Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: a randomised controlled trial

Not Applicable

Completed

• Conditions: Cardiac surgery; Cardiovascular/ Other and unspecified disorders of the circulatory system; Circulatory System

• Registration Number: ISRCTN92590475
• Lead Sponsor: niversity of Bristol

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32781894/ (added 27/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-18
• Study Completion: 2020-12-01
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1071

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: <br>1. Death<br>2. Myocardial infarction (MI; suspected events will be documented by serum troponin concentrations and electrocardiograph recording (ECG) and adjudicated)<br>3. Stroke (report of brain imaging (CT or MRI), in association with new onset focal or generalised neurological deficit)<br>4. Gut infarction (diagnosed by laparotomy or post mortem)<br>5. AKI Network criteria for stage 3 AKI [16]<br>6. Reintubation<br>7. Tracheostomy<br>8. Mechanical ventilation for >48 hours, including multiple episodes when separated by more than 12 hours<br>9. Reoperation <br>10. Percutaneous intervention<br>11. Sternal wound infection with dehiscence<br>12. Septicaemia confirmed by microbiology