A prospective randomised trial to study the effect of intravenous iron infusion versus oral iron therapy in pre-operative anaemia

Analysis of 175 patients (median age 65 range 53-77 years) who underwent orthopaedic surgery at the Launceston General Hospital (LGH) during the last 4 months revealed that approximately 25-30% of the patients had mild anaemia (Hb>100 g/L and below <140 for males and 120 for females). Unfortunately there is no data regarding haematinics deficiency or amount of blood transfusion in this cohort of patients. Hence the importance of this trial to study all of these factors in Tasmanian patients and provide a solution to this problem. To address this problem and improve health services at LGH, we are aiming to study patients with mild anaemia only (Hb>90 g/L) and have no specific cause for anaemia and randomise them between administration of oral iron therapy or intravenously (i.v.) As common practice we have performed 78 iron infusions at a single centre (Holman Clinic) in 2005 and 48 infusions in the last 6 months without a record of a single case of intolerability. All patients who received i.v. iron infusion preceded by premedications with antihistamine and low dose steroids, did not experience any side effects. In summary, this study is dealing with an important problem which is preoperative mild anaemia in orthopaedic patients which is usually significantly increased in this cohort of patients. Also, we are aiming to overcome exposing this group of patients (with low preoperative Hb) to unnecessary blood transfusion with subsequent hazards/complications of blood transfusion and complications of anaemia. Primary objectives: 1. To study the effect of haematinic replacement on peri-operative mild anaemia (Hb>90 g/L) in order to optimise preoperative haemoglobin level in patients who undergoing elective orthopaedic surgery. 2. To reduce pre, peri and postoperative exposure to allogeneic blood transfusion and hence to avoid its subsequent complications/hazards. Bearing in mind that the current shortage of blood supply might lead to cancellation of this type of elective surgery. Secondary objectives of the study: 1. As a pilot study of the effect of vitamin B12 on erythropoeisis in those patients, who are receiving iron therapy 2. To assess patient outcome, recovery and quality of life 3. To assess the benefits in minimising length of hospital stay 4. To obtain additional information on the transfusion needs of non-anaemic patients, and the relationship to their iron status.