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Study on Intravenous Ferric Carboxymaltose for Preoperative Anemia in Patients with Lower Limb Peripheral Artery Disease

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What is this trial about?

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

The study is focused on examining how intravenous iron treatment impacts patients with a specific type of anemia that occurs in individuals with chronic ischemia of the lower limbs. This condition involves inadequate blood supply to the legs. The treatment being studied uses a medication called Ferinject, which contains ferric carboxymaltose, and it is given through an injection directly into the veins. This method aims to address anemia, a condition where a person does not have enough healthy red blood cells to carry adequate oxygen to the body's tissues.

The main goal of this research is to see if this intravenous iron treatment can reduce the need for blood transfusions in patients with anemia ahead of their planned surgery for revascularization. Revascularization is a procedure used to improve blood flow to the lower limbs. By providing this iron treatment before surgery, the study aims to reduce complications associated with anemia and improve recovery outcomes.

Participants in this study include adults with anemia and chronic lower limb ischemia who are scheduled to undergo surgical procedures to restore blood flow. Throughout the study, researchers will be measuring various factors related to hemoglobin levels, which are crucial for transporting oxygen in the blood, as well as observing how this treatment may affect the length of hospital stays and the patients' overall recovery and quality of life after the surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of anemia, and planned revascularization surgery.

    Written informed consent is required to participate in the study.

  2. Step 2

    Preoperative treatment

    The treatment involves the administration of ferric carboxymaltose, a type of iron given through an intravenous (IV) infusion.

    This medication is provided to improve iron levels before surgery, aiming to reduce the need for blood transfusions.

  3. Step 3

    Surgery preparation

    The surgery is scheduled to occur between 48 hours and 3 weeks after inclusion in the study.

    The goal is to ensure optimal iron levels before the surgical procedure.

  4. Step 4

    Surgical intervention

    Participants undergo revascularization surgery for chronic lower limb ischemia.

    The surgery can be either endovascular or open, depending on the specific medical needs.

  5. Step 5

    Postoperative monitoring

    After surgery, hemoglobin levels are monitored to assess changes and recovery.

    The impact of anemia treatment on hospital stay, health outcomes, and quality of life is evaluated during the hospital stay and for 30 days post-surgery.

  6. Step 6

    Follow-up

    Participants are followed up for 30 days after the main surgery to monitor recovery and any need for transfusions.

    The study aims to determine the optimal timing for IV iron administration to improve hemoglobin levels effectively.

Who can join the trial?

7 criteria

  • Patients must be 18 years or older.
  • Patients must have a diagnosis of anemia. Anemia is when the blood has a lower than normal number of red blood cells. For this study, anemia is defined as having hemoglobin (Hb) levels less than 13.0 g/dL in men and less than 12 g/dL in women.
  • Patients must have chronic ischemia of the lower limbs. This means there is a long-term reduction in blood flow to the legs. The condition should be classified as Rutherford-Baker grades 2-5 or Fontaine grades II-IV.
  • Patients should be planning to have revascularization surgery. This is a procedure to restore blood flow, and it can be done through endovascular (inside the blood vessel) or open surgery.
  • The planned surgery should be scheduled to occur between 48 hours to 3 weeks after joining the study.
  • Patients must have iron deficiency anemia and be taking oral iron supplements. Iron deficiency anemia is when the body doesn't have enough iron to produce healthy red blood cells. The iron levels should be ferritin less than 100 ng/ml or ferritin between 100-500 ng/ml with an iron saturation (IST) less than 20%.
  • Patients must be able and willing to provide written informed consent. This means they agree to participate in the study after being informed about what it involves.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing anemia. Anemia is a condition where you don't have enough healthy red blood cells to carry oxygen to your body's tissues.
  • Patients who do not have chronic ischemia of the lower limb. This is a condition where there is reduced blood flow to the legs over a long period.
  • Patients who are not undergoing revascularization surgery. This is a type of surgery to restore blood flow to the legs.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Intravenous Iron is used in this trial to treat anemia in patients who are going to have surgery for peripheral artery disease in their legs. Anemia is a condition where you don't have enough healthy red blood cells to carry oxygen to your body's tissues. By giving iron directly into the bloodstream, this treatment aims to increase the iron levels in the body, which can help improve the production of red blood cells. The goal is to reduce the need for blood transfusions during and after surgery.

What is already known about the treatment

Intravenous Iron – This medication is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its effectiveness in treating anemia in patients with chronic ischemia of the lower limbs, particularly those undergoing revascularization surgery. The main therapeutic indication is to reduce the need for blood transfusions in these patients. At the molecular level, intravenous iron works by replenishing iron stores in the body, which is essential for the production of hemoglobin, a protein in red blood cells that carries oxygen. It is classified pharmacologically as an iron supplement.

Investigated diseases

Anemia in patients with chronic ischemia of the lower limb – This condition occurs when there is a deficiency of red blood cells or hemoglobin in the blood, leading to reduced oxygen delivery to tissues. In patients with chronic ischemia of the lower limb, this can exacerbate symptoms such as fatigue, weakness, and shortness of breath. The chronic ischemia itself is characterized by reduced blood flow to the legs, often due to narrowed or blocked arteries. Over time, this can lead to pain, especially during physical activity, and may progress to more severe complications if not managed. Anemia in this context can worsen the overall condition by further limiting the oxygen supply to already compromised tissues. The progression of anemia in these patients can vary, often influenced by the underlying causes and the individual's overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514593-50-00Protocol codeIRONPADEstimated enrolment240 patientsSponsorAsociacion Instituto De Investigacion Sanitaria Biobizkaia

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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