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

RecruitingPhase 3Ages 18 Years - anyAllJon Unosson
NCT05744219 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss. Post-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (IDA) and per-operative blood loss. Median blood loss following hepatopancreatobiliary (HPB) and complex aortic surgery typically range between 500-1000 ml. Bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. For the IRIS trial, it is hypothesized that intravenously (iv) administered Ferric Carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the RBC transfusion. Patients scheduled for elective HPB surgery or complex aortic surgery will be screened for eligibility and recruited into the study. By the end of the surgical procedure,

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📋 Eligibility rules (as published)
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
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What it tests

  • Ferric carboxymaltose
  • Placebo
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Where

1 site
Uppsala University Hospital
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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