Transfusion Medicine Reviews最新文献

{"title":"Toward Personalized Transfusion Strategies: The Emerging Role of Wearable Biosensors in Chronic Anemia Management","authors":"R.P.B. Tonino ,&nbsp;M.R. Schipperus ,&nbsp;J.J. Zwaginga","doi":"10.1016/j.tmrv.2025.150927","DOIUrl":"10.1016/j.tmrv.2025.150927","url":null,"abstract":"<div><div>Chronic transfusion-dependent anemia presents ongoing challenges in optimizing symptom control and functional outcomes, particularly in an older, often comorbid patient group. Conventional transfusion strategies based on fixed hemoglobin thresholds may inadequately address the individual variability in oxygen delivery needs and symptom burden. Wearable biosensor technologies enable continuous monitoring of physiological parameters such as heart rate, respiratory rate, and physical activity in real-world settings. These tools offer the potential to detect early deterioration and support more responsive, patient-centered transfusion decisions and improve hemovigilance. This review evaluates current evidence on the feasibility, acceptability, and clinical relevance of biosensor use in transfusion medicine. Findings from recent pilot studies demonstrate high data quality, favorable tolerability, and preliminary indications of physiological response following transfusion. However, the clinical utility of biosensor-guided transfusion strategies remains unproven, with key challenges including data interpretation, workflow integration, and validation of clinically meaningful endpoints. As the field moves toward personalized supportive care, biosensors may offer a novel means to optimize transfusion timing, preserve functional capacity, and enhance quality of life.</div></div>","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":"39 4","pages":"Article 150927"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145269061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ABO matching for platelet transfusions for prevention or treatment of bleeding: A systematic review with meta-analysis.","authors":"Lorna Cain, Asha Aggarwal, Louise J Geneen, Carolyn Dorée, Lise J Estcourt, Rebecca Cardigan, Michael Desborough","doi":"10.1016/j.tmrv.2025.150928","DOIUrl":"https://doi.org/10.1016/j.tmrv.2025.150928","url":null,"abstract":"<p><p>Transfusion of ABO identical platelets is recommended in national guidelines, though transfusion of ABO non-identical platelets has been widely adopted to ensure availability and reduce wastage. When ABO non-identical platelets are necessitated, there is a lack of consensus on prioritisation of major or minor compatibility. We conducted a systematic review and meta-analysis (PROSPERO CRD42023450792) of randomised and non-randomised studies to assess whether there is a difference when comparing ABO-identical and non-identical (major, minor, bi-directional mismatch) platelet transfusions. From 4177 potential references, 18 studies met our criteria: 3 randomised controlled trials (RCTs), 8 prospective and 7 retrospective observational studies. Evidence was very low certainty as to whether there was a difference from transfusion of ABO identical or non-identical platelets, where data were available, for clinically significant (WHO grade 2+ and 3+) bleeding, mortality, acute transfusion reactions, platelet refractoriness. Platelet increments were the most frequently reported outcomes. Overall, there was a paucity of evidence for clinical outcome data including bleeding risk for ABO identical compared to non-identical transfusion. We make recommendations for designing and reporting future platelet ABO matching studies based on our observations in this review. Future studies should consider the effect of repeated exposure to ABO identical or non-identical transfusions and known confounders.</p>","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":" ","pages":"150928"},"PeriodicalIF":2.5,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial Intelligence and Machine Learning in Transfusion Practice: An Analytical Assessment","authors":"Na Li ,&nbsp;Ruchika Goel ,&nbsp;Sheharyar Raza ,&nbsp;Kiarash Riazi ,&nbsp;Jie Pan ,&nbsp;Huong Quynh Nguyen ,&nbsp;Andrew W. Shih ,&nbsp;Adam D’Souza ,&nbsp;Rounak Dubey ,&nbsp;Aaron A.R. Tobian ,&nbsp;Donald M. Arnold","doi":"10.1016/j.tmrv.2025.150926","DOIUrl":"10.1016/j.tmrv.2025.150926","url":null,"abstract":"<div><div>Transfusion medicine is vital to healthcare and affects clinical outcomes, patient safety, and system resilience while addressing challenges such as blood shortages, donor variability, and rising costs. The integration of artificial intelligence (AI) and machine learning (ML) presents new opportunities to improve clinical decision-making and operational effectiveness in this field. This structured narrative review identified and evaluated studies applying AI and ML in transfusion medicine. A search of PubMed and Scopus for articles published between January 2018 and April 2025 yielded 565 publications. Studies were included if they applied AI or ML techniques, focused on transfusion management or decision support, and were evaluated using electronic health records or expert review. Four exemplar studies were selected, each representing a distinct AI paradigm: supervised, unsupervised, reinforcement, and generative learning. These studies were critically appraised for methodological rigor, clinical relevance, and potential for implementation in practice. The reviewed studies reflected a clear shift from traditional analytic methods toward more advanced computational approaches to improve prediction accuracy, optimize resource allocation, and support clinical decision-making. Three overarching themes emerged: the need to balance model complexity with interpretability and clinical feasibility; the impact of data quality and preprocessing on model performance and fairness; and the barriers to broader applicability and cross-institutional deployment. As technological barriers continue to decline, future challenges will increasingly center on privacy regulations, infrastructure constraints, and aligning model complexity with practical utility. Thoughtful integration of these considerations through scalable, clinical-grade, and transparent solutions will be critical in realizing the full potential of AI and ML in transfusion medicine.</div></div>","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":"39 4","pages":"Article 150926"},"PeriodicalIF":2.5,"publicationDate":"2025-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analytical Review: Neutrophil Extracellular Traps and Antiphospholipid syndrome.","authors":"Ayesha Butt, Anish Sharda, Alfred Ian Lee, Jason S Knight","doi":"10.1016/j.tmrv.2025.150909","DOIUrl":"https://doi.org/10.1016/j.tmrv.2025.150909","url":null,"abstract":"<p><p>Antiphospholipid syndrome (APS) is an autoimmune prothrombotic disorder defined by the presence of one or more antiphospholipid antibodies (aPL) in conjunction with clinical manifestations such as thrombosis and/or obstetrical complications. One of the notable recent developments in APS research is the identification of a contributory role for neutrophil extracellular traps (NETs) in its pathogenesis, establishing a mechanistic link between thrombosis, inflammation, and complement activation. NETs, composed of decondensed chromatin and neutrophil-derived granule proteins, are released in response to various infectious and sterile triggers. In individuals with APS, elevated NET levels and the presence of anti-NET antibodies have been observed, aligning with thrombotic events and enhanced complement system activation. Studies support an emerging model that neutrophils are primed in APS to form NETs as a central mechanism in the development of thrombosis. This review explores multiple mechanisms linking NETs and thrombosis in APS including: contribution of aPL to enhanced leukocyte adhesion and the induction of NETosis via P-selectin glycoprotein ligand-1 (PSGL-1) and the transcription factor KLF2; cyclic AMP and the adenosine A_2A receptor on the neutrophil surface as negative regulators of NETosis and thrombus formation in APS; and NET-mediated resistance to activated protein C leading to hypercoagulability, amongst others. Intervening in NET-related pathways represents a promising therapeutic strategy to mitigate thrombotic risk in APS, underscoring the need for ongoing investigation into neutrophil-mediated mechanisms in this autoimmune disorder.</p>","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":" ","pages":"150909"},"PeriodicalIF":2.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144812713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantifying Harms Associated With Red Cell ABO Incompatible Blood Transfusion: A Systematic Review of the UK SHOT Literature","authors":"Florence Oyekan PGDip ,&nbsp;Helinor McAleese MSc ,&nbsp;Montasir Ahmed MPhil ,&nbsp;Cath Booth MBBS ,&nbsp;Louise Bowles MBBS ,&nbsp;Michael F Murphy MD ,&nbsp;Florian Tomini PhD ,&nbsp;Laura Green MD ,&nbsp;Josephine McCullagh DClinSci","doi":"10.1016/j.tmrv.2025.150906","DOIUrl":"10.1016/j.tmrv.2025.150906","url":null,"abstract":"<div><div>ABO-incompatible (ABOi) red blood cell (RBC) transfusions can lead to severe clinical consequences, including patient death. Electronic systems, such as Bedside Electronic Transfusion Checks (BETC), have been developed to lower the risk of these serious incidents occurring due to errors in patient identification at the bedside; however, the benefits for patients have not yet been fully quantified. To address this gap, we aimed to quantify the harms (ie, morbidity and mortality) associated with ABOi RBC transfusions in the UK, enabling us to better understand the benefits of BETC in preventing these events for patients.</div><div>Twenty-seven years of published UK hemovigilance data from cases submitted to Serious Hazards of Transfusion (SHOT), including reports from 1996 to 2023 were reviewed using systematic review methodology by 2 independent reviewers. Data was collated into a Microsoft Excel database for further analysis. The data were analyzed to determine the number of reports of ABOi RBC transfusion and the rate of mortality/morbidity associated with these events. Morbidity was defined as hemolytic transfusion reaction (acute and delayed), any organ injury, extended length of hospital stays, the requirement for mechanical ventilation and ITU admission (including critical care units), and any other adverse events as reported in each case.</div><div>Over 27 years (1996-2023), 55.3 million RBC units were issued in the UK, with 368 ABO-incompatible (ABOi) transfusions, equating to 0.67 per 100,000 transfusions. Clinical errors accounted for 53.3% of the observed ABOi transfusions (0.36 per 100,000), primarily occurring during administration (0.16 per 100,000), blood collection (0.10 per 100,000), and sample collection (0.07 per 100,000). Laboratory errors made up for 13.6% of the observed ABOi transfusions (0.09 per 100,000), predominantly being a consequence of errors in pretransfusion testing (0.06 per 100,000). Mortality among the observed ABOi transfusions was 6.3% (0.04 per 100,000), with major morbidity at 23.9% (0.16 per 100,000), which includes ICU admissions (0.03 per 100,000) and hemolytic reactions (0.05 per 100,000).</div><div>While ABOi RBC transfusions have become rare in the UK, they are associated with significant short-term morbidity and mortality. Early SHOT reports lacked standardization and provide limited data on patient outcome. When patient outcome was reported, it was limited to short-term outcomes immediately post ABOi transfusions. No data was reported on longer -term patient outcomes limiting the ability to provide long-term outcome assessment. Enhancing hemovigilance practices is essential to reducing ABOi risks. National hemovigilance schemes worldwide need to harmonize/standardize the reporting of short-term and long-term outcome data collection for ABOi RBC transfusions so we can better understand the risk and burden of these events on patients.</div></div>","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":"39 3","pages":"Article 150906"},"PeriodicalIF":2.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144569926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ultra-Restrictive Transfusion Thresholds in Critically Ill Adults: Perhaps Not for Everyone","authors":"Orlando Rubén Pérez-Nieto ,&nbsp;Ignacio Rodríguez-Guevara ,&nbsp;Rafael Alfonso Reyes-Monge ,&nbsp;Marian Elizabeth Phinder-Puente","doi":"10.1016/j.tmrv.2025.150907","DOIUrl":"10.1016/j.tmrv.2025.150907","url":null,"abstract":"","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":"39 3","pages":"Article 150907"},"PeriodicalIF":2.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144580156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Journal Club","authors":"","doi":"10.1016/j.tmrv.2025.150915","DOIUrl":"10.1016/j.tmrv.2025.150915","url":null,"abstract":"","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":"39 3","pages":"Article 150915"},"PeriodicalIF":2.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144703832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clash of the Standards: An Institutional Approach to Fulfilling ABO Confirmation Mandates While Upholding Patient Blood Management Principles","authors":"Lisa Richards ,&nbsp;Jacob Pendergrast ,&nbsp;Michael Angers ,&nbsp;Grant Johnson ,&nbsp;Christine Cserti-Gazdewich","doi":"10.1016/j.tmrv.2025.150912","DOIUrl":"10.1016/j.tmrv.2025.150912","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;IQMH standard VI.1 TM042 states there shall be a 2&lt;sup&gt;nd&lt;/sup&gt; check of the ABO group (ABOConf) either by testing of a second sample or identifying supportive prior records, because verification is a pre-requisite for the provision of group-specific blood (GSB) for transfusion. The use of GSB in turn is valued in inventory management by decreasing the unnecessary use of group O red cells for non-O patients. However, Choosing Wisely advises against sampling more blood than is needed. As such, when lacking historical data, ABOConf demands additional venipuncture, though from the ensuing 7-10 ml specimen, only a few drops of blood are used. Our twin goal was to reduce ABOConf collections while decreasing turnaround times (TATs) by using existing samples. Avoiding new collections is patient-centred by eliminating repeat venipuncture discomfort and leveraging available alternative specimens, as iatrogenic blood loss is a known driver of anemia in healthcare. Furthermore, retroactive leveraging in a laboratory environment was recognized as uniquely free from the possibility of premeditated bedside \"double-draw\" fraud.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Design and Methods&lt;/h3&gt;&lt;div&gt;When an order for red cell transfusion is received, the laboratory information system assists in determining if ABOConf is required. This flag recruits a technologist to determine if, among previously-collected CBCs, there is a sample meeting Transfusion Medicine (TM) labelling requirements (ie- an independent collection in the last 3 days). If present, the sample is retrieved and re-processed in an ABOConf order under the Confirmatory Blood Type Medical Directive. The original collection information (collector/date/time) is documented in the Clinical Information System (CIS). The ABOConf order process includes documentation of the specimen number used for testing, with verification that the sample was a collection distinct from the original Type and Screen. Only if an appropriate CBC is unavailable will a new blood draw occur.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Six months (Jul-Dec 2024) were reviewed. Surgical order locations (Main Operating Room and Pre-operative Clinic) were assessed separately as a group exempt from the lab-ordered ABOConf process, owing to distinct expedient transfusion-readiness concerns. Of 567 non-surgical orders, 364 new collections (2,548 mL) were averted (64%), vs only 5 saved collections in 533 surgical samples (Z 22.2, p&lt; .00001). A 10 day audit showed a TAT decrease as well in the use of previously-collected samples (average 12 minutes vs 77 for new collections).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;The use of previously collected samples for ABOConf testing reduced sample collection significantly in the non-surgical population with significantly decreased TAT, while satisfying IQMH standards and Choosing Wisely recommendations. Future goals are to reduce specimen volume when ABOConf draws remain necessary, and to expand","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":"39 3","pages":"Article 150912"},"PeriodicalIF":2.5,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144723866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing Buffy Coat Pooling: Enhancing Platelet Yield Through Platelet Count-Based Sorting","authors":"Marco Amato ,&nbsp;Manfred Astl ,&nbsp;Lisa Seekircher ,&nbsp;Lena Tschiderer ,&nbsp;Peter Willeit ,&nbsp;Harald Schennach ,&nbsp;Anita Siller","doi":"10.1016/j.tmrv.2025.150908","DOIUrl":"10.1016/j.tmrv.2025.150908","url":null,"abstract":"<div><div>Optimizing platelet yield in pooled buffy coat (BC)-derived platelet products by sorting them according to donor whole blood (WB) platelet counts is a promising approach to increase the production of double-dose platelet concentrates while reducing the variability among products. We aimed to assess the benefit of sorting according to an HTML-report generated by an in-house developed preselection algorithm. In this study, we compared two approaches of BC pooling to produce pathogen-inactivated double-dose platelet concentrates. The platelet count of donor WB was measured using a hematology analyzer prior to pooling. In one group, six BCs were randomly assigned to pools, while in the other group, six BCs were sorted by platelet counts of WB samples prior to pooling according to an in-house developed preselection algorithm, selecting six BCs for each pool in a way that yields for each product are similar. All BCs were included as no minimum or maximum platelet count entry criteria were used. Yield and divisibility rate of both approaches were compared using Wilcoxon Rank−Sum Test to assess the impact of sorting by platelet count. Sorting BCs according to our in-house developed algorithm resulted in significantly higher median platelet concentrations (×10³/µL), rising from 1247 (interquartile range [IQR] 1207-1349) when randomly assigned to 1307 (IQR 1237-1381) when sorted (<em>P</em> = .0434). In line, yields per platelet unit (×10¹¹/unit) significantly increased from 4.6 (IQR 4.3-4.8) when randomly assigned to 4.8 (IQR 4.5-5.1) when sorted (<em>P</em> = .0191). The proportion of divisible pathogen-inactivated platelet units increased from 72.1% to 89.5%. For both approaches, all units were above the minimum threshold (&gt;2.0 × 10¹¹/unit) and no maximum threshold was defined. Assigning BCs to pools according to an in-house developed preselection algorithm enables the production of platelet concentrates with increased yields and leads to more standardized products.</div></div>","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":"39 3","pages":"Article 150908"},"PeriodicalIF":2.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144557572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Four-Factor Prothrombin Complex Concentrate is Superior to Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery—The FARES-II (LEX-211) Phase 3, Multicentre, Randomized, Clinical Trial","authors":"Keyvan Karkouti ,&nbsp;Jeannie Callum ,&nbsp;Cristina Solomon ,&nbsp;Sigurd Knaub ,&nbsp;Sylvia Werner ,&nbsp;Kenichi Tanaka ,&nbsp;Jerrold H. Levy","doi":"10.1016/j.tmrv.2025.150913","DOIUrl":"10.1016/j.tmrv.2025.150913","url":null,"abstract":"<div><h3>Introduction</h3><div>Cardiac surgery with cardiopulmonary bypass (CPB) is often complicated by coagulopathic bleeding, leading to morbidity and mortality. Although guidelines recommend using either frozen plasma (FP) or four-factor prothrombin complex (PCC) for bleeding management, the mainstay of therapy in North America is FP. This randomized controlled non-inferiority trial compared the efficacy and safety of PCC with FP in cardiac surgery.</div></div><div><h3>Design and Methods</h3><div>FARES-II (LEX-211; NCT05523297) included patients aged ≥18 years undergoing cardiac surgery with CPB. After protamine administration, patients who developed coagulopathic bleeding with INR ≥1.5 were randomized 1:1 to receive PCC (1500 IU if ≤60 kg; 2000 IU if &gt;60 kg) or FP (3 U if ≤60 kg; 4 U if &gt;60 kg). The clinical team was blinded to group allocation until treatment initiation. The primary endpoint was hemostatic response (effective if no additional hemostatic interventions were administered from 60 min to 24 h after treatment initiation). Safety endpoints included 30-day treatment-emergent serious adverse events, thromboembolic events and death.</div></div><div><h3>Results</h3><div>Of 538 enrolled patients at 12 sites, 420 were randomized, treated, consented and included in the analysis (PCC=213; FP=207). Baseline characteristics were comparable between groups; median (range) age was 66 years (20–88) and 74% of patients were male. Effective hemostasis was achieved in 77.9% (n=166) of PCC patients vs. 60.4% (n=125) of FP patients (difference 17.6%; 95% CI 8.7, 26.4; p&lt; 0.0001 for non-inferiority and superiority). Overall, the mean (95% CI) number of allogeneic blood product units transfused within 24 h post-CPB, including intervention FP, was 6.6 (5.9, 7.5) in PCC patients and 13.8 (12.3, 15.5) in FP patients (ratio 0.48; 95% CI 0.41, 0.57; p&lt; 0.0001). Treatment-emergent thromboembolic events and mortality occurred in 8.5% (n=18) and 3.3% (n=7) of PCC patients and 7.2% (n=15) and 3.9% (n=8) of FP patients, respectively. Treatment-emergent serious adverse events (36.2% vs. 47.3%; relative risk 0.76; 95% CI 0.61, 0.96; p=0.02) and acute kidney injury (10.3% vs. 18.8%; relative risk 0.55; 95% CI 0.34, 0.89; p=0.02) were significantly less frequent in the PCC group compared with the FP group.</div></div><div><h3>Conclusion</h3><div>PCC has superior hemostatic efficacy and may have safety advantages over FP in patients requiring coagulation factor replacement for bleeding during cardiac surgery. These findings support the use of PCC over FP for bleeding management in cardiac surgery.</div></div>","PeriodicalId":56081,"journal":{"name":"Transfusion Medicine Reviews","volume":"39 3","pages":"Article 150913"},"PeriodicalIF":2.5,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144723846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}