Conventional versus minimally invasive extra-corporeal circulation
Research type
Research Study
Full title
Conventional versus Minimally Invasive extra-corporeal circulation in patients undergoing Cardiac Surgery: a randomised controlled trial (COMICS)
IRAS ID
222991
Contact name
Gianni D Angelini
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Miniaturised heart lung machines (minimally invasive extra-corporeal circulation; MiECC) have been developed with the aim of reducing the number of post-operative complications arising from using conventional heart lung machines (CECC). Because of the variety of miniaturised systems that have been evaluated, the different types of patients and outcomes investigated, and the poor quality of previous studies, the effectiveness of MiECC in reducing post-operative complications has not been established and most hospitals continue to use CECC. \n\nOur primary hypothesis is that, compared to CECC, using MiECC during cardiac surgery reduces the proportion of patients having one of several serious post-operative complications (death, heart attack, stroke, gut infarction, severe acute kidney injury, reintubation, tracheostomy, mechanical ventilation for more than 48 hours, or reoperation). In addition, we hypothesise that MiECC reduces the amount of blood products transfused, time to discharge from the cardiac intensive care unit and hospital and the health care resources used during the hospital stay.\n\nWe propose to carry out a large, multicentre randomised controlled trial in 20 to 30 cardiac surgery centres in Europe and, potentially, Canada, Australia and the United States. Patients will be eligible if they are having coronary artery bypass surgery, aortic valve replace or both using a heart lung machine without circulatory arrest. Centres may recruit patients having all, or a subset of, operation types. \n\nWe expect 15% to 18% of patients to experience one or more of the serious complications (the primary outcome). In order to be able confidently to detect a reduction in the risk of this outcome, we plan to recruit 3,500 participants across all sites. In the UK we expect the participating centres to contribute around 650 patients of the total during the trial.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
17/SW/0250
Date of REC Opinion
5 Dec 2017
REC opinion
Further Information Favourable Opinion