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Study on Iron and Mannitol for Anemia Recovery in Patients After Major Surgery with Blood Loss

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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 effects of a treatment for anemia, a condition where the body doesn't have enough healthy red blood cells to carry adequate oxygen to the tissues. The treatment being tested is an intravenous medication called Ferric Carboxymaltose, which is a form of iron given through a vein. Iron is an essential mineral that helps the body produce red blood cells. The study will also involve the use of mannitol, a type of sugar alcohol used in medical settings, and electrolytes, which are minerals in the body that help balance the amount of water and acidity in the blood.

The purpose of the study is to see if giving 1000 mg of Ferric Carboxymaltose immediately after certain types of surgeries, such as liver or pancreatic surgery, or complex aortic surgery, can improve recovery. These surgeries often involve significant blood loss, which can lead to severe anemia. The study will look at various outcomes, including the number of blood transfusions needed, the severity of anemia after surgery, and changes in quality of life five weeks after surgery. Participants will be randomly assigned to receive either the Ferric Carboxymaltose treatment or a placebo.

The study will follow participants for up to five years to observe the long-term effects of the treatment. Researchers will assess whether the treatment affects recovery, the rate of complications after surgery, and the ability to receive further cancer treatments if needed. They will also monitor for any side effects during the treatment and the follow-up period. The goal is to determine if this iron treatment can help improve outcomes for patients undergoing major surgeries with significant blood loss.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Provide written informed consent to participate in the study.
Ensure eligibility by meeting criteria such as being over 18 years of age, weighing more than 50 kg, and being scheduled for specific surgeries like complex aortic surgery, liver resection, or pancreatic resection.
Step 2
Surgery and initial treatment
Undergo the scheduled surgery, which may involve significant blood loss.
Receive an intravenous administration of 1000 mg of Ferric Carboxymaltose immediately after the surgery. This is intended to help with recovery and manage anemia.
Step 3
Post-operative monitoring
Monitor recovery and health status for five weeks following the surgery.
Assess changes in quality of life using the FACT-An QoL questionnaire, which evaluates well-being and anemia-related symptoms.
Step 4
Follow-up assessments
Evaluate the effects of the treatment on hemoglobin levels and overall recovery five weeks after surgery.
Monitor for any complications, hospital readmissions, or additional surgeries needed within one year after the initial surgery.
Step 5
Long-term follow-up
Assess the impact of the treatment on the ability to receive cancer treatments if applicable, and monitor for spinal ischemia after complex aortic repair over a one-year period.
Report any adverse events related to the treatment during the five-week follow-up and continue monitoring for up to five years for any long-term effects, including morbidity, mortality, and recurrence of cancer.

Who can join the trial?

5 criteria

Provide written informed consent, which means you agree to participate in the study after understanding all the details.
Both male and female participants are eligible.
You must weigh more than 50 kg (about 110 pounds).
You must be older than 18 years of age.
You should be scheduled for complex aortic surgery, liver resection, or pancreatic resection. These are types of surgeries involving the heart's main artery, liver, or pancreas.

Who cannot join the trial?

9 criteria

Patients who have a known allergy to the study medication.
Patients who are pregnant or breastfeeding.
Patients with severe kidney disease, which means their kidneys are not working well.
Patients with severe liver disease, which means their liver is not working well.
Patients who have had a recent heart attack or stroke.
Patients with uncontrolled high blood pressure, which means their blood pressure is too high and not managed well.
Patients who have a history of certain blood disorders, which are problems with the blood.
Patients who are currently participating in another clinical trial.
Patients who have any other medical condition that the study doctors think would 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

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Region Oestergoetland
Linkoping, Sweden
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Region Skane Skanes Universitetssjukhus
Lund, Sweden
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Region Vaesterbotten
Umea, Sweden

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Investigated drugs

Ferric Carboxymaltose is an iron replacement medication used in this trial. It is administered intravenously, meaning it is given directly into a vein. The purpose of using this medication in the trial is to help improve recovery after surgeries that involve significant blood loss, such as liver or pancreas surgeries, or complex aortic surgeries. The trial aims to see if this iron treatment can reduce the need for blood transfusions, prevent severe anemia, and improve the quality of life for patients five weeks after their surgery.

Mannitol

What is already known about the treatment

Ferric Carboxymaltose – This medication is administered intravenously and is currently being studied in a phase III clinical trial. It is primarily used to treat anemia, particularly in patients who have experienced significant blood loss during surgery. Ferric Carboxymaltose 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 belongs to the pharmacological class of iron replacement products.

Investigated diseases

Anemia – Anemia is a condition characterized by a deficiency of red blood cells or hemoglobin, which leads to a reduced capacity of the blood to carry oxygen. This can result in symptoms such as fatigue, weakness, and shortness of breath. Anemia can develop due to various factors, including blood loss, decreased red blood cell production, or increased destruction of red blood cells. The progression of anemia depends on its underlying cause; for instance, it may develop gradually in cases of chronic disease or suddenly in cases of acute blood loss. As anemia progresses, individuals may experience worsening symptoms and a decrease in their ability to perform daily activities.