An observational study to determine the impact and effect of preoperative anaemia management in cardiac and vascular surgical patients: the UK CAVIAR Study
| ISRCTN | ISRCTN55032357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55032357 |
| ClinicalTrials.gov number | NCT02637102 |
| Secondary identifying numbers | 20538 |
- Submission date
- 06/06/2016
- Registration date
- 21/07/2016
- Last edited
- 31/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
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
Contact information
Public
Division of Surgery & Interventional Science
The Medical School Building
University College London
Level 4, 74 Huntley Street
London
WC1E 6AU
United Kingdom
Study information
| Study design | Multi-centre case-control study with cohort sub-study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | UK CAVIAR |
| Study objectives | 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(s) | London-Westminster REC, 27/11/2015, ref: 15/LO/1569 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2015 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 432; UK Sample Size: 432 |
| Total final enrolment | 228 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/03/2016 |
| Date of final enrolment | 31/03/2017 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
London
NW3 2QG
United Kingdom
Cambridge
CB23 3RE
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Liverpool
L14 3PE
United Kingdom
Cottingham
HU16 5JQ
United Kingdom
Nethermayne
Basildon
SS16 5NL
United Kingdom
Brighton
BN2 5BE
United Kingdom
Edinburgh
EH16 4SA
United Kingdom
Manchester
M13 9WL
United Kingdom
London
SE1 7EH
United Kingdom
Oldham
Manchester
OL1 2JH
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Treliske
Truro
TR1 3LQ
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Plymouth
PL6 8DH
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Leicester
LE1 5WW
United Kingdom
Sponsor information
University/education
1st Floor of Maple House
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/03/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | Not provided at registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/04/2017 | Yes | No | |
| Results article | 01/03/2020 | 31/12/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
31/12/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
20/04/2017: Publication reference added.
