many instances for which patients are currently transfused. Blood products are a limited precious resource. The risks of transfusion (however slight) are increasingly recognized. Transfusion practices highly variable among physicians.

Early guidelines for red cells:

Early guidelines for red cells The “10/30” rule of 1942 was abandoned by an NIH Consensus Conference in 1988. Trigger-based vs. symptom-based transfusion strategy debated. Consensus conference. Perioperative red blood cell transfusion. JAMA . 1988 Nov 11;260(18):2700-3.

Evolution of guidelines:

Evolution of guidelines Practice Guidelines for blood component therapy: A report by the American Society of Anesthesiologists Task Force on Blood Component Therapy. Anesthesiology . 1996 Mar;84(3):732-47. ASA practice guidelines adopted in 1996. Any rational recommendations for red cell transfusion in the Hb 7-10 g/dL range?

Transfusion provides no mortality benefit if Hb > 8.0 g/dL?:

Transfusion provides no mortality benefit if Hb > 8.0 g/dL? Retrospective study of 8787 elderly hip fracture patients with significant comorbidities. Transfused cohort compared to non-transfused cohort. Did red cell transfusion change mortality if patients had Hb > 8.0 g/dL? No. Perioperative blood transfusion and postoperative mortality. Carson JL, Duff A, Berlin JA, Lawrence VA, Poses RM, Huber EC, O'Hara DA, Noveck H, Strom BL. JAMA . 1998 Jan 21;279(3):199-205.

ICU randomized trial:

ICU randomized trial Is there any difference when ICU patients are transfused for Hb of 7.0 vs. 9.0 g/dL? A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. N Engl J Med . 1999 Feb 11;340(6):409-17.

No significant differences:

No significant differences Hebert PC, et. al. N Engl J Med . 1999.

Except in healthier ICU patients:

Except in healthier ICU patients Hebert PC, et. al. N Engl J Med . 1999. If transfusion had an obvious benefit, why was it so difficult to prove?

TRICC: Less is more:

TRICC: Less is more Hebert PC, et. al. N Engl J Med . 1999. “We recommend that critically ill patients receive red cell transfusions when their hemoglobin concentrations fall below 7.0 g/dL and that hemoglobin concentrations should be maintained between 7.0 and 9.0 g/dL. The diversity of the patients enrolled in this trial and the consistency of the results suggest that our conclusions may be generalized to most critically ill patients, with the possible exception of patients with active coronary ischemic syndromes.”

PICU randomized trial:

PICU randomized trial Transfusion strategies for patients in pediatric intensive care units. Lacroix J, Hébert PC, Hutchison JS, Hume HA, Tucci M, Ducruet T, Gauvin F, Collet JP, Toledano BJ, Robillard P, Joffe A, Biarent D, Meert K, Peters MJ; TRIPICU Investigators; Canadian Critical Care Trials Group; Pediatric Acute Lung Injury and Sepsis Investigators Network. N Engl J Med . 2007 Apr 19;356(16):1609-19. Is there any difference when PICU patients are transfused for Hb of 7.0 vs. 9.5 g/dL?

No significant differences:

No significant differences Lacroix J, et al.. N Engl J Med . 2007. “In stable, critically ill children a hemoglobin threshold of 7 g/dL for red cell transfusion can decrease transfusion requirements without increasing adverse outcomes.”

Analysis of 17 randomized trials:

Analysis of 17 randomized trials Randomized studies on red cell transfusion triggers. Cardiac, vascular, orthopedic surgery (8) Acute blood loss, trauma (5) Critical care (3) Leukemia with chemo or BMT (1) Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Carless PA, Henry DA, Carson JL, Hebert PP, McClelland B, Ker K. Cochrane Database Syst Rev . 2010 Oct 6;(10):CD002042.

Randomized trial composite:

Randomized trial composite Carless PA, et al. Cochrane Database Syst Rev . 2010.

TRICC: Ventilator time:

TRICC: Ventilator time Time spent on ventilator among 713 ventilated ICU patients? No difference. How about among 283 patients ventilated > 1 week? No difference. Do blood transfusions improve outcomes related to mechanical ventilation? Hébert PC, Blajchman MA, Cook DJ, Yetisir E, Wells G, Marshall J, Schweitzer I; Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group. Chest . 2001 Jun;119(6):1850-7. p=0.21 p=0.08

TRICC: Cardiovascular question:

TRICC: Cardiovascular question Mortality difference among 357 patients with admission or history of cardiac disease? No. How about among 257 patients with confirmed ischemic heart disease? No, sort of. Is a low transfusion threshold safe in critically ill patients with cardiovascular diseases? Hébert PC, Yetisir E, Martin C, Blajchman MA, Wells G, Marshall J, Tweeddale M, Pagliarello G, Schweitzer I; Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group. Crit Care Med. 2001 Feb;29(2):227-34. “Based on the results of this subgroup analysis, we suggest that most hemodynamically stable, critically ill patients with cardiovascular disease may receive a transfusion safely when Hb concentrations decrease below 7.0 g/dL and may be maintained at Hb between 7-9 g/dL. One possible exception may be patients with unstable coronary ischemic syndromes, such as acute myocardial infarction and unstable angina.”

Red cell triggers in cardiac patients:

Red cell triggers in cardiac patients Cardiac patients tolerate anemia less well. 1 TRICC is the largest randomized trial and shows no statistical difference between trigger of Hb 7.0 vs. 9.0 g/dL. Maybe acute MI, unstable angina excepted. Retrospective studies on MI or ACS patients give mixed messages. 1 Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Carson JL, Duff A, Poses RM, Berlin JA, Spence RK, Trout R, Noveck H, Strom BL. Lancet . 1996 Oct 19;348(9034):1055-60.

Elderly MI Medicare study:

Elderly MI Medicare study Retrospective study of 78,974 Medicare beneficiaries age 65 and older, with acute MI stratified by admission HCT. Blood transfusion in elderly patients with acute myocardial infarction. Wu WC, Rathore SS, Wang Y, Radford MJ, Krumholz HM. N Engl J Med. 2001 Oct 25;345(17):1230-6.

Positive association for blood:

Positive association for blood Odds ratio for 30-day mortality improved with transfusion for HCT < 33%. Odds ratio worsened if transfused for HCT > 33%. Adjusted for “clinical factors”. Wu WC, et al. N Engl J Med. 2001. “Blood transfusion is associated with a lower short-term mortality rate among elderly patients with acute myocardial infarction if the hematocrit on admission is 30.0 percent or lower and may be effective in patients with a hematocrit as high as 33.0 percent on admission.”

ACS clinical trials study:

ACS clinical trials study Retrospective study of 24,112 ACS trial patients (GUSTO IIb, PARAGON, PURSUIT) with detailed data. Compared the untransfused cohort with 2,401 who were transfused. What was the association of transfusion alone to adverse outcome (mortality/MI)? Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes. Rao SV, Jollis JG, Harrington RA, Granger CB, Newby LK, Armstrong PW, Moliterno DJ, Lindblad L, Pieper K, Topol EJ, Stamler JS, Califf RM. JAMA . 2004 Oct 6;292(13):1555-62.

Accounting for differences in baseline characteristics:

Accounting for differences in baseline characteristics Rao SV, et al. JAMA . 2004.

Accounting for propensity for bleeding or transfusion:

Accounting for propensity for bleeding or transfusion Rao SV, et al. JAMA . 2004.

Negative association persisted after adjustments:

Negative association persisted after adjustments Rao SV, et al. JAMA . 2004.

What is effect of nadir HCT on the harmful association?:

What is effect of nadir HCT on the harmful association? Rao SV, et al. JAMA . 2004. “When hematocrit level was included as a continuous variable in the logistic regression model, we found an association between transfusion and increased 30-day mortality at nadir hematocrit above 25%. This suggests that a hematocrit as low as 25% may be tolerated without blood transfusion in otherwise stable patients with ischemic heart disease.”

NSTE MI quality study:

NSTE MI quality study Retrospective study of 74,981 NSTE MI patients (non-CABG) from CRUSADE National Quality Improvement Initiative database. Compared the untransfused cohort with 12,724 who were transfused. What was the association of transfusion alone to adverse outcome (mortality/MI)? The implications of blood transfusions for patients with non-ST-segment elevation acute coronary syndromes: results from the CRUSADE National Quality Improvement Initiative. Yang X, Alexander KP, Chen AY, Roe MT, Brindis RG, Rao SV, Gibler WB, Ohman EM, Peterson ED; CRUSADE Investigators. J Am Coll Cardiol. 2005 Oct 18;46(8):1490-5.

Negative association persisted after adjustment:

Negative association persisted after adjustment Yang X, et al. J Am Coll Cardiol. 2005. The higher rate of death and MI among patients receiving blood transfusions remained significant after adjustment for a comprehensive list of patient and hospital characteristics. After adjustment, patients undergoing transfusion remained 67% more likely to die and 44% more likely to experience either death or MI than those who did not undergo transfusion during their care.

Washington Hospital PCI study:

Washington Hospital PCI study Retrospective study of 625 patients with nadir HCT 24-30% in Washington Hospital registry of percutaneous coronary intervention. Compared the untransfused cohort with 189 who were transfused. What was the association of transfusion alone to adverse outcome (mortality/MI)? Value of blood transfusion in patients with a blood hematocrit of 24% to 30% after percutaneous coronary intervention. Maluenda G, Lemesle G, Ben-Dor I, Collins SD, Syed AI, Li Y, Torguson R, Kaneshige K, Xue Z, Suddath WO, Satler LF, Kent KM, Lindsay J, Pichard AD, Waksman R. Am J Cardiol . 2009 Oct 15;104(8):1069-73.

Washington Hospital PCI study:

Washington Hospital PCI study Maluenda G, et al. Am J Cardiol . 2009. Our data suggest that RBC transfusion does not improve the 30-day and 1-year outcomes when used to treat patients with hematocrit nadir of 24% to 30% after PCI.

National Surgical Quality Improvement Program study:

National Surgical Quality Improvement Program study Retrospective study of 10,100 surgery patients (non-cardiac) in the American College of Surgery NSQIP database. All patients had baseline HCT < 30%. Compared cohort transfused 1 or 2 units of pRBC with untransfused cohort. What was the association of transfusion alone with 30-day mortality or morbidity? Association between intraoperative blood transfusion and mortality and morbidity in patients undergoing noncardiac surgery. Glance LG, Dick AW, Mukamel DB, Fleming FJ, Zollo RA, Wissler R, Salloum R, Meredith UW, Osler TM. Anesthesiology. 2011 Feb;114(2):283-92.

Negative association persisted after adjustment:

Negative association persisted after adjustment Glance LG, et al. Anesthesiology. 2011. We found that blood transfusion in the setting of non-cardiac surgery is associated with increased risk of 30-day mortality and pulmonary, septic, wound, and thromboembolic complications. The increased risk…was present after adjusting for patient demographics, functional status, comorbidities, and surgical complexity. Blood transfusion did not appear to be protective in patients with cardiovascular disease.

What to do about Hb 7-10 g/dL?:

What to do about Hb 7-10 g/dL? Randomized trials unanimously show no difference between restrictive and liberal transfusion triggers. Observational studies mostly show transfusions have negative association (or no association) with outcomes. A call for more randomized clinical trials! A call to action? 1 1 More on transfusion and adverse outcome: it's time to change. Spahn DR, Shander A, Hofmann A, Berman MF. Anesthesiology . 2011 Feb;114(2):234-6.

Ongoing randomized trials:

Ongoing randomized trials FOCUS, Transfusion trial: functional outcomes in cardiovascular patients undergoing surgical hip fracture repair. 1 MINT, Myocardial ischemia and transfusion. 1 TITRe 2, Trial indication threshold reduction on transfusion rates, morbidity and healthcare resources use following cardiac surgery. 2 1 University of Medicine and Dentistry in New Jersey 2 University of Bristol, UK

Rational transfusion in the Hb 7-10 g/dL range:

Rational transfusion in the Hb 7-10 g/dL range “Prophylactic”: stable isovolemic critically ill patients should avoid transfusions for Hb > 7.0 g/dL or HCT > 20%. Stable cardiac patients should avoid transfusions for Hb > 8.0 g/dL or HCT > 24%. “Symptomatic”: unstable isovolemic patients (including cardiac) may benefit from transfusion for tachycardia, hypotension, acidosis, shock, massive hemorrhage, etc.

Blood conservation approach:

Blood conservation approach Physician education and guidance Employ a restrictive transfusion trigger Boost endogenous production (B12, folate, Fe, vit. K, Epo?) Supplemental oxygen Limit phlebotomy Intra-operative conservation techniques Aggressive anemia abatement

Example of transfusion order with imbedded indications:

Example of transfusion order with imbedded indications The Transfusion Committee: Putting Patient Safety First , Saxena S, Shulman IA, AABB Press, Bethesda, 2006. Guidelines implemented at St. Vincent Hospitals in Indianapolis, IN since 2001.

Revised transfusion orders at John Muir Hospital:

Revised transfusion orders at John Muir Hospital First implemented in 2009, revised to current implementation in 2010.

Stanford/LPCH approach:

Stanford/LPCH approach Best practice alerts incorporated into electronic ordering system Suggests a threshold of Hb 7.0 g/dL (or 8.0 g/dL in cardiac ischemia) in stable, non-bleeding adults. Suggests a threshold of Hb 7.0 g/dL in stable critically-ill children. First implemented July 2010.

Proposed Health Connect indications:

Proposed Health Connect indications RED CELL TRANSFUSION INDICATION: (__) Rapid or ongoing blood loss. (__) Hb ≤ 7.0 g/dL or HCT ≤ 20% in a stable patient. (__) Hb ≤ 8.0 g/dL or HCT ≤ 24% in a stable patient with ischemic cardiac disease. (__) Other reason (specify)_______. PLATELET TRANSFUSION INDICATION: (__) Platelet count ≤ 10 K/uL in stable patient with failure of platelet production. (__) Platelet count ≤ 20 K/uL in patient with signs of hemorrhagic diathesis (petechiae, mucosal bleeding). (__) Platelet count ≤ 50 K/uL in patient with active bleeding or for imminent invasive procedure. (__) Platelet count ≤ 100 K/uL in cardiac surgery post-pump with evidence of platelet dysfunction, or in surgery of brain/eye/orbit. (__) Other reason (specify)________.

Proposed Health Connect indications:

Proposed Health Connect indications PLASMA TRANSFUSION INDICATION: (__) Acute reversal of Warfarin. (__) Thrombotic Thrombocytopenia Purpura/Hemolytic Uremic Syndrome. (__) INR > 1.8 with imminent invasive procedure or presence of (or potential for) significant hemorrhage. (__) Other reason (specify) _________. CRYOPRECIPITATE TRANSFUSION INDICATION: (__) Fibrinogen ≤ 100 mg/dL. (__) Fibrinogen ≤ 150 mg/dL with active hemorrhage. (__) Dysfibrogenemia. (__) Other reason (specify)_________.

Achievable steps at SCH:

Achievable steps at SCH Provider education Departmental meetings, educational venues Medical center grand rounds Health Connect order set changes with imbedded indications/best practices Transfusion service intranet site Quality review and feedback process Discussion among interested parties

The bottom line:

The bottom line Anemia is not normal, but blood transfusion provides limited benefit to stable patients with Hb 7-10 g/dL. There are risks associated with transfusion which must be weighed against the possible benefits. Save blood for those who would really benefit! “First do no harm.”

Summary:

Summary Tour of contemporary transfusion literature. Specific transfusion guidelines. Physician judgement still paramount. Refer to references: Santa Clara blood bank web site http://insidekp.kp.org/california/santaclara/departments/bloodbank/index.htm American Red Cross practice guideline http://www.redcrossblood.org/sites/arc/files/pdf/Practice-Guidelines-Nov2010-Final.pdf

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