FERRIC-CABG:IRON ISOMALTOSIDE IN CARDIAC SURGERY
Research type
Research Study
Full title
Effect of Iron Isomaltoside on Perioperative Myocardial Injury in Patients Undergoing Coronary Artery Bypass Graft ± Valve Surgery: The Ferric Iron in Coronary Artery Bypass Grafting (FERRIC-CABG) Trial
IRAS ID
269130
Contact name
Darlington Okonko
Contact email
Sponsor organisation
King's College London
Eudract number
2019-002661-35
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Open heart bypass surgery (usually called CABG) is the best way to improve symptoms, quality of life and survival in patients with severe narrowing of their heart arteries. However, this operation is associated with an unavoidable degree of damage called ’peri-operative myocardial injury’ which reduces the absolute benefits patient get from the operation. This injury is driven by low energy levels and high free radical levels in the heart during the operation. Iron is known to improve cellular energy and increase the production of antioxidants that remove free radicals. These benefits can be seen irrespective of whether patients are iron deficient. We aim to determine if giving intravenous iron before surgery can reduce the degree of injury patients suffer during CABG. To do this, we will randomise 240 patients undergoing CABG (with or without heart valve surgery) to intravenous iron or saline placebo infusions before the operation. The degree of peri-operative myocardial injury, levels of energy and free radicals in the heart, symptoms, quality of life and exercise performance will be measured.
REC name
Wales REC 3
REC reference
19/WA/0363
Date of REC Opinion
23 Apr 2020
REC opinion
Further Information Favourable Opinion