Iron DeficiencyNCT02637102
The UK CAVIAR Study
An observational study of Iron Deficiency and Cardiac Patients, run by University College, London.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency, Cardiac Patients, Anaemia
- What is being tested?
- Not applicable - observational study
- How many people
- 425 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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
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
- Being tested
- Not applicable - observational study
- Medical subject headings
- Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable - observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiac or vascular surgery | Not described Receives: Other: Not applicable - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Haemoglobin
Measured: From baseline to before surgery (within 10-42 days)
Secondary outcomes (11)
Changes in biomarkers of iron deficiency (e.g. hepcidin, ferritin, TfSats)
Measured: From baseline to after IV iron (within 4-6 weeks before surgery)
Haemoglobin
Measured: Before surgery (within 10-42 days) to post surgery (within 3 weeks)
Unit of blood transfused
Measured: Hospital stay (within 7 days)
ICU and hospital length of stay
Measured: Within 30 days
Renal function (change in creatinine)
Measured: From baseline to before surgery (within 10-42 days)
Renal function (change in creatinine)
Measured: From baseline to post surgery (within 3 weeks)
Complications
Measured: Within 30 days post surgery
Feasibility - number of successful patient recruitment and consent
Measured: Within a year
Total haemoglobin mass test (Sub-study ONLY)
Measured: From baseline to after IV iron (within 4-6 weeks before surgery)
Functional exercise testing (CPET or 6MWT) (Sub-study ONLY)
Measured: From baseline to after IV iron (within 4-6 weeks before surgery)
Quality of Life (Sub-Study ONLY)
Measured: From baseline to i) after IV iron (within 4-6 weeks before surgery), ii) post surgery (within 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toby Richards, MD FRCS, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637102
- Sponsor's protocol ID
- 15/0659
- Status last verified
- May 2023
- First submitted
- 27 Nov 2015
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28420664
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02637102
- Acronym / sponsor ID
- 15/0659
- Conditions
- Iron Deficiency, Cardiac Patients, Anaemia, Vascular Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiac or vascular surgery | – | Other: Not applicable - observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- Able to provide informed consent
- (if applicable) Able to perform CPET or 6MWT if consented to take part in the sub study
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable - observational study | Other | Patients undergoing cardiac or vascular surgery |
Primary outcome
Change in Haemoglobin
Time frame: From baseline to before surgery (within 10-42 days)
11 secondary outcomes
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)
Haemoglobin
Time frame: Before surgery (within 10-42 days) to post surgery (within 3 weeks)
Unit of blood transfused
Time frame: Hospital stay (within 7 days)
ICU and hospital length of stay
Time frame: Within 30 days
Renal function (change in creatinine)
Time frame: From baseline to before surgery (within 10-42 days)
Renal function (change in creatinine)
Time frame: From baseline to post surgery (within 3 weeks)
Complications
Time frame: Within 30 days post surgery
Feasibility - number of successful patient recruitment and consent
Time frame: Within a year
Total haemoglobin mass test (Sub-study ONLY)
Time frame: 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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 28420664Chau 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toby Richards, MD FRCS principal investigator
University College, London
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency and Cardiac Patients, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Haemoglobin (time frame: From baseline to before surgery (within 10-42 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023; AzTrials last refreshed its copy on 4 Nov 2026.