A prospective randomised trial to study the effect of intravenous iron infusion versus oral iron therapy in pre-operative anaemia
- Conditions
- Pre-operative anaemia in elective surgery patients e.g. in orthoplasty (hip- and Knee replacement) and gynaecological elective surgery etc...Blood - Haematological diseases
- Registration Number
- ACTRN12609000596202
- Lead Sponsor
- Clifford Craig Medical Research Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
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.
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. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end points will be Haemoglobin (Hb) level pre-operatively via full blood count.[Hb level immediately pre-operatively and 48 hours post-operatively.];Amount of blood transfusion required during the peri-operative admission via documenation in the patients files.[immediate peri-operative and 72 hours post-operative time.]
- Secondary Outcome Measures
Name Time Method Assessment of quality of life questionnaires including symptoms/signs related to anaemia (scale) and to iron treatment will be reveiwed as well as presence of complications potentially related to anaemia.[SF-36 Quality of Life Questionnaire completed at 6, 12 and 24 weeks post-operatively];The secondary objective to test whether addition of one injection of Vit. B12 1000 mcg will make a difference in the preoperative Hb or outcome in each assigned iron group (intravenous or oral). This showed, however, no difference between both primary treatment groups.[immediate Preopertaive Hb as well as postoperative Hb]