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Intravenous iron sucrose (+/- erythropoetin) versus oral iron for correction of post-operative anaemia in women with gynaecological malignancies

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87948966
Enrollment
45
Registered
2005-09-30
Start date
2005-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia Haematological Disorders Other anaemias

Interventions

Randomised controlled trial: 1. Group O will receive a 6 week course of oral iron therapy 2. Group I will receive a 200 mg intravenous dose of iron sucrose 3. Group E will receive a 200 mg dose of iro

Sponsors

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1. Change in haemoglobin levels from day 1 to day 21 2. Change in ferritin concentration 3. Change in transferritin 4. Quality of life scores 5. Post-operative blood transfusion 6. Length of stay

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026