Improving recovery after surgery with intravenous iron treatment
Improved Recovery by Iron Following Surgery With Blood Loss, a Double-blind Multi-centre Randomized Controlled Phase III Drug Trial (the IRIS-trial)
This study tests if giving intravenous iron to patients who lose a lot of blood during major surgeries can help them recover better and need fewer blood transfusions.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 338 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Hospital Academic / other |
| Locations | 1 site (Uppsala, Sverige) |
| Trial ID | NCT05744219 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of intravenous Ferric Carboxymaltose on recovery following major surgeries that involve significant blood loss, such as liver and aortic surgeries. Patients scheduled for these procedures will be screened for eligibility and, if they experience blood loss between 400-4000 ml during surgery, will be randomized to receive either the iron treatment or a placebo. The study aims to determine if this intervention can enhance post-operative recovery and reduce the need for red blood cell transfusions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old, weighing more than 50 kg, who are scheduled for complex aortic surgery or liver/pancreatic resections.
Not a fit: Patients with severe anemia, contraindications to Ferric Carboxymaltose, or those with a short expected survival may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery times and outcomes for patients undergoing major surgeries with blood loss.
How similar studies have performed: Other studies have shown promising results with intravenous iron treatments in similar surgical contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Uppsala, Sverige
- Uppsala University Hospital — Uppsala, Sverige, Sweden (Recruiting)
Study contacts
- Study coordinator: Jon Unosson, MDPhD
- Email: jon.unosson@surgsci.uu.se
- Phone: +46186110000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.