Condition category
Haematological Disorders
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Barclay

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes