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Study on Treating Postoperative Anemia in Older Cardiac Surgery Patients with Ferric Derisomaltose and Sodium Chloride

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of iron deficiency anemia in older patients who have undergone heart surgery. The treatment being tested is an intravenous iron solution called Monofer, which contains the active substance ferric derisomaltose. This solution is given through a vein to help increase iron levels in the body. The study also involves the use of a 0.9% Sodium Chloride Intravenous Infusion Solution, which is a common fluid used in medical settings.

The purpose of the study is to determine how effective the intravenous iron treatment is in reducing disability 90 days after heart surgery. Participants in the study will receive either the iron solution or the sodium chloride solution. The study will monitor the participants' health and recovery over a period of time to see how the treatment affects their recovery and overall well-being.

Throughout the study, various health indicators will be observed, such as the need for blood transfusions, changes in blood iron levels, and any complications that may arise after surgery. The study aims to provide valuable information on how intravenous iron can help improve recovery in patients with iron deficiency anemia following heart surgery.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is confirmed to be mentally competent and aged 70 years or older.
The patient has undergone elective aortic valve replacement (AVR) or coronary artery bypass grafting (CABG) surgery, possibly combined with rhythm surgery.
The patient is expected to have an uncomplicated recovery, with no need for inotropic agents or ventilation, and is expected to be discharged to a general ward by the first postoperative day (POD 1).
The patient has moderate postoperative iron deficiency anaemia, with hemoglobin (Hb) levels between 85 and 110 g/L, ferritin levels below 100 micrograms per liter, or iron saturation (TSAT) below 20%.
Step 2
Treatment administration
The patient receives treatment with intravenous iron to address postoperative iron deficiency anaemia.
The specific medication used is Monofer (ferric derisomaltose), administered as a solution for injection or infusion.
Additionally, a 0.9% sodium chloride solution is used for intravenous infusion.
The treatment aims to improve the patient's condition by the 90th day after surgery.
Step 3
Monitoring and assessment
The primary goal is to assess the patient's disability using the 12-item World Health Organization Disability Assessment score 2.0 (WHODAS-12) at 90 days after surgery.
Secondary assessments include monitoring postoperative red blood cell (RBC) transfusions, changes in reticulocyte hemoglobin content from randomization to hospital discharge, and hemoglobin levels at discharge.
Hospital complications are recorded according to the Nederlandse Hart Registratie (NHR).
The number of days the patient is alive and out of the hospital by POD 90 is also tracked.
Changes in patient-reported outcomes regarding dyspnoea symptoms are assessed at POD 90 using the RDS.

Who can join the trial?

10 criteria

Must be **mentally competent**, meaning able to understand and make decisions about their own health care.
Must be **70 years old or older**.
Must be scheduled for **elective AVR or CABG surgery**. This includes surgeries for heart valve replacement (AVR) or heart artery bypass (CABG), and may also include additional heart rhythm surgeries.
Must have an **expected uncomplicated recovery** after surgery, which means:
- No need for special medications to support the heart (inotropic agents) or breathing machines (ventilation) at the time of final inclusion, which is the day after surgery (POD 1).
- Expected to be moved to a regular hospital ward the day after surgery (POD 1).
- Must have **moderate postoperative iron deficiency anemia (IDA)**, which is defined as:
  - Hemoglobin (Hb) levels between 85 and 110 grams per liter (g/L). Hemoglobin is a protein in red blood cells that carries oxygen.
  - Ferritin levels less than 100 micrograms per liter (µg/L). Ferritin is a protein that stores iron in the body.
  - Iron saturation (TSAT) less than 20%. This measures how much iron is available in the blood.
  - Both **male and female** participants are eligible.
  - Participants should not belong to a **vulnerable population**, meaning they should not be in a situation that makes it hard to protect their own interests.

Who cannot join the trial?

6 criteria

Patients who are not experiencing iron deficiency anemia. This is a condition where the body doesn't have enough iron, leading to fewer red blood cells.
Patients who have not undergone cardiac surgery. This refers to any surgery performed on the heart or its vessels.
Patients who are under 18 years old. The study is only for adults.
Patients who are unable to give informed consent. This means they cannot understand the study well enough to agree to participate.
Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amphia Hospital
Breda, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Verified
St. Antonius Ziekenhuis
Nieuwegein, The Netherlands

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Investigated drugs

Intravenous Iron is used in this trial to treat anemia that occurs after surgery. Anemia is a condition where there are not enough healthy red blood cells to carry oxygen to the body's tissues. This can happen after surgery, especially in older patients. The intravenous iron is given directly into the bloodstream to quickly increase iron levels, which helps the body produce more red blood cells. The goal is to see if this treatment can reduce disability and improve recovery 90 days after cardiac surgery.

What is already known about the treatment

Intravenous Iron – This medication is administered through an injection directly into the bloodstream, typically used in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating iron deficiency anemia, particularly in older patients who have undergone cardiac surgery. The main therapeutic indication is to address anemia caused by a lack of iron, which is essential for producing healthy red blood cells. At the molecular level, intravenous iron works by replenishing iron stores in the body, allowing for the production of hemoglobin and improving oxygen transport in the blood. It is classified as an iron supplement in pharmacology.

Investigated diseases

Iron Deficiency Anemia – Iron deficiency anemia is a condition where the body lacks enough iron to produce adequate levels of hemoglobin, the protein in red blood cells responsible for carrying oxygen. This deficiency leads to symptoms such as fatigue, weakness, and pale skin due to reduced oxygen delivery to tissues. The condition can develop gradually as iron stores are depleted, often due to blood loss, poor diet, or an inability to absorb iron efficiently. As the anemia progresses, individuals may experience shortness of breath, dizziness, or cold hands and feet. It is commonly diagnosed through blood tests that measure hemoglobin and iron levels. Managing iron deficiency anemia typically involves addressing the underlying cause and replenishing iron levels.