Propofol cardioplegia for Myocardial Protection Trial: ProMPT

Phase 4

Completed

• Conditions: Cardiac disease/coronary surgery; Circulatory System; Heart failure

• Registration Number: ISRCTN84968882
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25004932

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-11
• Study Completion: 2016-12-31
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Current inclusion criteria as of 01/02/2011:
1. Male or female
2. Age =18 to =80 years
3. Having elective or urgent CABG or AVR with CPB at the BHI
4. Able to give full informed consent for the study

Previous inclusion criteria:
1. Male or female
2. Aged greater than or equal to 16 years to less than or equal to 80 years
3. Having elective or urgent CABG or AVR with CPB at the Bristol Heart Institute (BHI)
4. Able to give full informed consent for the study

Exclusion Criteria

Current inclusion criteria as of 01/02/2011:
1. Previous cardiac surgery
2. Combined CABG and AVR
3. Emergency or salvage operation
4. Chronic renal failure requiring dialysis
5. Current congestive heart failure
6. Left ventricular ejection fraction less than 30% (i.e. poor LV function)
7. Allergy to peanuts, eggs, egg products, soybeans or soy products
8. Already participating in another clinical (interventional) study

Previous inclusion criteria:
2. Concomitant CABG/AVR procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure(s) as of 01/02/2011:<br>The primary outcome will be myocardial injury, assessed by measuring myocardial Troponin T in serum from blood samples collected pre-operatively and at 1, 6, 12, 24 and 48 hours post chest closure. <br><br>Previous primary outcome measure(s):<br>Myocardial injury, assessed by measuring myocardial Troponin T in serum from blood samples collected pre-operatively and 1, 6, 12, 24 and 48 hours post cross-clamp release