The UK CAVIAR Study

May 12, 2023 updated by: University College, London

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

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing cardiac or vascular surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Haemoglobin
Time Frame: From baseline to before surgery (within 10-42 days)
From baseline to before surgery (within 10-42 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
From baseline to after IV iron (within 4-6 weeks before surgery)
Haemoglobin
Time Frame: Before surgery (within 10-42 days) to post surgery (within 3 weeks)
Before surgery (within 10-42 days) to post surgery (within 3 weeks)
Unit of blood transfused
Time Frame: Hospital stay (within 7 days)
Hospital stay (within 7 days)
ICU and hospital length of stay
Time Frame: Within 30 days
Within 30 days
Renal function (change in creatinine)
Time Frame: From baseline to before surgery (within 10-42 days)
From baseline to before surgery (within 10-42 days)
Renal function (change in creatinine)
Time Frame: From baseline to post surgery (within 3 weeks)
From baseline to post surgery (within 3 weeks)
Complications
Time Frame: Within 30 days post surgery
Within 30 days post surgery
Feasibility - number of successful patient recruitment and consent
Time Frame: Within a year
Within a year
Total haemoglobin mass test (Sub-study ONLY)
Time Frame: From baseline to after IV iron (within 4-6 weeks before surgery)
From baseline to after IV iron (within 4-6 weeks before surgery)
Functional exercise testing (CPET or 6MWT) (Sub-study ONLY)
Time Frame: From baseline to after IV iron (within 4-6 weeks before surgery)
From baseline to after IV iron (within 4-6 weeks before surgery)
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)
From baseline to i) after IV iron (within 4-6 weeks before surgery), ii) post surgery (within 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Toby Richards, MD FRCS, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/0659

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Iron Deficiency

Clinical Trials on Not applicable - observational study

3
Subscribe