A single-centre randomised controlled trial of propofol cardioplegia on blood and myocardial biomarkers of stress and injury in patients having isolated coronary artery bypass grafting (CABG) or aortic valve replacement (AVR) using cardiopulmonary bypass (CPB) - Propofol cardioplegia for Myocardial Protection Trial: ProMPT

Phase 1

• Conditions: Myocardial injury after CABG or AVR surgery using cardiopulmonary bypass

• Registration Number: EUCTR2009-015779-28-GB
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-28
• Study Completion: 2016-12-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Participants may enter the study if ALL of the following apply: • Male or female • Age =18 to =80 years • Having elective or urgent CABG or AVR with CPB at the BHI • Able to give full informed consent for the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients may not enter the study if ANY of the following apply: • Previous cardiac surgery • Combined CABG and valve replacement • Emergency or salvage operation • Chronic renal failure requiring dialysis • Current congestive heart failure • Left ventricular ejection fraction <30% (i.e. Poor LV Function) • Allergy to peanuts, eggs, egg products, soybeans or soy products • Already participating in another clinical (interventional) study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified