Coronary Artery Disease, Valvular Heart Disease
Conditions
Keywords
Cardioplegia, Blood transfusion, Cardiac function, Myocardial edema, Coronary artery disease, Valve disease
Brief summary
This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia to more dilute 4:1 blood cardioplegia during cardiac surgery. The hypothesis is that all-blood cardioplegia will be associated with less blood transfusion and better cardiac function.
Detailed description
This is a single centre randomized, double blind, 2 arm, parallel group pilot study comparing all-blood cardioplegia to 4:1 blood cardioplegia in patients undergoing cardiac surgery. This pilot study will support the design of a larger multicentre trial. Subjects undergoing cardiac surgery will be randomized to receive either standard of care (4:1) or all-blood cardioplegia for myocardial protection. Neither of these cardioplegia approaches would be considered investigational. Each is in use at numerous cardiac surgical centres around the world. The cardioplegia will be delivered using the Quest medical MPS system which is a Health Canada Approved device. Clinical endpoints will be evalauted (rate of blood transtransfusion, ICU stay, etc…). In a subset of subjects who meet specific criteria, ventricular function will be evaluated in the operating room using the CD Leycom INCA conductance catheter system.
Interventions
OTHERAll-blood cardioplegia
The treatment group will receive all-blood cardioplegia for myocardial protection during surgery
PROCEDUREStandard cardioplegia
This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery
Sponsors
Pam Trenholm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients (male and female) undergoing isolated coronary artery bypass grafting, * isolated aortic or mitral repair or replacement, and * combined aortic or mitral valve repair or replacement and * coronary bypass grafting
Exclusion criteria
* reoperation, * endocarditis, * dialysis dependant renal failure, * pre-operative ECMO or LVAD support, * contraindication to blood transfusion (ie. Jehovah's Witness), and * use of irreversible anti-platelet (other than ASA) and anticoagulant agents within 48h (ie. plavix, dabigitran, GpIIb/IIIa inhibitors, argatroban).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood transfusion | 30 days | Number of units of packed red blood cells transfused |
| Intra-op diastolic function | day 1 | Left ventricular chamber stiffness constant measured by conductance catheter in the operating room |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 day | Mortality |
| Duration of Ventilation | 30 day | — |
| Lentgh of stay ICU | 30 days | — |
| Length of stay - hospital | 30 day | — |
| Other blood product administration | 30 day | — |
| Hgb - arrival ICU | day 1 | — |
| Hgb - prior to Discharge | 30 days | — |
| Lowest post op Hgb | 30 days | — |
| Volume of crystalloid delivered in cardioplegia | day 1 | — |
| Fluid balance | 30 d | — |
| Reoperation rate for bleeding | 30 days | — |
| Inotrope score | 30 day | Score incorporating amount and number of inotropes administered |
| Low output syndrome | 30 days | — |
| Troponin | 24 hours post op | — |
| Infection | 30 days | Composite according to standardized definitions |
| intra-op Ventricular function | day 1 | as determined by conductance catheter |
Countries
Canada
Outcome results
None listed