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Introduction Reduced thrombin generation is an important component of post cardiopulmonary bypass (CPB) coagulopathy. To replenish coagulation factors and enhance thrombin generation in bleeding surgical patients, frozen plasma (FP) and four-factor prothrombin complex concentrate (4F-PCC) are used. However, the efficacy–safety balance of 4F-PCC relative to FP in cardiac surgery is unconfirmed.Methods and analysis LEX-211 (FARES-II) is an active-control, randomised, phase 3 study comparing two coagulation factor replacement therapies in bleeding adult cardiac surgical patients at 12 hospitals in Canada and the USA. The primary objective is to determine whether 4F-PCC (Octaplex/Balfaxar, Octapharma) is clinically non-inferior to FP for haemostatic effectiveness. Inclusion criteria are any index (elective or non-elective) cardiac surgery employing CPB and coagulation factor replacement with 4F-PCC or FP ordered in the operating room for bleeding management. Patients will be randomised to receive 1500 or 2000 international units of 4F-PCC or 3 or 4 units of FP, depending on body weight. The primary endpoint of haemostatic treatment response is ‘effective’ if no additional haemostatic intervention is required from 60 min to 24 hours after the first initiation of 4F-PCC or FP; or ‘ineffective’ if any other haemostatic intervention (including a second dose of study drug) is required. An estimated 410 evaluable patients will be required to demonstrate non-inferiority (one-sided α of 0.025, power ≥90%, non-inferiority margin 0.10). Secondary outcomes include transfusions, bleeding-related clinical endpoints, coagulation parameters and safety.Ethics and dissemination The trial has been approved by the institutional review boards of all participating centres. Trial completion is anticipated at the end of 2024, and results will be disseminated via publications in peer-reviewed journals and conference presentations in 2025. The results will advance our understanding of coagulation management in bleeding surgical patients, potentially reducing the need for allogeneic blood products and improving outcomes in surgical patients.Trial registration number NCT05523297.

Background Up to 50% of blood is transfused inappropriately despite best evidence. In 2020, Choosing Wisely Canada launched a major national programme, ‘Using Blood Wisely’, the aim was to engage hospitals to audit their red blood cell transfusion use against national benchmarks and participate in a programme to decrease inappropriate use.Study design Using Blood Wisely is a quality improvement programme including national benchmarks, an audit tool, recommended evidence-based effective interventions and a designation to reward success. Hospital engagement was measured using the number of hospitals signing up, performing a baseline audit, submitting the planning survey, entering two or more audits and achieving hospital designation. Barriers to implementation were collected.Results From 1 September 2020 to 31 December 2022, 229 individual hospitals signed up over time to participate. Their results are reported as 159 hospitals and hospital groups. Collectively, this accounts for 72% of the blood used in Canada. Overall, 147 (92%) performed a baseline audit, 10 (6%) submitted a planning survey and 130 (82%) entered two or more audits. At baseline (time of enrolment), 75 (51%) met both benchmarks. The designation was awarded to 62 (39%) hospital groups (a total of 105 individual hospitals) that met and sustained benchmarks. Barriers to implementation included human resource shortages, lack of local expertise to advise the team, need for more education of transfusion prescribers and competing priorities.Conclusion In its initial phase, Using Blood Wisely engaged a substantial number of hospitals in transfusion quality improvement work and maintained that engagement. This large-scale engagement across a big country was more successful than anticipated. Additional efforts are needed to rigorously evaluate the programme’s impact on utilisation.

Introduction Iron deficiency anaemia (IDA) is common in patients with heart failure (HF) and is associated with advanced HF and increased mortality. Intravenous iron supplementation increases exercise tolerance, improves quality of life, and decreases symptoms among patients with HF with reduced ejection fraction (HFrEF) and iron deficiency. Despite this, many patients are not screened or treated for IDA. We aimed to increase rates of screening and treatment of IDA among HF patients through the introduction of curated materials to aid HF clinicians with appropriate screening and treatment.Methods We conducted a retrospective chart review to identify the baseline number of HFrEF patients screened and treated for IDA at two ambulatory cardiology clinics in Toronto, Ontario. A quality improvement initiative was then introduced, which consisted of education and curated materials to aid clinicians in the screening and treatment of IDA among HFrEF patients. The proportion of patients screened and treated for IDA preintervention and postintervention were compared using χ2 tests of Independence.Results In the preintervention cohort, 36.3% (n=45) of patients with anaemia were screened for IDA. Among those screened, 64.4% (n=29) had IDA. Only 17.2% (n=5) of these were treated with IV iron. After implementation of the quality improvement initiative, 90.9% (n=60) of patients with anaemia were screened for IDA (p