Intravenous iron sucrose (+/- erythropoetin) versus oral iron for correction of post-operative anaemia in women with gynaecological malignancies
ISRCTN | ISRCTN87948966 |
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DOI | https://doi.org/10.1186/ISRCTN87948966 |
Secondary identifying numbers | N0128158020 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 13/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip Barclay
Scientific
Scientific
Anaesthesia Department
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | 1. To see whether anaemia following major gynaecological cancer surgery can be treated more effectively using two injections of an intravenous iron preparation instead of a 6-week course of iron tablets 2. To see whether adding erythropoetin as well as intravenous iron is more effective than using intravenous iron alone |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Anaemia |
Intervention | 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 iron sucrose followed by 200 IU/Kg epoetin alpha |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Iron sucrose (+/- erythropoetin), oral iron |
Primary outcome measure | 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 outcome measures | Not provided at time of registration |
Overall study start date | 01/03/2005 |
Completion date | 01/03/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 45 |
Key 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 |
Key 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 |
Date of first enrolment | 01/03/2005 |
Date of final enrolment | 01/03/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthesia Department
Liverpool
L8 7SS
United Kingdom
L8 7SS
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Liverpool Women's Hospital NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |