Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial

Launched by JON UNOSSON · Feb 15, 2023

Keywords

ClinConnect Summary

The IRIS trial is a study designed to see if giving patients intravenous (IV) iron, specifically Ferric Carboxymaltose, can help them recover better after major surgeries that involve blood loss, like operations for liver cancer or complex aortic aneurysms. After surgery, many patients experience low levels of red blood cells (anemia) because they have lost blood during the procedure and may not have enough iron in their bodies. This study will look at whether the IV iron can improve recovery and reduce the need for blood transfusions.

To participate in the trial, patients need to be adults over 18 years old, weighing more than 50 kg, and scheduled for specific types of complex surgery. They will be randomly assigned to receive either the IV iron or a placebo (an inactive treatment). The study will track various outcomes, including how many patients need blood transfusions, their levels of hemoglobin (a measure of red blood cells), and their quality of life five weeks after surgery. The trial is currently recruiting participants at hospitals in Sweden, and it aims to enroll 338 patients in total.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of written informed consent
• • 2. Male and female patients
• • 3. Weight \> 50 kg
• • 4. \> 18 years of age
• • 5. Scheduled for complex aortic surgery, liver resection or pancreatic resection
• Exclusion Criteria:
• • 1. Short expected survival (less than six months)
• • 2. Intra-venous iron therapy within one month prior to surgery
• • 3. Severe anaemia (B-Hb \<80 mg/L) prior to surgery
• • 4. Contraindication to Ferric Carboxymaltose according to SmPC
• • 5. Iron overloading disorder, i.e. hemochromatosis
• • 6. Risk of small for size future liver remnant
• • 7. Pre-operative renal replacement therapy
• • 8. Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study
• • 9. Another planned major surgical procedure before the five week follow up
• • 10. Unsuitable for inclusion according to the investigator
• • 11. Pregnancy