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

ISRCTN	ISRCTN87948966
DOI	https://doi.org/10.1186/ISRCTN87948966
Secondary identifying numbers	N0128158020

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

Dr Philip Barclay
Scientific

Anaesthesia Department
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

Anaesthesia Department

Liverpool
L8 7SS
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Liverpool Women's Hospital NHS Trust (UK)

No information available

NHS R&D Support Funding (UK)

No information available

Intention to publish date
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