Cardiac surgery Circulatory System Cardiovascular/ Other and unspecified disorders of the circulatory system
Conditions
Interventions
This study is a multi-centre, two-group parallel randomised controlled trial to investigate the effects of using MiECC in all patients having elective or urgent coronary artery bypass grafting (CABG),
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 and <85 years 2. Undergoing any elective or urgent CABG, AVR surgery, or CABG+AVR surgery, using extra-corporeal circulation without circulatory arrest
Exclusion criteria
Exclusion criteria: 1. Requirement for emergency or salvage operation 2. Requirement for major aortic surgery (e.g. aortic root replacement) 3. Contraindication or objection (e.g. Jehovah’s Witnesses) to transfusion of blood products 4. Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded) 5. Inability to give informed consent for the study (e.g. learning or language difficulties)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of post-operative serious adverse events (SAEs) are measured using questions to patients during hospital stay and at 30 days post randomisation via a postal or telephone questionnaire. All SAEs that qualify for the primary outcome will be objectively defined and validated. The following events will qualify: 1. Death 2. Myocardial infarction (MI; suspected events will be documented by serum troponin concentrations and electrocardiograph recording (ECG) and adjudicated) 3. Stroke (report of brain imaging (CT or MRI), in association with new onset focal or generalised neurological deficit) 4. Gut infarction (diagnosed by laparotomy or post mortem) 5. AKI Network criteria for stage 3 AKI [16] 6. Reintubation 7. Tracheostomy 8. Mechanical ventilation for >48 hours, including multiple episodes when separated by more than 12 hours 9. Reoperation 10. Percutaneous intervention 11. Sternal wound infection with dehiscence 12. Septicaemia confirmed by microbiology | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality is measured using questionnaires 30 days after randomisation 2. Other SAEs are measured using questionnaires 30 days after randomisation 3. Units of RBC transfused up to 30 days after randomisation 4. Other blood products transfused up to 30 days after randomisation 5. Time to discharge from cardiac ICU is measured using patient notes during the index admission 6. Time to discharge from hospital is measured using patient notes following the index admission 7. Delirium in ICU, assessed with the Intensive Care Delirium Screening Checklist (ICDSC) [17] for up to 5 days; this outcome will only be collected in a subset of participating hospitals that have the capability to do so. 8. Health related quality of life is measured using the HRQoL using the EQ-5D-5L [18] up to 90 days after randomisation; responses to this instrument can be mapped on to ‘valuations’ for the economic evaluation 9. Health and social care resources and associated costs up to 90 days after randomisation are measured using the patient in hospital stay and again at 30 and 90 days post randomisation via a postal or telephone questionnaire | — |
Countries
England, Germany, Greece, Saudi Arabia, Switzerland, Türkiye, United Kingdom
Outcome results
None listed