Intravenous Iron Treatment for Older Adults with Postoperative Anemia After Elective Cardiac Surgery

What this Trial Is About

Researchers are studying the effect of intravenous iron treatment on postoperative iron deficiency anemia in older patients who have undergone elective cardiac surgery with cardiopulmonary bypass. The study aims to assess how this treatment impacts disability 90 days after surgery. This is a randomized, placebo-controlled, double-blind trial involving 310 elderly patients aged 70 years and older who have moderate postoperative iron deficiency anemia. Participants will receive either a single dose of intravenous ferric derisomaltose, dosed at 20mg per kilogram of body weight and infused over approximately 60 minutes, or a placebo consisting of sodium chloride 0.9% solution. Vital signs are monitored during the infusion and for 30 minutes afterward. The treatment is given on postoperative day 1 after uncomplicated elective aortic valve repair or coronary artery bypass graft surgery. During the study, participants will be evaluated for disability using the WHO Disability Assessment score 12-item version at 90 days after surgery. Additional assessments include patient-reported outcomes on breathing difficulty and quality of life, blood transfusion requirements, hemoglobin and reticulocyte hemoglobin content changes, hospital complications, and functional tests such as the 6-minute walk test. Safety and health status are monitored throughout the study period, which extends to 90 days post surgery.

Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients