Intravenous iron for treatment of Sub-optimal iron stores in Non-Anaemic Patients presenting for major Surgery

Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: 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 CONDITION: Blood ‐ Anaemia Iron deficiency; ; Iron deficiency Surgery ‐ Other surgery PRIMARY OUTCOME: Feasibility of Research Protocol‐patient acceptability. Acceptability will be defined by participation in and completion of the full protocol.[Greater than 80% of patients tolerate physiological testing (6 Minute Walk Test (6MWT) and Near Infrared Spectroscopy (NIRS) at the end of 12 month recruitment] Feasibillity of Research Protocol‐recruitment rate[Six patients per month over a 12 month recruitment period] SECONDARY OUTCOME: Change in haemogloblin‐ as part of full blood count; automated analyser or haemoglobinometer. Most methods based on spectrophotometry. [At admission and 30 days post‐operative ; ] Change in iron stores‐assessed by immunoassay[At admission and 30 days post‐operative] Change in reticulocytes‐assessed by fresh blood incubated with: ; 1. supravital stain for ribosomal RNA and examined by microscopy; or ; 2. fluorescent dye taken up by RNA and cells counted by flow cytometry. ; ; Most current haematology analysers have reticulocyte modules to perform semi‐automated or automated reticulocyte counts. Principle of test depends on the specific instrument. ; ; The absolute reticulocyte count is calculated from the reticulocyte percentage and the red cell count.[At admission and 30 days post‐operative] Cost Effectiveness‐hospitalisation costs will be calculated using a bottom up approach. These data will be sourced from the health service clinical costing system which captures episode‐level costs categorised into relevant cost buckets. These costs will be collected for the relevant admission and any re‐admissions within 30 days post discharge.[Admission and any re‐admissions within 30 days post discharge] Mitochondrial Function (NIRS)[One week pre‐operative and 30 days post operative] Physical Functioning (6MWT)[One week pre‐operative and 30 days post operative] Transfusion (number of red cell units transfused during admission) assessed by medical records[Admission] World Health Organisation Disability Assessment Schedule 2.0 Questionnaire[Baseline and 30 days post‐operative] 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).
Epistemonikos ID: 8f034941566bb6446e5fdeafbce6c0cac51c9168
First added on: Aug 24, 2024