Intravenous iron sucrose (+/- erythropoetin) versus oral iron for correction of post-operative anaemia in women with gynaecological malignancies
- Conditions
- AnaemiaHaematological DisordersOther anaemias
- Registration Number
- ISRCTN87948966
- Lead Sponsor
- Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 45
45 patients in 3 groups.
1. Pre-operative inclusion criteria:
1.1. All patients who are due to undergo major gynae-oncological surgery
1.2. Aged greater than 18 years
2. Post-operative inclusion criteria:
2.1. Iron deficiency type anaemia due to peri-operative blood loss
2.2. Haemoglobin (Hb) less than 10 g/dl on day 1 following surgery
1. Pre-operative exclusion criteriaL
1.1. Patients requiring peri-operative therapeutic anti-coagulant therapy
1.2. Pre-operative anaemia
1.3. Liver disease
1.4. Chronic renal failure
1.5. Uncontrolled hypertension
1.6. Ischaemic heart disease requiring a transfusion threshold above 7 g/dl
1.7. History of anaphylaxis to oral iron sulphate, iron sucrose or epoietin alpha
2. Post-operative exclusion criteria:
2.1. Severe anaemia requiring transfusion of red cells: Day 1 [Hb] less than 7
2.2. Massive blood transfusion associated with disseminated intravascular coagulation (DIC)
2.3. Continuing requirement for blood product administration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method