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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing cardiac or vascular surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable - observational study | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Haemoglobin | From baseline to before surgery (within 10-42 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
Able to provide informed consent
(if applicable) Able to perform CPET or 6MWT if consented to take part in the sub study
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Toby Richards, MD FRCS | University College, London | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28420664 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
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| 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) |
| Renal function (change in creatinine) | From baseline to post surgery (within 3 weeks) |
| Complications | Within 30 days post surgery |
| Feasibility - number of successful patient recruitment and consent | Within a year |
| Total haemoglobin mass test (Sub-study ONLY) | From baseline to after IV iron (within 4-6 weeks before surgery) |
| Functional exercise testing (CPET or 6MWT) (Sub-study ONLY) | From baseline to after IV iron (within 4-6 weeks before surgery) |
| Quality of Life (Sub-Study ONLY) | From baseline to i) after IV iron (within 4-6 weeks before surgery), ii) post surgery (within 3 weeks) |
| Related Info | View source |
| D006425 | Hemic and Lymphatic Diseases |