Klompas, Allan M.

Importance Patients undergoing cardiac surgery with cardiopulmonary bypass often require platelet transfusions for bleeding. Platelets are routinely stored at room temperature (20-24 °C) for up to 5 to 7 days; however, cold storage (1-6 °C) may allow for increased storage duration without loss of hemostatic function. Objective To determine the maximum cold-storage duration, up to 21 days, for which cold-stored platelets (CSPs) are noninferior or superior in hemostatic efficacy to room-temperature platelets (RTPs) when transfused in actively bleeding patients undergoing cardiac surgery with cardiopulmonary bypass. Design, Setting, and Participants A phase 3, multicenter, randomized, partially blinded, adaptive, noninferiority, storage duration–ranging trial conducted in pediatric and adult patients undergoing cardiac surgery with planned cardiopulmonary bypass at 27 sites in the US and Australia from December 2021 to March 2025. Statistical analysis was conducted from September 9 to October 3, 2025. Intervention Patients were randomized 2:1 to receive CSPs with a maximum of 21 days of storage vs RTPs with a maximum of 7 days of storage. Main Outcomes and Measures The primary outcome was a hemostatic efficacy score with values ranging from 1 to 5 and higher values indicating greater bleeding. The noninferiority margin was 1 point. The success criterion was met if at least 1 cold-storage duration of 7 days or more had a posterior probability of noninferiority of at least 97.5%. The secondary outcome was 24-hour chest tube output. Results Of the 1000 patients who underwent platelet transfusion, 989 were included in the primary analysis (650 CSPs and 339 RTPs). The cohort had a mean (SD) age of 42.1 (30.1) years and 67.8% were male. CSPs were noninferior to RTPs for the primary outcome, with a probability of greater than 99.9% for all cold-storage durations. Pooled across storage durations, CSPs had a mean difference from RTPs of 0.09 (95% credible interval, −0.06 to 0.23). Median (IQR) chest tube output at 24 hours (8.9 mL/kg [5.2-15.4] for CSPs vs 8.4 mL/kg [5.5-15.9] for RTPs; difference in medians, 0.4 [95% CI, −1.0 to 1.5]) was not statistically different between study groups. In a post hoc analysis, as all storage durations were noninferior, considering the CSPs as a single group, the hemostatic efficacy score was similar between both groups: mean (SD) of 3.08 (1.15) CSPs vs 2.99 (1.10) RTPs. There were no differences in venous or arterial thrombotic events, transfusion-associated adverse events, acute respiratory distress syndrome, kidney failure, septic shock, and mortality between the study groups, except for increased reexploration rates in the CSP group. Conclusions and Relevance For patients undergoing cardiac surgery, CSPs stored up to 21 days are noninferior to RTPs for the control of active surgical bleeding. Use of CSPs may allow for increased availability of platelets by reducing wastage and shortages and may allow for incorporation of platelets into inventory at locations where platelets cannot be maintained due to the 5- to 7-day shelf life of RTPs. Trial Registration ClinicalTrials.gov Identifier: NCT04834414

ABSTRACT Background The Extracorporeal Life Support Organization recommends daily antithrombin monitoring and supplementation to achieve > 50%–80% activity during extracorporeal membrane oxygenation (ECMO). Evidence supporting this practice is uncertain, and whether it confers clinical benefit or harm is unclear. Methods This was a systematic review with meta‐analysis to evaluate the safety and efficacy of antithrombin supplementation during ECMO. We systematically searched databases and registers for studies comparing patients on ECMO who received antithrombin supplementation to those who did not. Random effects meta‐analysis was performed. Risk of bias was independently assessed by two investigators. A priori subgroup and sensitivity analyses were performed to explore reasons for heterogeneity. Results A total of 11 studies were identified. In the pooled meta‐analysis, antithrombin supplementation resulted in no difference in bleeding events (OR 1.38, 95% CI, 0.88–2.17, p = 0.16), thrombotic events (OR 1.57, 95% CI, 0.84–2.90, p = 0.15), or mortality (OR 1.21, 95% CI, 0.81–1.81, p = 0.35) when compared to those who did not receive antithrombin. Subgroup analysis revealed no difference in bleeding events or mortality in pediatric or adult patients; however, pediatric patients that received antithrombin were more likely to experience a thrombotic event (OR 1.70, 95% CI, 1.51–1.91). Sensitivity analysis in only low risk of bias studies confirmed these findings. Conclusions Antithrombin supplementation was not associated with differences in mortality or hemostatic outcomes during ECMO support and may be associated with harm in pediatric patients on ECMO.

Preoperative anemia is common and associated with worse outcomes in cardiac surgery including acute kidney injury, red blood cell transfusion, cardiovascular complications, stroke, infection, and death. Patient blood management programs, which include dedicated clinical programs to diagnose and treat anemia in advance of surgery (ie, preoperative anemia programs), have been highlighted as a means to optimize the blood health of each patient, thereby decreasing risk for allogeneic transfusion and improving clinical outcomes. However, there remain implementation challenges for preoperative anemia programs, including difficulties with education of patients and staff, short lead times to address anemia, infrastructure and staffing limitations, lack of clear leadership or ownership of preoperative anemia, the need to develop treatment algorithms and ensure appropriate infusion therapy support, lack of capital support, and insurance/reimbursement concerns, amongst others. The purpose of this advisory from the Society of Cardiovascular Anesthesiologists (SCA) Clinical Practice Improvement Committee and the Subcommittee on Patient Blood Management with endorsement from the Society for the Advancement of Patient Blood Management (SABM) is to provide guidance on the development and implementation of a preoperative anemia clinic or service line, including identification and navigation through potential logistical barriers. A detailed analysis of financial incentives is highlighted in our companion article in this edition focuses on the return on investment of anemia management. Although originating with a focus on anemia before cardiac surgery, this advisory is broadly applicable to all perioperative patients.

AbstractBackgroundSome patients express concerns regarding receipt of allogeneic blood transfusions from donors potentially vaccinated against SARS‐CoV‐2 (COVID‐19). However, limited information exists about patients' expression of these concerns or how to address them during the blood transfusion consent process. In this study, we describe our experience of working collaboratively with patients with vaccine‐related transfusion concerns prior to elective surgery, summarizing treatment decisions and clinical outcomes.Study Design and MethodsThis observational descriptive study includes patients seen in our Bloodless Medicine and Surgery clinic between June 2022 and June 2024 for vaccine‐related transfusion concerns prior to elective surgery. A shared decision‐making framework was employed to foster conversation, share information, provide reassurance, reconcile conflict, and match preferences with available care options. Patient characteristics, treatment decisions, and surgical outcomes were reviewed and summarized.ResultsThirty‐five patients were included, with median (1st, 3rd quartile) age of 61 (53, 69) years. Cardiac surgery was the most common type of surgery (29%). Twelve patients (34%) were anemic preoperatively, and all received preoperative treatment. After discussion with a Bloodless Medicine specialist, 24 (68.6%) decided to consent to the use of all blood products, 5 (14.3%) accepted only red blood cells, and 6 (17.1%) declined all blood products. Among 28 patients undergoing surgery, only 4 (14%) received allogeneic transfusion perioperatively.ConclusionMany patients concerned about the vaccination status of blood donors may ultimately consent to allogeneic blood products after shared decision‐making with a Bloodless Medicine specialist, highlighting the importance of patient empowerment and collaborative care.

Pulmonary alveolar proteinosis (PAP) is a rare syndrome in which phospholipoproteinaceous matter accumulates in the alveoli leading to compromised gas exchange. Whole-lung lavage is considered the gold standard for severe autoimmune PAP and offers favorable long-term outcomes. In this case report, we describe the perioperative management and procedural specifics of a patient undergoing WLL for PAP in which an anesthesiologist serves as the proceduralist and a separate anesthesiologist provides anesthesia care for the patient.

AbstractBackgroundRecently the US Food and Drug Administration has granted variances to select blood centers to supply cold‐stored platelet components (CSP). In hemorrhage resuscitation warming of blood components with approved fluid warming devices is common.Study Design and MethodsPathogen‐reduced apheresis platelet units were collected and stored in one of two ways: (1) CSP‐I, (2) CSP‐D. CSP‐I were collected and immediately stored at 1–6°C until used. CSP‐D were collected and stored at 20–24°C for 5 days and transferred to storage at 1–6°C until use. Aggregometry using arachidonic acid (AA), adenosine diphosphate (ADP) and collagen as agonists was performed on the unit samples before and after the units were infused through a Ranger blood‐warming device.ResultsCSP‐I, 23 units, had very high aggregation responses to all agonists (all ≥47.6 ± 20.7). There was a statistically significant reduction in ADP‐induced aggregometry results from 55.1 ± 23.2 before compared to 33.5 ± 14.6 following infusion of the PLT through the blood warmer (p < .001). There were no differences in AA and collagen aggregometry results before and after the infusion of the platelets through the blood warmer. CSP‐D had 5 of the 15 units with visible clotting in the bag. The 10 CSP‐Ds studied had lower aggregation than all agonists before and after infusion through the blood‐warming device (all ≤49.9 ± 35.9).ConclusionWe detected a statistically significant reduction in ADP‐induced aggregometry in CSP‐I run through a Ranger blood‐warming device with no change with AA or collagen agonist aggregometry.

AbstractBackgroundAL amyloidosis is associated with acquired factor X (FX) deficiency. Experience related to its management is limited to case reports and series using prothrombin complex concentrate, fresh frozen plasma, plasma exchange, recombinant activated factor seven, and desmopressin with limited and variable efficacy. FX concentrate has not been widely used in its management.Study Design and MethodsWe report our experience with the perioperative use of FX concentrate (Coagadex) in two patients with AL amyloidosis‐associated acquired FX deficiency requiring surgery, using their individual pharmacokinetic studies to manage perioperative hemostasis. Pharmacokinetic studies involved obtaining post‐infusion FX activity at 10 min, 2, and 4 h following the administration of FX concentrate to calculate the FX half‐life.ResultsBoth patients' plasma FX activity was successfully increased to provide perioperative hemostatic support. Monitoring FX activity post‐surgery was also utilized to maintain FX activity levels to prevent post‐operative bleeding.ConclusionPharmacokinetic studies have a useful role in tailoring preoperative FX repletion in patients with AL amyloidosis associated with acquired FX deficiency.