The UK CAVIAR Study

NCT02637102 | Completed

• 1 other identifier: 15/0659
• Study Type: observational
• Target: 425
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Deficiency; Cardiac Patients; Anaemia; Vascular Patients

Outcome Measures

Primary Outcomes (1)

• Change in Haemoglobin

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

Secondary Outcomes (11)

• 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)

Study Arms (1)

Patients undergoing cardiac or vascular surgery

Other: Not applicable - observational study

Interventions

Not applicable - observational study OTHER

Patients undergoing cardiac or vascular surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring major cardiac or vascular surgery will be identified from routine clinical care. Most patients are routinely referred for pre-operative assessment, although local protocols vary between centres. Assesments at the pre-operative assessment clinic (PAC) may include (but not limited to) routine blood tests (full blood count, urea and electrolytes, etc.), history and examination, cardiorespiratory fitness assessment by 6 minute walk test (6MWT) or cardiopulmonary exercise testing (CPET). In some centres, patients with anaemia will receive intravenous iron at PAC or in a separate anaemia clinic.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College, London: lead

Related Publications (1)

• Chau M, Richards T, Evans C, Butcher A, Collier T, Klein A. The UK Cardiac and Vascular Surgery Interventional Anaemia Response (CAVIAR) Study: protocol for an observational cohort study to determine the impact and effect of preoperative anaemia management in cardiac and vascular surgical patients. BMJ Open. 2017 Apr 18;7(4):e014872. doi: 10.1136/bmjopen-2016-014872.

  PMID: 28420664 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Iron Deficiencies; Anemia

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Toby Richards, MD FRCS

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 22, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2019
• Last Updated: May 16, 2023

Record last verified: 2023-05