Breaking Trials: ITACS Trial on Preoperative IV Iron for Anaemia Before Cardiac Surgery

Recorded at the excellent ANESTHESIOLOGY® 2025 in San Antonio. Hear Andy Cumpstey and Mike Grocott interview Paul Myles, a Professor of Anaesthesiology and Perioperative Medicine at Monash University in Melbourne, Australia. Here we focus upon his group's approach to large pragmatic, multicenter international trials and the process of selecting and developing study questions within a clinical trials network. Myles presents the ITACS trial (intravenous iron treatment for anaemia before cardiac surgery), designed because anaemia is common (~30%) in elective cardiac surgery and is associated with increased complications, longer hospital stay, mortality, and greater transfusion requirements, while prior randomized evidence supporting routine preoperative IV iron clinics has been weak despite observational associations. The two-arm randomized controlled trial enrolled about 1,000 patients scheduled for cardiac surgery 1–26 weeks ahead across 33 hospitals in 10 countries; patients with anaemia due to causes unlikely to benefit from iron (e.g., megaloblastic anemia, certain iron storage diseases) were excluded, while non–iron deficiency anaemia was included. Participants received a single 1 g dose of IV iron in the weeks preoperatively, with a primary endpoint of days alive and at home at 90 days to capture patient-centered recovery and the functional impact of complications. Results included a statistically significant one-day improvement in days alive and at home, modestly higher preoperative haemoglobin, markedly improved iron indices, and a marked reduction in red cell transfusions intraoperatively and through 30 days and 3 months; the team estimated saving 44 units of red cells per 100 patients treated. The one-day benefit was mainly driven by fewer readmission days, and a formal cost-effectiveness analysis (with Australian resource-use data) is underway with planned publication within six months. The discussion highlights why mild anaemia matters in major surgery due to postoperative blood loss and recovery, and notes that while extrapolation to other major surgeries with expected blood loss >500 mL may be considered, the hosts and Myles emphasize ongoing equipoise and the need for additional large randomized trials outside cardiac surgery. -- We strongly suggest you investigate our forthcoming EBPOM Ireland conference, being held in the beautiful location of Dingle. World leading experts in perioperative medicine presenting the latest cutting edge research in periperative medicine and enhanced recorvery after surgery. Find more information at EBPOM.org