A Phase III Trial of Intravenous Ferric Carboxymaltose to Improve Recovery After Major Surgery with Blood Loss Including Liver, Pancreas, and Aortic Procedures

What this Trial Is About

Researchers are studying whether an intravenous iron treatment called Ferric Carboxymaltose can help improve recovery after major surgeries that cause blood loss, such as complex aortic surgery or liver and pancreatic resections. Post-operative anemia, often caused by pre-existing iron deficiency and blood loss during surgery, can slow recovery. This Phase III randomized controlled trial aims to see if giving Ferric Carboxymaltose after surgery reduces the need for blood transfusions and improves health outcomes. Participants who experience blood loss between 400 and 4000 ml during surgery are randomly assigned to receive either a single intravenous dose of 1000 mg Ferric Carboxymaltose or a placebo saline solution. This treatment is given by infusion as soon as the surgery ends. The study compares these two groups to evaluate differences in recovery and anemia outcomes over the following weeks. During the study, participants are monitored for up to five weeks after surgery. Researchers assess recovery by looking at death rates, red blood cell transfusions, severe anemia occurrences, and quality of life measures. They also track hemoglobin levels, complications, overall recovery, performance status, hospital readmissions, and long-term outcomes from medical records. The study continues until a set number of patients have completed follow-up to fully evaluate the effects of the iron treatment.

Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial