AnemiaPhase 4NCT07238972
Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After Cardiac Surgery
A Phase 4 study testing Ferric derisomaltose in people with Anemia and Iron Deficiencies, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anemia, Iron Deficiencies, Iron Deficiency Anemia
- What is being tested?
- Ferric derisomaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2025to Oct 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul
About this study
Official title: Impact of Postoperative Intravenous Iron Supplementation on the Incidence of Long-term Anemia in Patients Undergoing Cardiac Surgery
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.
Read more
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.
- Being tested
- Ferric derisomaltose, Placebo (0.9% saline)
- Medical subject headings
- Anemia, Iron Deficiencies, Anemia, Iron-Deficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric derisomaltoseDrug
Ferric derisomaltose is administered as a single intravenous infusion at 20 mg/kg (maximum 1,000 mg), diluted in 100 mL normal saline, infused over 30 minutes on postoperative day 1.
Placebo (0.9% saline)Drug
The placebo consists of 100 mL of 0.9% normal saline administered intravenously over 30 minutes on postoperative day 1, matched in appearance and timing to the ferric derisomaltose infusion to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Ferric derisomaltose | Experimental | Participants receive a single intravenous dose of ferric derisomaltose 20 mg/kg (maximum 1,000 mg) diluted in 100 mL normal saline and infused over 30 minutes on postoperative day 1. Receives: Drug: Ferric derisomaltose |
| Placebo | Placebo comparator | Participants receive an equal volume of 0.9% saline placebo via intravenous infusion over 30 minutes on postoperative day 1. Receives: Drug: Placebo (0.9% saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Anemia at 6 Months After Cardiac Surgery
Proportion of participants with anemia at 6 months following cardiac surgery, defined as hemoglobin <13.0 g/dL in males and <12.0 g/dL in females. Hemoglobin is assessed at routine outpatient follow-up using standard laboratory testing.
Measured: Postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel-arm, postoperative anemia treatment trial evaluating intravenous ferric derisomaltose versus placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238972
- Sponsor's protocol ID
- 4-2025-1187
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Postoperative Intravenous Iron Supplementation on the Incidence of Long-term Anemia in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07238972
- Acronym / sponsor ID
- 4-2025-1187
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A parallel-arm, postoperative anemia treatment trial evaluating intravenous ferric derisomaltose versus placebo.
| Arm | Type | Receives |
|---|---|---|
| Ferric derisomaltose | Experimental | Drug: Ferric derisomaltoseParticipants receive a single intravenous dose of ferric derisomaltose 20 mg/kg (maximum 1,000 mg) diluted in 100 mL normal saline and infused over 30 minutes on postoperative day 1. |
| Placebo | Placebo comparator | Drug: Placebo (0.9% saline)Participants receive an equal volume of 0.9% saline placebo via intravenous infusion over 30 minutes on postoperative day 1. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric derisomaltoseFerric derisomaltose is administered as a single intravenous infusion at 20 mg/kg (maximum 1,000 mg), diluted in 100 mL normal saline, infused over 30 minutes on postoperative day 1. | Drug | Ferric derisomaltose |
| Placebo (0.9% saline)The placebo consists of 100 mL of 0.9% normal saline administered intravenously over 30 minutes on postoperative day 1, matched in appearance and timing to the ferric derisomaltose infusion to maintain blinding. | Drug | Placebo |
Primary outcome
Incidence of Anemia at 6 Months After Cardiac Surgery
Time frame: Postoperative 6 months
Proportion of participants with anemia at 6 months following cardiac surgery, defined as hemoglobin <13.0 g/dL in males and <12.0 g/dL in females. Hemoglobin is assessed at routine outpatient follow-up using standard laboratory testing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric derisomaltose in people with Anemia and Iron Deficiencies, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Anemia at 6 Months After Cardiac Surgery (time frame: Postoperative 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.