Warner, Matthew A.

Abstract Introduction: Iron deficiency (ID) is a global epidemic with discrepant definitions of both ID and anemia in pregnancy. Iron requirements increase during pregnancy and deficiencies should be corrected to avoid adverse maternal-fetal outcomes. Current guidelines recommend only screening for ID during pregnancy in the presence of anemia despite the global epidemic of ID in reproductive-age females and availability of ferritin as a high-value biomarker. To address this unmet need and gap in care, we implemented a standardized approach to screening and treating ID in pregnancy. Methods: In March 2024 at the ASH Quality Improvement Training Institute, our multidisciplinary team with representatives from hematology, obstetrics, anesthesiology, and patient blood management developed a quality improvement (QI) initiative to standardize an approach to screening and treating ID in pregnancy. After local dissemination and education of the standardized care pathway via patient/provider handouts and divisional presentations, obstetric providers paired ferritin testing with two standard hemoglobin assessments in early (8-12 weeks gestation) and late (24-28 weeks gestation) pregnancy to minimize lab draws and optimize logistics. The process was facilitated by modifying prenatal order sets in the electronic medical record. ID was defined as a ferritin <50 mcg/L and anemia was defined as a hemoglobin <11 g/dL. If ID was present in early pregnancy, oral iron supplementation was offered; if ID was present in late pregnancy, an IV iron infusion (low molecular weight iron dextran, 1 gram) was offered regardless of anemia status. Results: Obstetric data were captured pre-intervention from January 2023 – February 2024 (n=2097 pregnancies) and post-intervention from March 2024 – June 2025 (n=2429 pregnancies). Ferritin screening rates improved from 10% (205/2097) to 63% (1534/2429). Of those ferritin tests, 66% demonstrated ID in the pre-intervention cohort and 69% demonstrated ID in the post-intervention cohort. Anemia rates by measured hemoglobin during pregnancy were 25% in both the pre-intervention and post-intervention cohorts despite 92% having documentation of prenatal vitamins containing iron (PNV). Iron dextran infusion rates improved from 0.9% (18/2097) to 21% (507/2429). Of those receiving IV iron dextran, 39% had documentation of both PNV as well as additional oral iron supplementation. Overall, the median hemoglobin improved from 10.7 to 11.8 g/dL in those receiving IV iron dextran. This included increases from 12.0 to 12.8 g/dL in those without anemia and from 11.2 to 12.1 g/dL in those with ferritin 30-50 mcg/L after IV iron. Prior to initiation of this QI project, 3.1% of pregnancies (65/2097) required a blood transfusion during admission for delivery. After initiation of this project, 2.7% of pregnancies (65/2429) required a blood transfusion, of which 46 did not receive IV iron and 33 did not have a ferritin checked. Conclusions: ID in pregnancy is underrecognized and undertreated. Through a multidisciplinary QI initiative, screening for ID improved from 10% to over 60% of pregnancies within one year of project initiation. Over the same period, there was a 20-fold increase in the number of IV iron dextran infusions resulting in an increase in median hemoglobin by over 1 g/dL and a signal for decreased transfusion requirements. This occurred despite almost universal supplementation with a PNV. This standardized approach to screening and treating ID was performed by the obstetrics teams and could be implemented within varied practice models. Given the potential implications for reevaluation of appropriate reference ranges and equitable prenatal care globally, additional studies are warranted to better characterize ID in pregnancy as well as clinical sequelae for both mothers and infants. Simultaneously, discussions are needed around current guidelines and recommendations for both screening and treating ID in pregnancy.

Background: Transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO) are leading causes of transfusion-related morbidity and mortality. Soluble factors in erythrocyte supernatant may increase risk for these complications. The authors hypothesized that point-of-care allogeneic erythrocyte washing may be an effective intervention to mitigate elevations in soluble factors as well as physiologic responses associated with transfusion-associated respiratory complications in the setting of cardiac surgery. Methods: This is a two-center, nonblinded, randomized clinical trial evaluating point-of-care washed versus standard issue allogeneic erythrocyte transfusions administered during or on the day of cardiac surgery. The primary analysis was performed via modified intention to treat. The primary outcomes assessed were changes in intermediate markers of lung injury as well as cardiopulmonary physiologic responses to erythrocyte transfusion. Secondary outcomes included the duration of intensive care unit and hospital stay, durations of mechanical ventilation and oxygen supplementation, presence of TRALI or TACO, and mortality. Results: Among 154 analyzed patients (81 washed, 73 standard issue), the median age was 66 yr, and 77 (50.0%) were women. The median (interquartile range) number of allogeneic erythrocyte units transfused on the day of surgery was 3.0 (2.0 to 5.0) in the washed erythrocyte group and 3.0 (2.0 to 4.0) in the standard issue group (P = 0.13). No between-group differences were identified in any of the assessed recipient lung injury biomarkers (all P values > adjusted alpha). Durations of intensive care unit stay (median [interquartile range], 3.0 [2.0 to 5.0] vs. 3.0 [2.0 to 4.0] days; P = 0.117) and hospital length of stay (12.0 [9.0 to 17.0] vs. 12.0 [9.0 to 17.0] days; P = 0.801) were similar, as were the number of ventilator-free days at day 28 (27.0 [27.0 to 27.0] vs. 27.0 [26.0 to 27.0]; P = 0.699) and oxygen-free days at day 28 (24.0 [19.0 to 26.0] vs. 24.0 [22.0 to 26.0]; P = 0.400). No significant differences were noted in mortality rate or in incidence rates for TRALI, TACO, and acute kidney injury. Conclusions: Among patients undergoing cardiovascular surgery with high risk of erythrocyte transfusion, point-of-care washing of allogeneic erythrocyte transfusions did not mitigate changes in intermediate markers of lung injury or cardiopulmonary physiologic responses to erythrocyte transfusion and was not associated with improved clinical outcomes.

Importance Anemia is a common complication of surgery and acute illness that is associated with adverse clinical outcomes. The role of anemia prevention and treatment strategies in this setting remains unclear. Objective To evaluate the effect of a multifaceted anemia management bundle vs standard care on posthospitalization hemoglobin recovery and multidimensional functional outcomes in survivors of acute illness. Design, Setting, and Participants This parallel group randomized clinical trial, known as the Practical Anemia Bundle for Sustained Blood Recovery, was conducted at postsurgical and medical intensive care units at a large US medical center. Critically ill patients (aged ≥18 years) with moderate to severe anemia (hemoglobin concentration <10 g/dL) were enrolled between March 2022 and November 2023. Participants were randomly assigned 1:1 to the intervention or standard care group. Intention-to-treat analyses were performed between July 2024 and January 2025. Intervention The intervention bundle was delivered throughout the duration of hospitalization and included optimized phlebotomy practices, clinical decision support, and pharmacological anemia treatment with intravenous iron. Main Outcomes and Measures The primary outcome was the mean difference in hemoglobin concentration at 1 month after hospital discharge. Results A total of 100 patients (median [IQR] age, 68 [61-72] years; 57 men [57.0%]; 65 [65.0%] with postsurgical admission to the intensive care unit) were enrolled during acute illness. Forty-nine patients (49.0%) were assigned to receive the intervention, and 51 (51.0%) were assigned to receive standard care. Hemoglobin concentration at 1 month after discharge was greater in patients receiving the intervention vs standard care (median [IQR], 12.2 [11.8-13.0] g/dL vs 11.5 [10.2-12.6] g/dL; adjusted mean difference, 0.69 [95% CI, 0.13-1.20] g/dL; P = .02). Conclusions and Relevance This randomized clinical trial found that a multifaceted anemia prevention and treatment bundle was feasible, was well tolerated, and improved posthospitalization hemoglobin concentrations up to 3 months in critically ill adults. These findings can inform the design of future trials. Trial Registration ClinicalTrials.gov Identifier: NCT05167734

BACKGROUND: Preoperative anemia is common and associated with adverse outcomes in surgical patients. There is limited information to guide the design and implementation of preoperative anemia clinics (PAC), which represents a critical barrier to entry for many practices. METHODS: This is a descriptive observational study highlighting the design and implementation of a multidisciplinary PAC, including key steps in planning, stakeholder engagement, organizational structure, identification of target populations, establishing anemia treatments, information technology and electronic health record integration, provider training, and data infrastructure. Demographic and clinical characteristics, laboratory results, and anemia treatments for individuals evaluated in the PAC from November 4, 2019 through September 15, 2023 are enumerated. Patient-reported outcomes (PROs) assessing changes in anemia symptoms and well-being after surgery are evaluated for 2 subsets of patients (one before PAC implementation [pre-PAC], another after PAC implementation [post-PAC]), without formal statistical comparison given limited sample sizes. RESULTS: The PAC was initiated as a multidisciplinary effort under support from a Mayo Clinic Practice Transformation Award in 2019, including broad representation from anesthesiology, surgery, and medical practices, along with institutional project management support (eg, project manager, information technologists, systems engineers). While initially limited to cardiac surgery patients, the PAC underwent planned incremental expansion to include other surgical services. Over the study period, 1188 PAC consultations across 1159 unique patients met eligibility criteria, with a median age of 66 (57–73) years and 58.1% women. The most common etiology of anemia was iron deficiency (69.1%) followed by anemia related to cancer (17.3%). Anemia-directed therapies were recommended in 1038 (87.4%) encounters, with 730 (70.3%) of those receiving recommended treatment preoperatively. Seven hundred nine (97.1%) treatments included intravenous iron and 146 (20.0%) included erythropoiesis-stimulating agents. Fifteen pre-PAC and 38 post-PAC implementation patients completed PROs. PAC implementation was accompanied by earlier resolution of anemia symptoms and less pronounced declines in postoperative well-being scores. CONCLUSIONS: This report highlights the key steps for successful PAC implementation. Treatment is possible for most patients and may be accompanied by improvements in patient-important outcomes.