The UK CAVIAR Study

Study Overview
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Brief Summary
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CAVIAR is a multicentre prospective observational study. Centres for cardiac and vascular surgery assess and manage patients in different ways before surgery. Some centres have introduced the use of intravenous iron therapy for patients with anaemia in the preoperative setting. Consequently regional variation exists in the assessment and management of patients before cardiac and vascular surgery. We aim to observe and measure these differing pathways and observe if there is variation in iron deficiency and anaemia and the impact of these variables on patient cardiorespiratory function as well as post-operative outcomes. [Sub-Study] For patients who are receiving intravenous iron therapy as part of their routine clinical care, we wish to observe this effect in more detail. We will assess the impact of the treatment on well-being, blood count and fitness. Information will be collected through Quality of Life questionnaires, total haemoglobin mass test (via blood collection) and fitness testing.

Official Title
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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

Conditions
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Iron Deficiency, Cardiac Patients, Anaemia, Vascular Patients

Intervention / Treatment
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* Other: Not applicable - observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged 18 years or older Screening [Hb] < 120 g/L (for females) or < 130g/L (for males) Undergoing elective cardiac OR vascular surgery: Coronary artery bypass (CABG), or valvular surgery, or combined CABG and valve surgery. Repair or replacement of thoracic or abdominal aorta (open or endovascular). Able to provide informed consent (if applicable) Able to perform CPET or 6MWT if consented to take part in the sub study Exclusion Criteria: Pregnancy or lactation Adults with known underlying history of learning disabilities, or adults who do not have mental capacity to consent for themselves Prisoners Renal dialysis (current or planned within the next 12 months)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing cardiac or vascular surgery<br> | Other: Not applicable - observational study<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Haemoglobin |  | From baseline to before surgery (within 10-42 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in biomarkers of iron deficiency (e.g. hepcidin, ferritin, TfSats) |  | From baseline to after IV iron (within 4-6 weeks before surgery) | 
| Haemoglobin |  | Before surgery (within 10-42 days) to post surgery (within 3 weeks) | 
| Unit of blood transfused |  | Hospital stay (within 7 days) | 
| ICU and hospital length of stay |  | Within 30 days | 
| Renal function (change in creatinine) |  | From baseline to before surgery (within 10-42 days) | 
| Renal function (change in creatinine) |  | From baseline to post surgery (within 3 weeks) | 
| Complications |  | Within 30 days post surgery | 
| Feasibility - number of successful patient recruitment and consent |  | Within a year | 
| Total haemoglobin mass test (Sub-study ONLY) |  | From baseline to after IV iron (within 4-6 weeks before surgery) | 
| Functional exercise testing (CPET or 6MWT) (Sub-study ONLY) |  | From baseline to after IV iron (within 4-6 weeks before surgery) | 
| Quality of Life (Sub-Study ONLY) |  | From baseline to i) after IV iron (within 4-6 weeks before surgery), ii) post surgery (within 3 weeks) |