The effect of postoperative intravenous iron in anaemic, older cardiac surgery patients on disability-free survival (AGE ANEMIA study): Study protocol for a multi-centre, double blind, randomized, placebo-controlled trial

Background: Postoperative anaemia is common in older cardiac surgery patients and often caused by iron deficiency. Anaemia may negatively affect recovery after cardiac surgery. This study aims to determine the efficacy of treatment of postoperative iron deficiency anaemia (IDA) with intravenous iron (IVI) on disability 90 days after cardiac surgery in older patients. Methods: This is a randomized placebo-controlled double blind multi-centre trial. In total, 310 patients aged ≥70 years with moderate IDA on postoperative day 1 (haemoglobin 85 - 110 g/L and ferritin concentration < 100 μg/L or iron saturation Discussion: The results of this study will demonstrate whether early treatment of postoperative IDA with IVI improves disability at 90 days in older cardiac surgery patients. Trial registration: Registered at ClinicalTrials.gov as NCT04913649 at June 4th, 2021.