Development of a Risk Assessment Model for Predicting Red Blood Cell Transfusion in Neonatal Patients.

BACKGROUND: The goal was to develop a risk assessment model for predicting red blood cell (RBC) transfusion in neonatal patients to assist hospital blood supply departments in providing small portions of RBCs to those requiring RBC transfusion on time. METHODS: Clinical information was collected from 1,201 children admitted to the neonatal unit. Clinical factors associated with predicting RBC transfusion were screened, and prediction models were developed using stepwise and multifactorial logistic regression analyses, followed by the evaluation of prediction models using receiver operating characteristic curves, calibration curves, and decision curve analysis (DCA). RESULTS: Overall, 81 neonatal patients were transfused with RBCs, and the variables of gestational age at birth, age < 1 month, receipt of mechanical ventilation, and infant anemia were included in the final prediction model. The area under the curve of the prediction model was 0.936 (0.921 - 0.949), which was significantly higher than that of the individual indicators of gestational age at birth, age at admission < 1 month, receipt of mechanical ventilation, and infant anemia (p < 0.001). DCA showed a standardized net benefit for the possible risk of infant RBC transfusion at 0.1 - 1.0. CONCLUSIONS: We developed a risk assessment model to predict the risk of RBC transfusion in neonatal patients that can effectively assess the risk of RBC transfusion in children.

Penny-wise and pound-foolish: the challenges of preoperative anaemia management.

The timely correction of anaemia before major surgery is important for optimising perioperative patient outcomes. However, multiple barriers have precluded the global expansion of preoperative anaemia treatment programmes, including misconceptions about the true cost/benefit ratio for patient care and health system economics. Institutional investment and buy-in from stakeholders could lead to significant cost savings through avoided complications of anaemia and red blood cell transfusions, and through containment of direct and variable costs of blood bank laboratories. In some health systems, billing for iron infusions could generate revenue and promote growth of treatment programmes. The aim of this work is to galvanise integrated health systems worldwide to diagnose and treat anaemia before major surgery.

Physicians' experience in blood supply shortages and the top factors that impact the clinical, economic, and humanistic outcomes of patients with myelodysplastic syndromes in 5 European countries.

OBJECTIVE: Blood supply shortages may create unnecessary burden, including treatment delay, worsened quality of life, or increased healthcare resource utilization in patients with myelodysplastic syndromes (MDS). This study examined physicians' experience with blood supply shortages in the MDS population. Additionally, physicians' perspectives on the factors that impact clinical, economic, and humanistic outcomes of patients with MDS were investigated. METHODS: A total of 378 physicians primarily specializing in hematology/oncology across the UK, France, Germany, Italy, and Spain completed the survey (n ≈ 75 in each country). Physicians answered questions regarding adequacy of blood supply for patients with MDS who require red blood cell (RBC) transfusions and identified factors impacting the clinical, economic, and humanistic outcomes in the MDS population. RESULTS: Over 65% of physicians reported that their patients with MDS requiring RBC transfusions encountered RBC transfusion delays due to blood supply shortage. Among physicians who reported delays, 13.8% of patients were impacted, ranging from 11.0% in Spain to 19.4% in Italy. On average, patients experienced a 4.2-day delay in receiving RBC transfusions due to blood supply shortages, and 16.7% of patients required additional healthcare provider visits. Eastern Cooperative Oncology Group performance status, threshold hemoglobin levels, and age were the top factors reported by more than two-thirds of physicians that impact outcomes of patients with MDS. CONCLUSION: Our findings support the need for new treatments in MDS that reduce transfusions and thus blood supply needs, and that would have a beneficial effect on clinical, humanistic, and economic outcomes.

Economic evaluation of restrictive vs. liberal transfusion strategy following acute myocardial infarction (REALITY): trial-based cost-effectiveness and cost-utility analyses.

AIMS: To estimate the cost-effectiveness and cost-utility ratios of a restrictive vs. liberal transfusion strategy in acute myocardial infarction (AMI) patients with anaemia. METHODS AND RESULTS: Patients (n = 666) with AMI and haemoglobin between 7-8 and 10 g/dL recruited in 35 hospitals in France and Spain were randomly assigned to a restrictive (n = 342) or a liberal (n = 324) transfusion strategy with 1-year prospective collection of resource utilization and quality of life using the EQ5D3L questionnaire. The economic evaluation was based on 648 patients from the per-protocol population. The outcomes were 30-day and 1-year cost-effectiveness, with major adverse cardiovascular events (MACEs) averted as the effectiveness outcome. and a 1-year cost-utility ratio.The 30-day incremental cost-effectiveness ratio was €33 065 saved per additional MACE averted with the restrictive vs. liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE-reducing (i.e. dominant). At 1 year, the point estimate of the cost-utility ratio was €191 500 saved per quality-adjusted life year gained; however, the cumulated MACE was outside the pre-specified non-inferiority margin, resulting in a decremental cost-effectiveness ratio with a point estimate of €72 000 saved per additional MACE with the restrictive strategy. CONCLUSION: In patients with AMI and anaemia, the restrictive transfusion strategy was dominant (cost-saving and outcome-improving) at 30 days. At 1 year, the restrictive strategy remained cost-saving, but clinical non-inferiority on MACE was no longer maintained. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02648113. ONE SENTENCE SUMMARY: The use of a restrictive transfusion strategy in patients with acute myocardial infarction is associated with lower healthcare costs, but more evidence is needed to ascertain its long-term clinical impact.

Implementation of a patient blood management program in hematopoietic stem cell transplantation (Editorial, p. 2763).

BACKGROUND: Recipients of hematopoietic stem cell transplantation (HSCT) are among the highest consumers of allogeneic red blood cell (RBC) and platelet (PLT) components. The impact of patient blood management (PBM) efforts on HSCT recipients is poorly understood. STUDY DESIGN AND METHODS: This observational study assessed changes in blood product use and patient-centered outcomes before and after implementing a multidisciplinary PBM program for patients undergoing HSCT at a large academic medical center. The pre-PBM cohort was treated from January 1 through September 31, 2013; the post-PBM cohort was treated from January 1 through September 31, 2015. RESULTS: We identified 708 patients; 284 of 352 (80.7%) in the pre-PBM group and 225 of 356 (63.2%) in the post-PBM group received allogeneic RBCs (p < 0.001). Median (interquartile range [IQR]) RBC volumes were higher before PBM than after PBM (3 [2-4] units vs. 2 [1-4] units; p = 0.004). A total of 259 of 284 pre-PBM patients (91.2%) and 57 of 225 (25.3%) post-PBM patients received RBC transfusions when hemoglobin levels were more than 7 g/dL (p < 0.001). The median (IQR) PLT transfusion quantities was 3 (2-5) units for pre-PBM patients and 2 (1-4) units for post-PBM patients (p < 0.001). For patients with PLT counts of more than 10 × 109 /L, a total of 1219 PLT units (73.4%) were transfused before PBM and 691 units (48.8%) were transfused after PBM (p < 0.001). Estimated transfusion expenditures were reduced by $617,152 (18.3%). We noted no differences in clinical outcomes or transfusion-related adverse events. CONCLUSION: Patient blood management implementation for HSCT recipients was associated with marked reductions in allogeneic RBC and PLT transfusions and decreased transfusion-related costs with no detrimental impact on clinical outcomes.

Genetically-engineered pigs as sources for clinical red blood cell transfusion: What pathobiological barriers need to be overcome?

An alternative to human red blood cells (RBCs) for clinical transfusion would be advantageous, particularly in situations of massive acute blood loss (where availability and compatibility are limited) or chronic hematologic diseases requiring frequent transfusions (resulting in alloimmunization). Ideally, any alternative must be neither immunogenic nor pathogenic, but readily available, inexpensive, and physiologically effective. Pig RBCs (pRBCs) provide a promising alternative due to their several similarities with human RBCs, and our increasing ability to genetically-modify pigs to reduce cellular immunogenicity. We briefly summarize the history of xenotransfusion, the progress that has been made in recent years, and the remaining barriers. These barriers include prevention of (i) human natural antibody binding to pRBCs, (ii) their phagocytosis by macrophages, and (iii) the T cell adaptive immune response (in the absence of exogenous immunosuppressive therapy). Although techniques of genetic engineering have advanced in recent years, novel methods to introduce human transgenes into pRBCs (which do not have nuclei) will need to be developed before clinical trials can be initiated.

A model-based cost-effectiveness analysis of Patient Blood Management.

BACKGROUND: Patient blood management (PBM) is a multidisciplinary concept focused on the management of anaemia, minimisation of iatrogenic blood loss and rational use of allogeneic blood products. The aims of this study were: (i) to analyse post-operative outcome in patients with liberal vs restrictive exposure to allogeneic blood products and (ii) to evaluate the cost-effectiveness of PBM in patients undergoing surgery. MATERIALS AND METHODS: A systematic literature review and meta-analysis were performed to compare post-operative complications in predominantly non-transfused patients (restrictive transfusion group) and patients who received one to three units of red blood cells (liberal transfusion group). Outcome measures included sepsis with/without pneumonia, acute renal failure, acute myocardial infarction and acute stroke. In a second step, a health economic model was developed to calculate cost-effectiveness of PBM (PBM-arm vs control-arm) for simulated cohorts of 10,000 cardiac and non-cardiac surgical patients based on the results of the meta-analysis and costs. RESULTS: Out of 478 search results, 22 studies were analysed in the meta-analysis. The pooled relative risk of any complication in the restrictive transfusion group was 0.43 for non-cardiac and 0.34 for cardiac surgical patients. In the simulation model, PBM was related to reduced complications (1,768 vs 1,245) and complication-related deaths (411 vs 304) compared to standard care. PBM-related costs of therapy exceeded costs of the control arm by € 150 per patient. However, total costs, including hospitalisation, were higher in the control-arm for both non-cardiac (€ 2,885.11) and cardiac surgery patients (€ 1,760.69). The incremental cost-effectiveness ratio including hospitalisation showed savings of € 30,458 (non-cardiac and cardiac surgery patients) for preventing one complication and € 128,023 (non-cardiac and cardiac surgery patients) for prevention of one complication-related death in the PBM-arm. DISCUSSION: Our results indicate that PBM may be associated with fewer adverse clinical outcomes compared to control management and may, thereby, be cost-effective.

Anticoagulation and Transfusions Management in Veno-Venous Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: Assessment of Factors Associated With Transfusion Requirements and Mortality.

PURPOSE: We describe an approach for anticoagulation and transfusions in veno-venous-extracorporeal membrane oxygenation (VV-ECMO), evaluating factors associated with higher transfusion requirements, and their impact on mortality. METHODS: Observational study on consecutive adults supported with VV-ECMO for acute respiratory distress syndrome (ARDS). We targeted an activated partial thromboplastin time of 40 to 50 seconds and a hematocrit of 24% to 30%. Univariate and multiple analyses were done to evaluate factors associated with transfusion requirements and the influence of increasing transfusions on mortality during ECMO. RESULTS: In a cohort of 82 VV-ECMO patients (PRedicting dEath for SEvere ARDS on VV-ECMO [PRESERVE] score: 4, Interquartile range [IQR]: 3-5, Respiratory Extracorporeal Membrane Oxygenation Survival Prediction [RESP] score: 2, IQR: 2-4), 76 (92.7%) patients received at least 1 unit of packed red blood cells (PRBCs) during the intensive care unit stay related to ECMO (median PRBC/d 156 mL, IQR: 93-218; median ECMO duration 14 days, IQR: 8-22). A higher requirement of PRBC transfusions was associated with pre-ECMO hematocrit, and with the following conditions during ECMO: platelet nadir, antithrombin III (ATIII), and stage 3 of acute kidney injury (all P < .05). Sixty-two (75.6%) patients survived ECMO. Pre-ECMO hospital stay, PRBC transfusion, and septic shock were associated with mortality (all P < .05). The adjusted odds ratio for each 100mL/d increase in PRBC transfusion was 1.9 (95% confidence interval [CI]: 1.1-3.2, P = .01); for the development of septic shock it was 15.4 (95% CI: 1.7-136.8, P = .01), and for each day of pre-ECMO stay it was 1.1 (95% CI: 1-1.2, P = .04). CONCLUSION: Implementation of a comprehensive protocol for anticoagulation and transfusions in VV-ECMO for ARDS resulted in a low PRBC requirement, and an ECMO survival comparable to data in the literature. Lower ATIII emerged as a factor associated with increased need for transfusions. Higher PRBC transfusions were associated with ECMO mortality. Further investigations are needed to better understand the right level of anticoagulation in ECMO, and the factors to take into account in order to manage personalized transfusion practice in this select setting.

Treating Anemia in the Preanesthesia Assessment Clinic: Results of a Retrospective Evaluation.

BACKGROUND: Perioperative anemia is challenging during hospital stay because anemia and red blood cell (RBC) transfusions are associated with an increased morbidity and mortality. With the implementation of patient blood management (PBM), a preanesthesia assessment clinic to screen and treat anemia before elective surgery was institutionalized at Muenster University Hospital, Germany. The main objective of this study was to evaluate the association between treating preoperative anemic patients with intravenous iron (IVI) and (primarily) presurgical hemoglobin levels and (secondarily) use of RBCs and mortality. METHODS: Between April 1, 2014, and July 4, 2016, patients scheduled for elective surgery with a risk for RBC transfusions >10% in 2013 were screened for preoperative anemia and, if indicated, treated with IVI. Patients' data, time span between visit in the anesthesia/PBM clinic and surgery, demographic data, type of surgery, the difference of hemoglobin levels between visit and surgery, RBC transfusion, infectious-related International Classification of Disease codes during hospital stay, and 1-year survival were determined retrospectively by screening electronic data files. In addition, patients were interviewed about adverse events, health-related events, and infections via telephone 30, 90, and 365 days after visiting the anesthesia/PBM clinic. RESULTS: A total of 1101 patients were seen in the anesthesia/PBM clinic between days -28 and -1 (median [Q1-Q3], -3 days [-1, -9 days]) before elective surgery. Approximately 29% of patients presented with anemia, 46.8% of these anemic patients were treated with ferric carboxymaltose (500-1000 mg).In the primary analysis, hemoglobin levels at median were associated with a reduction between the visit in the anesthesia/PBM clinic and the surgery in all nonanemic patients on beginning of medical treatment (nonanemic patients at median -2.8 g/dL [-4, -0.9 g/dL], while anemic patients without IVI presented with median differences of -0.8 g/dL [-2, 0 g/dL] and anemic patients with IVI of 0 g/dL [-1.0, 0.5 g/dL]). Hemoglobin levels raised best at substitution 22-28 days before surgery (0.95 g/dL [-0.35, 1.18 g/dL]). Due to the selection criteria, transfusion rates were high in the cohort. Overall, there was no association between IVI treatment and the use of RBC transfusions (odds ratio for use of RBCs in anemic patients, no IVI versus IVI: 1.14; 95% confidence interval, 0.72-1.82). Patients treated with or without IVI presented a comparable range of International Classification of Disease codes related to infections. Telephone interviews indicated similar adverse events, health-related events, and infections. Cox regression analysis showed an association between anemia and reduced survival, regardless of IVI. CONCLUSIONS: An anemia clinic within the preanesthesia assessment clinic is a feasible and effective approach to treat preoperative anemia. The IVI supplementation was safe but was associated with decreased RBC transfusions in gynecology/obstetric patients only. The conclusions from this retrospective analysis have to be tested in prospective, controlled trials.

Transfusion of packed red blood cells at the end of shelf life is associated with increased risk of mortality - a pooled patient data analysis of 16 observational trials.

Observational studies address packed red blood cell effects at the end of shelf life and have larger sample sizes compared to randomized control trials. Meta-analyses combining data from observational studies have been complicated by differences in aggregate transfused packed red blood cell age and outcome reporting. This study abrogated these issues by taking a pooled patient data approach. Observational studies reporting packed red blood cell age and clinical outcomes were identified and patient-level data sets were sought from investigators. Odds ratios and 95% confidence intervals for binary outcomes were calculated for each study, with mean packed red blood cell age or maximum packed red blood cell age acting as independent variables. The relationship between mean packed red blood cell age and hospital length of stay for each paper was analyzed using zero-inflated Poisson regression. Random effects models combined paper-level effect estimates. Extremes analyses were completed by comparing patients transfused with mean packed red blood cell aged less than ten days to those transfused with mean packed red blood cell aged at least 30 days. sixteen datasets were available for pooled patient data analysis. Mean packed red blood cell age of at least 30 days was associated with an increased risk of in-hospital mortality compared to mean packed red blood cell of less than ten days (odds ratio: 3.25, 95% confidence interval: 1.27-8.29). Packed red blood cell age was not correlated to increased risks of nosocomial infection or prolonged length of hospital stay.

The Age of BLood Evaluation (ABLE) randomised controlled trial: description of the UK-funded arm of the international trial, the UK cost-utility analysis and secondary analyses exploring factors associated with health-related quality of life and health-care costs during the 12-month follow-up.

BACKGROUND: At present, red blood cells (RBCs) are stored for up to 42 days prior to transfusion. The relative effectiveness and safety of different RBC storage times prior to transfusion is uncertain. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of transfusing fresher RBCs (stored for ≤ 7 days) compared with current standard-aged RBCs in critically ill patients requiring blood transfusions. DESIGN: The international Age of BLood Evaluation (ABLE) trial was a multicentre, randomised, blinded trial undertaken in Canada, the UK, the Netherlands and France. The UK trial was funded to contribute patients to the international trial and undertake a UK-specific health economic evaluation. SETTING: Twenty intensive care units (ICUs) in the UK, as part of 64 international centres. PARTICIPANTS: Critically ill patients aged ≥ 18 years (≥ 16 years in Scotland) expected to require mechanical ventilation for ≥ 48 hours and requiring a first RBC transfusion during the first 7 days in the ICU. INTERVENTIONS: All decisions to transfuse RBCs were made by clinicians. One patient group received exclusively fresh RBCs stored for ≤ 7 days whenever transfusion was required from randomisation until hospital discharge. The other group received standard-issue RBCs throughout their hospital stay. MAIN OUTCOME MEASURES: The primary outcome was 90-day mortality. Secondary outcomes included development of organ dysfunction, new thrombosis, infections and transfusion reactions. The primary economic evaluation was a cost-utility analysis. RESULTS: The international trial took place between March 2009 and October 2014 (UK recruitment took place between January 2012 and October 2014). In total, 1211 patients were assigned to receive fresh blood and 1219 patients to receive standard-aged blood. RBCs were stored for a mean of 6.1 days [standard deviation (SD) ± 4.9 days] in the group allocated to receive fresh blood and 22.0 days (SD ± 8.4 days) in the group allocated to receive standard-aged blood. Patients received a mean of 4.3 RBC units (SD ± 5.2 RBC units) and 4.3 RBC units (SD ± 5.5 RBC units) in the groups receiving fresh blood and standard-aged blood, respectively. At 90 days, 37.0% of patients in the group allocated to receive fresh blood and 35.3% of patients in the group allocated to receive standard-aged blood had died {absolute risk difference 1.7% [95% confidence interval (CI) -2.1% to 5.5%]}. There were no between-group differences in any secondary outcomes. The UK cohort comprised 359 patients randomised and followed up for 12 months for the cost-utility analysis. UK patients had similar characteristics and outcomes to the international cohort. Mean total costs per patient were £32,346 (95% CI £29,306 to £35,385) in the group allocated to receive fresh blood and £33,353 (95% CI £29,729 to £36,978) in the group allocated to receive standard-aged blood. Approximately 85% of the total costs were incurred during the index hospital admission. There were no significant cost differences between the two groups [mean incremental costs for those receiving fresh vs. standard-aged blood: -£231 (95% CI -£4876 to £4415)], nor were there significant differences in outcomes (mean difference in quality-adjusted life-years -0.010, 95% CI -0.078 to 0.057). LIMITATIONS: Adverse effects from the exclusive use of older RBCs compared with standard or fresh RBCs cannot be excluded. CONCLUSIONS: The use of RBCs aged ≤ 7 days confers no clinical or economic benefit in critically ill patients compared with standard-aged RBCs. FUTURE WORK: Future studies should address the safety of RBCs near the end of the current permitted storage age. TRIAL REGISTRATION: Current Controlled Trials ISRCTN44878718. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 62. See the NIHR Journals Library website for further project information. The international ABLE trial was also supported by peer-reviewed grants from the Canadian Institutes of Health Research (177453), Fonds de Recherche du Québec - Santé (24460), the French Ministry of Health Programme Hospitalier de Recherche Clinique (12.07, 2011) and by funding from Établissement Français du Sang and Sanquin Blood Supply.

Effect of liberal blood transfusion on clinical outcomes and cost in spine surgery patients.

BACKGROUND CONTEXT: Blood transfusions in spine surgery are shown to be associated with increased patient morbidity. The association between transfusion performed using a liberal hemoglobin (Hb) trigger-defined as an intraoperative Hb level of ≥10 g/dL, a postoperative level of ≥8 g/dL, or a whole hospital nadir between 8 and 10 g/dL-and perioperative morbidity and cost in spine surgery patients is unknown and thus was investigated in this study. PURPOSE: This study aimed to describe the perioperative outcomes and economic cost associated with liberal Hb trigger transfusion among spine surgery patients. STUDY DESIGN/SETTING: This is a retrospective study. PATIENT SAMPLE: The surgical billing database at our institution was queried for inpatients discharged between 2008 and 2015 after the following procedures: atlantoaxial fusion, anterior cervical fusion, posterior cervical fusion, anterior lumbar fusion, posterior lumbar fusion, lateral lumbar fusion, other procedures, and tumor-related surgeries. In total, 6,931 patients were included for analysis. OUTCOME MEASURES: The primary outcome was composite morbidity, which was composed of (1) infection (sepsis, surgical-site infection, Clostridium difficile infection, or drug-resistant infection); (2) thrombotic event (pulmonary embolus, deep venous thrombosis, or disseminated intravascular coagulation); (3) kidney injury; (4) respiratory event; and (5) ischemic event (transient ischemic attack, myocardial infarction, or cerebrovascular accident). MATERIALS AND METHODS: Data on intraoperative transfusion were obtained from an automated, prospectively collected anesthesia data management system. Data on postoperative hospital transfusion were obtained through a Web-based intelligence portal. Based on previous research, we analyzed the data using three definitions of a liberal transfusion trigger in patients who underwent red blood cell transfusion: a liberal intraoperative Hb trigger as a nadir Hb level of 10 g/dL or greater, a liberal postoperative Hb trigger as a nadir Hb level of 8 g/dL or greater, or a whole hospital nadir Hb level of 8-10 g/dL. Variables analyzed included in-hospital morbidity, mortality, length of stay, and total costs associated with a liberal transfusion strategy. RESULTS: Among patients with a whole hospital stay nadir Hb between 8 and 10 g/dL, transfused patients demonstrated a longer in-hospital stay (median [interquartile range], 6 [5-9] vs. 4 [3-6] days; p<.0001) and a higher perioperative morbidity (n=145 [11.5%] vs. n=74 [6.1%], p<.0001) than those not transfused. Even after adjusting for age, gender, race, American Society of Anesthesiologists class, Charlson Comorbidity Index score, estimated blood loss, baseline Hb value, and surgery type, logistic regression analysis revealed that patients with a nadir Hb of 8-10 g/dL who were transfused had an independently higher risk of perioperative morbidity (odds ratio=2.11, 95% confidence interval, 1.44-3.09; p<.0001). Estimated additional costs associated with liberal trigger use, defined as a transfusion occurring in patients with a whole hospital stay nadir Hb of 8-10 g/dL, ranged from $202,675 to $700,151 annually. CONCLUSIONS: Transfusion using a liberal trigger is associated with increased morbidity, even after controlling for possible confounders. Our results suggest that modification of transfusion practice may be a potential area for improving patient outcomes and reducing costs.

Red blood cell components: Meeting the quantitative and qualitative transfusion needs.

Red blood cell (RBC) transfusion is a very common therapeutic intervention. However, because of multiple recent studies improving our understanding of appropriate transfusion scenarios, the total number of RBC units transfused per year is actually decreasing in the developed world and there are no longer major shortages of RBC products for general use. Nonetheless, there are an increasing number of "special" uses, which can put strains on the blood supply for particular types of products; these may produce shortages of specific types of RBCs or require collections targeting certain types of donors. This review will focus on several broad topics, including providing some examples of "special" settings that require, or could require, special types of RBC products.

Clinical Decision Support Reduces Overuse of Red Blood Cell Transfusions: Interrupted Time Series Analysis.

BACKGROUND: Red blood cell transfusion is the most common procedure in hospitalized patients in the US. Growing evidence suggests that a sizeable percentage of these transfusions are inappropriate, putting patients at significant risk and increasing costs to the health care system. METHODS: We performed a retrospective quasi-experimental study from November 2008 until November 2014 in a 576-bed tertiary care hospital. The intervention consisted of an interruptive clinical decision support alert shown to a provider when a red blood cell transfusion was ordered in a patient whose most recent hematocrit was ≥21%. We used interrupted time series analysis to determine whether our primary outcome of interest, rate of red blood cell transfusion in patients with hematocrit ≥21% per 100 patient (pt) days, was reduced by the implementation of the clinical decision support tool. The rate of platelet transfusions was used as a nonequivalent dependent control variable. RESULTS: A total of 143,000 hospital admissions were included in our analysis. Red blood cell transfusions decreased from 9.4 to 7.8 per 100 pt days after the clinical decision support intervention was implemented. Interrupted time series analysis showed that significant decline of 0.05 (95% confidence interval [CI], 0.03-0.07; P < .001) units of red blood cells transfused per 100 pt days per month was already underway in the preintervention period. This trend accelerated to 0.1 (95% CI, 0.09-0.12; P < .001) units of red blood cells transfused per 100 pt days per month following the implementation of the clinical decision support tool. There was no statistical change in the rate of platelet transfusion resulting from the intervention. CONCLUSIONS: The implementation of an evidence-based clinical decision support tool was associated with a significant decline in the overuse of red blood cell transfusion. We believe this intervention could be easily replicated in other hospitals using commercial electronic health records and a similar reduction in overuse of red blood cell transfusions achieved.

Outcomes of a Quality Improvement Initiative to Prevent Unnecessary Packed Red Blood Cell Transfusions Among Extremely Low Birth-Weight Neonates.

BACKGROUND: Extremely low birth-weight (ELBW) infants frequently receive packed red blood cell (PRBC) transfusions. Recent studies have shown that more restrictive PRBC transfusion guidelines limit donor exposure and reduce transfusion-related costs without any increase in adverse clinical outcomes. PURPOSE: We developed and implemented an evidence-based PRBC transfusion guideline for ELBW infants treated in our unit and then measured provider adherence to this guideline. METHODS/SEARCH STRATEGY: We performed a retrospective review of all PRBC transfusions given to ELBW infants in 2012 (preguideline) and the first half of 2014 (postguideline). We identified the indication for each transfusion by reviewing physiological/laboratory data and the daily clinical note. We then determine whether each transfusion met criteria according to our new evidence-based guideline. FINDINGS/RESULTS: When extrapolating the newly developed protocol to 2012 data, less than 15% of transfusions among ELBW infants would have met the current evidence-based standard. Conversely, during the first 6 months of 2014, 61% of transfusions were administered in adherence to the guideline (P < 001). Using current cost estimates, this represents a projected cost savings of $31,000 in that 6-month period. IMPLICATIONS FOR PRACTICE: A multidisciplinary approach to improving PRBC transfusion practices results in potentially safer, more cost-effective care for ELBW infants. IMPLICATIONS FOR RESEARCH: Given the frequency, potential harms, and costs associated with PRBC transfusions in ELBW infants, it seems both feasible and important to pursue prospective clinical trials comparing permissive and restrictive approaches to transfusion in this vulnerable population.

Transfusion strategy in hematological intensive care unit: study protocol for a randomized controlled trial.

BACKGROUND: Packed red blood cell (PRBC) transfusion is required in hematology patients treated with chemotherapy for acute leukemia, autologous (auto) or allogeneic (allo) hematopoietic stem cell transplantation (HSCT). In certain situations like septic shock, hip surgery, coronary disease or gastrointestinal hemorrhage, a restrictive transfusion strategy is associated with a reduction of infection and death. A transfusion strategy using a single PRBC unit has been retrospectively investigated and showed a safe reduction of PRBC consumption and costs. We therefore designed a study to prospectively demonstrate that the transfusion of a single PRBC unit is safe and not inferior to standard care. METHODS: The 1versus2 trial is a randomized trial which will determine if a single-unit transfusion policy is not inferior to a double-unit transfusion policy. The primary endpoint is the incidence of severe complication (grade ≥ 3) defined as stroke, transient ischemic attack, acute coronary syndrome, heart failure, elevated troponin level, intensive care unit transfer, death, new pulmonary infiltrates, and transfusion-related infections during hospital stays. The secondary endpoint is the number of PRBC units transfused per patient per hospital stay. Two hundred and thirty patients will be randomized to receive a single unit or double unit every time the hemoglobin level is less than 8 g/dL. All patients admitted for induction remission chemotherapy, auto-HSCT or allo-HSCT in hematology intensive care units will be eligible for inclusion. Sample size calculation has determined that a patient population of 230 will be required to prove that the 1-unit PRBC strategy is non-inferior to the 2-unit PRBC strategy. Hemoglobin threshold for transfusion is below 8 g/dL. Estimated percentage of complication-free hospital stays is 93 %. In a non-inferiority hypothesis, the number of patients to include is 230 with a power of 90 % and an alpha risk of 5 %. TRIAL REGISTRATION: 14-128; Clinicaltrials.gov NCT02461264 (registered on 3 June 2015).

Neonatal transfusion models to determine the impact of using fresh red blood cells on inventory and exposure.

BACKGROUND: Data on age of blood and its impact on donor exposure and inventory in the paediatric setting are lacking. The standard of practice of reserving a specific red blood cell (RBC) unit for neonates who may require repeat transfusions is unique to the paediatric setting. Requiring transfusion of fresher RBC units may increase the exposure of neonates to multiple units and negatively affect the supply of fresh RBC. We constructed a transfusion model based on a 6 months of retrospective neonatal transfusion data at our institution. MATERIALS AND METHODS: All neonates (≤4 months old) at Texas Children's Hospital who received a RBC transfusion from June to November 2011 were included and RBC transfusion data were compiled. The age of blood at the time of each RBC transfusion was recorded. These data were reviewed to calculate exposure and inventory impact if each transfusion had been restricted to RBC either ≤7 or ≤14 days old at transfusion. RESULTS: A total of 216 neonates received 938 RBC transfusions. Of these, 393 (42%) were fresh RBC (≤14 days old), even without a required age guideline. Requiring fresh (≤14 days) RBC for all transfusions in this period would have resulted in 70 additional fresh units and one or more additional exposures in 44 patients. Requiring fresher (≤7 days old) RBC would have resulted in an additional 147 units and. one or more additional exposures in 54 patients. DISCUSSION: The more conservative model of fresh (≤7 days old) RBC would greatly increase fresh RBC inventory requirements, and 25% of transfused neonates would require additional RBC exposure. Based on retrospective data and the two transfusion models, it can be concluded that requiring RBC ≤14 days old for neonatal transfusion would best balance the use of fresher RBC with the smallest increase in patient exposure (20%) and minimum impact on the RBC inventory.

The evolution of perioperative transfusion testing and blood ordering.

The evolution of modern anesthesia and surgical practices has been accompanied by enhanced supportive procedures in blood banking and transfusion medicine. There is increased focus on the preparation and the use of blood components including, but not limited to, preventing unnecessary type and screen/crossmatch orders, decreasing the time required to provide compatible red blood cells (RBCs), and reducing the waste of limited blood and personnel resources. The aim of this review is to help the anesthesiologist and surgical staff identify patients at highest risk for surgical bleeding. In addition, this review examines how anesthesia and transfusion medicine can efficiently and safely allocate blood components for surgical patients who require transfusions. The following databases were searched: PubMed, EMBASE, Google Scholar, and the Cochrane Library from January 1970 through March 2014. Subsequent reference searches of retrieved articles were also assessed. Several innovations have drastically changed the procedures by which blood is ordered, inventoried, and the speed in which blood is delivered for patient care. Before entering an operating room, patient blood management provides guidance to clinicians about when and how to treat preoperative anemia and intra- and postoperative strategies to limit the patient's exposure to blood components. Timely updates of the recommendations for blood orders (maximum surgical blood ordering schedule) have enhanced preoperative decision making regarding the appropriateness of the type and screen versus the type and crossmatch order. The updated maximum surgical blood ordering schedule reflects modern practices, such as laparoscopy, improved surgical techniques, and use of hemostatic agents resulting in a more streamlined process for ordering and obtaining RBCs. The electronic (computer) crossmatch and electronic remote blood issue have also dramatically reduced the amount of time required to obtain crossmatch-compatible RBCs when compared with the more traditional serologic crossmatch methods. These changes in blood banking methods have resulted in more efficient delivery of blood to surgical patients.

Medical complications, resource utilization and costs in patients with myelofibrosis by frequency of blood transfusion and iron chelation therapy.

Iron chelation therapies (ICTs) can help eliminate iron surplus in erythrocyte transfusion-dependent (TD) patients with myelofibrosis (MF). The study assessed adjusted incidence rate ratios (aIRRs) of MF-related complications and resource utilization (RU) and adjusted mean monthly inpatient cost differences in patients with TD MF treated with versus without ICT (ICT+ vs. ICT-) using data from two healthcare claims databases. Patients with ≥ 2 MF International Classification of Diseases, 9th Revision (ICD-9) diagnosis codes ≥ 30 days apart were included. Among 571 patients with TD MF, 103 (18%) were ICT+ and 468 (82%) were ICT-. ICT+ patients had lower rates of thrombocytopenia (aIRR: 0.55; p < 0.001), pancytopenia (0.53; p < 0.001), emergency room visits (0.84 [95% confidence interval: 0.74-0.96]) and inpatient stays (0.75 [0.64-0.87]), but higher rates of outpatient visits (1.21 [1.18-1.23]). Adjusted mean complication-related inpatient cost difference per month was lower in ICT+ patients (-$1804 [$570]; p = 0.004). ICT+ patients had significantly lower rates of acute care, but higher rates of outpatient care.

PREPARE: the prevalence of perioperative anaemia and need for patient blood management in elective orthopaedic surgery: a multicentre, observational study.

BACKGROUND: Patient blood management (PBM) can prevent preoperative anaemia, but little is known about practice in Europe. OBJECTIVE: To assess the pre and postoperative prevalence and perioperative management of anaemia in patients undergoing elective orthopaedic surgery in Europe. DESIGN: An observational study; data were collected from patient records via electronic case report forms. SETTING: Seventeen centres in six European countries. Centres were stratified according to whether they had a PBM programme or not. PATIENTS: One thousand five hundred and thirty-four patients undergoing major elective hip, knee or spine surgery [49.9% hip, 37.2% knee, 13.0% spine; age 64.0 years (range 18 to 80), 61.3% female]. MAIN OUTCOME MEASURES: Prevalence of preoperative (primary endpoint) and postoperative anaemia [haemoglobin (Hb) <13 g dl (male), Hb <12 g dl (female)], perioperative anaemia management, time to first blood transfusion and number of transfused units. Data are shown as mean (SD) or median (interquartile range). RESULTS: Anaemia prevalence increased from 14.1% preoperatively to 85.8% postoperatively. Mean Hb decrease was 1.9 (1.5) and 3.0 (1.3) g dl in preoperatively anaemic and nonanaemic patients, respectively (P < 0.001). In PBM (n = 7) vs. non-PBM centres, preoperative anaemia was less frequent (8.0 vs. 18.5%; P < 0.001) and iron status was assessed more frequently (ferritin 11.0 vs. 2.6%, transferrin saturation 11.0 vs. 0.1%; P < 0.001). Perioperative anaemia correction (mainly transfusion) was given to 34.3%. Intraoperatively, 14.8% of preoperatively anaemic and 2.8% of nonanaemic patients received transfusions [units per patient: 2.4 (1.5) and 2.2 (1.4), median time to first intraoperative transfusion: 130 (88, 158) vs. 179 (135, 256) min; P < 0.001]. Postoperative complications were more frequent in preoperatively anaemic vs. nonanaemic patients (36.9 vs. 22.2%; P = 0.009). CONCLUSION: Most patients who underwent elective orthopaedic surgery had normal preoperative Hb levels but became anaemic after the procedure. Those who were anaemic prior to surgery had an increased intraoperative transfusion risk and postoperative complication rate. PBM measures such as iron status assessment and strategies to avoid transfusion are still underused in Europe.