Capital Health
Halifax, Nova Scotia, Canada
NCT Number: NCT01623193
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.
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Notify Me16 year and older
All sexes
Interventional
Not applicable
Halifax, Nova Scotia, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 30 days
Number of units of packed red blood cells transfused
Time frame: day 1
Left ventricular chamber stiffness constant measured by conductance catheter in the operating room
Time frame: 30 day
Mortality
Time frame: 30 day
Time frame: 30 days
Time frame: 30 day
Time frame: 30 day
Time frame: day 1
Time frame: 30 days
Time frame: 30 days
Time frame: day 1
Time frame: 30 d
Time frame: 30 days
Time frame: 30 day
Score incorporating amount and number of inotropes administered
Time frame: 30 days
Time frame: 24 hours post op
Time frame: 30 days
Composite according to standardized definitions
Time frame: day 1
as determined by conductance catheter
Pam Trenholm
Other
The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery
Acronym: ABC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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