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
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives1. 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) studiedAnaemia
InterventionRandomised 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Iron sucrose (+/- erythropoetin), oral iron
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/03/2005
Completion date01/03/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants45
Key inclusion criteria45 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 criteria1. 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 enrolment01/03/2005
Date of final enrolment01/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Anaesthesia Department
Liverpool
L8 7SS
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan