The UK CAVIAR Study

Completed

• Conditions: Vascular Patients; Anaemia; Iron Deficiency; Cardiac Patients
• Interventions: Other: Not applicable - observational study

• Registration Number: NCT02637102
• Lead Sponsor: University College, London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-27
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-22
• Primary Completion: 2018-03
• Study Completion: 2019-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing cardiac or vascular surgery	Not applicable - observational study	-

Primary Outcome Measures

Name	Time	Method
Change in Haemoglobin	From baseline to before surgery (within 10-42 days)

Secondary Outcome Measures

Name	Time	Method
ICU and hospital length of stay	Within 30 days
Complications	Within 30 days post surgery
Feasibility - number of successful patient recruitment and consent	Within a year
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)
Renal function (change in creatinine)	From baseline to post surgery (within 3 weeks)
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)