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Completed

NCT Number: NCT02637102

The UK CAVIAR Study

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.

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Key information

Conditions

Iron Deficiency Anaemia Anemia Cardiac Patients Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Not applicable - observational study

Other

Primary outcomes

  1. Change in Haemoglobin

    Time frame: From baseline to before surgery (within 10-42 days)

Secondary outcomes

  1. Changes in biomarkers of iron deficiency (e.g. hepcidin, ferritin, TfSats)

    Time frame: From baseline to after IV iron (within 4-6 weeks before surgery)

  2. Haemoglobin

    Time frame: Before surgery (within 10-42 days) to post surgery (within 3 weeks)

  3. Unit of blood transfused

    Time frame: Hospital stay (within 7 days)

  4. ICU and hospital length of stay

    Time frame: Within 30 days

  5. Renal function (change in creatinine)

    Time frame: From baseline to before surgery (within 10-42 days)

  6. Renal function (change in creatinine)

    Time frame: From baseline to post surgery (within 3 weeks)

  7. Complications

    Time frame: Within 30 days post surgery

  8. Feasibility - number of successful patient recruitment and consent

    Time frame: Within a year

  9. Total haemoglobin mass test (Sub-study ONLY)

    Time frame: From baseline to after IV iron (within 4-6 weeks before surgery)

  10. Functional exercise testing (CPET or 6MWT) (Sub-study ONLY)

    Time frame: From baseline to after IV iron (within 4-6 weeks before surgery)

  11. Quality of Life (Sub-Study ONLY)

    Time frame: From baseline to i) after IV iron (within 4-6 weeks before surgery), ii) post surgery (within 3 weeks)

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Dec 22, 2015
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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