Not Yet RecruitingPhase 4

Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After Cardiac Surgery

South Korea180 participantsStarted 2025-12

Plain-language summary

Postoperative anemia is highly prevalent among patients undergoing cardiac surgery and is associated with delayed functional recovery, increased morbidity, and impaired long-term outcomes. Preoperative iron deficiency is common in this population and contributes to inadequate erythropoietic recovery after surgery. Functional iron deficiency frequently develops even in patients without preoperative deficiency due to blood loss, hemodilution, and inflammation-mediated disruption of iron homeostasis. Despite this clinical burden, standardized strategies for postoperative anemia management have not been established. This prospective, randomized, double-blind, placebo-controlled clinical trial evaluates whether early postoperative intravenous iron supplementation improves long-term anemia outcomes in patients undergoing cardiac surgery with cardiopulmonary bypass. Adult patients with preoperative anemia (hemoglobin \<13 g/dL) or iron deficiency (ferritin \<100 ng/mL or transferrin saturation \<20%) will be screened. Eligible participants with postoperative day (POD) 1 hemoglobin \<10 g/dL will be randomized in a 1:1 ratio to receive either ferric derisomaltose (20 mg/kg, maximum 1,000 mg) or a matched placebo administered intravenously over 30 minutes on POD 1. All perioperative management outside the intervention follows current institutional standards. The primary outcome is the incidence of anemia at 6 months following surgery. Secondary outcomes include perioperative hemoglobin trends, functional recovery assessed by cardiopulmonary exercise testing and the 6-minute walk test at 6 months, transfusion requirements, postoperative complications including MAKE-90 and STS major morbidity, and changes in biomarkers of erythropoiesis and iron metabolism (erythroferrone, erythropoietin, hepcidin, and iron profile). Blood samples for biomarker analysis are collected at predefined perioperative timepoints. Ferric derisomaltose allows high-dose single-session iron repletion with a favorable safety profile and minimal risk of anaphylaxis when administered slowly. Prior studies in cardiac surgery and heart failure populations support its efficacy and safety at doses up to 20 mg/kg. The intervention is expected to facilitate erythropoietic recovery, reduce the duration of postoperative anemia, and improve long-term functional status. The trial aims to generate evidence to inform postoperative anemia management strategies in cardiac surgery patients.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged ≥19 years scheduled to undergo cardiac surgery requiring cardiopulmonary bypass Preoperative anemia defined as hemoglobin \<13.0 g/dL, or preoperative iron deficiency defined as ferritin \<100 ng/mL or transferrin saturation \<20% Ability to understand the study information and provide written informed consent prior to surgery Postoperative day 1 hemoglobin \<10.0 g/dL on the first CBC following surgery (required for final enrollment) Exclusion Criteria: * Emergency surgery Preoperative major organ failure requiring intensive care unit management Active infection prior to surgery, including sepsis Active bleeding prior to surgery Pregnancy or breastfeeding Use of erythropoiesis-stimulating agents or intravenous iron therapy within 3 months prior to surgery Iron overload defined as ferritin ≥500 ng/mL or transferrin saturation ≥45% Aplastic anemia Hemolytic anemia Hemochromatosis or hemosiderosis Decompensated liver cirrhosis, acute hepatitis, or alcohol dependence Known hypersensitivity to intravenous iron formulations Participation in another clinical trial that may influence outcomes Inability to understand or provide informed consent due to language barriers, illiteracy, or cognitive impairment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Anemia at 6 Months After Cardiac Surgery

Timeframe: Postoperative 6 months

Trial details

NCT IDNCT07238972

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-08

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