None listed
Conditions
Brief summary
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.
Interventions
Randomisation: Intravenous iron polymaltose (Ferrosig,SIGMA,australia), oral iron sulphate 250 mg orally (PO) daily. As following: Arm 1: a single dose of intravenous iron polymaltose (Ferrosig,SIGMA,australia) infused over 120 min 3-4 weeks prior to surgery with a variable dose according patient's body weight (iron dose in mg = body weight (maximum 90 kg) in kg x (target Hb - actual Hb in g/L) x constant factor (0.24) + iron depot (500) 3-4 weeks prior to surgery. Arm 2: Oral iron sulphate 250
Randomisation: Intravenous iron polymaltose (Ferrosig,SIGMA,australia), oral iron sulphate 250 mg orally (PO) daily. As following: Arm 1: a single dose of intravenous iron polymaltose (Ferrosig,SIGMA,australia) infused over 120 min 3-4 weeks prior to surgery with a variable dose according patient's body weight (iron dose in mg = body weight (maximum 90 kg) in kg x (target Hb - actual Hb in g/L) x constant factor (0.24) + iron depot (500) 3-4 weeks prior to surgery. Arm 2: Oral iron sulphate 250 mg daily 3-4 weeks prior to surgery until the date of surgery. For the intravenous iron polymaltose it will be given as a single dose according body weight infused over 120 minutes, 3-4 weeks prior to surgery. Oral iron sulphate supplementation will be given as 250 mg daily for 3-4 weeks prior to surgery. A treatment with the addition of vit B12 100 mcg intramuscular single injection 3-4 weeks prior to surgery. was considered as a pilot study within the original trial arms as patients randomly assigned to the Vit B12 versus no treatment in each active treatment group.
Sponsors
Clifford Craig Medical Research Trust
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria is a preoperative Hb above 90 g/L but less than 140 g/L for males and 120 g/L for females as compared to the reference normal range and measured at the Launceston General Hospital (LGH) Laboratory.
Exclusion criteria
Patients with any specific causes for anaemia apart from haematincs deficiency, or a haemoglobin below 90 g/L will be excluded from the study and will be investigated throughly and offered the appropriate treatment according the cause of anaemia. Any hypersensitivity reactions to any of the drugs involved in this study are considered as exclusion criteria. Exclusion criteria: 1. Presence of a specific cause for anaemia apart from haematinic deficiency 2. Vitamin B12/folate deficiency (Megaloblastic anaemia) 3. Myelodysplasia 4 4. Aplastic Anaemia 5. Haemolysis 6. Bone marrow diseases 7. Malignancy 8. Renal insufficiency 9. Other disorders as documented by clinician. A. Documented iron overload status. B.Patients with polycythaemia (according World Health Organization criteria) will be excluded from the normal control group.
Outcome results
None listed