The UK CAVIAR Study

University College London (UCL)

Status: Completed

Conditions: Cardiac Patients; Iron Deficiency; Vascular Patients; Anaemia

Treatments: Other: Not applicable - observational study

Study type: Observational

Funder types: Other

Identifiers

NCT02637102

15/0659

Details and patient eligibility

About

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.

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

   • Coronary artery bypass (CABG), or valvular surgery, or combined CABG and valve surgery.
   • Repair or replacement of thoracic or abdominal aorta (open or endovascular).

4. Able to provide informed consent

5. (if applicable) Able to perform CPET or 6MWT if consented to take part in the sub study

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)

Trial design

425 participants in 1 patient group

Patients undergoing cardiac or vascular surgery

Treatment:

Other: Not applicable - observational study