The UK CAVIAR Study
Research type
Research Study
Full 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.
IRAS ID
188848
Contact name
Toby Richards
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
3 years, 0 months, 29 days
Research summary
This is a multicentre centre, observational pilot study in patients awaiting cardiac and vascular surgery. Patients undergoing routine preparation for surgery will be tested to determine changes in [hb] and markers of iron deficiency and assess if this correlates with a change in the outcomes. Outcome measurements include requirement for blood transfusion, post-operative morbidity (Post-Operative Morbidity Survey (POMS)) and health related quality of life (EQ-5D-5L and multi-fatigue inventory (MFI)). Patients will be followed for 30 days to calculate Days Alive and Out of Hospital (DAOH). A sub group of patients will be assessed for changes in tHb-mass, and exercise capacity.
The primary objective is to determine the impact and effect of iron deficiency in patients undergoing vascular and cardiac surgery in patients who are anaemic before surgery.
The secondary objectives are to
1. define ‘Good Responders’ and identify which markers of iron status are associated with a good response to intravenous iron.
2. gather data on change in cardiorespiratory status, haemoglobin mass measurements and markers of iron deficiency.
3. observe patient outcomes following operation including Days Alive and Out of Hospital at 30 days.
4. gather information about the feasibility of setting up these investigations in the preoperative setting to guide a future RCT.Main inclusion criteria are patients undergoing elective major cardiac or vascular surgery and are at least 18 years of age, with a screening haemoglobin concentration less than 130g/L, 10-42 days before planned operation.
Exclusion criteria includes a known history of acquired iron overload or a family history of haemochromatosis or thalassemia (TSAT>50%), a known hypersensitivity to iron therapy, renal dialysis (planned or within the next 12 months), received erythropoietin, i.v. iron therapy in the previous 12 weeks.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/1569
Date of REC Opinion
27 Nov 2015
REC opinion
Further Information Favourable Opinion