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

Phase 4

• Conditions: Surgery - Other surgery; Iron deficiency; Blood - Anaemia

• Registration Number: ACTRN12620000314921
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-06
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibillity of Research Protocol-recruitment rate[Six patients per month over a 12 month recruitment period];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]