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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery

Conditions
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Coronary Artery Disease, Valvular Heart Disease

Intervention / Treatment
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* Other: All-blood cardioplegia
* Procedure: Standard cardioplegia


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery | Procedure: Standard cardioplegia<br>* This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery<br>|
| Experimental: Treatment<br>Patients receive all-blood cardiolpegia for myocardial protection during surgery | Other: All-blood cardioplegia<br>* The treatment group will receive all-blood cardioplegia for myocardial protection during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion | Number of units of packed red blood cells transfused | 30 days | 
| Intra-op diastolic function | Left ventricular chamber stiffness constant measured by conductance catheter in the operating room | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality | 30 day | 
| 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 | Score incorporating amount and number of inotropes administered | 30 day | 
| Low output syndrome |  | 30 days | 
| Troponin |  | 24 hours post op | 
| Infection | Composite according to standardized definitions | 30 days | 
| intra-op Ventricular function | as determined by conductance catheter | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardioplegia, Blood transfusion, Cardiac function, Myocardial edema, Coronary artery disease, Valve disease