Condition category
Haematological Disorders
Date applied
18/12/2012
Date assigned
30/01/2013
Last edited
23/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Heyman Luckraz

ORCID ID

Contact details

Cardiothoracic Surgery
Heart & Lung Centre
Royal Wolverhampton NHS Trust
Wednesfield Road
Wolverhampton
WV10 0QP
United Kingdom

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 who’s 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 measures

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

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

http://www.royalwolverhamptonhospitals.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/05/2016: No publications found, verifying study status with principal investigator