The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study

• Blood transfusion [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  Number of units of packed red blood cells transfused
  
  
• Intra-op diastolic function [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  Left ventricular chamber stiffness constant measured by conductance catheter in the operating room
  
  

• Mortality [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
  Mortality
  
  
• Duration of Ventilation [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  
• Lentgh of stay ICU [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  
• Length of stay - hospital [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  
• Other blood product administration [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  
• Hgb - arrival ICU [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  
• Hgb - prior to Discharge [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  
• Lowest post op Hgb [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  
• Volume of crystalloid delivered in cardioplegia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  
• Fluid balance [ Time Frame: 30 d ] [ Designated as safety issue: No ]
  
• Reoperation rate for bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  
• Inotrope score [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  Score incorporating amount and number of inotropes administered
  
  
• Low output syndrome [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  
• Troponin [ Time Frame: 24 hours post op ] [ Designated as safety issue: No ]
  
• Infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  Composite according to standardized definitions
  
  
• intra-op Ventricular function [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  as determined by conductance catheter
  
  

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.