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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Patients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery |
|
| Treatment | Experimental | Patients receive all-blood cardiolpegia for myocardial protection during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All-blood cardioplegia | Other | The treatment group will receive all-blood cardioplegia for myocardial protection during surgery |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality | 30 day |
| Duration of Ventilation | 30 day | |
| Lentgh of stay ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacy O'Blenes, MD | Dalhousie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Health | Halifax | Nova Scotia | Canada |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Standard cardioplegia | Procedure | This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery |
|
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |