Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0128158020
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Iron sucrose (+/- erythropoetin), oral iron
Primary outcome measures
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 trial start date
01/03/2005
Overall trial end date
01/03/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant 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
Recruitment start date
01/03/2005
Recruitment end date
01/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthesia Department
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Liverpool Women's Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary