The UK CAVIAR Study

Iron Deficiency Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637102
• Other study ID #: 15/0659
• Status: Completed
• Start date: November 2015
• Est. completion date: April 2019

Study information

• Verified date: May 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: April 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anaemia
• Anemia
• Cardiac Patients
• Iron Deficiency
• Vascular Patients

Intervention

Other:
• Not applicable - observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Outcome

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

External Links

•   Related Info
•   Related Info