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THE USE OF RED CELL ADDITIVE SOLUTIONS AND SPECIAL ATTRIBUTES IN NEONATAL PATIENTS

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THE USE OF RED CELL ADDITIVE SOLUTIONS AND SPECIAL ATTRIBUTES IN NEONATAL PATIENTS Ryan Pyles MLT(ASCP) CM SSM Cardinal Glennon Children s Hospital, St Louis, MO Introduction Currently many blood banks
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THE USE OF RED CELL ADDITIVE SOLUTIONS AND SPECIAL ATTRIBUTES IN NEONATAL PATIENTS Ryan Pyles MLT(ASCP) CM SSM Cardinal Glennon Children s Hospital, St Louis, MO Introduction Currently many blood banks manage two RBC inventories. In an attempt to provide low additive solution (AS) containing RBC units to neonatal patients. Although older publications suggest a safety benefit to decreasing AS exposure, there are no published studies showing overt clinical complications with AS exposure in neonatal patients. Discuss/describe different formulations of popular red cell additive solutions and anticoagulant preservative solutions commonly used in neonatal transfusions. - AS-1 - AS-3 - AS-5 - CPD - CPDA-1 Objectives Additive Solutions Anticoagulant Preservatives Objectives Discuss/review literature concerning use of red cell additive solutions for both small and large volume neonatal transfusion. Discussion will focus on some of the most common concerns associated with transfusion of additive solutions to neonatal patients. Objectives Discuss survey results concerning: RBC additive of choice for neonatal patients in a variety of clinical settings. Policies concerning CMV seronegative blood product usage for neonatal patients. Policies concerning irradiated blood product usage for neonatal patients. What are RBC Additive Solutions & Anticoagulant Preservatives? AS-1: Adsol AS-3: Nutricel Additive Solutions AS-5: Optisol CPD CPDA-1 Anticoagulant Preservative WHAT S IN THE BAG? CPD AS ml RBCs Residual Plasma No additive solution Hct: 65%-80% ml RBCs Residual Plasma ml of additive solution Hct: 55%-65% Circular of Information for the use of Human Blood and Blood components pg 8-9 CPD Preservatives ADVANTAGES DISADVANTAGES Higher hematocrit (65%~80%). Safety of CPD is well known. Shorter expiration date than additive solution RBC units; 21~35 days compared to 42 days. Increased donor exposure due to shorter shelf life. No additive solutions. Additive Solutions ADVANTAGES DISADVANTAGES Longer expiration date than CPD units; 42 days compared to 21~35 days Decreased donor exposure; one unit can be split several times to service one high need pt or several moderate need pt s Several studies exist supporting small volume ( 10mL-15mL/kg) AS RBC transfusions are safe for neonatal pt s Large volume neonatal transfusion ( 20-25mL/kg) of AS RBCs has not been studied. Possible exposure to large doses of adenine, dextrose, and mannitol Lower hematocrit than CPD RBC units (55%~65%) Clinical Concerns Associated With AS 1. Adenine: Metabolites can cause crystals to form in renal tubules causing liver and kidney problems 2. Mannitol: large molecule; high osmolality Pulls water into vessels Concern about causing osmotic diuresis and compromising cerebral blood flow in neonates Philps, FS et al. J Pharm Exp Ther, 1952 Clinical Concerns Associated With AS 3. Potassium: Cardiac arrhythmia 4. Hypernatremia: Sodium in the blood product 5. Hypocalcemia: Citrate & phosphate chelate patient s calcium Philps, FS et al. J Pharm Exp Ther, 1952 AS-1* (Adsol) Dextrose 2200 mg/100ml AS-3* (Nutricel) 1100 mg/100ml AS-5* (Optisol) 900 mg/100ml CPD** 1610 mg/63ml CPDA-1** 2010 mg/63ml Adenine 27 mg/100ml 30 mg/100ml 30 mg/100ml 0 mg/63ml 17.3 mg/63ml Mannitol 750 mg/100ml Monobasic Sodium Phosphate Sodium Chloride Sodium Citrate 0 mg/100ml 276 mg/100ml 900 mg/100ml 0 mg/100ml 525 mg/100ml 410 mg/100ml 0 mg/100ml 588 mg/100ml Key Differences 0 mg/63ml 0 mg/63ml 0 mg/100ml 140 mg/63ml 140 mg/63ml 877 mg/100ml 0 mg/100ml 1660 mg/63ml 0 mg/63ml 0 mg/63ml 1660 mg/63ml Citric Acid 0 mg/100ml 42mg/100mL 0 mg/100ml 206mg/63mL 206mg/63mL Shelf Life 42 DAYS 42 DAYS 42 DAYS 21 DAYS 35 DAYS AABB Technical Manual 17 th Edition pg Safety of Red Cells Preserved in Extended Storage Media for Neonatal Transfusions Luban, Strauss, and Hume Theoretical calculations based on the amounts of additives transfused to neonatal patients in defined clinical settings based on known toxicology of additive solutions. First clinical setting: Small volume transfusion ( 10mL/kg) given to infant weighing 1 kg, to replace phlebotomy losses. Second clinical setting: Exchange transfusion of an infant weighing 3kg, receiving 1 unit of reconstituted whole blood. Third clinical setting: Multiple units over prolonged periods of time ex: cardiac bypass or ECMO. Luban et al. Transfusion, 1991 Toxic Threshold Calculations: Large Volume Transfusions Dose of additive (mg/kg) 1 kg infant 10mL/kg AS RBC 3 kg infant Exchange Tx 240mL R-WB, 80% 3 kg infant 2 AS RBC ECMO / CPB Retain 240 ml Dose judged to pose risk (mg/kg/hr) Dextrose Sodium Citrate Phosphate 60 Adenine Mannitol Luban et al. Transfusion, 1991 Safety of Red Cells Preserved in Extended Storage Media for Neonatal Transfusions Luban, Strauss, and Hume Challenges to accurately estimate additive exposure and asses toxic dose: Clinical setting Duration of exposure to additive solutions Physiology Bioavailability of solutes Intracellular trapping of solutes Dispersion to extracellular compartments of solutes The protein binding, metabolism, and excretion after transfusion. Patient s renal and hepatic status Luban et al. Transfusion, 1991 Clinical Studies Support Low Volume Transfusions with Additive RBC Units Six studies Different age of product, type of solution, dose transfused No evidence of hyperglycemia, hypoglycemia, hypocalcemia, hyperkalemia, hyponatremia No clinical adverse consequences or significant differences in blood chemistry were observed Luban et al. Curr Op Hematol, 2002 Blood Component Preferences of Transfusion Services Supporting Infant Transfusions: A University Health System Consortium Benchmarking Study Purpose: The extent of acceptability of RBCs stored in additive solutions for low volume neonatal transfusion among hospitals is currently unknown. Included questions concerning the use of AS for low volume neonatal transfusion ( 20ml/kg). Survey Results: 60% accepted the use of at least one (AS-1, AS-3, or AS-5) for neonatal transfusions with a preference for AS-3. 45% accepted the use of all three additive solutions. Fung et el Transfusion, 2010 Blood Component Preferences of Transfusion Services Supporting Infant Transfusions: A University Health System Consortium Benchmarking Study Conclusion: Although many institutions will use AS, many will not This survey was not designed to determine the reasons for these preferences. Possible reasons for these preferences may include. Lack of awareness of current data concerning the use of AS for neonatal transfusion. Lack of acceptance of current data. More data may be needed. Fung et el Transfusion, 2010 Comparison of CPDA vs. AS Red Cell Transfusion To Infants on ECMO Anne F. Eder, MD PhD, Kristine Gray, MT(ASCP), Catherine S. Manno, MD Department of Pathology and Laboratory Medicine, The Children s Hospital of Philadelphia, Philadelphia, P A Introduction Transfusion protocols for infants on extracorporeal membrane oxygenation (ECMO) were developed in the absence of definitive evidence to guide decisions. Consequently, practices vary among pediatric institutions with respect to the selection of red cell components ( i.e., maximum storage time prior to transfusion; preservative/anticoagulant solution) and further modification of the units (i.e., supernatant removal; washing). Two different transfusion protocols evolved at The Children s Hospital of Philadelphia in an effort to balance disparate concerns among groups of specialist physicians. Reflecting primarily theoretical considerations regarding additive solutions (AS), in particular, their mannitol and adenine content, a protocol for infants in the neonatal intensive care unit specifies type O red cells less than 10 days old collected in CPD or CPDA-1 (CPD/A). If only AS units are available the supernatant is removed prior to transfusion. In contrast, cardiologists and anesthesiologists at our institution preferentially requested AS units over CPD/A units, primarily because of the lower concentration of extracellular potassium and decreased risk of attendant cardiac toxicity following massive transfusion. Consequently, infants in the cardiac intensive care unit (CICU) receive primarily ABO/Rh type-specific red cells, collected in AS-1 or AS-3 (AS1/3); some may also receive CPD/A units based on available inventory. Our CICU experience suggests that infants on ECMO tolerate AS1/3 units as well as CPD/A units. To substantiate the comparative safety of transfusing large volumes of AS1/3 units compared to fresh CPD/A units to infants less than four months on ECMO, a retrospective audit of transfusions in the CICU was conducted. Methods Infants in the CICU who received whole unit red cell transfusion on ECMO were selected for retrospective audit. Hemoglobin, sodium, potassium, calcium, glucose and creatinine values were compared before and after the transfusion of CPD/A red cell units or AS1/3 red cell units. Post-transfusion laboratory values were measured within 4 hours of the transfusion. The pre- and post-transfusion mean laboratory values were compared with paired t-tests (one-tailed for hematocrit; two tailed for all other analytes). Pretransfusion laboratory values were subtracted from posttransfusion results to express mean changes in blood chemistry levels, so that a positive value indicates an increase; a negative value, a decrease after transfusion. The mean changes (D) were then compared with unpaired t-tests. Table 1. Red Cell Transfusions Audited CPD or CPDA Transfusions AS-1 or AS-3 Transfusions Tx Patient Age Indication for ECMO Tx Patient Age Indication for ECMO 1 A 2 m Tetralogy of Fallot/ARDs 1 A 2 m Tetralogy of Fallot/ARDs 2 B 2 d Bridge to heart transplant 2 B 2d Bridge to heart transplant 3 C 3 d Transposition of the great 3 B 4 C arteries 4 E 3m Bridge to lung transplant 5 D 2d Cardiac arrest, congenital 5 E 6 D heart disease 6 F 5d Transposition of the great arteries, double outlet right ventricle sp surgery Table 2. Laboratory Values with Transfusion CPD/A AS1/3 Pre Post p Pre Post p Hct, % Na, mmol/l K, mmol/l GLC, mg/dl Ca, mg/dl Crt, mg/dl Table 3. Comparison of Changes in Laboratory Values After CPD/A vs. AS1/3 Transfusion CPD/A AS1/3 ( ) ( ) p Hct, % Na, mmol/l K, mmol/l GLC, mg/dl Ca, mg/dl Crt, mg/dl Results Four infants received 6 CPD/A units; four infants received 6 AS1/3 units (Table 1). Hematocrit was significantly increased after transfusion of CPD/A (p=0.04) or AS1/3 (p=0.02) units, with mean differences of 3.4% after CPD/A and 2.8% after AS1/3 transfusions (p, NS)( Table 2,3). No other statistically significant differences between pre- and post-transfusion laboratory values were observed (Table 2). Mean differences in serum chemistry values ( D) following CPD/A or AS1/3 transfusion were compared (Table 3). These changes observed in laboratory values following transfusion of CPD/A or AS1/3 units were not statistically or clinically significant. No adverse reactions to blood transfusion were reported. Conclusions Transfusion of AS1/3 units appears to be tolerated as well as CPD/A units by infants on ECMO, suggesting removal of AS supernatant or washing is unnecessary. The data support less reliance on CPD/A units for infants, an important consideration in light of the decreasing availability and greater expense of these units compared to AS units. The data also support simplification of transfusion protocols at our institution, eliminating the need for a separate inventory of CPD/A units or further manipulation of red cell units for infants on ECMO. Comparison of CPDA vs AS Red Cell Transfusion to Infants on ECMO Purpose: Transfusion protocols were developed for infants on ECMO in the absence of definitive evidence to guide clinical decisions. Practices vary among pediatric institutions with respect to: Selection of red cell components. Maximum storage time before transfusion. Additive solution/anticoagulant preservative used. Further modification to the units (washing, supernatant removal, etc) Eder et el, Children s Hospital of Philadelphia, Comparison of CPDA vs AS Red Cell Transfusion to Infants on Ecmo Comparison of CPDA vs AS Red Cell Transfusion to Infants on ECMO Retrospective audit included 4 infants receiving 6 CPD/A units and 4 infants receiving 6 AS-1/3 units. (Both groups received whole red cell transfusions) Study compared pre & 4 hour post transfusion values for Hct, Na, K+, Ca, Glucose, and Creatinine. Study results: Hct increased significantly after CPD/A(mean difference 3.4%) RBC transfusion compared to AS-1/3(mean difference 2.8%) RBC transfusion. No other statistically significant differences between pre and post transfusion laboratory values were observed. Eder et el, Children s Hospital of Philadelphia, Comparison of CPDA vs AS Red Cell Transfusion to Infants on Ecmo Current Conclusions (1) Commentary on the Safety of Red Cells Preserved in Extended Storage Media for Neonatal Transfusions. Amount of additive solution transfused to during small volume transfusion settings was far below the toxic dose. Several complicating factors to accurately estimate the toxic dose of additive solution transfused neonates to during large volume transfusion. Clinical studies in support of small volume transfusion with additive RBC s. Review of six clinical studies shows no evidence of adverse consequences or significant differences in blood chemistries Current Conclusions (2) University Health Consortium Survey of blood component preferences for transfusion services. Included questions concerning use of AS for low volume neonatal transfusion ( 20ml/kg) Survey results indicated that the majority of transfusions services were willing to use at least one additive solution. Many respondents indicated the willingness to use all three additive solutions. Comparison of 4 neonates receiving 6 CPD/A vs 4 neonates receiving 6 AS1/3 whole unit transfusions. No statistically significant differences between pre and post transfusion laboratory values except Hct%. Survey of the Use of Red Cell Additive Solutions & Special Attributes in Neonatal Patients Ryan Pyles 1, Jimmy Lowery 2, Meghan Delaney 3,4 1. SSM Health Cardinal Glennon Children s Hospital, St Louis, MO 2. American Red Cross, Durham, NC 3. Blood Works Northwest, Seattle, WA 4. University of Washington, Department of Laboratory Medicine & Pediatrics, Seattle, WA Survey Goal Assess the transfusion practice for neonatal patients at a subset of institutions concerning: 1: RBC additive of choice in a variety of clinical settings, including additional modifications 2: Policies concerning CMV seronegative blood products 3: Policies concerning Irradiated blood products Methods Survey: 78 facilities throughout the U.S.A. 21 centers participated (27% response rate) Definitions Neonates: 4months of age Small volume transfusion: 20mL/kg Large volume transfusion: 20 ml/kg Responding Centers Demographics 24% - pediatric only. 76% - adult & pediatric. Average NICU bed size was 81 beds. 90.5% identified as academic facilities Results, Use of AS-1 & AS-3 in Small and Large Volume Neonatal Transfusion RBC Dose CPD CPDA AS-1 AS-3 AS-5 * n = 21 Small Volume Transfusion ( 20mL/kg) Large Volume Transfusion ( 20mL/kg) 14% 14% 24% 38% 0% 14% 14% 29% 43% 0% 72% (15 of 21 centers) Results, Additional Modifications for AS RBCs in Large Volume Transfusion Settings Clinical setting General Surgery n=13 Fresh ( 7-10 d) Washed Supernatant Reduced No Modification 61% 8% 8% 23% Results, Additional Modifications for AS RBCs in Large Volume Transfusion Settings Clinical setting General Surgery n=13 Cardiac Surgery n=12 Fresh ( 7 10 d) Washed Supernatant Reduced No Modification 61% 8% 8% 23% 75% 8% 0% 17% Results, Additional Modifications for AS RBCs in Large Volume Transfusion Settings Clinical setting Fresh ( 7 10 d) Washed Supernatant Reduced No Modification General Surgery n=13 Cardiac Surgery n=12 ABO Incompatible Heart Transplant n=7 61% 8% 8% 23% 75% 8% 0% 17% 29% 43% 14% 14% Results, Additional Modifications for AS RBCs in Large Volume Transfusion Settings Clinical setting General Surgery n=13 Cardiac Surgery n=12 ABO Incompatible Heart Transplant n=7 Extra Corporeal Life Support n=10 Fresh ( 7 10 d) Washed Supernatant Reduced No Modification 61% 8% 8% 23% 75% 8% 0% 17% 29% 43% 14% 14% 80% 10% 0% 10% Results, Additional Modifications for AS RBCs in Large Volume Transfusion Settings Clinical setting General Surgery n=13 Cardiac Surgery n=12 ABO Incompatible Heart Transplant n=7 Extra Corporeal Life Support n=10 Exchange Transfusion n=13 Fresh ( 7 10 d) Washed Supernatant Reduced No Modification 61% 8% 8% 23% 75% 8% 0% 17% 29% 43% 14% 14% 80% 10% 0% 10% 69% 15% 8% 8% Survey Conclusions A majority (72%) of respondents have transitioned to the use of AS-1 or AS-3 for large volume neonatal transfusions in a variety of clinical settings. The use of AS units appears widely accepted in large volume transfusion, even though there are not clinical studies to support the practice. Many respondents choose fresh RBC products, possibly due to the risk of transfusion associated hyperkalemia, although the reason for the fresh product was not investigated The survey does not provide a guidance for practice, but offers a snapshot of practice. Further research into the best product parameters for large volume neonatal transfusion are needed. Thank You Questions? A Word About RBC Product Processing All Neonates Case-By-Case Basis Not Available and Not Provided CMV Seronegative 26% 21% 47% Leukocyte Reduced 100% 0% 0% Irradiated 89% 11% 0% * n = 19 Current Practice for Prevention of Transfusion Transmitted CMV Infection in the United States Common methods to avoid TT-CMV infection - Transfuse leukocyte reduced CMV seronegative RBC units - Transfuse leukocyte reduced RBC units Wide variety of practices for the provision of CMV-safe blood products No uniform practice for specific patient populations among institutions. Academic institutions were more likely to believe that leukocyte reduced blood products are equivalent to CMV seronegative blood products. Smith et al, Vox Sanguinis, 2010
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