Back to resultsThe ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study (ABC)
Primary Purpose
Coronary Artery Disease, Valvular Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
All-blood cardioplegia
Standard cardioplegia
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Cardioplegia, Blood transfusion, Cardiac function, Myocardial edema, Coronary artery disease, Valve disease
Eligibility Criteria
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).
Sites / Locations
- Capital Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Treatment
Arm Description
Patients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery
Patients receive all-blood cardiolpegia for myocardial protection during surgery
Outcomes
Primary Outcome Measures
Blood transfusion
Number of units of packed red blood cells transfused
Intra-op diastolic function
Left ventricular chamber stiffness constant measured by conductance catheter in the operating room
Secondary Outcome Measures
Mortality
Mortality
Duration of Ventilation
Lentgh of stay ICU
Length of stay - hospital
Other blood product administration
Hgb - arrival ICU
Hgb - prior to Discharge
Lowest post op Hgb
Volume of crystalloid delivered in cardioplegia
Fluid balance
Reoperation rate for bleeding
Inotrope score
Score incorporating amount and number of inotropes administered
Low output syndrome
Troponin
Infection
Composite according to standardized definitions
intra-op Ventricular function
as determined by conductance catheter
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01623193
Brief Title
The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study
Acronym
ABC
Official Title
The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2012 (Actual)
Primary Completion Date
May 27, 2016 (Actual)
Study Completion Date
May 27, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pam Trenholm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Valvular Heart Disease
Keywords
Cardioplegia, Blood transfusion, Cardiac function, Myocardial edema, Coronary artery disease, Valve disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients receive all-blood cardiolpegia for myocardial protection during surgery
Intervention Type
Other
Intervention Name(s)
All-blood cardioplegia
Intervention Description
The treatment group will receive all-blood cardioplegia for myocardial protection during surgery
Intervention Type
Procedure
Intervention Name(s)
Standard cardioplegia
Intervention Description
This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery
Primary Outcome Measure Information:
Title
Blood transfusion
Description
Number of units of packed red blood cells transfused
Time Frame
30 days
Title
Intra-op diastolic function
Description
Left ventricular chamber stiffness constant measured by conductance catheter in the operating room
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Mortality
Description
Mortality
Time Frame
30 day
Title
Duration of Ventilation
Time Frame
30 day
Title
Lentgh of stay ICU
Time Frame
30 days
Title
Length of stay - hospital
Time Frame
30 day
Title
Other blood product administration
Time Frame
30 day
Title
Hgb - arrival ICU
Time Frame
day 1
Title
Hgb - prior to Discharge
Time Frame
30 days
Title
Lowest post op Hgb
Time Frame
30 days
Title
Volume of crystalloid delivered in cardioplegia
Time Frame
day 1
Title
Fluid balance
Time Frame
30 d
Title
Reoperation rate for bleeding
Time Frame
30 days
Title
Inotrope score
Description
Score incorporating amount and number of inotropes administered
Time Frame
30 day
Title
Low output syndrome
Time Frame
30 days
Title
Troponin
Time Frame
24 hours post op
Title
Infection
Description
Composite according to standardized definitions
Time Frame
30 days
Title
intra-op Ventricular function
Description
as determined by conductance catheter
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy O'Blenes, MD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Health
City
Halifax
State/Province
Nova Scotia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study
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