None listed
Conditions
Brief summary
Iron infusions are a commonly used therapy to correct iron deficiency anaemia (low blood haemoglobin). They are used with increasing frequency in surgical patients with the aim being to optimise a patient’s own blood stores prior to surgery and improve post-surgical outcomes. International guidelines recommend the pre-operative administration of iron to surgical patients who are not anaemic, but have iron stores considered sub-optimal, when substantial blood loss that would result in depletion postoperatively is anticipated. However, this is based on limited evidence, and with uncertain outcomes. This pilot study will examine the feasibility and tolerability of a research protocol to compare outcomes (including recovery of iron stores, exposure to blood transfusion and quality of recovery after surgery) in a group of hospital patients having major surgery. Non-anaemic patients with suboptimal iron will either receive an iron infusion pre-operatively or placebo. Patients will be examined by questionnaire, physiological testing and blood tests post-operatively and at one month after their operation to quantify and qualify outcomes for comparison between these groups.
Interventions
Ferinject ® (Ferric carboxymaltose)
1000mg in 50mL 0.9% sodium chloride
One time intravenous infusion between one and four weeks prior to surgery
Intravenous Infusion
Infusions will be administered at the time of enrolment and attendance at physiological testing. This timing will be dictated by the timing of referral to the Anaesthesia Preoperative Clinic and performance of screening bloods. Treatment will occur as soon as possible after this attendance
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Non-anaemic adults (haemoglobin >130g/L for males and 120g/L for females) 18 years of age or older with ferritin levels < 100 mcg/L 2. Planned elective major surgical procedure with anticipated blood loss greater than 500 ml (as listed in Fiona Stanley Hospital Pre-operative Blood Management algorithm).
Exclusion criteria
1. Anaemia (defined as per WHO criteria including haemoglobin <130g/L for males and 120g/L for females) 2. Pre-operative evidence of bone marrow insufficiency (i.e. pre-operative haemoglobin <100 g/L, neutrophil count <1.8 x109/L, platelets <100 x109/L) or known haemoglobinopathy 3. Diagnosed iron overload state (e.g. hereditary haemochromatosis) 4. Patients unable/unwilling to receive blood products 5. Pregnancy or lactation 6. Patients administered parenteral iron or erythropoietin within six weeks prior to surgery or with known allergy/hypersensitivity to Ferric carboxymaltose (Ferinject®) 7. Chronic renal disease requiring dialysis 8. Chronic liver disease or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal range 9. Patients unable to complete 6MWT 10. Patients unwilling/unable to give consent
Outcome results
None listed