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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
The treatment group will receive all-blood cardioplegia for myocardial protection during surgery
This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery
Capital Health
Halifax, Nova Scotia, Canada
Blood transfusion
Number of units of packed red blood cells transfused
Time frame: 30 days
Intra-op diastolic function
Left ventricular chamber stiffness constant measured by conductance catheter in the operating room
Time frame: day 1
Mortality
Mortality
Time frame: 30 day
Duration of Ventilation
Time frame: 30 day
Lentgh of stay ICU
Time frame: 30 days
Length of stay - hospital
Time frame: 30 day
Other blood product administration
Time frame: 30 day
Hgb - arrival ICU
Time frame: day 1
Hgb - prior to Discharge
Time frame: 30 days
Lowest post op Hgb
Time frame: 30 days
Volume of crystalloid delivered in cardioplegia
Time frame: day 1
Fluid balance
Time frame: 30 d
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Reoperation rate for bleeding
Time frame: 30 days
Inotrope score
Score incorporating amount and number of inotropes administered
Time frame: 30 day
Low output syndrome
Time frame: 30 days
Troponin
Time frame: 24 hours post op
Infection
Composite according to standardized definitions
Time frame: 30 days
intra-op Ventricular function
as determined by conductance catheter
Time frame: day 1