Transfusion strategy trials excluding patients transfused outside the trial study period are more likely to report a trend favouring restrictive strategies: a meta-analysis.

OBJECTIVE: Some large, randomized trials investigating red cell transfusion strategies have significant numbers of transfusions administered outside the trial study period. We sought to investigate the potential impact of this methodological issue. STUDY DESIGN AND SETTING: Meta-analysis of randomized controlled trials comparing liberal versus restrictive transfusion strategies in cardiac surgery and acute myocardial infarction patients. The outcome of interest was 30-day or in-hospital mortality. RESULTS: In cardiac surgery, the pooled risk ratio for mortality was 0.83 (95% CI 0.62-1.12, P=0.22) times lower in the restrictive group when compared to the liberal group in trials applying a transfusion strategy throughout the patient's entire perioperative period, and 1.33 (95% CI 0.84-2.11, P=0.22) times higher in the restrictive group in trials not applying transfusion strategies throughout the entire perioperative period. When combined, the risk ratio for mortality was 0.98 (95% CI 0.73-1.32, P=0.89). In patients with acute myocardial infarction, the risk ratio for mortality was 0.72 (95%CI 0.40-1.28, P=0.26) times lower in the restrictive group when compared to the liberal group in one trial excluding patients administered the intervention pre-randomization and 1.19 (95% CI 0.96-1.47, P=0.11) times higher in the restrictive group in one trial including patients receiving the intervention pre-randomization. When combined the risk ratio for mortality was 1.00 (0.62-1.59, P=0.99). CONCLUSION: Though not statistically significant, there was a consistent difference in trends between randomized controlled trials administering significant numbers of transfusion outside the trial study period compared to those that did not. The implications of our results may extend to randomized controlled trials in other settings that ignore if and how frequently an investigated therapy is administered outside the trial window.

Antithrombin concentrates may benefit cardiopulmonary bypass patients with suspected heparin resistance: A retrospective analysis of real-world data.

Background: Heparin resistance is a common complication of surgical patients requiring anticoagulation, such as those undergoing cardiopulmonary bypass (CPB). Treatments to address heparin resistance include supplementation of antithrombin (AT) or fresh frozen plasma (FFP). This retrospective database analysis compared key outcomes in suspected heparin-resistant patients undergoing CPB treated with AT or FFP. Methods: De-identified United States electronic health records (Cerner Health Facts®) were queried. International Classification of Diseases (ICD-9/10) codes were used to determine CPB procedures and FFP administration. AT administration was identified using medication data, while a combination of lab and medication data examining activated clotting times detected heparin resistance in FFP patients. Adult inpatients (≥18 years old) seen between 2001 and 2018 were included. Differences in mortality, intensive care unit (ICU) length of stay (LOS), and hospital-free days (using a 30-day post-discharge period) were assessed with univariate models as well as adjusted logistic regression models controlling for patient characteristics and Charlson Comorbidity Index (CCI) scores. Results: Of the 502 patients identified, 247 received AT and 255 received FFP. The FFP cohort was associated with a higher CCI compared to the AT cohort (3.3 ± 2.4 vs. 2.3 ± 2.0, P < .001). The AT cohort was associated with a 71% (Odds Ratio [OR]: 0.29, 95% Confidence Interval [CI]: P = .003) and 66% (OR: 0.34, 95% CI: P = .01) reduction in mortality when compared to FFP using univariate and adjusted logistic regression models, respectively. Similarly, use of AT also showed a 22% shorter ICU LOS (P = .02) and 10% more hospital-free days in the 30 days following discharge (P = .004) according to the univariate models, though statistical significance was absent within adjusted models in both ICU LOS (P = .08) and hospital-free days (P = .53). Conclusions: Compared to FFP, AT use suggests a reduction in the odds of mortality in suspected heparin-resistant patients undergoing CPB, though larger prospective studies are necessary to elucidate potential differences in hospital-free days or ICU LOS across treatment modalities.

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.

Determination of Unnecessary Blood Transfusion by Comprehensive 15-Hospital Record Review.

BACKGROUND: Although unnecessary blood component transfusions are costly and pose substantial patient risks, the extent of unnecessary blood use in a community hospital setting has not been systematically measured. METHODS: A 15-hospital observational analysis was performed using comprehensive retrospective review. Approximately 100 encounters (x¯â€¯= 103.9, standard deviation [SD] ± 7.6) per hospital (6,696 total component transfusion events) were reviewed between 2012 and 2018. Review was performed by two medical directors. Findings were supported by blind intra- and inter-reviewer double review and blind external review by 10 independent reviewers. RESULTS: Patients received an average of 4.3 (± 1.3) units. Only 8.2% (± 6.7) of patient encounters did not receive unnecessary units. Fifty-five percent (54.6% ± 13.5) could have been managed without at least one component type, while 44.6% (± 14.9) could have been managed completely without transfusion. Forty-five percent (45.4% ± 17.0) of red blood cell, 54.9% (± 19.3) of plasma-cryoprecipitate, and 38.0% (± 15.6) of plateletpheresis encounters could likely have been managed without transfusion. Between 2,713 units (40.5%) and 3,306 units (49.4%) were likely unnecessary. In patients who could have been managed without transfusion of at least one component type, unnecessary blood use was associated with a 0.38 (± 0.11)-day increase in length of hospital stay for each additional unnecessary unit received (p < 0.001). CONCLUSION: Substantial unnecessary blood use was identified, all of which was unrecognized by hospitals prior to review. Unnecessary blood use was attributed to overreliance on laboratory transfusion criteria and failure to follow common blood management principles, which resulted in potential harm to patients and avoidable cost.

Recommendations From the International Consensus Conference on Anemia Management in Surgical Patients (ICCAMS).

BACKGROUND: Perioperative anemia has been associated with increased risk of red blood cell transfusion and increased morbidity and mortality after surgery. The optimal approach to the diagnosis and management of perioperative anemia is not fully established. OBJECTIVE: To develop consensus recommendations for anemia management in surgical patients. METHODS: An international expert panel reviewed the current evidence and developed recommendations using modified RAND Delphi methodology. RESULTS: The panel recommends that all patients except those undergoing minor procedures be screened for anemia before surgery. Appropriate therapy for anemia should be guided by an accurate diagnosis of the etiology. The need to proceed with surgery in some patients with anemia is expected to persist. However, early identification and effective treatment of anemia has the potential to reduce the risks associated with surgery and improve clinical outcomes. As with preoperative anemia, postoperative anemia should be treated in the perioperative period. CONCLUSIONS: Early identification and effective treatment of anemia has the potential to improve clinical outcomes in surgical patients.

Creating blood conservation for a cardiothoracic surgical hospital: when you have to start from scratch!

BACKGROUND: This improvement report presents a hospital blood-management programme, a hospital-specific model that differs from patient blood managment and was aimed at improving operational standards of transfusion. We identified the challenges of the transfusion process and suggest practical strategies for improving them. The aim of this article was to investigate the effect of the programme on the transfusion of blood components. METHODS: In January 2019, the programme was started to improve the transfusion process. The data before and after the start of the programme were compared. Frequency distribution was obtained for each variable for statistical analysis and the chi-squared test with continuity correction was used to compare these variables for the years 2018 and 2019. RESULTS: Transfusion of total blood components decreased by 23.2%, fresh whole blood by 46.7%, fresh frozen plasma by 38.4%, pooled platelets by 14.0% and red blood cells by 9.66%. Autologous transfusion increased 11.7-fold. The emergency department (76.0%) and intensive care unit transfusion rate (9.26%) decreased significantly. CONCLUSION: This programme is an example for hospitals where patient blood management cannot be applied. The programme can be considered the first step for blood management and may be applied to blood management in institutions worldwide. The difficulty of blood supply and increased cost will increase the importance of hospital blood-management programmes in the coming years.

Iron metabolism and iron deficiency anemia in women.

Iron deficiency (ID) and iron deficiency anemia (IDA) are highly prevalent among women across their reproductive age. An iron-deficient state has been associated with and causes a number of adverse health consequences, affecting all aspects of the physical and emotional well-being of women. Heavy menstrual bleeding, pregnancy, and the postpartum period are the major causes of ID and IDA. However, despite the high prevalence and the impact on quality of life, ID and IDA among women in their reproductive age is still underdiagnosed and undertreated. In this chapter we summarized the iron metabolism and the diagnosis and treatment of ID and IDA in women.

Patient Blood Management: Improving Outcomes for Millions While Saving Billions. What Is Holding It Up?

Patient blood management (PBM) offers significantly improved outcomes for almost all medical and surgical patient populations, pregnant women, and individuals with micronutrient deficiencies, anemia, or bleeding. It holds enormous financial benefits for hospitals and payers, improves performance of health care providers, and supports public authorities to improve population health. Despite this extraordinary combination of benefits, PBM has hardly been noticed in the world of health care. In response, the World Health Organization (WHO) called for its 194 member states, in its recent Policy Brief, to act quickly and decidedly to adopt national PBM policies. To further support the WHO's call to action, this article addresses 3 aspects in more detail. The first is the urgency from a health economic perspective. For many years, growth in health care spending has outpaced overall economic growth, particularly in aging societies. Due to competing economic needs, the continuation of disproportionate growth in health care spending is unsustainable. Therefore, the imperative for health care leaders and policy makers is not only to curb the current spending rate relative to the gross domestic product (GDP) but also to simultaneously improve productivity, quality, safety of patient care, and the health status of populations. Second, while PBM meets these requirements on an exceptional scale, uptake remains slow. Thus, it is vital to identify and understand the impediments to broad implementation. This includes systemic challenges such as the so-called "waste domains" of failure of care delivery caused by malfunctions of health care systems, failure of care coordination, overtreatment, and low-value care. Other impediments more specific to PBM are the misperception of PBM and deeply rooted cultural patterns. Third, understanding how the 3Es-evidence, economics, and ethics-can effectively be used to motivate relevant stakeholders to take on their respective roles and responsibilities and follow the urgent call to implement PBM as a standard of care.

A Global Definition of Patient Blood Management.

While patient blood management (PBM) initiatives are increasingly adopted across the globe as part of standard of care, there is need for a clear and widely accepted definition of PBM. To address this, an expert group representing PBM organizations from the International Foundation for Patient Blood Management (IFPBM), the Network for the Advancement of Patient Blood Management, Haemostasis and Thrombosis (NATA), the Society for the Advancement of Patient Blood Management (SABM), the Western Australia Patient Blood Management (WAPBM) Group, and OnTrac (Ontario Nurse Transfusion Coordinators) convened and developed this definition: "Patient blood management is a patient-centered, systematic, evidence-based approach to improve patient outcomes by managing and preserving a patient's own blood, while promoting patient safety and empowerment." The definition emphasizes the critical role of informed choice. PBM involves the timely, multidisciplinary application of evidence-based medical and surgical concepts aimed at (1) screening for, diagnosing, and appropriately treating anemia; (2) minimizing surgical, procedural, and iatrogenic blood losses and managing coagulopathic bleeding throughout the care; and (3) supporting the patient while appropriate treatment is initiated. We believe that having a common definition for PBM will assist all those involved including PBM organizations, hospital administrators, individual clinicians, and policy makers to focus on the appropriate issues when discussing and implementing PBM. The proposed definition is expected to continue to evolve, making this endeavor a work in progress.

Management of Perioperative Iron Deficiency in Cardiac Surgery: A Modified RAND Delphi Study.

BACKGROUND: Over the last decade, preoperative anemia has become recognized as a clinical condition in need of management. Although the etiology of preoperative anemia can be multifactorial, two thirds of anemic elective surgical patients have iron deficiency anemia. At the same time, one third of nonanemic elective surgical patients are also iron deficient. METHODS: Modified RAND Delphi methodology was used to identify areas of consensus among an expert panel regarding the management of iron deficiency in patients undergoing cardiac surgery. A list of statements was sent to panel members to respond to using a five-point Likert scale. All panel members subsequently attended a face-to-face meeting. The initial survey was presented and discussed, and panel members responded to each statement on the Likert scale again. Based on the second survey, the panel came to a consensus on recommendations. RESULTS: The panel recommended all patients undergoing cardiac surgery be evaluated for iron deficiency, whether or not anemia is present. Evaluation should include iron studies and reticulocyte hemoglobin content. If iron deficiency is present, with or without anemia, patients should receive parenteral iron. Erythropoietin-stimulating agents may be appropriate for some patients. CONCLUSIONS: Consensus of an expert panel resulted in a standardized approach to diagnosing and managing iron deficiency in patients undergoing cardiac surgery.

The cost of one unit blood transfusion components and cost-effectiveness analysis results of transfusion improvement program.

BACKGROUND: This study aims to analyze the cost of the entire transfusion process in Turkey including evaluation of the cost of transfusion from the perspective of hospital management and determination of savings achieved with the transfusion improvement program. METHODS: Invoices, labor, material costs were calculated with micro-costing method, while general production expenses were calculated with gross costing method between January 2018 and December 2019. Unit costs for each blood product were calculated separately by collecting unit acquisition costs, material costs, labor costs, and general production expenses and, then, distributed into six different blood products as follows: erythrocyte suspension, fresh frozen plasma, pooled platelet, apheresis platelet, cryoprecipitate, fresh whole blood. The total costs for 2018 and 2019 were calculated and the savings achieved were estimated. The Turkish Lira was converted into the United States Dollar ($) currency using the purchasing power parity. RESULTS: In 2018/2019, the blood component transfusion cost was $240.90/251.18 for erythrocyte suspension, $120.00/128.67 for fresh frozen plasma, $313.50/322.19 for pooled platelet, $314.24/325.73 for apheresis platelet, $104.95/113.99 for cryoprecipitate, and $189.91/209.09 for fresh whole blood. The total transfusion cost was $6,224,208.33 in 2108 and $5,308,148.43 in 2019. As a result of the transfusion improvement program launched in 2019, the amount of blood components decreased by 23.24%, compared to the previous year, and a saving of $916,059.9 was achieved. CONCLUSION: The transfusion is a burden for both the hospital management systems and the country's economy. To accurately calculate and manage this economic burden is important for sustainable healthcare services.

An Ovine Model of Hemorrhagic Shock and Resuscitation, to Assess Recovery of Tissue Oxygen Delivery and Oxygen Debt, and Inform Patient Blood Management.

BACKGROUND: Aggressive fluid or blood component transfusion for severe hemorrhagic shock may restore macrocirculatory parameters, but not always improve microcirculatory perfusion and tissue oxygen delivery. We established an ovine model of hemorrhagic shock to systematically assess tissue oxygen delivery and repayment of oxygen debt; appropriate outcomes to guide Patient Blood Management. METHODS: Female Dorset-cross sheep were anesthetized, intubated, and subjected to comprehensive macrohemodynamic, regional tissue oxygen saturation (StO2), sublingual capillary imaging, and arterial lactate monitoring confirmed by invasive organ-specific microvascular perfusion, oxygen pressure, and lactate/pyruvate levels in brain, kidney, liver, and skeletal muscle. Shock was induced by stepwise withdrawal of venous blood until MAP was 30 mm Hg, mixed venous oxygen saturation (SvO2) < 60%, and arterial lactate >4 mM. Resuscitation with PlasmaLyte® was dosed to achieve MAP > 65 mm Hg. RESULTS: Hemorrhage impacted primary outcomes between baseline and development of shock: MAP 89 ±â€Š5 to 31 ±â€Š5 mm Hg (P < 0.01), SvO2 70 ±â€Š7 to 23 ±â€Š8% (P < 0.05), cerebral regional tissue StO2 77 ±â€Š11 to 65 ±â€Š9% (P < 0.01), peripheral muscle StO2 66 ±â€Š8 to 16 ±â€Š9% (P < 0.01), arterial lactate 1.5 ±â€Š1.0 to 5.1 ±â€Š0.8 mM (P < 0.01), and base excess 1.1 ±â€Š2.2 to -3.6 ±â€Š1.7 mM (P < 0.05). Invasive organ-specific monitoring confirmed reduced tissue oxygen delivery; oxygen tension decreased and lactate increased in all tissues, but moderately in brain. Blood volume replacement with PlasmaLyte® improved primary outcome measures toward baseline, confirmed by organ-specific measures, despite hemoglobin reduced from baseline 10.8 ±â€Š1.2 to 5.9 ±â€Š1.1 g/dL post-resuscitation (P < 0.01). CONCLUSION: Non-invasive measures of tissue oxygen delivery and oxygen debt repayment are suitable outcomes to inform Patient Blood Management of hemorrhagic shock, translatable for pre-clinical assessment of novel resuscitation strategies.

Physician autonomy and patient rights: lessons from an enforced blood transfusion and the role of patient blood management.

This article provides an ethical and medico-legal analysis of ruling no. 465 of 30 May 2018 issued by the Court of Termini Imerese (Palermo) and confirmed on appeal on 11 November 2020, which, in the absence of similar historical precedents in Europe, convicted a medical doctor of a crime of violent assault for having ordered the administration of a blood transfusion to a patient specifically declining blood transfusion on religious grounds. We analyse the Court's decision regarding the identification of assault in performing the blood transfusion and its decision not to accept exculpatory urgent 'necessity' as a defence. In addition, we present an updated revision of the current standard of care in transfusion medicine as well as the ethical principles governing the patient's declining of transfusion. In doing so, we highlight that respect for the patient's self-determination in declining transfusions and respect for the professional autonomy of the doctor protecting the safety and life of the patient could be equally satisfied by applying the current peer-reviewed evidence.

Deploying Healthcare Providers during COVID-19 Pandemic.

As the COVID-19 pandemic runs its course around the globe, a mismatch of resources and needs arises: In some areas, healthcare systems are faced with increased number of COVID-19 patients potentially exceeding their capacity, while in other areas, healthcare systems are faced with procedural cancellations and drop in demands. TeamHealth (Knoxville, TN), a multidisciplinary healthcare organization was able to roll out a systemic approach to redeploy its clinicians practicing in the fields of emergency medicine, hospital medicine and anesthesiology from areas of less need (faced with reduced or no work) to areas outside of their normal practice facing immediate need.