Plain English Summary
Background and study aims
This study is comparing two different iron supplements for people with a low red blood cell
count (anaemia) who are undergoing heart operation. Doctors know that people who have a low number of red blood cells (anaemia) before surgery can take longer to recover. This includes an increase need for blood transfusion after the operation and staying longer in intensive care. Previous studies investigating red blood cell (RBC) transfusion after heart operation have shown associations with pneumonia, wound infection and other severe bacterial infections. The aims of this trial are to find out: Effect of iron supplement injection as compared to iron tablets on the pre-operative haemoglobin levels; If an iron supplement injection can reduce blood transfusion; The effect on intensive care and in-hospital stay; The effect on post-operative complications
Who can participate?
You may be able to enter this trial if you: Are aged 50 years or older ; Have low red blood cells (anaemia) but do not need a blood transfusion ; Need a heart operation
What does the study involve?
Participants are randomly allocated (by computer) to one of two groups (this is called a randomised study). Neither you nor your doctor will be able to decide which group you are in.
People in group 1 have iron (ferrous sulphate) tablets. You start taking these at least 14
days before your surgery.
People in group 2 have an iron supplement called Ferinject. You have Ferinject through a drip
into a vein at least 3-6 weeks before your surgery.
The trial team will ask you to fill out questionnaires: Before you start treatment ; Just before your surgery; Between 6 and 8 weeks after surgery. This is called a quality of life study.
Taking part in this trial will not change the surgery you have. Your surgeon will discuss your
operation with you. You will see the doctors and have some tests before you start treatment. The tests include: Physical examination; Blood pressure recording ; Blood tests. You will have another blood test
; On the day of your operation ; A few days after your operation; And 6 to 8 weeks later.
What are the possible benefits and risks of participating?
You will benefit from closer monitoring of your blood count as well as the administration of
iron supplements that would treat the anaemia that might otherwise have gone unnoticed
until a later date nearer the operation. The treatment with iron injection may improve the
anaemia and reduce the likelihood of needing a blood transfusion.
The inconvenience to participants has been kept to a minimum by scheduling the screening
blood test to coincide with the routine surgical outpatient appointment. Consent and iron
supplement injection as well as the questionnaires will all be administered at the time of
the pre-operative admission clinic visit. The effect of the iron supplementation on
haemoglobin levels will be assessed at the time of admission for surgery. Finally, the post-
operative questionnaires will completed at the time of the post-op visit to the Out Patient Department. Hence patients will not need any additional hospital visit.
The most common side effects of Ferinject are:
Headaches
Feeling dizzy
Feeling and being sick
Diarrhoea
A rash
Stomach ache
The most common side effects of ferrous sulphate are:
Constipation
Upset stomach
Black stools
Where is the study run from?
The CIRTACS study has been set up by the Royal Wolverhampton NHS Trust (UK).
When is the study starting and how long is it expected to run for?
The CIRTACS trial is expected to start in the beginning of March 2013. The trial will take
place in New Cross Hospital, Wolverhampton. You will be participating in the study for a
minimum of 10 weeks and a maximum of 20 weeks. The trial will recruit 60 patients.
Who is funding the study?
This trial is sponsored by the Royal Wolverhampton NHS Foundation Trust with some
external funding from Tripartite Award (UK).
Who is the main contact?
1. Dr Heyman Luckraz, heyman.luckraz@nhs.net
2. Dr Matthew Brookes, m.j.brookes@bham.ac.uk
3. Dr Hari Padmanabhan, hari.padmanabhan@nhs.net
Trial website
Additional identifiers
EudraCT number
2012-005666-35
ClinicalTrials.gov number
Protocol/serial number
2012-003-0301-CARD
Study information
Scientific title
Can intravenous iron reduce transfusion rates in anaemic patients undergoing cardiac surgery?
Acronym
CIRTACS
Study hypothesis
To assess the effect of pre-operative intravenous ferric carboxymaltose (Ferinject) therapy as compared to current practice (oral iron 200mg BD), on pre-operative haemoglobin levels in anaemic (Female <11.5g/dl or Male <12.5g/dl) patients undergoing elective cardiac surgery. Does its use lead to an increase in the patient's haemoglobin pre-surgery?
Ethics approval
West Midlands Black Country NRES Committee, 02/01/2013
Study design
Pilot prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Use of iron supplement injection (Ferinject) in anaemic patients undergoing heart surgery.
Intervention
Anaemic patients undergoing elective cardiac surgery are consented to the trial will be given one of the following at pre-operative admission clinic (POAC)
1. Intravenous ferric carboxymaltose (Ferinject) in a single administration, in accordance with manufacturers instructions (Max dose:1000mg), will be administered over 30 minutes within the preoperative clinic. .A second dose will be given to those patients whos requirements are more tham 1000mg. Patients undergoing the infusion will have their pulse, blood pressure, temperature and oxygenation saturations monitored before and after the infusion and as indicated by their clinical picture. In case of any emergency, the same protocol will be followed as per for all patients attending the POAC.
2. Standard current practice (Oral iron 200mg bd). Currently no guidance on the preoperative management of anaemia is available. Current practice in these anaemic patients is to utilise allogenic blood transfusion in the pre-, peri- and postoperative period as and when indicated. The CIRTACS trial is expected to start in the beginning of March 2013. The trial will take place in New Cross Hospital, Wolverhampton. Recruited patients will be participating in the study for a minimum of 10 weeks and a maximum of 20 weeks. The trial will recruit 60 patients.
Intervention type
Drug
Phase
Not Applicable
Drug names
intravenous ferric carboxymaltose (Ferinject)
Primary outcome measure
1. Haemoglobin (g/dl) increment after intravenous ferric carboxymaltose (Ferinject)
2. Proportion of patients achieving an increase in Haemoglobin level >1.5g/dl pre-op after intravenous ferric carboxymaltose (Ferinject)
Secondary outcome measures
1. Units of blood transfusion post-op (in theatre and CICU)
2. Duration of CICU and In-hospital LOS
3. Rates of post-operative complications (listed above)
4. Change in quality of life
5. Factors associated with anaemia and iron therapy i.e. serum ferritin, sTFR, iron, transferring, CRP, erythropoietin (EPO) and iron binding capacity, hepcidin
6. Cost savings
Overall trial start date
01/03/2013
Overall trial end date
28/02/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Elective cardiac surgery
3. Pre-operative haemoglobin (Hb) level >1g/dl below the normal range (i.e. women <11.5g/dl and men <12.5 g/dl)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Pregnancy
2. Patient participating in another trial
3. Patients unable to give written consent
4. Patients with a recognised allergy or other contraindication to intravenous iron or related products
5. Low haemoglobin attributable to haemoglobinopathy
6. Anaemia secondary to known co-existing and uncorrected B12 or folate deficiency
7. Patients already receiving oral or intravenous iron treatment
8. Patients with evidence of significant symptomatic anaemia which would normally require urgent transfusion at the time of assessment
9. Patients with a Hb less than 9.0 g/dl
Recruitment start date
01/03/2013
Recruitment end date
28/02/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiothoracic Surgery, Heart & Lung Centre
Wolverhampton
WV10 0QP
United Kingdom
Sponsor information
Organisation
Royal Wolverhampton Hospitals NHS Trust (UK)
Sponsor details
Research and Development
New Cross Hospital
Wednesfield Road
Wolverhampton
WV10 0QP
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Wolverhampton NHS Foundation Trust - Tripartite Award (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
Basic results (scientific)
Publication list
2017 results in British Society of Gastroenterology Annual General Meeting 2017 https://gut.bmj.com/content/66/Suppl_2/A113.2