Condition category
Haematological Disorders
Date applied
06/06/2016
Date assigned
21/07/2016
Last edited
21/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Anaemia is a condition where a person does not have enough red blood cells or haemoglobin (the iron-containing protein in blood that binds to oxygen) to carry enough oxygen around their body. It is common in patients undergoing surgery on their heart (cardiac) and/or blood vessels (vascular). Being anaemic may increase the need for a blood transfusion after surgery. In patients who are unwell and requiring surgery, it is not known what the cause of this anaemia is nor if this affects whether the person is suitable for surgery. Without understanding the cause of the anaemia or the effect this may have on an individual it is not currently possible to recommend specific treatments. There is considerable variation in the way patients are assessed before surgery and how they are managed during and afterwards in different regions of the UK. For example, there are some centres treating patients with anaemia before the operation (iron management) in an attempt to reduce the need for blood transfusion. However, it is not known who these treatments are most appropriate for or how they affect an individual before their operation. The aim of this study therefore is to assess how patients are managed before their operation in different UK hospitals to see if there is any variation or effect of anaemia on patient’s outcome from surgery.

Who can participate?
Adult patients who are having elective (planned) heart or blood vessel surgery.

What does the study involve?
In this study the normal pathways of care patients receive in different hosptials are observed, and there are no changes to planned surgery or how patients are managed by their surgeon/consultant. Patients are identified through routine clinical care and are categorised into those who receive iron management and those who do not, as part of their normal care. For all participants, medical history, medications, blood results, exercise test results (if applicable) and information gathered during and after surgery is collected. In addition, the research team take extra blood samples from patients (to measure haemoglobin levels), ask patients to complete Quality of Life questionnaires, and follow up patients progress after discharge. A small number of patients who received treatment for iron management also have a total hemoglobin mass test (a more accurate measure of haemoglobin levels) and an exercise test before surgery and then 4-6 weeks later.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating in this study. There is a small risk of pain, discomfort or bruising when blood samples are taken.

Where is the study run from?
Royal Free Hosptial (London) and 16 other NHS hospitals in England (UK)

When is the study starting and how long is it expected to run for?
August 2015 to December 2017

Who is funding the study?
National Institute of Academic Anaesthesia (UK)

Who is the main contact?
Ms Marisa Chau

Trial website

Contact information

Type

Public

Primary contact

Ms Marisa Chau

ORCID ID

Contact details

Division of Surgery & Interventional Science
The Medical School Building
University College London
Level 4
74 Huntley Street
London
WC1E 6AU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02637102

Protocol/serial number

20538

Study information

Scientific title

The UK CArdiac and Vascular surgery Interventional Anaemia Response study: An observational cohort study to determine the impact and effect of anaemia in patients awaiting vascular and cardiac surgery

Acronym

UK CAVIAR

Study hypothesis

The primary objective is to determine the impact and effect of iron deficiency in cardiovascular patients who are anaemic before surgery.

The secondary objectives are to:
1. Define ‘Good Responders’ and identify which markers of iron status are associated with a good response to intravenous iron
2. Gather data on change in cardiorespiratory status, haemoglobin mass measurements and markers of iron deficiency.
3. Observe patient outcomes following operation including Days Alive and Out of Hospital at 30 days.
4. Gather information about the feasibility of setting up these investigations in the preoperative setting to guide a future RCT

Ethics approval

London-Westminster REC, 27/11/2015, ref: 15/LO/1569

Study design

Multi-centre case-control study with cohort sub-study

Primary study design

Observational

Secondary study design

Cohort study

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

Specialty: Surgery

Intervention

Patients will be identified through routine clinical care (e.g. preadmission clinic, or surgical outpatient, etc.) and will be categorised into the two arms: control (patients who do not receive iron management) and study arm (patients who do receive iron management (i.e. IV iron)). In addition, a sub-set of patients in the study arm (Sub-study arm) will be asked to complete additional assessments (i.e. exercise testing and/or total haemoglobin mass test) to explore the effects of IV iron may have on patient’s fitness and outcome.

Patients will be observed through normal pathways of care and there is no change to the planned surgery or how patients are managed by their surgeon /consultant. Majority of the data (e.g. medical history, medications, blood results, exercise test results (if applicable), intra- and postoperative information) will be collected from the patient’s medical records. Apart from routine information, the study will, in addition:
1. Collect extra blood samples:
Control arm: One before and one after surgery
Study arm (and sub-study arm): One before and one after IV iron, and one after surgery
2. Complete Quality of Life questionnaires (i.e. Single Question Outcome Measure (SQOM), Multidimensional Fatigue Inventory-20 (MFI-20), and European Quality of Life (EQ-5D-5L))
Control arm: N/A
Study arm: One before and one after IV iron
Sub-study arm: One before and one after IV iron, and one at follow-up
3. Follow-up on patient’s progress post-discharge
Sub-study arm perform total haemoglobin mass test (if applicable) and perform a repeat exercise test (CPET or 6MWT) after IV iron if an exercise test was conducted routinely at baseline (if applicable)

Variations in centres with and without anaemia management and patient’s outcome post-surgery (e.g. transfusion needs, quality of life, cardiorespiratory status and total haemoglobin mass test (if applicable), etc. ) will be examined, as well as the relationship between different markers of iron deficiency to the change in outcome.

Total duration of observation: Until discharge after index operation, commencing from recruitment
Total duration of follow-up: Up to 30-45 days post-operation

Intervention type

Other

Phase

Drug names

Primary outcome measures

Haemoglobin is measured using blood testing at baseline, before surgery (within 10-42 days), and within 3 weeks post-surgery.

Secondary outcome measures

1. Biomarkers of iron deficiency (e.g. hepcidin, ferritin, TfSats) are measured using blood testing from baseline and after IV iron (within 4-6 weeks before surgery)
2. Unit of blood transfused during hospital stay (within 7 days) is measured through medical record review
3. ICU and hospital length of stay (within 30 days) is measured through medical record review
4. Renal function is assessed by measuring creatinine concentration at baseline, before surgery (within 10-42 days) and post-surgery (within 3 weeks)
5. Complication rate within 30 days post-surgery is measured through medical record review
6. Recruitment rate is determined by the number of consented eligible participants within one year, as assessed by observations of the research and hospital staff team
7. Quality of Life questionnaires (i.e. EQ-5D-5L, multi-fatigue inventory (MFI), and Single question outcome measure (SQOM) at baseline, after IV iron (within 4-6 weeks before surgery) and post-surgery (within 3 weeks)

Sub-study only:
1. Total hemoglobin mass is measured using the total haemoglobin mass test at baseline and after IV iron (within 4-6 weeks before surgery)
2. Physical fitness is measured using functional exercise testing (CPET or 6MWT) at baseline and after IV iron (within 4-6 weeks before surgery)

Overall trial start date

01/08/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female adults aged 18 years or older
2. Screening [Hb] < 120 g/L (for females) or < 130g/L (for males) 
3. Undergoing elective cardiac OR vascular surgery: 
3.1. Coronary artery bypass (CABG), or valvular surgery, or combined CABG and valve surgery.
3.2. Repair or replacement of thoracic or abdominal aorta (open or endovascular)
4. Able to provide informed consent
5. Able to perform CPET or 6MWT if consented to take part in the sub study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 432; UK Sample Size: 432

Participant exclusion criteria

1. Pregnancy or lactation
2. Adults with known underlying history of learning disabilities, or adults who do not have mental capacity to consent for themselves
3. Prisoners
4. Renal dialysis (current or planned within the next 12 months)

Recruitment start date

01/03/2016

Recruitment end date

31/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

Papworth Hospital
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Trial participating centre

Cardiff and Vale University Health Board
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Liverpool Heart and Chest Hospital
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Trial participating centre

Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom

Trial participating centre

The Essex Cardiothoracic Centre
University Hospital Nethermayne
Basildon
SS16 5NL
United Kingdom

Trial participating centre

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

St. Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Royal Oldham Hospital
Rochdale Road Oldham
Manchester
OL1 2JH
United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Royal Cornwall Hospital
2 Penventinnie Lane Treliske
Truro
TR1 3LQ
United Kingdom

Trial participating centre

Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Blackpool Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

Leicester Royal Infirmary Hospital
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

1st Floor of Maple House
149 Tottenham Court Road
London
W1T 7DN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

National Institute of Academic Anaesthesia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

31/03/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes