Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial (IRIS)
Surgery, Liver Metastases, Liver Cancer
About this trial
This is an interventional treatment trial for Surgery
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent Male and female patients Weight > 50 kg > 18 years of age Scheduled for complex aortic surgery, liver resection or pancreatic resection Exclusion Criteria: Short expected survival (less than six months) Intra-venous iron therapy within one month prior to surgery Severe anaemia (B-Hb <80 mg/L) prior to surgery Contraindication to Ferric Carboxymaltose according to SmPC Iron overloading disorder, i.e. hemochromatosis Risk of small for size future liver remnant Pre-operative renal replacement therapy Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study Another planned major surgical procedure before the five week follow up Unsuitable for inclusion according to the investigator Pregnancy
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Iv Iron
Placebo
Ferric Carboxymaltose, single dose, Intra venous 1000 mg in 100 ml 0.9% NaCl
Placebo, single dose, Intra venous 0.9% NaCl 100 ml