- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02637102
The UK CAVIAR Study
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Toby Richards, MD FRCS, University College, London
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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.
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