Improving recovery after surgery with intravenous iron treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Uppsala University Hospital
  Uppsala, Sverige, Sweden Recruiting

Study contacts

• Study coordinator: Jon Unosson, MDPhD
• Email: jon.unosson@surgsci.uu.se
• Phone: +46186110000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.